Hancock Jaffe Announces Objectives for Upcoming CoreoGraft Study
IRVINE, Calif., Jan. 28, 2019 (GLOBE NEWSWIRE) -- Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a Company specializing in medical devices that restore cardiac and vascular health, today announced its objectives for its upcoming CoreoGraft® study at the Texas Heart Institute. The study will begin the week of January 28.
The CoreoGraft animal study will focus on short term graft patency and graft viability. Five CoreoGrafts will be surgically implanted over a three-week period and continuously monitored for thirty days for flow rates and patency using transonic probes. The implantable probe will verify flows and patency of the grafts. Following the monitoring part of the trial, the CoreoGrafts will undergo pathology examinations to look for evidence of cellular abnormalities that might lead to failure or impact graft performance.
HJLI expects to provide an update after the first implantation. The performance results of the study and the pathology are expected to be released in April of 2019. Provided that the study is successful, Hancock Jaffe would then seek a Pre-FDA meeting to discuss the additional pre-clinical testing that will be necessary for in-human trials.
Robert Berman, Hancock Jaffe’s Chief Executive Officer stated, “Short term and long term saphenous vein graft failures continue to be a major problem for patients undergoing coronary bypass surgeries, and are a source of frustration for cardiac surgeons and interventional cardiologists. The CoreoGraft has the potential to set a new standard of care for the hundreds of thousands of patients that undergo bypass surgery each year.”
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 SVG from the leg of the patient, and to use pieces of the SVG as grafts to revascularize 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. 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 excess of 50%. The risk of death from cardiac events increases significantly following SVG failure.
Hancock Jaffe believes that its CoreoGraft will avoid the two main causes of SVG failure: size mismatch (fluid dynamics); and a thickening of the interior of the SVG graft that begins immediately following the harvest procedure (known as the “endothelial-to-mesenchymal transition” or “EndoMT”). Size mismatch occurs because the diameter of SVGs is often significantly larger than the diameter of the coronary arteries, causing flow disturbances leading to graft thrombosis or development of intimal hyperplasia resulting in graft failure. The diameter of HJLI’s CoreoGrafts closely match the diameter of the coronary arteries, eliminating the size mismatch which leads to clotting.
Scientists have discovered that the thickening of the interior of SVG’s which leads to graft failure is caused by a layer of endothelial cells on the inner surface of the SVG. When the endothelial cells are disturbed as part of the SVG harvest procedure, a chain reaction begins which causes the cells to thicken and the inside of the graft to narrow, resulting in blood clots and graft failure. Because the tissue used to make the CoreoGrafts is completely different than SVG tissue, the CoreoGraft may not suffer from the EndoMT that plagues SVGs.
Hancock Jaffe has two important studies starting this quarter. In addition to the CoreoGraft study, HJLI will begin first-in-human testing of its VenoValve®, a potential cure for severe cases of chronic venous insufficiency, a debilitating condition caused by venous reflux in the lower extremities and which afflicts 4.5 million people in the U.S.
About Hancock Jaffe Laboratories, Inc.
HJLI specializes in developing and manufacturing bioprosthetic medical devices to establish improved standards of care for treating cardiac and vascular diseases. HJLI currently has three product candidates: the porcine tissue based VenoValve®, which is intended to be surgically implanted in the deep venous system of the leg to treat Chronic Venue Insufficiency; the CoreoGraft®, a bovine tissue based off the shelf conduit intended to be used for coronary artery bypass surgery, and a porcine tissue based heart valve, which based upon its relatively small size and increased output, may be an ideal candidate for pediatric aortic/mitral valve replacement.
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, the performance of the new board members described herein) 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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Released January 28, 2019