Requests Pre-IDE Meeting with FDA
IRVINE, CA / ACCESSWIRE / October 27, 2020 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that it has submitted a Pre-IDE filing to the U.S. Food and Drug Administration ("FDA") and has requested a meeting with the FDA to discuss a few key matters in advance of the filing of its IDE application for the VenoValve U.S. pivotal trial.
An investigational device exemption or IDE allows a medical device to be used to collect safety and effectiveness data as part of a clinical study such as a pivotal trial. Upon successful completion of the pivotal trial, the next step is to file a premarket approval application or PMA, to begin commercialization of the device. It is not uncommon for companies to file a Pre-IDE submission and to request a Pre-IDE meeting with the FDA, in anticipation of filing an IDE application. Based in part on the outcome of the Pre-IDE meeting, HJLI expects to be in a position to file the IDE application for the VenoValve in the first quarter of 2021.
The Pre-IDE submission includes a synopsis of HJLI's proposed parameters for the VenoValve U.S. pivotal trial including patient exclusion and inclusion criteria, the number of sites, the size of the study, primary and secondary endpoints, and performance and safety goals. The submission also includes a summary of the results from the VenoValve first-in-human trial. Additional sections of the Pre-IDE filing address the clinical need for the VenoValve, the design concept and functionality of the device, manufacturing and quality control processes, and HJLI's strategy for complying with the myriad of non-clinical testing (e.g. biocompatibility, durability, fatigue, hydrodynamic performance, sterilization, etc.) and animal safety testing required by the FDA as part of the IDE application process.
Robert Berman, Hancock Jaffe's CEO, stated "Our goal is to meet and consult with the FDA on a few key areas prior to the filing of our IDE application with the hope of setting the stage for a smoother application process. We have all been looking forward to the time when we will be ready to file the application for VenoValve U.S. pivotal trial and we are excited to be approaching that important milestone."
Next steps for the VenoValve include the continued monitoring of the remaining two VenoValve patients in our first-in-human study, a Pre-IDE meeting with the FDA, the completion of functional testing and a GLP animal safety study mandated by the FDA, and the filing of the IDE application with the FDA for the VenoValve U.S. pivotal trial.
The VenoValve treats a condition known as Chronic Venous Insufficiency ("CVI"). CVI occurs when the valves in the veins of the leg are injured or destroyed, causing blood to flow backwards (reflux), resulting in increased pressure in the veins (venous hypertension). Deep venous CVI is a serious condition, often resulting in debilitating pain, swelling, and open sores (venous ulcers) on the lower leg.
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 $38 Billion a year. There are currently no FDA approved devices, or effective treatments for deep venous CVI.
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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