enVVeno Medical Reports First Quarter 2026 Financial Results and Provides Business Update Highlighting Strategic Advancement of the enVVe System

"With a strong balance sheet, significant physician interest in the enVVe valve, and a clearly defined regulatory pathway, we are well positioned to execute the TAVVE study and advance the Company towards multiple near-term and long-term milestones," said Robert Berman, Chief Executive Officer of enVVeno Medical.

Landmark FDA IDE Approval for TAVVE Study

In April 2026, enVVeno Medical announced that the U.S. Food and Drug Administration (FDA) granted IDE approval for the Company's Transcatheter Venous Valve Endoprosthesis (TAVVE) pivotal study, marking the first-ever FDA approval for a U.S. pivotal study of a non-surgical replacement venous valve. The study will evaluate the Company's minimally invasive enVVe® System for the treatment of patients with severe deep chronic venous insufficiency (CVI), a condition affecting approximately 3 million patients in the United States with limited treatment options.

Summary of Financial Results for the First Quarter 2026

Cash and investments totaled $24.9 million as of March 31, 2026, compared to $28.2 million as of December 31, 2025. The Company believes its current cash and investment resources are sufficient to fund operations into the third quarter of 2027, including advancement of the TAVVE pivotal study.

Cash burn for the first quarter was $3.3 million, consistent with the Company's projected cash burn rate of approximately $3 million to $4 million per quarter. The Company anticipates that its cash burn rate may increase to approximately $4 million to $5 million per quarter in 2026 as it prepares for and initiates the TAVVE pivotal study.

Net loss for the first quarter of 2026 was $3.8 million, or a net loss of $5.89 per basic and diluted common share, compared to a net loss of $4.5 million, or a net loss of $7.75 per basic and diluted common share, in the first quarter of 2025.

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:

Jenene Thomas, JTC Team, LLC