Transcript PlaqueView (tm) “The Stroke Predictor”

“Paying for clinical trials with an SBIR grant”
Our experience obtaining millions of dollars through the
NIH's Phase II Competing Renewal program
Adapted from a presentation to:
Washington Technology Center SBIR Breakfast
June 12, 2007
William Ross - Director of Software Engineering, Pathway MRI &
Vice-President, VPDiagnostics
[email protected]
Dr. William Kerwin - Associate Professor,
Vascular Imaging Laboratory,
University of Washington
[email protected]
Background
Vascular Imaging Lab (VIL) researchers developed
advanced imaging technology to visualize and quantify
atherosclerosis (hardening of the arteries)
●
Dr. Kerwin of VIL teamed up with small business
Pathway MRI and submitted Phase I & II SBIR
proposals to NIH to fund commercialization of
the technology
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A software product, the Pathway Carotid Artery
Platform (PCAP), was successfully delivered at the
end of Phase II
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PCAP was intended to help physicians identify patients
most at risk for stroke
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Stroke Facts
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#3 cause of death
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#1 cause of long-term disability
●
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At least 88% caused by
atherosclerotic plaque
(“hardening of the arteries”)
“Vulnerable” plaque in the Carotid
artery breaks off, travels to brain,
blocks blood vessels, causes
stroke
MRI imaging of Carotid plaque
Carotid plaque
specimen
Carotid plaque
MRI
Vulnerable plaque
(Display in “Notes” view for more information)
PCAP 3D display of Carotid plaque
Vulnerable plaque
SBIR Timeline
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NIH/NHLBI funded Pathway MRI and VIL
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Phase I: $99K Developed image analysis algorithms
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Phase II: $940K Developed commercial product, submitted
“clinical aid” 510K to FDA
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Pathway/VIL SBIR Collaboration Agreement since 2002
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Pathway licensed VIL Intellectual Property (IP) in 2005
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3 Patents Pending
(Display in “Notes” view for more information)
At conclusion of SBIR Phase II
Pathway MRI:
● Had completed commercial software product: PCAP
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Had exclusive, worldwide license to UW Intellectual Property
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Had no FDA approval to market
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Was out of money
Result:
● Product & IP license sold to investor to create
VPDiagnostics, Inc.
(Display in “Notes” view for more information)
Main Barrier to Commercial Success
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FDA approval as “Diagnostic” tool requires clinical trials
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Clinical trials require years to perform, cost millions of $
NIH SBIR Phase II Competing Renewal
=
A way through the FDA barrier
(Display in “Notes” view for more information)
SBIR Phase II Competing Renewal program
“Activities supported by a competing continuation of a
Phase II SBIR grant may include an extension and
expansion of preclinical research and development,
clinical testing, and other scientific research and
development activities that would ultimately be useful in
meeting the requirements and expectations of
Federal regulatory processes.”
PA-06-079 - NIH/NIMH
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SBIR Phase II Competing Renewal
Who is eligible:
● SBIR/STTR Phase II grantees (still small business)
NIH only (NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDDK,
NHLBI, NIMH, and NINDS)
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The product must be one for which Federal regulatory
approval is required
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Product can be devices, drugs, vaccines, therapeutics, and
medical implants
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Also supports continuing refinements to durable medical
equipment (DME) designs
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(Display in “Notes” view for more information)
SBIR Phase II Competing Renewal
What is available:
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Up to $1M/year (varies by Institute/Center)
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Up to 3 years support
(Display in “Notes” view for more information)
Our Phase II Competing Renewal Proposal
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Submitted Phase II Competing Renewal proposal 8/2005
Enhance PCAP with:
- Stroke Risk Score
- 3D Surgical Planning Tool
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Perform multi-center clinical trial
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Obtain FDA approval
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Develop & validate Training Program
Obtain procedure codes (CPT) and Medicare reimbursement
codes (HCPCS)
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Requested $2.6M over 3 years
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Proposal Highlights
Phase II Momentum:
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Successful commercialization in Phase II
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Planned 510K FDA submission in Phase II
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Patent awarded in Phase II
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Intellectual Property license for VIL technology
Keep Momentum Going:
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>$300K cost sharing
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Strong R&D proposal
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Training Course & Reimbursement
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Strong commercialization proposal
(Display in “Notes” view for more information)
Proposal Not Funded
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CSR score of 216
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Reviewers focused exclusively on scientific issues
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NIH FY2006 budget cut = less SBIR $
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12/2005 - NIH Program Director encouraged us to
resubmit
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Resubmitted Proposal 4/2006
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Addressed all reviewer comments
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Added Vascular Surgeon
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Added more patents
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Now had enhanced product with 3D display
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510K submission to FDA complete
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Requested $2.87M
(Display in “Notes” view for more information)
Proposal Funded
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CSR score of 153 (63 point improvement)
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Reviewers approved requested budget
Phase II Competing Renewal grant for $2.93M awarded
April 2007
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(Display in “Notes” view for more information)
Conclusion
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Significant post-Phase II funding is available from NIH
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Be patient, start process while in Phase II
Cover all the commercialization issues, but remember that the
science is what reviewers really care about
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Resubmission can pay off
(Display in “Notes” view for more information)
SBIR Phase II Competing Renewal
Official information:
PA-07-280 - NIH/CDC/FDA Omnibus Solicitation for SBIR
PHS 2007-2 - Omnibus Solicitation for SBIR/STTR Grant
Applications
SBIR Consultant:
Dr. Alan Berson
[email protected]
(415) 883-3773