FlowKeepers

Device for Preventing Circulatory Ailments

Patented, developed and ownedby

Amiram Katz, MD,

The Problem Medical Applications:

• Patients at risk for developing DVT & PE (VTE)

• Patients with non-healing wounds of different etiologies

• Patients with limb edema of different etiologies

• Patients with ischemia of the extremities

The Problem General Consumer

• Healthy individuals with leg swelling and discomfort on prolonged travels

• Healthy individuals on long travels with risk factors for DVT (obesity, hormone replacement therapy/ oral contraceptives, smoking, age>40, smoking, varicose veins and others – see below)

• Healthy concerned individuals on long travels

The Problem: Medical –Pulmonary Embolism

• Should be reported as the third leading (>200,000 - next slide) cause of death in the US after heart (941,000) and cancer (541,000) related deaths.

• In July 2000 statistics, stroke was reported as third, withonly 158,000 fatalities.

• PE is under reported due to declining autopsy rates .

The Problem (PE):

The Problem Deep Vein Thrombosis (DVT) & PE =VTE

(venous thrombo embolism):• More than 1,000,000 Americans are reported to suffer

from VTE annually (98 Mayo Clinic Health Letter).• It is estimated that the real incidence of VTE is 5-10 times

higher (most events are silent).• About 10% of healthy individuals have a genetic tendency

to clot more than normal (thrombophillias), of which they are not aware (NEJM 2001;344:1222-1231

• People at VTE risk (other than genetic - see next slide) - probably make 20% - 50% of the population admitted to hospitals

• Total population at risk annually – between 10 – 30 million Americans

The Problem Embolic Strokes

• Embolic strokes, due to patent foramen ovale (PFO – a virtual hole communicating both sides of the heart), which is common (10-20% of the population) which allows paradoxic (from the right atrium to the left atrium) emboli, which are not included in VTE statistics.

• Many of the acute strokes taking place in prolonged flights, might be secondary to paradoxic emboli. They can be trigerred by lifting a heavy suite case, or involved in any activity that increase intra abdominal pressure.

The Problem (VTE):American College of Chest Physicians

The Problem - VTE

The Problem - VTE

The Problem Chronic Ulcers - Diabetes:(Data from: Diabetes 1996 Vital Statistics and,

Levin ME. Diab Care 1995; 18:1983-1993)

• 16 Million Americans with Diabetes. Of them,• 5%-6% admitted annually with non-healing ulcers

of their feet (One Million Patients). Of them,• Close to 70,000 end up with amputations with an

annual cost of $1.5 Billion. • $10 Billion spent annually on Diabetic Wound

Care (Diabetic non-healing ulcers).

The Problem Chronic Ulcers:Venous Insufficiency

(Rudolph DM. J Wound Ostomy Continence Nurs 1998; 25:245-55, and

Onegnace K, Phillips T. Emerg Med 1993; 25:45-53

• 1% of the population and 3.5% of people >65 years, suffer from venous ulcers (3:1 women/men)

• Recurrence rate of venous ulcers is 70%. • The estimate per episode cost of care can exceed

$40,000. • $5 Billion spent annually on Venous Ulcer Care.

The Problem: Prolong Travels in Tight Seats

The Problem: “Economy Class Syndrome”• The Aviation Health Institute, Oxford, UK, estimates

that there are 2,000 deaths and 30,000 flight related VTE cases a year in Britain.

• 0.5 Billion passengers on flights > 6 hrs in, into and out of USA annually.

• 4 hrs of travel (plane, train or car) = x4 chance of suffering from DVT or PE (Ferrari et al. Chest 1999; 115:440-444).

• Prolonged air travel is associated with 10% incidence of L.E. venous thrombi confirmed by Doppler studies (mostly sub clinical - Scurr Lancet 2001; 357:1485-9)

Our Solution:

Our Solution:

• Electric muscle stimulation was shown to be effective in DVT prevention since the 60’s (Browse et al. BMJ 1970, 3, 615-618)

• It was abandoned due to clumsy instrumentation and old technology (diode boxes, metal electrodes, etc.)

• Later attempts to implement modern electronics to the devices were not successful due to stimulation parameters of the TENS Units used (patients could not tolerate the high frequency stimulation)

Our Solution:

• Fifteen years of R&D with:– Several US issued patents and Brands and two

generations of manufactured devices

• Clinical work during which:– Optimal current parameters were determined and

patented– Skin resistance and morphometric variants studied in 20

volunteers– Electrodes optimal size, shape and structure were

determined

Our Solution:• Effective calf contraction every 10 seconds

resulting in:– venous emptying (it takes 5 seconds to refill an emptied

vein) by active muscle contraction– increase in venous flow velocity in the central femoral

vein (CFV) of 100%-1000% – improved arterial blood flow with

• improved oxygenation

• reduction of peripheral resistance

– activation of the fibrinolytic (clot preventing) system

Our Solution: D-preVenT™(disposable non-woven wrap for hospital environment)

Our Solution: FlowKeepers®

(Durable structure for prolonged use)

FlowKeepers® - Next Generation

FlowKeepers® - Next Generation(With reusable cuff)

How does it work?

Approved Institution Review Board (IRB) Studies We Completed:

• Doppler studies in 10 healthy volunteers –statistically significant increases in flow, measured at the central femoral vein (up to 4 fold increase when lying and sitting and up to 10 fold increase, standing).

• Patients with ankle edema of various etiologies - statistically significant relief of the treated limb:

- Bilateral edema: 3.7-9.5% reduction of leg volume in one day of use

- Unilateral edema: 7.7-39% reduction of leg volume in two days of use

Additional Studies Done:

• TcpO2 (transcutaneous oxygen pressure) measurements in

patients with foot ulcers, PVD and healthy volunteers, showed 20% 100% increase with calf stimulation when measured at the MTP (base of the toe) joint area.

A Patient’s Story

“July 19, 2000, I had my first operation due to blood clot in my leg. I needed a second operation, but my leg and ankle were too swollen for surgery. About July 26th, I received a FlowKeeprs and used it about seven or eight hours a day. It helped to reduce the swelling in my ankle from 27.5 to under 24cm in circumference in about five days and I could proceed with my surgery.About two weeks after my second operation, my leg got swollen and painful again. Around August 8th, I was able to use the FlowKeepers again when my surgery wound closed. It helped to keep the swelling down and reduce pain so I was able to walk around.It reduces my need for pain medications and I am still using it for 5-6 hours a day. Today, one year later, if I do not use FlowKeepers for one or two days, I notice that by the end of the day, the swelling and pain has returned.” Geza TothFairfield, Connecticut

Amiram,

The FlowKeepers device worked like a charm! It worked flawlessly the entire (flight) duration of my recent trips to Spain and Calgary. It provided great relief as my ankles were not swollen at all. A true test of its effectiveness!

Even while sleeping, the device is at work. All I am required to do is turn it on and off and the device does the rest. Remarkable!!

I continue to read with great interest the best advice to combat this dreaded ailment ('Economy Class Syndrome') but am now more than confident that you have a winner.

I have recommended this product to all of the travelers in my office.

Louis A. Sorrentino III, Vice President – SH&E Safety PracticeManaging Director, Internal Evaluation Program, Flight Safety Foundation

Contraindications

• Absolute:– Acute DVT

– Broken, infected or irritated skin at the electrode attachment area

– Known allergy to electrode gel

– Pregnancy

– Age < 18

• Relative:– Pacemakers and internal defibrillators (see next slide)

Pacemakers/ Internal Defibrillators Safety

Who is not receiving effective non-pharmacologic thrombo-

prophylaxis?

• All patients undergoing one day surgery, recovering motionlessly at home

• All patients undergoing cosmetic surgery at the physician’s office

• All patients discharged from the hospital

• Many patients with risk factors for VTE

Regulatory Status• FDA approval route: 510K

• The device is categorized as a Powered Muscle Stimulator

• This class has two existing standard indications of relevance (classified under 21 CFR 890.5850):– “3. Increasing local blood circulation”– “5. Immediate post surgical stimulation of calf

muscles to prevent venous thrombosis”

• We have identified predicate devices (substantially equivalent)

Current Certificates of Assessment –

• EC Det Norske Veritas: Certificate No. 2002-OSL-MDD-0089

• CE 0434