enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval

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enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval

Nov 19, 2024

Definitive One Year Data from PMA Application to be Presented Wednesday at 51st Annual VEITH Symposium

Company to Host a Conference Call with the PIs Presenting the Pivotal Trial Data on Wednesday, November 20^th at 2:00 PM Eastern Time - Click Here to Access

IRVINE, CA / November 19, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced it has submitted its application with the U.S. Food and Drug Administration (FDA) seeking approval to market and sell the VenoValve in the United States. Four (4) out of five (5) modules that comprise the VenoValve PMA application have been submitted, reviewed and approved by the FDA. The fifth and final module of the application contains the clinical data from the SAVVE pivotal trial as well as proposed labeling for the device.

"We are thrilled to get this last step of the PMA review process underway and look forward to further interactions with the FDA," said Robert Berman, enVVeno Medical's Chief Executive Officer. "It is difficult to predict precisely how long the PMA process will take, but we expect to learn more and potentially have a decision in the second half of 2025."

The VenoValve, which has been designated as a breakthrough device by the FDA and is therefore subject to priority review, is intended to treat severe deep venous Chronic Venous Insufficiency (CVI), a debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension).

Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for deep venous CVI and the company estimates that there are approximately 2.5 million candidates each year in the U.S. for the VenoValve.

The Company is also developing a next-generation, non-surgical transcatheter based replacement venous valve called enVVe, which could appeal to an even larger market in terms of both patients and physicians. The Company expects enVVe to be ready for its own pivotal trial during the middle of 2025.

Definitive data that supports the VenoValve PMA application will be presented Wednesday, November 20, 2024, at the 51^st Annual Vascular and Endovascular, Techniques and Horizons (VEITH) Symposium in New York City. Following Wednesday's presentation, the Company will host a live video conference call with the PI Presenters at 2:00 PM Eastern Time. To access the call visit the Events page on the Investor section of the Company's website or click here.

About enVVeno Medical Corporation

enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. The Company's lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe®. CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal and become chronic. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the SAVVE U.S. pivotal study and the company is currently performing the final testing necessary to seek approval for the enVVe pivotal trial.

Cautionary Note on Forward-Looking Statements

This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (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 and timing (may differ significantly from those set forth or implied in the forward-looking statements. 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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INVESTOR CONTACT:

Jenene Thomas, JTC Team, LLC
[email protected]
(908) 824-0775

SOURCE: enVVeno Medical Corporation

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