Hancock Jaffe Laboratories to Conduct Analysis for FDA Submission Package for Bioprosthetic Heart Valve
IRVINE, Calif., July 11, 2018 (GLOBE NEWSWIRE) -- Hancock Jaffe Laboratories, Inc. (Nasdaq:HJLI) (Nasdaq:HJLIW), a company specializing in bioprosthetic medical devices to establish improved standards of care for treating cardiac and vascular diseases, today announced that it has initiated an analysis of its bioprosthetic heart valve in order to determine what additional testing is needed in order to submit an Investigational Device Extension (IDE) application to the United States Food and Drug Administration (FDA).
The company has engaged Michael Nilo of Nilo Medical Consulting Group, to assist with the initial regulatory analysis. Mr. Nilo has significant insider experience with the FDA, having worked as a lead reviewer with the FDA’s cardiac medical device review team. The company has also retained Boston MedTech Advisors, which in addition to its expertise with the FDA and regulatory agencies throughout the world, also specializes in competitive market analyses and strategies for medical device development and commercialization.
“Prior to our IPO, we indicated our intention to move forward with the development of each of our 3 products,” said Robert Berman, Hancock Jaffe’s CEO. “We are beginning to execute that strategy and expect to achieve multiple milestones for each of our products in the coming months.”
While suitable for patients of all ages, Hancock Jaffe’s smaller diameter, porcine tissue-based bioprosthetic heart valve, addresses the specific needs of pediatric patients undergoing valve replacements for congenital and/or acquired cardiac valve disease. The heart valve makes use of titanium wires embedded within the wall of the bioprosthetic valve itself, eliminating the need for externally supporting structures commonly referred to as stents. Hancock Jaffe’s unique, stentless design enables a larger valve to be placed in the patient’s annulus, the site of the inflow of the patient’s original valve. Preclinical studies have demonstrated that the internalization of the supporting structures greatly increases the volume of blood with each heartbeat. The combination of reduced size and increased output makes the bioprosthetic heart valve an ideal candidate for pediatric patients who would otherwise need multiple valve replacement surgeries to implant successively larger heart values to accommodate growth.
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, is an ideal candidate for pediatric aortic/mitral valve replacement.
Forward-Looking Statements: Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Hancock Jaffe Laboratories, Inc.’s current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Risk Factors" and other sections of our S-1. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.
HJLI Press Contacts:
Robert Berman, CEO
Tel: 949-261-2900
Email:
Jules Abraham
CoreIR
Tel: 917-885-7378
Email:
