First-Ever FDA IDE Approval for a U.S. Pivotal Study of a Non-surgical Replacement Venous Valve

IDE approval positions enVVeno to advance what could become the first effective treatment option for the approximately 3 million U.S. patients suffering from DVI

Watch the "What This Means" video here

IRVINE, CA / ACCESS Newswire / May 12, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today announced that Robert Berman, Chief Executive Officer of enVVeno Medical participated in a Virtual Investor "What This Means" segment.

As part of the segment, Mr. Berman discussed the Company's recent news announcing the U.S. Food and Drug Administration's (FDA) first-ever IDE approval awarded to enVVeno to proceed with a U.S. pivotal study of a non-surgical replacement venous valve.

The Virtual Investor "What This Means" segment featuring enVVeno Medical is now available here.

About enVVeno Medical Corporation

enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, 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 deep venous disease. The Company is currently developing the enVVe system, which includes a first-in-class non-surgical replacement venous valve being developed for the treatment of severe Deep Venous Insufficiency (DVI). The enVVe valve is designed to act as one-way valve, to help assist in propelling blood up the leg, and back to the heart and lungs. As a transcatheter delivered device, the enVVe procedure will be performed under light sedation and should not require an over-night hospital stay.

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.

INVESTOR CONTACT:
JTC Team, LLC
Jenene Thomas
NVNO@jtcir.com
(908) 824-0775

SOURCE: enVVeno Medical Corporation

View the original press release on ACCESS Newswire

enVVeno Medical Discusses FDA IDE Approval in Virtual Investor "What This Means" Segment