Hancock Jaffe Submits Application to INVIMA for First-In-Human VenoValve Trial in Colombia
IRVINE, Calif., Sept. 24, 2018 (GLOBE NEWSWIRE) -- Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a company specializing in medical devices that restore cardiac and vascular health, announced today that it has completed and submitted its application to INVIMA (the Colombian equivalent of the US FDA) for approval of its first-in-human trial for the VenoValve®. INVIMA is the last regulatory approval that HJLI needs in order to begin its first-in-human testing in Colombia. HJLI expects to receive a response from INVIMA within 60 days.
In order to facilitate the INVIMA application process and its first-in-human trial in Columbia, HJLI has hired Bioaccess™, a U.S. based contact research organization (CRO) that specializes in obtaining regulatory approval and in facilitating clinical trials in Colombia. Bioaccess will continue to provide CRO assistance to HJLI throughout its trial in Colombia.
“The Colombian first-in-human study is a monumental milestone for our company and we are currently on schedule to begin the trial in December of 2018,” said Robert Berman, Hancock Jaffe’s CEO. “Preparation for the Colombia trial entailed an enormous amount of time and effort, and it is a credit to our internal team and the folks at Bioacess, who worked together seamlessly to meet our tight submission schedule.”
Hancock Jaffe is developing the VenoValve to treat severe cases of Chronic Venous Insufficiency (“CVI”) a condition that occurs when the valves in the veins of deep venous system of the leg are injured or destroyed, causing blood to pool in the lower extremities. Severe CVI includes swelling, debilitating pain, and skin ulcerations that become ongoing, open wounds. Approximately 4.5 million people in the U.S. suffer from severe CVI and the U.S. economic burden of venous ulcers from CVI has been estimated to be as high as $38 Billion a year. There are currently no FDA approved treatments for deep venous CVI.
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 Venous 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.
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 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, the performance of the new board members described herein) 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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