Grafts Open and Fully Functional at 90 Days
IRVINE, CA / ACCESSWIRE / August 14, 2019 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health, today provided an update on the status of its CoreoGraft animal feasibility study. For the three (3) test subjects that were evaluated via angiogram ninety (90) days post CoreoGraft bypass surgery, the CoreoGrafts are functioning perfectly with no signs of thrombosis, aneurysmal degeneration, neointimal hyperplasia, changes in the lumen, or other problems that are known to plague saphenous vein grafts ("SVGs") and attempts by others to create small caliber (3 mm and 4 mm) grafts.
Dr. Marc H. Glickman, Hancock Jaffe's Chief Medical Officer stated, “Having small caliber grafts that look this good at 90 days post-surgery is a significant milestone for Hancock Jaffe. In the thirty plus years that I have been a vascular surgeon and involved in product development, I have not seen or heard about any successful organic or synthetic small caliber grafts. The clinicians that we are working with on the CoreoGraft have personally experienced many failed attempts over the years, and they are as impressed as I am with the performance of the CoreoGrafts.”
CoreoGrafts in the three (3) pre-existing test subjects will be evaluated again at 180 days post-surgery, approximately 90 days from now. HJLI also added two additional animal test subjects to the feasibility study, where CoreoGrafts were implanted “on-pump” with the use of a cardio pulmonary bypass machine. CoreoGrafts in the new test subjects will be evaluated 90 days post-surgery, at which time HJLI expects to have the data that it needs to end the feasibility study and open a dialogue with the FDA regarding the approval pathway for the CoreoGraft. The next CoreoGraft study will likely be a GLP animal study, which will be conducted under specific conditions prescribed by the FDA.
HJLI has been conducting a series of experimental acute (shorter-term) and chronic (longer-term) animal feasibility studies to evaluate the safety and performance of the CoreoGraft and the procedures to implant the CoreoGraft under a variety of conditions. The knowledge HJLI gains from the animal feasibility study will be valuable in finalizing device design and in developing required GLP study designs for FDA approval submissions.
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. 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%. In addition to high SVG failure rates, the SVG harvest procedure itself is invasive, painful, and subject to complication rates exceeding 20%. The CoreoGraft is being developed for bypass patients where SVG harvest is not an option and to potentially replace SVGs. Lower failure and complication rates would be advantageous to both doctors and patients, and would lower the overall costs associated with CABG surgeries.
Approximately 200,000 CABG surgeries are performed each year in the U.S., representing more than 55% of all cardiac surgeries and accounting for between $15 Billion and $25 Billion in annual expenditures. With an average of three grafts used per surgery, HJLI estimates the potential U.S. addressable market for the CoreoGraft to be more than $2 Billion per year. There are currently no FDA approved prosthetic grafts for CABG surgeries.
About Hancock Jaffe Laboratories, Inc.
HJLI specializes in developing and manufacturing bioprosthetic (tissue based) medical devices to establish improved standards of care for treating cardiac and vascular diseases. HJLI 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. For more information, please visit HancockJaffe.com.
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SOURCE: Hancock Jaffe Laboratories, Inc.