Hancock Jaffe Enrolls Initial Patients for First-in-Human CoreoGraft Study

Rhea-AI Summary

Hancock Jaffe Laboratories (HJLI) has announced the enrollment of the first two patients for its first-in-human CoreoGraft study, aimed at providing a safer alternative for coronary artery bypass grafting (CABG) using their innovative conduits. This trial, conducted at the Italian Hospital Asuncion in Paraguay, will eventually include up to five patients. Initial findings from animal studies indicate promising results, including high graft patency rates. HJLI estimates the U.S. market potential for the CoreoGraft at over $2 billion annually due to the high failure rates of traditional grafts.

Positive

• Successful enrollment of two patients for the first-in-human CoreoGraft study.
• Promising results from prior animal studies with 100% graft patency at 30, 90, and 180 days.
• Potential U.S. market for CoreoGraft estimated at over $2 billion annually.

Negative

• None.

Two of Five Patients Enrolled for the Study

IRVINE, CA / ACCESSWIRE / August 25, 2020 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that it has enrolled the first two patients for its first-in-human CoreoGraft study. The first implant of the CoreoGraft conduits will take place in the coming weeks and HJLI will announce the schedule when available. The first-in-human trial will consist of up to 5 patients.

Interim results for patients in the CoreoGraft study, which will take place at Italian Hospital Asuncion in Paraguay, will be available 30 days, 90 days, 180 days, and 365 days post-surgery. CoreoGrafts will be implanted in patients requiring coronary artery bypass grafting ("CABG") for severe coronary artery diseases. The 3 mm CoreoGraft conduit is being used as a substitute for saphenous vein grafts in these patients. Saphenous vein grafts are known to have high short-term and long-term failure rates. Once the CoreoGrafts are implanted, they will be evaluated at each interval of the follow-up period for signs of failure including "openness" or "patency", blood clots ("thrombus") and other changes commonly associated with graft failure.

Robert Berman, Hancock Jaffe's CEO stated, "We have several upcoming milestones to be excited about including the beginning of our first-in-human trial for the CoreoGraft, the conclusion of our first-in-human trial for the VenoValve, and preparations for the VenoValve U.S. pivotal trial. We believe that the combination of our clinical advancements together with the steps we are taking to position the company for long term success, will continue to add to our momentum through the remainder of 2020 and beyond."

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 in 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. The Company will provide periodic updates on additional patient enrollment and dates for surgeries once they are available.

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.

HJLI Press Contacts:

Amy Carmer
Tel: 949-261-2900
Email: ACarmer@HancockJaffe.com

SOURCE: Hancock Jaffe Laboratories, Inc.

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FAQ

What is the CoreoGraft study by Hancock Jaffe (HJLI)?

The CoreoGraft study is a first-in-human clinical trial to evaluate the effectiveness of HJLI's innovative conduits for coronary artery bypass grafting (CABG).

How many patients are enrolled in the CoreoGraft study?

Currently, two patients have been enrolled for the CoreoGraft study, which will include up to five patients in total.

What are the expected outcomes of the CoreoGraft study?

The study will evaluate graft patency and failure rates at intervals of 30, 90, 180, and 365 days post-surgery.

What is the market potential for CoreoGraft?

HJLI estimates the U.S. market potential for CoreoGraft to exceed $2 billion annually due to high failure rates of traditional grafts.