may 2008 company presentation uk. - confidential - 2 flowmedic’s goal is to be a global market...
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May 2008
Company PresentationUK
- Confidential -2
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
Mission Statement
- Confidential -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
- Confidential -4
Core Technology and Applications
Core Technology
Professional / Hospital
Home / Managed Care
Outpatient Clinics
OTC / Consumer
Post Op DVT Prophylaxis
Pre Op DVT Prophylaxis
Ven
us U
lcer H
ealingD
VT
T
reat
men
t
PAD
Intermittent Claudication
Neu
rop
athy
DV
T
Pro
ph
ylax
is
Improved Circulation
Edema reduction
Blo
od
S
timu
lation
DV
T
Pro
ph
ylax
is
PAD
CLI
Neu
rop
athyW
ou
nd
H
ealin
g
- Confidential -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
Actual Future
Peripheral Arterial Disease
- Confidential -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
- Confidential -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
PAD Prevalence Data
Higher Prevalence and Mortality than Many Leading Diseases
- Confidential -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
- Confidential -10
FM220TM Arterial Circulation System
FeaturesPortableEasily operated by patientsData logger for patient follow-upLight weightBattery operatedImproved hemodynamic performance at lowerlower peak pressure
StatusFDA 510K clearance and CE certifiedHCPCS code attained for arterial compression therapyCompleted clinical trials in PAD and Claudicant subjects Ongoing multi center clinical trial in USCommercially launched in the EU
Cleared b
y the
FDA & C
E mark
Improved Patient Compliance
- Confidential -11
The OTC opportunity - Some Statistic Numbers….
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.
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
- Confidential -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
- Confidential -13
AviafitTM/HomefitTM Pulsating Leg Band
FeaturesConvenient: very small footprint & lightweightWorn on both legs, over or under the clothingPortable, for use at home, office or travelSimple to usePleasant massage effect20 hours of continuous battery operation
StatusCompletion of in vitro verification, validation data and clinical data showing the positive effect of the product on flow parameters CE Mark receivedFDA clearance under 510K Class II classificationSuccessful launched in Europe throughpharmacy channels (> 1,000 PO’s)
Reusable StrapDevice Body
Device Panel
- Confidential -14
AviafitTM/HomefitTM Benefits
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
- Confidential -15
Intellectual Property
54 filed and 19 granted / published patent applicationsPCT- 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 trademarks3 in Europe (CTM) and 2 in Japan
11 trademark applications: 3 in Europe (CTM), 6 in the U.S. and 2 in Israel
- Confidential -16
Company Management and Medical Advisory Board
Company ManagementProf. Shlomo Ben-Haim, MD - Co-Founder and ChairmanLewis C. Pell – Co-Founder and Director Dr. Benny Rousso - Co-Founder, Director and CTONissim Greisas – General Manager
Medical Advisory BoardProf. Daniel Burkhoff – Leading researcher in the cardiovascular field. Adjunct Associate Professor at Columbia University John Scurr, MD – Middlesex Hospital and University College Hospital, LondonRon Karmeli, MD - Chief of the Vascular Surgery Department, Carmel Hospital, Haifa, IsraelBenjamin 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
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