No Device Failures in Eight Test Subjects
IRVINE, CA / ACCESSWIRE / June 27, 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. There have been no device failures in eight animal test subjects where CoreoGrafts have been implanted as heart bypass grafts, with one group observed at 30 days, and another group observed at 45 days post-surgery. In particular, the CoreoGrafts have showed no signs of thrombosis, aneurysmal degeneration, neointimal hyperplasia, stenosis, 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, “Overall, the CoreoGrafts have performed very well throughout our feasibility study. I was particularly surprised how pristine some of our CoreoGrafts looked at 45 days, especially in light of the difficulties that others have experienced when attempting to create small caliber grafts. Our early success is extremely encouraging, and we have not seen anything to dissuade our belief that the CoreoGraft will be a viable product.”
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 challenges of animal feasibility studies include technical challenges related to implantation surgical procedures, and anatomical challenges related to the animal test subjects, primarily due to physiological and anatomical differences in the animal test subjects versus humans. 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 expects to add two additional animal test subjects to the feasibility study, testing different implantation techniques. The remaining animals in the feasibility study that were observed at 45 days will be observed again at 90 days post-surgery. Hancock Jaffe will provide the next CoreoGraft update at that time. With anticipated positive results at 90 days, HJLI plans to initiate a dialogue with the FDA to discuss regulatory approval plans. HJLI expects the next studies after the feasibility study to be a GLP studies, where the studies are conducted in accordance with standards and guidelines acceptable for FDA 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.
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.
Cautionary Note on Forward-Looking Statements
This press release and any statements of stockholders, directors, employees, representatives and partners of Hancock Jaffe Laboratories, Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, with respect to our first-in-human VenoValve study) may differ significantly from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.
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