Initial Implantation Phase for First-in-Man Study Now Completed
IRVINE, CA / ACCESSWIRE / November 15, 2019 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI)(NASDAQ:HJLIW), a developer of medical devices that restore cardiac and vascular health, announced today that it has enrolled and successfully implanted the 10th patient to complete the initial implantation phase of the first-in-man VenoValve study being conducted in Colombia. The surgery went very well with no early signs of adverse events.
Hancock Jaffe's first-in-man study is the precursor to seeking permission from the U.S. Food and Drug Administration ("FDA") to conduct the VenoValve U.S. pivotal trial. In consultation with the FDA, HJLI agreed to conduct a first-in-man study of between five and ten patients that suffer from chronic venous insufficiency ("CVI"). On October 24, 2019, HJLI released six month data on the first 5 patients that received VenoValves. The six month data showed significant improvements in all study endpoints, minimal safety issues, and dramatic improvement and healing of venous ulcers.
Dr. Marc. H. Glickman, Hancock Jaffe's Senior Vice President and Chief Medical Officer, who was in Bogota for the VenoValve implantation procedure stated, "We have continued to refine and simplify the surgical procedure throughout the first-in-man study, so that we can now teach other vascular surgeons to replicate the success that we have had as we prepare for the U.S. pivotal trial."
Next steps for the VenoValve include the continual monitoring of all VenoValve recipients, reengagement with the U.S. Food and Drug Administration ("FDA"), presentation of the six (6) month data to potential strategic partners, and a series of FDA mandated testing, all of which are in preparation for the filing of an IDE application with the FDA for the U.S. pivotal trial. HJLI will also develop a smaller version of the VenoValve.
Approximately 2.4 million people in the U.S. suffer from CVI due to reflux in the deep venous system, representing the potential for recurring revenue of hundreds of millions of dollars per year. Estimates indicate that direct medical costs from CVI in the U.S. exceed $30 Billion a year. There are currently no FDA approved devices or effective treatments for deep venous CVI.
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.