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May 2008 - PowerPoint PPT Presentation

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May 2008

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  1. May 2008 Company Presentation UK

  2. Mission Statement FlowMedic’s goal is to be a global market leader providers of innovative, non-invasive medical devices for prevention and treatment of venous and arterial circulatory disorders in the extremities for both the medical and the OTC consumer markets

  3. Flowmedic Structure • Established in 2003 • Privately owned by IBV private equity investment group • Fully owned subsidiaries in Israel (R&D) and the US (sales & marketing) • Outsourced manufacturing firmly established in China

  4. Core Technology and Applications Post Op DVT Prophylaxis PAD Venus Ulcer Healing Wound Healing DVT Treatment Professional / Hospital Outpatient Clinics Neuropathy Core Technology Pre Op DVT Prophylaxis CLI PAD Improved Circulation Blood Stimulation DVT Prophylaxis DVT Prophylaxis Home / Managed Care OTC / Consumer Neuropathy Intermittent Claudication Edema reduction

  5. FlowMedic Scope of Products & Indications • Venous Indications • DVT Prophylaxis (ortho, trauma, bariatric, stroke) • DVT Treatment • Arterial Indications • Peripheral Arterial Disease (PAD) • Intermittent Claudication (IC) • Critical Limb Ischemia (CLI) • Diabetic Indications • Extremities Ulcers Wound Healing (WH) • Neuropathy (N) • Health & Wellness (OTC) • DVT Prevention • Blood Stimulation • Edema Reduction Peripheral Arterial Disease • Actual • Future

  6. Market Opportunity FlowMedic products are geared towards a population of 20-30 million European and double that number worldwide affected by crippling and costly venous/ arterial and correlated disease indications, representing cumulative addressable markets of over $3.0 billion in revenues

  7. Arterial Disease Implications • Peripheral Arterial Disease (PAD) affects 12 million U.S. citizens and approximately 30 million people worldwide (F&S and Datamonitor 2004) • Approximately 20% of the population over 70 and 30% of all diabetics are thought to have PAD (Clinical Cardiology Review, 2002) • Close to one million Americans are diagnosed for leg pain caused by poor vascular circulation, called Intermittent Claudication (ADA Consensus Statement) • Critical Limb Ischemia (CLI), a PAD related condition, affects 750,000 individuals in the United States, primarily diabetics • Every year, over 150,000 lower limb amputations are performed in the U.S. due to severe PAD and CLI • Leg ulcers affect as many as 2.5 million people in the U.S. causing substantial pain and loss of function Severity Stage

  8. PAD Prevalence Data Higher Prevalence and Mortality than Many Leading Diseases

  9. Flowmedic Unique Elastic Recoil™ Physiological Effect • Improved circulation in arteries that may be stiff due to diabetes, atherosclerosis, or other circulatory problems without causing user discomfort and associated low compliance– a major drawback of Intermittent Pneumatic Compression (IPC) devices • Increases arterial-venous pressure differences (by enhancing venous return) through mechanical compression • Improves pain-free walking distance • Improve quality of life

  10. FM220TMArterial Circulation System • Features • Portable • Easily operated by patients • Data logger for patient follow-up • Light weight • Battery operated • Improved hemodynamic performance at lower lower peak pressure • Status • FDA 510K clearance and CE certified • HCPCS codeattained for arterial compression therapy • Completed clinical trials in PAD and Claudicant subjects • Ongoing multi center clinical trial in US • Commercially launched in the EU Cleared by the FDA & CE mark Improved Patient Compliance

  11. The OTC opportunity - Some Statistic Numbers…. • Over 250 million people with high income aged 50-80 living in Western countries • More than 500 million people fly > 4 hours flights annually • Clinical studies show that 1- 10% of fliers develop DVT • In the US, there are more than 18,750 air travel related DVT cases per month • 30,000 world wide estimated flight related DVT deaths cases every year SOURCE: Reuters Business Insight; Internet sources, National Heart, Lung and Blood Institute; Scurr JH,(2001) Lancet, 357, 1485–1489; Jacobson BF, S Afr Med J. 2003 Jul;93(7):522-8; Hughes RJ,Lancet. 2003 Dec 20;362(9401):2039-44.

  12. Product Description AviafitTM/HomefitTM is a light-weight, portable product that apply mechanical compression to stimulate circulation of blood in the legs while creating a pleasant, massage effect AviafitTM/HomefitTM prevents blood stagnation, and reduces the risk of life-endangering blood cloth formation

  13. AviafitTM/HomefitTMPulsating Leg Band • Features • Convenient: very small footprint & lightweight • Worn on both legs, over or under the clothing • Portable, for use at home, office or travel • Simple to use • Pleasant massage effect • 20 hours of continuous battery operation • Status • Completion of in vitro verification, validation data and clinical data showing the positive effect of the product on flow parameters • CE Mark received • FDA clearance under 510K Class II classification • Successful launched in Europe through pharmacy channels (> 1,000 PO’s) Device Panel Reusable Strap Device Body

  14. AviafitTM/HomefitTMBenefits • Improve wellbeing and quality of life • Effectively stimulates blood circulation in the legs, reducing the risk of Deep Vein Thrombosis (DVT) • Effective results even while user is passive • Portable, battery-operated permits movement during use • Pleasant massage-like feeling • Applicable over or under the clothing – whatever is more convenient Excellent alternative to elastic socks, medicine and foot massagers

  15. Intellectual Property • 54 filed and 19 granted / published patent applications • PCT- WO 02/069879 – A portable device for the enhancement of circulation and for the prevention of stasis related deep vein thrombosis. Priority date: 5 March 2001 ( Published 12 Sep 2002) • 24 new patent applications filed since (including also CIP applications and PCT applications) • National phase filed in USA, Japan, Canada, China, India, Australia, New Zealand, Brazil, Mexico, a regional phase in Europe and registration in Hong Kong • 5 registered trademarks • 3 in Europe (CTM) and 2 in Japan • 11 trademark applications: 3 in Europe (CTM), 6 in the U.S. and 2 in Israel

  16. Company Management and Medical Advisory Board • Company Management • Prof. Shlomo Ben-Haim, MD - Co-Founder and Chairman • Lewis C. Pell – Co-Founder and Director • Dr. Benny Rousso - Co-Founder, Director and CTO • Nissim Greisas – General Manager • Medical Advisory Board • Prof. Daniel Burkhoff– Leading researcher in the cardiovascular field.Adjunct Associate Professor at Columbia University • John Scurr, MD – Middlesex Hospital and University College Hospital, London • Ron Karmeli, MD - Chief of the Vascular Surgery Department, Carmel Hospital, Haifa, Israel • Benjamin Brenner, MD - Director of the Thrombosis and Homeostasis Unit and Deputy Director of the Department of Hematology at the Rambam Medical Center in Haifa, Israel