FlowAid Receives FDA US Market Clearance for the FA100 SCCD

NEW YORK–(BUSINESS WIRE)– Having received CE
Mark approval in July and Health
Canada approval in August of last year, FlowAid Medical Technologies
Corp. of New York City, announced today it has received U.S. Food and
Drug Administration FDA clearance for its FA100 SCCD (Sequential
Continuous Contraction Device) for the following indications: increase
of local blood circulation, immediate post-surgical stimulation of calf
muscles to prevent venous thrombosis, prevention or retardation of
disuse atrophy and edema reduction. The FA100 SCCD is the first device
of its kind cleared by the FDA for the indication of edema reduction.

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The FlowAid FA100 SCCD (Photo: Business Wire)

The FA100 SCCD is a small, lightweight, portable, and handheld 4-channel
electrical muscle stimulator that is easy to use and provides
comfortable, low-frequency stimulation in a proprietary sequential
pattern. The FA100 SCCD operates without any external pressure to the
leg, allows complete mobility and does not interfere with daily
activities.

The primary mechanism of the FA100 is to activate the calf muscle pump,
the body’s natural built-in system pump, using a sequential pattern of
electrical stimulation that causes a peristaltic wave of muscle
contractions running distal to proximal along the lower leg. The muscle
contractions periodically compress the deep veins of the lower leg,
forcing the partial emptying of the deep veins and resulting in
increased arterial flow.

Clinical trials and evaluations of the FA100 SCCD have been ongoing, and
professional interest is evident on every continent. Dr Guido Giacalone,
Director of the Lymfoedeem Centrum in Belgium, will be doing a large
study on the effects of the device on Lymphedema and Prof. Raj Mani,
Consultant in Clinical Sciences at Southampton University Hospital NHS
Trust and Visiting Professor at the Shanghai Jiao Tong University School
of Medicine, will be supervising a worldwide study on effects of the
device on Diabetic Peripheral Neuropathy. Past
publications and case study results using the FA100 SCCD can be
viewed on our website.

FlowAid CEO Jacob Brezel: “We are very excited to be able to make the
FA100 SCCD available to patients in the United States who will benefit
from low-frequency, comfortable stimulation of the calf muscles to
increase blood flow. We plan to submit additional FDA applications to
expand our claims for other disease-specific indications, including the
treatment of Diabetic Peripheral Neuropathy and Lymphedema.”

FlowAid Medical Technologies Corp. is an emerging growth company focused
on treating blood circulatory disorders of the extremities by
continuously upgrading current medical solutions with new innovative
cutting edge technologies. Our mission is to improve the quality of
patient care and the productivity of health care delivery through the
development of certain non-invasive medical devices and procedures for
increasing blood flow and circulatory enhancement based upon many years
of R&D, the involvement of many multidisciplinary professionals and
patient feedback.

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