Hancock Jaffe Enrolls Two Additional Patients for First-in-Human VenoValve Study
Implantations Expected to Take Place Later this Month
IRVINE, CA / ACCESSWIRE / June 3, 2019 / Hancock Jaffe Laboratories, Inc. (NASDAQ: HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health, announced today that it has enrolled two additional patients for its VenoValve® first-in-human study in Bogota, Colombia. HJLI expects to implant VenoValves in the two additional patients by the end of June, 2019.
Robert Berman, Hancock Jaffe's Chief Executive Officer stated, "We have now enrolled seven patients for our first-in-human Bogota trial. We will continue screening patients and hope to enroll the remaining patients and complete the remaining implantations for the first phase of the trial within the next few months."
The initial phase of the first-in-human Colombian study will include up to ten patients who suffer from severe, chronic venous insufficiency (CVI) of the deep vein system. The VenoValve is being tested to reduce deep venous reflux, a major cause of CVI. The reduction of reflux will lower venous hypertension, with the goal of improving the quality of lives for patients suffering from deep venous CVI. In addition to measuring reflux, endpoints for the first-in-human VenoValve study include VCSS measurements, VAS scores, and VEINES scores, three well known clinical assessments for venous disease and assessments of improvement in the patient's quality of life and reduction in pain.
The purpose of the first-in-human study is to provide HJLI with valuable feedback to make any necessary product modifications or adjustments to the surgical implantation procedure for the VenoValve. HJLI expects to use the data from its first-in-human study in Bogota as part of its Investigational Device Exemption ("IDE") application which will be submitted to the U.S. Food and Drug Administration ("FDA") to begin the VenoValve U.S. pivotal trial.
HJLI will continue to provide updates on patient enrollment and additional VenoValve implantations. HJLI also recently announced that on June 7, 2019, it will report initial data on the first five patients that received VenoValves, and will present a case management report at the Expert Venous Management ("EVM") Conference at the Englewood Hospital Medical Center in Englewood, New Jersey.
Approximately 2.4 million patients in the U.S. suffer from CVI due to reflux in the deep venous system, and there are currently no FDA approved treatments for the disease.
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.
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, 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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SOURCE: Hancock Jaffe Laboratories, Inc.
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Released June 3, 2019