Eight Patients Now Part of First-in-Man Bogota Study
IRVINE, CA / ACCESSWIRE / August 20, 2019 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health, has successfully implanted VenoValves in two additional patients, as part of HJLI’s first-in-man Bogota study. Eight patients have now received VenoValves as part of the initial phase of the first-in-man study. The procedures very went well and there are no early signs of adverse events.
Dr. Marc H. Glickman, Hancock Jaffe’s Senior Vice President and Chief Medical Officer, who was present at the surgeries in Bogota, Colombia stated, “Each time we implant VenoValves, the procedures get better and better. We are carefully chronicling all that we learn from these surgeries to pass on that knowledge for our U.S. pivotal trial.”
The first phase of the first-in-human Colombian study will be between five and ten patients who suffer from severe, chronic venous insufficiency (CVI) of the deep vein system, a condition that occurs when the valves in the veins of the venous system of the leg are injured or destroyed, causing blood to flow backwards (reflux) and pool in the lower extremities. Reflux causes increased venous pressure (venous hypertension) which often results in debilitating symptoms such as swelling, intense pain, and skin ulcerations that become ongoing, open wounds.
In July of 2019, ninety-day data from the first-in-man study was released which indicated substantial improvements in all end points of the study, including reflux (68% average improvement), manifestations of the disease (45% average improvement VCSS); and pain (39% average improvement VAS). The next data from the first-in-man study is expected to be released in late October of 2019, at which point five patients will be more than 6 months post VenoValve surgery, and three patients will be between 2 to 4 months post-surgery. The company believes that the October data will be sufficient to re-engage the FDA, in preparation for filing the Investigational Device Exemption (IDE) application for the U.S. pivotal trial, which the company expects to file in early 2020. The first-in-human Bogota study for the VenoValve is the precursor to the U.S. pivotal trial, for which the company hopes to receive approval in the second half of 2020.
Approximately 2.4 million patients in the U.S. suffer from CVI due to reflux in the deep venous system, representing a potential addressable U.S. market in excess of $14 Billion. Direct medical expenses in the U.S. for venous ulcers from CVI exceed $30 Billion per 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 third product candidate, which is a porcine tissue-based heart valve, which may be a candidate for pediatric aortic/mitral valve replacement. Hancock Jaffe has a 19-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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