Updated VenoValve data will include 8 Patients at 180 days – including 1 Patient at 365 Days Post VenoValve Surgery
IRVINE, CA / ACCESSWIRE / February 26, 2020 / Hancock Jaffe Laboratories, Inc. (Nasdaq:HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health, announced today that on Wednesday, March 4, 2020, Dr. Jorge Hernando Ulloa, the Principal Investigator for HJLI’s first-in-man VenoValve study in Colombia, will present updated VenoValve data at the Thirty Second Annual Meeting of the American Venous Forum. The meeting is taking place March 3 to March 6 at the Omni Amelia Island Plantation Hotel at Amelia Island, Florida.
Contemporaneously with Dr. Ulloa’s presentation at the American Venous Forum meeting, HJLI will release select VenoValve data from the presentation, which will include updated reports from 8 patients that are 180 days post VenoValve surgery (including 1 Patient that is now 365 days post VenoValve surgery).
The VenoValve is currently undergoing a first-in-man study in Colombia and was developed to treat chronic venous insufficiency (“CVI”) due to valvular incompetence of the deep vein system. CVI is a condition that occurs when the valves in the veins of the leg are injured or destroyed, causing blood to flow backwards. The backwards flow of blood is known as reflux, and leads to the pooling of blood in the lower leg and increased venous pressure (venous hypertension) in the veins of the leg.
Endpoints for the VenoValve first-in-man study include reflux, measured by doppler, a VCSS score used by the clinician to measure disease severity, a VAS score used by the patient to measure pain, and VEINES qol/sym used to measure quality of life.
HJLI will submit the data from its first-in-man Colombia study as part of its Investigational Device Exemption (“IDE”) application to be submitted to the U.S. Food and Drug Administration (“FDA”) in order to begin the U.S. pivotal trial for the VenoValve. HJLI expects to file the IDE application in Q3 of 2020.
Approximately 2.4 million people in the U.S. suffer from CVI due to reflux in the deep venous system. Patients with venous ulcers from CVI in the U.S. spend an average of approximately $30,000 per year on wound care. Estimates indicate that direct medical costs from CVI in the U.S. exceed $30 Billion per year. There are currently no FDA approved devices or effective treatments for deep venous CVI.
The American Venous Forum (AVF) is dedicated to improving the care of patients with venous and lymphatic disease. Founded in 1987, AVF fosters cutting edge research and clinical innovation and educates health care professionals, patients and policy makers about venous and lymphatic diseases.
AVF’s leadership and membership are recognized internationally as thought leaders, expert investigators and clinicians in venous and lymphatic disease.
About Hancock Jaffe Laboratories, Inc.
Hancock Jaffe Laboratories (NASDAQ:HJLI) specializes in developing and manufacturing bioprosthetic (tissue based) medical devices to establish improved standards of care for treating cardiac and vascular diseases. Hancock Jaffe currently has two lead product candidates: the VenoValve®, a porcine based valve which is intended to be surgically implanted in the deep venous system of the leg to treat reflux associated with Chronic Venous Insufficiency; and the CoreoGraft®, a bovine tissue based off the shelf conduit intended to be used for coronary artery bypass surgery. Hancock Jaffe has a 20-year history of developing and producing FDA approved medical devices that sustain or support life. The current management team at Hancock Jaffe has been associated with over 80 FDA or CE marked medical devices. For more information, please visit HancockJaffe.com.
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SOURCE: Hancock Jaffe Laboratories, Inc.
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