CoreoGraft Study Approved by the Superintendent of Health of the National Health Council of Paraguay
IRVINE, CA / ACCESSWIRE / May 12, 2020 / Hancock Jaffe Laboratories, Inc. (HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that the Company has received approval from the Superintendent of Health of the National Health Counsel for the Republic of Paraguay to conduct a first-in-human study for its CoreoGraft bioprosthetic graft.
The first-in-human study will initially consist of five patients who will receive CoreoGrafts as part of their coronary artery bypass graft ("CABG") surgeries. The CoreoGraft patients will be monitored for a one-year period post CoreoGraft surgery, with interim results reported at 30, 90, 180, and 365 days. Enrollment for the first-in-human study will begin as soon as COVID-19 restrictions are lifted in Paraguay.
The primary investigator for the first-in-human trial will be Dr. Adrian Ebner, a specialist in Cardiovascular Surgery and Endovascular Interventional Cardiology and the Chairman of the Board of Clinical Research and Cardiovascular Clinical Studies at the Italian Hospital Asuncion in Paraguay. Dr. Ebner has been involved in more than 70 first-in-human studies for products that have gone on to receive CE Marking, FDA approvals, or that have been acquired by large medical device companies. The CoreoGraft surgeries will be conducted under the supervision of Dr. Marc H. Glickman, Hancock Jaffe's Senior Vice President and Chief Medical Officer.
Dr. Glickman stated, "I have previously worked with Dr. Ebner and am excited to collaborate with him on our CoreoGraft first-in-human trial. Much like we have done with our VenoValve first-in-human study, we will apply what we learn from the CoreoGraft study to enhance our surgical technique and improve the product, all in preparation for seeking U.S. regulatory approval for the CoreoGraft."
In January of 2020, HJLI released positive results from its six (6) month CoreoGraft animal feasibility study. At thirty (30), ninety (90), and one hundred and eighty (180) days post CoreoGraft bypass surgeries, all grafts we patent (open), when the implantations went smoothly and there were no technical errors. At the conclusion of the study, pathology examinations of the grafts and surrounding tissue showed no signs of thrombosis, infection, aneurysmal degeneration, changes in the lumen, or other problems that are known to plague saphenous vein grafts ("SVGs"). In addition, the pathology examinations indicated a thin layer of endothelial cells in the CoreoGrafts that were implanted for 90 days, and more complete endothelization was observed for grafts implanted for 180 days both throughout the CoreoGrafts and into the left anterior descending arteries. Endothelialization is thought to be a critical step in establishing the long-term biocompatibility of cardiovascular devices.
For patients with suitable veins, the current standard of care for most CABG surgeries is to harvest the saphenous vein from the leg of the patient, dissect the SVGs into multiple grafts, and to use the dissected 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 also 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 as high as 75%. Eventually, the CoreoGraft could become a viable alternative to using SVGs.
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 VenoValveÒ, 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. 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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