Nanotechnology for Medical Devices and Biomaterial Applications Michael Weiner, CEO, Biophan Technologies, Inc. World Nano-Economic Congress (WNEC) Ireland April 20, 2005 Cautionary Statement Certain statements included.
Download ReportTranscript Nanotechnology for Medical Devices and Biomaterial Applications Michael Weiner, CEO, Biophan Technologies, Inc. World Nano-Economic Congress (WNEC) Ireland April 20, 2005 Cautionary Statement Certain statements included.
Slide 1
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 2
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 3
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 4
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 5
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 6
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 7
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 8
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 9
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 10
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 11
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 12
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 13
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 14
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 15
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 16
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 17
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 18
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 19
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 20
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 21
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 22
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 23
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 24
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 25
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 26
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 27
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 28
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 29
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 30
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 2
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 3
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 4
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 5
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 6
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 7
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 8
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 9
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 10
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 11
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 12
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 13
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 14
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 15
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 16
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 17
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 18
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 19
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 20
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 21
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 22
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 23
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 24
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 25
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 26
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 27
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 28
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 29
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
(OTC BB: BIPH)
Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
–
–
–
–
–
–
–
Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
•
•
•
•
•
•
•
•
Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
•
•
•
•
•
•
Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
(OTC BB: BIPH)
Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
(OTC BB: BIPH)
Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
(OTC BB: BIPH)
Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)
Slide 30
Nanotechnology for Medical Devices
and Biomaterial Applications
Michael Weiner, CEO, Biophan Technologies, Inc.
World Nano-Economic Congress (WNEC) Ireland
April 20, 2005
Cautionary Statement
Certain statements included in this presentation may constitute forward-looking statements
within the meaning of applicable securities laws. These statements reflect what Biophan
anticipates, expects or believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such forward looking
statements as a result of a variety of factors including, but not limited to: Biophan's ability to
develop its technologies; the approval of Biophan's patent applications; the successful
implementation of Biophan's research and development programs; the ability of Biophan to
demonstrate the effectiveness of its technology; the acceptance by the market of
Biophan's technology and products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device manufacturers for the
licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its
operating and research and development activities until it generates revenues sufficient to do
so; and the timing of projects and trends in future operating performance, as well as other
factors expressed from time to time in Biophan's periodic filings with the Securities and
Exchange Commission (the "SEC"). As a result, this presentation should be read in conjunction
with Biophan's periodic filings with the SEC which are incorporated herein by reference. The
forward-looking statements contained herein are made only as of the date of this presentation,
and Biophan undertakes no obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
(OTC BB: BIPH)
Nanotechnology for Medical Devices
and Biomaterial Applications
• A Revolution Of Unknown Dimensions is underway in Medical
Devices and Biomaterials
• It appears to be BIG!
• It has been a long time in coming, and is based on many
sedimentary layers:
– Instrumentation
- Fabrication
– Microscopy, SEM, TEM, AFM
- Semiconductors
– Thin Film
- Cold War
– Bioterrorism defense
- Lucrative medical markets
– Government funding
- Nanoeconomics (gold
in the hills)
(OTC BB: BIPH)
Point of View Worth 80 I.Q. Points
- Alan Kay
• It is not just “nano”
• It is thin film coating, MEMS, particulates, extensions of
bio and pharma
• Combined with the rapid growth and successful economic
of implantable devices
• And the tremendous economic success of drug delivery
coatings on stents
• And there is a lot of money available for relative high risk
R&D
• Medicine will change for the better
• Fortunes will be made
(OTC BB: BIPH)
Some Observations and Trends
• The Drexler “Nanobot” a smart mechanical contraption
with smarts and power, is only one small dimension of
possibility space. It has been much in the public mind.
• However, smart particulates, active thin-film coatings,
circulating synthetic antibodies, are working in labs today
• To fully understand the future dimensions of nanotech on
medicine, one has to think on broader dimensions than
what is “technically” considered “nano.”
• Because the innovations are moving all along the
continuum of nano and micro and MEMS and coatings,
and the innovations, to be valuable, do not need to be
“nano.” Many are.
(OTC BB: BIPH)
Putting Things in Three Categories
• That which we know about and might be here already
• That which we think is coming
• The unexpected, breakthrough innovations
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Explosive Atmosphere of Innovation
--A Unique Time in History
• Only 45 years since the first successful implantable device
(Wilson Greatbatch’s pacemaker, licensed to Medtronic)
• Only three years since the success of drug coated stents
• Frost & Sullivan predicting a $40 BILLION MARKET
• Unparalleled worldwide government investment in
nanotech
• Public markets and venture capital supportive of nanotech
• Enormous open opportunity for intellectual property
generation
• Instrumentation and new know-how open many new
potentials
(OTC BB: BIPH)
Some Examples
• New nanocoatings and material surfaces can
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Improve biocompatibility and growth
Replace polymers for elution
Increase the elution life
Non-invasively control the elution rate
Add diagnostics without power
Expand minimally invasive surgery
Improve life and functionality of devices
• Thin film coatings can provide multiple functionality
• Lab on a Chip can be within a Thin Film Coating
(OTC BB: BIPH)
Some Nanotechnology Capabilities
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Combine radiation and hyperthermia or ablation
Attack cancer and other undesirables
Redirect cancer cells
Make non-toxic chemotherapy agents
Improve drug targeting
Provide non-invasive visualization
Provide non-invasive drug delivery and dosing
Preparing drugs as nanoparticles can improve drug
solubility, uptake and delivery, either orally, intravenously
or topically
(OTC BB: BIPH)
Economics
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Many publicly funded nanotech companies
Alternatives to Venture Capital Financing
Biomedical and Pharmaceutical industries value IP
Enormous base of R&D and publications
Very fast acceleration of compounding technologies
Emergence of multi-purpose start-ups and small
companies (Biophan, Arrowhead, NanoProprietary,
Nanosys, Ardesta, Advance Nano, et al)
• Significant market cap potentials for pre-revenue ventures
(Biophan at $200 million)
• 20 year growth in sophistication of University tech transfer
(OTC BB: BIPH)
Biophan’s Mission
• Enable over $12 billion worth of medical devices shipping
annually safe for use with MRI, and imageable. Many are not:
– Guidewires, catheters, endoscopes, biopsy needles
– Pacemakers, defibrillators, neurostimulators, drug
pumps (safety issues, also imaging issues), pain
control devices
– Stents, embolism clips, aneurysm clips, artificial hips,
knees, most other orthopedics
• Bring other innovations for competitive advantage to
biomedical device and pharmaceutical companies.
(OTC BB: BIPH)
Biophan’s Solutions
• MRI Safety: (many products contraindicated)
– RF filter from Johns Hopkins (heating)
– Biophan multi-filar wire solution (heating)
– “Anti-Antenna” lead design (induced voltages)
• Image Compatibility
• Nanomagnetic particle thin film coatings (Nanoset, LLC
and Alfred University)
– Minimize image artifacts
– Makes catheters, guidewires, stents, and devices visible under
MRI
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Core Business
• Offering our customers competitive advantage
– Through proprietary solutions that can gain marketshare for them
– FDA approval is pursued by the customer
– Marketing and distribution of the final device is theirs
• We sell high margin components and develop annuities for our
shareholders
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Relationship With Boston Scientific
• Joint development agreement, originally entered into
November, 2003
• Recently moved to second and third phase, and has
expanded to multiple products
• One of the companies referred to in recent 10Q
• Reached agreement on term sheet, working on final
contract phase
(OTC BB: BIPH)
MRI Device Imaging
1
2
3
Biophan’s thin-film
nanomagnetic particle
coating technology
provides a controllable,
“magnetic” signal
capable of creating an
image of the coated
device.
#3 is uncoated.
SE coronal image of 3 aluminum wires (1/32”). Wire (3) is uncoated.
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Coronary Stents
A stent is a support device for permanent
expansion of blood vessel to restore blood flow.
Implantation is done with X-ray guidance in a
Cathlab, which exposes the patient to ionizing
radiation and potentially kidney damaging X-ray
contrast agents.
Stent
Implantation
After implantation, there is currently no way to
show a potential restenosis (re-narrowing) of
the blood vessel using non-invasive diagnostic
systems. Diagnosis requires another
catheterization procedure.
Biophan’s technology presents an alternative – using an MRI system
for diagnosis of restenosis. MRI diagnosis provides advantages,
since it is non-invasive and uses no harmful radiation and no iodine
contrast agents.
(OTC BB: BIPH)
1.5 Tesla MRI Artifacts of Current Stents
Cobalt
Expanded
Stents
Original size
316L stainless
steel
Crimped
Stents
With existing
stent
technology, no
useful images
can be
obtained from
within common
stents using
MRI.
(OTC BB: BIPH)
Imaging of In-Stent Blood Clots
Using Biophan Resonator Technology
Resonant Stent
Blood Clot
Cross
Sectional
Schematic of
Stent with
blood clot
Video
Biophan’s technology enables
imaging of the blood clot
within the stent
1 Tesla Philips NT, head coil, TR=300ms,
TE=6ms, FA=40°, transversal
(OTC BB: BIPH)
Making Stents Imageable
• Seeing blockage of stents has required an invasive
procedure
• Stents imageable under MRI would be competitively
advantaged
• Biophan’s business is competitive advantage for our
customers through technology innovation
• Nanoset has a thin-film, nanomagnetic coating solution
• AMRIS, now Biophan-Europe, has a “retrofit” solution
• Both solutions are PATENTED!
• Together we “cover the waterfront”
(OTC BB: BIPH)
Implications
• Impact the $5+ billion stent market
• Help manufacturers make pacemakers, defibrillators,
neurostimulators safe, and imageable – competitive
advantage to our licensees
• Make guidewires, catheters, endoscopes, biopsy
needles safe and image compatible
• Opens the field of interventional medicine under MRI
(currently only X-Ray/Fluoroscopy)
(OTC BB: BIPH)
Controlled
Magnetic Field B
Controlled
Magnetic Field
Controlled
Magnetic Field A
Surface Elution on Demand
Particle type A
Drug A
Particle type B
Drug B
Drug bound to
NMP carrier
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Reloading Drug Eluting Coatings
Drug bound to
NMP carrier
Controlled
Magnetic Field
Concentration Gradient
Drug
Molecules
Polymer Coating
Nanomagnetic layer
Substrate
(OTC BB: BIPH)
Guided Drug Delivery
Solid tumor
Other options for targeting:
1 - Direct injection into tumor
site
2 - Coating NMP with
antibodies to target tumor
Apply magnetic
field to concentrate
particles
Inject NMPs IV,
NMP will circulate through
the blood stream
Modulate field to
release drug from
particles
(OTC BB: BIPH)
NanoView™
MRI Contrast Agents
Nano-particulate technology has the potential to
provide a new consumable product capable of
significantly enhancing MR detection sensitivity
(i.e. lowest detectable concentration) and
specificity (i.e. the ability to reliably detect the
desired substance).
(OTC BB: BIPH)
Biothermal Battery
• Goal: To provide a long-lived electrical power system
for implanted medical devices
– Powered by body heat differential.
• Acquired 51% interest in TE-Bio, which holds an
issued U.S. patent for the battery
• Batteries are a $500 million market, sell for $100 to
$225 each in the pacemaker, defibrillator and drug
pump markets
• Sold to same customers who need MRI safety
(OTC BB: BIPH)
Agreement with NASA
• Announced agreement with NASA Ames Research
Center for Nanotechnology to jointly develop the
biothermal battery
– NASA wants technology for their long duration
manned MARS mission for biosensing and
miniature therapeutic devices
– Biophan gets commercial rights to jointly
developed and NASA developed technology
– Nanotechnology and materials science advances
makes the biothermal battery possible
(OTC BB: BIPH)
PROTECTED, PROTECTED!
• Technologies covered by
– 114 U.S. Patents
• 36 ISSUED
• 78 pending or allowed
• Owned by Biophan or licensed exclusively to
Biophan for the medical market
• Plus many International patents
(OTC BB: BIPH)
Other Markets
• Battery: $500 million
• Contrast Agents: $800 million
• Drug Pumps: $1 billion
• Drug Delivery: $40 billion
Cautions:
Penetration can take time
FDA approval and/or CE Mark could take time
Bright side is, once deal is underway, patents and annuity streams can
last a long time
(OTC BB: BIPH)
Biophan (OTC: BIPH)
We don’t make medical devices;
We make them safe, and imageable, for MRI
And other competitive advantages for our customers
Four of our six technologies are based on nanotechnology
WWW.BIOPHAN.COM
(OTC BB: BIPH)
Thank You!
More good things will unfold in 2005!
BIO PHA N
med
rma
ano
Technologies
(OTC BB: BIPH)