Hancock Jaffe Successfully Completes VenoValve Implantation for First-in-Human Study
Six Patients Now Part of First-in-Human Bogota Study
IRVINE, CA / ACCESSWIRE / June 13, 2019 / Hancock Jaffe Laboratories, Inc. (NASDAQ: HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health, has successfully implanted the VenoValve in an additional patient. The procedure very went well and there are no early signs of adverse events. Six out of the ten patients that are to be a part of the initial phase of HJLI's first-in-human Bogota study have now been successfully implanted.
Dr. Marc H. Glickman, Hancock Jaffe's Senior Vice President and Chief Medical Officer, who was present at the surgery in Bogota, Colombia stated, "The VenoValve surgery went exceptionally well. We improve our technique after each implant of the VenoValve. We take what we learn from the prior surgeries and use that information to improve the surgical procedure. That is one of the purposes of the first-in-human study and the knowledge we gain will be extremely helpful for our U.S. pivotal trial."
The first phase of the first-in-human Colombian study will include 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.
On June 7, 2019, HJLI released the first data from the first-in-human Bogota study, which included one patient that was more than ninety days post VenoValve surgery and four patients that were forty-five days post VenoValve surgeries. In all four patients with working VenoValves, reflux was significantly reduced. Reflux is the primary endpoint for the first-in-human study. For the patient that is ninety days post VenoValve surgery, clinical manifestations of the disease were greatly improved, including the VCSS score, a measurement of venous disease severity tracked by the clinician, which improved 57%; the VEINES scores, the patient's assessment of the impact of the disease on the patient's quality of life, which improved 25%; and the VAS score, a widely used measurement in clinical research based upon the patient's own assessment for pain, which improved 57%. All comparison scoring was based on assessments pre-surgery and 90 days after surgery. At the time the first data was released, one VenoValve patient was occluded.
HJLI will continue to provide updates on patient enrollment and additional VenoValve implantations. HJLI expects to release its next VenoValve data at the end of September, at which point patient number one will be seven months post VenoValve surgery, patients two through five will be five months post VenoValve surgeries, and patient six will be ninety days post VenoValve surgery.
The first-in-human Bogota study for the VenoValve is the precursor to the 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 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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Released June 13, 2019