Initial Patient Data to be Released on June 7th for First-In-Human VenoValve Study
IRVINE, CA / ACCESSWIRE / May 28, 2019 / Hancock Jaffe Laboratories, Inc. (NASDAQ: HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health, will report initial data on the first five patients that received VenoValves as part of the first-in-human study in Bogota, Colombia, and will present a case management report at the Expert Venous Management (“EVM”) Conference at the Englewood Hospital Medical Center in Englewood, New Jersey on June 7, 2019.
The Hancock Jaffe presentation at the EVM conference will be delivered by Dr. Jorge Hernando Ulloa, the primary investigator for Hancock Jaffe’s first-in-human VenoValve trial in Bogota, Colombia. Dr. Marc H. Glickman, Hancock Jaffe’s Senior Vice President and Chief Medical Officer will also be participating in the discussion.
The EVM Conference is a teaching forum open to vascular surgeons, interventional radiologists, interventional cardiologists, cardiologists, phlebologists, general surgeons, and other medical professionals currently treating venous disease. The conference faculty includes key opinion leaders in vascular medicine, and features case presentations and case discussions in an informal, interactive format.
Robert Berman, Hancock Jaffe’s Chief Executive Officer stated, “We are excited to have this opportunity to present the first report from our first-in-human VenoValve study to the vascular community. Although the conference is limited to medical professionals, we will also take the opportunity to release initial results from the VenoValve study to our shareholder base the morning of June 7th and the case management report will be presented at the EVM conference in the afternoon,” concluded Berman.
The VenoValve is being tested to reduce or eliminate deep venous reflux, a major cause of Chronic Venous Insufficiency (“CVI”). The reduction or elimination of reflux would lower venous hypertension and result in greatly improved quality of lives for patients suffering from deep venous CVI. In addition to measuring reflux, endpoints for the first-in-human VenoValve study include VCSS measurements, VAS scores, and VEINES scores, three well known clinical assessments for venous disease and assessments of improvement in the patient’s quality of life and reduction in pain.
The initial phase of the first-in-human Colombian study will initially include up to ten patients who suffer from severe, chronic venous insufficiency (CVI) of the deep vein system. HJLI ha implanted the VenoValve in 5 patients. The purpose of the first-in-human study is to provide HJLI with valuable feedback to make any necessary product modifications or adjustments to the surgical implantation procedure for the VenoValve.
HJLI expects to use the data from its first-in-human study in Bogota as part of its Investigational Device Exemption (“IDE”) application which will be submitted to the U.S. Food and Drug Administration (“FDA”) to begin the VenoValve U.S. pivotal trial. Approximately 2.4 million patients in the U.S. suffer from CVI due to reflux in the deep venous system, and there are currently no FDA approved treatments for the 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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