Hancock Jaffe Engages Syntactx for VenoValve U.S. Pivotal Trial
Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI) has engaged Syntactx LLC to support its VenoValve U.S. pivotal trial. Syntactx will help with strategy, clinical operations, regulatory affairs, and safety as HJLI prepares for trial approval. The partnership involves industry experts with extensive experience in vascular devices. HJLI is currently preparing a Pre-IDE submission for the FDA, expecting to meet with the agency in late 2020 or early 2021. Approximately 2.4 million people in the U.S. suffer from chronic venous insufficiency (CVI), which has significant healthcare costs.
- Engagement of Syntactx enhances regulatory and clinical trial support.
- Syntactx has a strong track record with vascular devices.
- VenoValve shows promising results in first-in-human trials.
- No FDA approved devices currently exist for deep venous CVI.
- Potential delays in FDA interactions may impact trial timelines.
Syntactx to provide CRO Services
IRVINE, CA / ACCESSWIRE / October 8, 2020 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that it has engaged Syntactx LLC to assist Hancock Jaffe with the VenoValve U.S. pivotal trial. Syntactx will work with Hancock Jaffe in several key areas including strategy, clinical operations, regulatory affairs, and safety, as the company prepares for, seeks approval, and conducts the U.S. pivotal trial for the VenoValve.
Founded in 2010, Syntactx is considered to be the preeminent contract research organization for vascular devices, and includes Dr. Kenneth Ouriel, the former Chairman of Surgery at the Cleveland Clinic, Dr. Mark Adelman, former Professor and Chief of Vascular and Endovascular Surgery at New York University Langone Medical Center, and Dorothy Abel, who spent over 30 years evaluating vascular and endovascular devices with the Center for Devices and Radiological Health at the U.S. Food and Drug Administration ("FDA"),
Dr. Marc Glickman, Hancock Jaffe's Senior Vice President and Chief Medical Officer stated, "I have known Ken, Mark, and Dorothy professionally for many years and believe that Syntactx has assembled a world class team with unparalleled experience and success in guiding vascular devices through the regulatory and clinical approval processes."
Dr. Kenneth Ouriel, Syntactx President and CEO stated, "As a vascular surgeon, I am very familiar with the debilitating impact of deep venous chronic venous insufficiency ("CVI") and the many failed attempts to address the disease over the years. I am impressed with the clinical success that Hancock Jaffe has reported regarding its first-in-human trial. I am excited for Syntactx to partner in a U.S. pivotal trial for a product that could be transformational in the treatment of vascular disease."
HJLI is currently preparing a Pre-IDE submission for the FDA and expects to meet with the FDA in the late fourth quarter of 2020 or early first quarter of 2021 to discuss several issues related to the VenoValve U.S. pivotal trial. The company expects to file an IDE application seeking approval from the FDA for the U.S. pivotal trial in Q1 of 2021. Syntactx will assist HJLI with its submissions and interactions with the FDA.
CVI occurs when the valves in the veins of the leg are injured or destroyed, causing blood to flow backwards, which is known as reflux. Reflux results in increased venous pressure (venous hypertension), damage to the veins, and results in the pooling of blood in the lower leg. Deep venous CVI is a serious condition, often resulting in debilitating pain, swelling, and open sores (venous ulcers) on the lower leg.
The VenoValve is a porcine based bioprosthetic device that is implanted in the deep femoral vein of CVI sufferers. During HJLI's first-in-human trial, the VenoValve has demonstrated the potential to improve reflux, alleviate disease manifestations ("VCSS scores"), reduce pain ("VAS Scores"), promote venous ulcer healing, and to improve the quality of the lives of VenoValve patients ( in patients' quality of live ("VEINES Scores"). HJLI has reported one-year results for eight patients and will be reporting on the final three patients in the first-in-human trial which will conclude at the end of 2020.
Approximately 2.4 million people in the U.S. suffer from CVI due to reflux in the deep venous system. Estimates indicate that direct medical costs from CVI in the U.S. exceed
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, 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.
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