First CoreoGraft Recipient Discharged from the Hospital
IRVINE, CA / ACCESSWIRE / October 28, 2020 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that the first heart bypass surgery in HJLI's first-in-human CoreoGraft study was successfully completed and the patient has been discharged from the hospital. The protocol for the first-in-human study provides that the patient is to return for follow-up visits 30 days, 90 days, 180 days, and 365 days post-surgery.
The first CoreoGraft patient is a 65-year-old male who needed triple coronary artery bypass graft ("CABG") surgery. The left internal mammary artery was used as a bypass graft to the left anterior descending artery, and CoreoGrafts were used to bypass blockages in the distal right coronary artery, and the left circumflex artery. Saphenous vein grafts ("SVGs") the current standard of care for patients in need of multiple bypass grafts, were not available and suitable for this patient.
The 3 mm CoreoGraft is a potential substitute for SVGs which are commonly used in patients needing CABG surgeries. SVGs are known to have high short-term and long-term failure rates. In addition, the SVG harvest procedure can be painful, and is subject to complications. The CoreoGraft first-in-human study is taking place at Italian Hospital Asuncion in Paraguay.
Robert Berman, Hancock Jaffe's CEO stated, "Having two potentially live sustaining medical devices reach first-in-human trials is quite a milestone for a small company like Hancock Jaffe, especially in light of the recent challenges caused by the COVID-19 pandemic. Thank you to Dr. Marc Glickman and the rest of our team at Hancock Jaffe for their unwavering dedication to our company and the clinical advancement of our products."
A first-in-human study is a critical developmental step in testing the feasibility of a medical device. The purpose of a first-in-human study is to obtain valuable feedback both on the device itself, and the surgical procedure used to implant the device, so that any necessary changes and improvements can be implemented to increase the chances of clinical success.
Dr. Marc Glickman, Hancock Jaffe's Senior Vice President and Chief Medical Officer stated, "I am extremely encouraged by the early feedback that we have received from surgeons who have worked with the CoreoGraft both in animals, and now in humans. Surgeons like the way the CoreoGraft feels, handles, sews, and the simplicity of the product. It is extremely important for doctors to like using a new medical device. Now we will begin to monitor the performance of the device in humans."
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 saphenous veins into multiple grafts, and to use the dissected SVGs 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.
HJLI will provide periodic updates on CoreoGraft patients following the surgeries, as well as additional patient enrollments and scheduled surgeries for the CoreoGraft first-in-human study.
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.
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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.
SOURCE: Hancock Jaffe Laboratories, Inc.