Five Patients Now Part of First-in-Human Bogota Study
IRVINE, CA / ACCESSWIRE / April 11, 2019 / Hancock Jaffe Laboratories, Inc. (NASDAQ: HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health, has successfully implanted VenoValves in four additional patients for its first-in-human study in Bogota, Colombia. The surgeries went well and there are no early signs of adverse events. HJLI previously announced that the four implantations would take place prior the end of April 2019.
Robert Berman, Hancock Jaffe’s Chief Executive Officer stated, “It is amazing to observe these surgeries, and then watch our patients get up and walk less than two hours after the procedure. The patients are very appreciative to receive a device that could potentially reduce or eliminate the debilitating symptoms from chronic venous insufficiency, and we are thankful to them for providing the feedback that we need to continue the development of our device.”
The first phase of the first-in-human Colombian study will include 5 to 10 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, and resulting in increased venous pressure (venous hypertension). Severe CVI often results in significant disability which includes swelling, intense pain, and skin ulcerations that become ongoing, open wounds.
Following implantations of the VenoValve and as part of the study, patients undergo duplex scans, which are used to measure reflux time – the duration of reflux in the deep venous system. The VenoValve was developed to reduce or eliminate deep venous reflux, a major cause of 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.
HJLI has had several Pre-FDA meetings to discuss the pre-clinical and clinical pathway for FDA approval for the VenoValve. Preclinical prototype testing, including in vivo animal studies, and in vitro hemodynamic studies, have demonstrated that the VenoValve mimics the function of a properly functioning native venous valve. Based upon feedback from the FDA, HJLI agreed to conduct a small first-in-human study in Colombia prior to the U.S. pivotal trial. The first-in-human study will provide HJLI with valuable feedback to make any necessary product modifications or adjustments to the surgical implantation procedures for the VenoValve.
HJLI expects to release preliminary data on the first group of VenoValve recipients in June of 2019 and will continue for follow the patients in Colombia for period of 6 months. The company will next provide news on the VenoValve once it has enrolled additional patients for the Bogota study. 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 condition.
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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