Transcript TromboCytest

Allied Innovations, Moscow
TromboCytest
Medical diagnostics device to screen thrombocyte
dysfunction and control antithrombotic therapies
Zufar Gabbasov and
Vladimir Kazaritskiy
Allied
Company’s profile
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Name: Allied Innovations
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Type: legal entity (Ltd.), Moscow, Russia.
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History: Launched in 2012 to develop and commercialize
new medical equipment for cardiology and hematology
applications
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Key officers: CEO – Vladimir Kazaritskiy; CRDO – Zufar
Gabbasov
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Ownership: private ownership, 100% owned by physical
persons, Russian nationals
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Current company size: 7 employees
Description of the problem
Allied
innovations
Platelet dysfunction is the primary cause of thrombosis, which
leads to stroke, myocardial infarction, pulmonary embolism and
other serious conditions. Antiplatelet therapy is the current
criterion standard for the treatment of patients undergoing
percutaneous coronary intervention and patients who have acute
coronary syndromes, which count millions worldwide and this
number is growing as the population is aging.
• Problem is that patients who receive currently available
antiplatelet therapy may still develop atherothrombotic events.
• Patients, undergoing cardiopulmonary bypass and stent
angioplasty (~500.000 annually in USA only) are in the risk
group of developing life-threatening hemorrhage and thrombosis
with 1-2% mortality rate. Platelet function control is critical to
define proper therapy and reduce mortality for these patients.
• There is a clinical need to monitor platelet function in acute
cardiovascular conditions and provide reliable prognosis on an
individual basis with the use of a new point-of-care (POC)
platelet aggregation diagnostics platform.
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Market size and structure
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• The suggested TromboCytest diagnostics device is
positioned for hemostasis and hematology segments of
the in–vitro diagnostics (IVD) market.
• Global IVD market is steady growing and expected to
exceed $9.5 billion by 2017 (www.idataresearch.net)
• Hematology and hemostasis segment has 11% of the
global IVD market and a growth rate with CAGR equal to
15%.
• The market is oligopolized by few leading international
companies, accounting for approximately 80% of the
market: Roche Diagnostics (22%), Abbot Diagnostics
(12.6%), Ortho/Life Scan (11.1%) and others.
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Innovative solution
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Cell adhesion protein
Glass binding protein
Glass
Principle: The TromboCytest device consists of microfluidic
chamber with platelet adhesion sensor plate and optical recording
unit of cell adhesion. A controlled shear-flow of platelets is
streamed through the chamber and amount of platelet cells bound
to the sensor plate is read by a high-precision optoelectronic
system. The major technical breakthrough provided is a real-time
laser-based detection of the live platelet cells events. Sensing
technique of monitoring real-time platelet adhesion, actual design,
sensor composition are kept as know-how.
Innovative solution benefits
• Proposed device will ensure platelet test directly at
the patient's bedside, with the result available
within 10-15 minutes to serve in developing
prognosis.
• At acute situations like heart attack this expressanalysis will help to provide adequate therapy in
short
time
and
prevent
life-threatening
complications
• Innovative
automotive
and digital
one device
design.
disposable shear-flow bio-cartridge,
system of high-precision laser optics
display visualization are all united in
in extremely space and cost-saving
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Competitors and advantages
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The leading competitor is Siemens PFA100 System estimating closure time. It is
the first commercially available in-vitro test
to incorporate the high-shear flow as well
as platelet adhesion and aggregation that
would occur after a vascular injury.
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The list price for the PFA-100 System is
$15,000 and bio- cartridges are sold in
pack of 20 that cost $300 each. Sales
volume of the PFA -100 is estimated to be
as high as $30M/year.
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TromboCytest abvantages over the close competitors: (i) reliable,
high-precision diagnostics; (ii) real time detection of platelet adhesion
kinetics ; (iii) usable away from laboratory/office (i.e., a point of care
(POC) test); (iv) the patentable process and device forming a platform of
cell function kinetics measurements.
Device
Cost/test
Time/test
Precision rate
Sensitivity
TromboCytest
$10
<15 min
0.7-0.8
High
PFA-100
$15
20 min
<0.5
Low
VerifyNow
$46
13 min
0.61
Low
AggRAM
$54
55 min
0.63
High
Business model
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Potential revenue schemes:
1) Licensing of patented technology and clinically tested
device to major IVD market players.
2) Acquisition by a major IVD market player.
3) Production and sales of proprietary device and
expendables on IVD market.
4) Service model, software as a service at the potential
extension of platelet function analysis in order to study
other than cardiovascular symptoms.
Current status of the project
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Proof of concept prototype and testes, including a stable structure of the light flux with
the use of optic modulators of laser beam, a shear flow (blood circulation) unit, an
analyzer system with optoelectronic and photometric modules, a computing algorithm
and microprocessor system as a single plate computer, and others were developed.
Monthly development plan
System-Level design of the device: development of detailed product architecture with
determined components to be produced or purchased and identification potential
suppliers. Form study prototype built
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Device and technology patenting (PCT application).
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Testing and Refinements: a number of prototypes are built and tested, whether
performance of the product matches the specifications.
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Functional prototype and clinical tests.
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Team and resources
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Dr. V. Kazaritskiy, CEO, PhD in Physics, experienced manager of S&M
companies in biomedical and pharmaceutical markets, which are Allied
Biotechnologies, Siblarex Group, DIOD and others, engaged in crosscountry transfers of research results and innovation products for
industrial markets, trained in Rospatent and the Institute of Professional
Appraisal for IP evaluation and licensing, major in law. Personally
developed contacts in business parks of Germany and Switzerland,
Dr. A. Angersbach, CEO of EloSystems GbR (Henniningsdorf, Berlin) –
a foreign participant of the project.
Dr. Z. Gabbasov, CRDO, PhD in biology, over 30 years in R&D of
medical equipment, specialist in hematology, cardiology and
cardiovascular medicine, recognized as one of the leading
scientists in platelet biology, both domestically and internationally
Dr. Gabbasov scientific collaborations include Drs. G. Niccoli (Rome),
M. Cattaneo (Milan) – leading specialists in the area.
Other team members include specialists in biomedicine, optics,
electronics and others of Departments of Non-Invasive Arithmology of the Center for
Cardiovascular Surgery, and Molecular Mechanisms of Thrombolysis of the Institute
for General Pathology and Pathophysiology. Prototype manufacture platform consists of
companies SpecRobot KEMZ, Kovrov, NPP FOCUS, St.-Petersburg and IMTEK, Moscow.
Resources needed
and investment proposal
Allied
innovations
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We seek $1.33 M of equity financing to develop alpha prototypes and
assess whether the product works as intended, make patent application,
clinical tests, etc. If potential investor agreed, the expected investments
could be partly consist of Skolkovo grant of $1M total funding for the first
2 years of the project. An application is currently been preparing for
submission to Skolkovo Centre.
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The investor is expected to get a share in the company.
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Potential next co-funding round of max $1.63M grant by Skolkovo to
make product beta-prototypes and assess reliability, identify any bugs in
the product, make clinical tests, approbation and launching to provide
commercial sales within 5 year term has been agreed.
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The project’s IRR attains 90%, ROI (third production year) - 200%. 3rd
production year = what year of investment? Give grounds! What are
your estimated sales/earnings in year 3 and your share on the market?
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Proposed exit for investor: buy-out by the next round investor(s) in 2016
or acquisition by a global market player.
Other applications
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innovations
• Cardiovascular diseases are the leading causes of disability and
death, and so monitoring of platelet antiaggregation therapy for
patients with risks of thrombotic complications is extremely
important
• As the suggested technology and device form a measuring biosensor platform to develop diagnostics systems for analysis of wide
range of cell functions or dysfunctions, it is considered extension of
the test-systems to immunology, oncology, microbiology, and
others
• Health care benefits are expected to be provided with the help of
the developed technique advantages that bring physiologically
relevant blood flow conditions to the live-cell assay, bridging the
gap between in-vitro and in-vivo experiments