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Hancock Jaffe Announces Successful Start to CoreoGraft Study

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conix   Monday, 03/18/19 10:44:23 AM
Re: jfk post# 6
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Hancock Jaffe Announces Successful Start to CoreoGraft Study at Texas Heart Institute

Excellent Initial Flow Rates Achieved with CoreoGrafts for Bypasses Completed in Two Test Subjects


IRVINE, California., March 18, 2019 – Hancock Jaffe Laboratories, Inc. (NASDAQ: HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health, today announced the successful start of its CoreoGraftÒ pre-clinical feasibility study at the Texas Heart Institute. Bypasses using the CoreoGraft have now been successfully completed in two test subjects. Following the surgeries, flow rates were excellent as measured with Transonic probes.

During the initial surgeries, the CoreoGraft bypass conduits were attached from the ascending aorta to the left anterior descending artery (LAD). The bypass surgeries were performed on beating hearts, without a cardiopulmonary bypass machine. Flow rates will be continually monitored for a period up to 30 days, checking for any indications of short-term graft failure.



“Because a high percentage of saphenous vein grafts begin to occlude and fail immediately following heart bypass surgeries, the 30-day period following surgeries is a critical period for us to show efficacy for the CoreoGrafts,” said Robert Berman, Hancock Jaffe’s Chief Executive Officer. “Initial flow rates following the first two surgeries were very good and the goal is to maintain high flow rates throughout the 30-day test periods of our study.”



One additional bypass surgery with the CoreoGraft will be performed in the coming days. Following the 30- day monitoring portions of the trial, the CoreoGraft implants will undergo pathology examinations to look for evidence of cellular abnormalities that might lead to failure or adversely impact graft performance. HJLI expects to release results from the CoreoGraft study in June of 2019. Provided that the study is successful, the next step would be to seek a Pre-FDA meeting to discuss the additional pre-clinical testing that will be necessary before in-human trials.



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 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. 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%. The CoreoGraft study at Texas Heart was designed to monitor short-term patency rates both immediately after surgery and for a 30-day period.



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 VenoValveÒ, HJLI’s other lead product and a potential cure for severe chronic venous insufficiency, is also scheduled to be released at the end of 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 CoreoGraftÒ, 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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