Longer-Term Phase of the Trial Started with Additional Test Subjects
IRVINE, CA / ACCESSWIRE / May 21, 2019 / Hancock Jaffe Laboratories, Inc. (NASDAQ: HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health, has announced the expansion of its feasibility study for the CoreoGraft. The pre-clinical study has been expanded to include additional animals and a longer term. One group of new test subjects will be monitored for up to 90 days, and the other for up to 180 days. CoreoGrafts have been successfully implanted in all of the additional test subjects and the expanded study is already underway.
The original CoreoGraft feasibility study consisted of three animals which were to be monitored for 30 days. Historically, the U.S. Food and Drug Administration ("FDA") prefers to see data from multiple time periods and from more than one site. The expanded study will now yield pre-clinical CoreoGraft implantation data for 30-day, 60-day, 90-day and 180-day periods and will add one additional site to the study.
"We are encouraged enough by the early CoreoGraft results to immediately expand the study to include additional data points that are meaningful to the FDA," said Robert Berman, Hancock Jaffe's Chief Executive Officer. "We remain on track to release 30-day CoreoGraft feasibility data at the end of June 2019, but instead of reporting on only three test subjects, we expect to report on a much larger group."
Concurrently with the expanded pre-clinical trial, HJLI expects to open a dialogue with the FDA to discuss the clinical pathway for FDA approval of the CoreoGraft. HJLI will announce the date of the first FDA meeting once it has been scheduled, and the results of its dialogue with the FDA once it is completed. In addition to releasing the 30-day data at the end of June, HJLI also expects to release 60-day, 90-day and 180-day data from the expanded trial when it is available.
HJLI's CoreoGraft® is a potential alternative to using saphenous vein grafts ("SVGs") to revascularize the heart during coronary artery bypass graft ("CABG") surgeries. The current standard of care for most CABG surgeries is to harvest the saphenous vein from the leg of the patient, and to use pieces of the SVG as grafts to bypass blockages around the heart. In addition to the vein harvest procedure being invasive, painful, and subject to its own complications for the patient, SVGs are known to have high short term and long-term failure rates when used as grafts around the heart. Studies indicate that up to 40% of SVGs fail within one year of CABG surgeries, with a significant percentage failing within the first 30 days. Eight to ten years after surgery, SVG failure rates are known to be in as high as 75%. HJLI began it feasibility study for the CoreoGraft at the Texas Heart Institute and has added American Pre-Clinical Services in Minneapolis as an additional site for the feasibility study.
Approximately 200,000 CABG surgeries are performed each year in the U.S., utilizing between 400,000 and 600,000 bypass grafts. Heart disease remains the number one killer in the U.S. accounting for approximately 600,000 deaths each year. CABG surgery is the most common cardiac operation accounting for approximately 62% of all cardiac surgeries.
The CoreoGraft is one of HJLI's two lead products. Initial results from HJLI's first-in-human trial for the VenoValve®, HJLI's other lead product and a potential cure for severe chronic venous insufficiency, is also scheduled to be released in June of 2019.
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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