IRVINE, Calif., Aug. 09, 2018 (GLOBE NEWSWIRE) — Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a company specializing in bioprosthetic medical devices that establish improved standards of care for treating cardiac and vascular diseases, today announced that it has received approval for the first-in-human testing of its VenoValve® bioprosthetic medical device from the Medical Research Committee at Fundación Santa Fe de Bogotá (“FSFB”), in Bogota Colombia, The company previously received approval from the FSFB’s Ethics Committee.
Hancock Jaffe will now begin gathering the information necessary to submit an application for approval to Instituto Nacional de Vigilancia de Medicamentos y Alimentos (“INVIMA”), which is the Colombian equivalent of the U.S. Food and Drug Administration. INVIMA approval is required to import investigational medical devices and conduct human clinical trials in Colombia.
Hancock Jaffe is developing the VenoValve to treat severe cases of Chronic Venous Insufficiency (“CVI”). CVI occurs when the valves within the deep venous system of the leg are injured or destroyed, causing blood to pool in the lower extremities. CVI may result in swelling, debilitating pain, and skin ulcerations. Practitioners rate the severity of chronic venous disease based upon a system called Clinical-Etiology-Anatomy-Pathophysiology (“CEAP”), a rating system of C0 to C6, with C4, C5, and C6 being patients with the most severe pathology. Approximately 4.5 million people in the U.S. suffer from severe CVI and the condition results from between 400,000 to 700,000 hospitalizations per year. There are currently no FDA approved treatments for deep venous CVI.
About Hancock Jaffe Laboratories, Inc.
HJLI specializes in developing and manufacturing bioprosthetic medical devices that establish improved standards of care for treating cardiac and vascular diseases. HJLI currently has three product candidates: the porcine tissue based VenoValve®, which is intended to be surgically implanted in the deep venous system of the leg to treat Chronic Venue Insufficiency; the CoreoGraft®, a bovine tissue based off the shelf conduit intended to be used for coronary artery bypass surgery, and a porcine tissue based heart valve, which based upon its relatively small size and increased output, is an ideal candidate for pediatric aortic/mitral valve replacement.
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