Hancock Jaffe Announces Date for VenoValve Pre-IDE Meeting with FDA

Rhea-AI Summary

Hancock Jaffe Laboratories (NASDAQ:HJLI) announced a Pre-IDE meeting with the FDA on December 22, 2020 to discuss the pivotal trial for their VenoValve device, which addresses Chronic Venous Insufficiency (CVI). The meeting will cover design, functionality, and trial protocols. The company aims to integrate FDA feedback into its IDE application, anticipated for submission in Q1 2021. Approximately 2.4 million Americans suffer from CVI, leading to significant medical costs exceeding $38 billion annually, highlighting the need for effective treatment options.

Positive

• Scheduled Pre-IDE meeting with FDA for December 22, 2020 to discuss VenoValve trial.
• Potential to expedite IDE application expected in Q1 2021.
• Addresses significant medical need as CVI currently has no FDA-approved treatments.

Negative

• Dependence on FDA feedback for IDE application may delay trial initiation.
• No FDA-approved devices currently available for CVI, indicating high competition and risk.

Meeting with FDA Set for December 22

IRVINE, CA / ACCESSWIRE / November 5, 2020 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that the Pre-IDE meeting with the U.S. Food and Drug Administration ("FDA") regarding the VenoValve U.S. pivotal trial has been set for December 22, 2020.

Topics to be discussed at the December 22 virtual meeting with the FDA include the VenoValve design and functionality, the protocol for the U.S. pivotal trial (e.g. sample size, study design, endpoints, performance goals, safety), and HJLI's non-clinical testing plan for the VenoValve. HJLI expects to incorporate feedback from the FDA into its IDE application, which it hopes to file in the first quarter of 2021. 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.

Robert Berman, Hancock Jaffe's CEO, stated "Our goal was to meet with the FDA before the end of the year with sufficient time to incorporate any FDA feedback into our IDE application. Our team has been working extremely hard on all of the VenoValve non-clinical functional and safety testing that is required by the FDA to be included in the IDE application and we hope the meeting will lead to a smoother and faster IDE approval process."

On October 27, 2020, HJLI announced that it had filed a Pre-IDE filing with the FDA and had requested a meeting. The Pre-IDE submission included 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 included 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.

Next steps for the VenoValve include the continued monitoring of the remaining two VenoValve patients in our first-in-human study, 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 VenoValveÒ, 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 CoreoGraftÒ, 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.

CONTACT:

Investor Relations
Investorrelations@hancockjaffe.com

SOURCE: Hancock Jaffe Laboratories, Inc.

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FAQ

What is the purpose of Hancock Jaffe's December 22 meeting with the FDA regarding HJLI?

The meeting is set to discuss the design, functionality, and trial protocols for the VenoValve pivotal trial.

When does Hancock Jaffe plan to file its IDE application for the VenoValve?

Hancock Jaffe expects to file the IDE application in the first quarter of 2021.

What condition does the VenoValve treat and how prevalent is it in the U.S.?

The VenoValve is intended to treat Chronic Venous Insufficiency, which affects approximately 2.4 million people in the U.S.

What are the expected costs associated with Chronic Venous Insufficiency in the U.S.?

Direct medical costs from Chronic Venous Insufficiency in the U.S. exceed $38 billion annually.