TromboCytest

1. Allied Innovations, Moscow TromboCytest Medical diagnostics device to screen thrombocyte dysfunction and control antithrombotic therapies Zufar Gabbasov and Vladimir Kazaritskiy

2. Allied innovations Company’s profile • Name: Allied Innovations • Type: legal entity (Ltd.), Moscow, Russia. • History: Launched in 2012 to develop and commercialize new medical equipment for cardiology and hematology applications • Key officers: CEO – Vladimir Kazaritskiy;CRDO – ZufarGabbasov • Ownership:private ownership, 100% owned by physical persons, Russian nationals • Current company size:7 employees

3. Allied innovations Description of the problem • 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 acutecardiovascularconditions and provide reliable prognosis on an individual basis with the use of a new point-of-care (POC) platelet aggregation diagnostics platform.

4. Allied innovations Market size and structure • 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.

5. Allied innovations Innovative solution Cell adhesion protein Glass binding protein Glass Principle: The TromboCytestdevice 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.

6. Allied innovations 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 express-analysis will help to provide adequate therapy in short time and prevent life-threatening complications • Innovative disposable shear-flow bio-cartridge, automotive system of high-precision laser optics and digital display visualization are all united in one device in extremely space and cost-saving design.

7. The leading competitor is Siemens PFA-100 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. 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. Allied innovations Competitors and advantages TromboCytest abvantagesover 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.

8. Allied innovations Business model 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.

9. Allied innovations

10. Allied innovations Team and resources 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 cross- country 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 specialistsin 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.

11. Allied innovations Resourcesneeded and investment proposal • 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. • The investor is expected to get a share in the company. • 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. • 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? • Proposed exit for investor: buy-out by the next round investor(s) in 2016 oracquisition by a global market player.

12. Allied innovations Other applications • Cardiovascular diseases are the leading causes of disability and death, and so monitoring ofplatelet antiaggregation therapy for patients with risks of thrombotic complicationsis extremely important • As the suggested technology and device form a measuring bio-sensor 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