enVVeno Medical Reports Third Quarter 2025 Financial Results and Provides Corporate Update

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- Cash and investments are sufficient to fund current operations through Q2 2027, not including VenoValve commercialization and the enVVe IDE study

- Cash burn of $4.2 million in Q3 remains in line with projected quarterly range

- Ongoing engagement with FDA for supervisory appeal of the VenoValve PMA decision with feedback expected by the end of 2025

IRVINE, CA / ACCESS Newswire / October 31, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno Medical" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today reported financial results for the third quarter 2025.

Summary of Financial Results for the Third Quarter 2025

The Company ended the quarter with $31.0 million in cash and investments. With the VenoValve commercializations costs and enVVe IDE expenses currently on hold pending resolution with the FDA, this capital has the potential to fund the Company through the second quarter of 2027. The Company expects its cash burn rate to increase from current levels in the event the Company proceeds to commercialization of the VenoValve and the IDE study with enVVe.

Cash burn for the quarter was $4.2 million, consistent with the Company's projected cash burn rate of approximately $4-5 million per quarter.

The Company reported net losses of $4.5 million and $5.6 million for the three months ended September 30, 2025 and 2024, respectively, representing a decrease in net loss of $1.1 million, or 20%, due to a decrease in operating expenses of $1.3 million, partially offset by a decrease in other income of $0.2 million.

"We are well capitalized and should have sufficient capital to cover the period of our ongoing discussions with the FDA seeking a potential commercial path forward for the VenoValve and clarity for the enVVe IDE study," commented Robert Berman, CEO of enVVeno Medical. "Our recent in-person appeal meeting with the FDA provided a focused setting to address the concerns outlined in the not-approvable letter, including safety concerns raised by the FDA, proposed mitigations, the VenoValve's effectiveness, and also provided the opportunity for the Agency to hear directly from one of our primary investigators and a patient from the VenoValve study. We look forward to our continued interactions with the FDA and remain committed to the 2.5 million patients suffering from severe deep chronic venous insufficiency."

Clinical Program Progress

VenoValve®: Novel, First-In-Class Surgical Replacement Venous Valve

• Filed a request for supervisory appeal of the not-approvable letter from the Center for Devices and Radiological Health (CDRH) received on August 19, 2025, in response to its Premarket Approval (PMA) application for the VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI)

• Completed the in-person appeal meeting with the FDA. Participants included a patient as well as one of the primary investigators from VenoValve U.S. pivotal study

• Decision from this stage of the appeal expected before year end 2025

enVVe®: Novel, First-In-Class Non-Surgical Transcatheter-Based Replacement Venous Valve

• Successfully completed final wave for the shorter-term subjects in 6-month pre-clinical GLP study

• Successfully completed other testing necessary for IDE filing and awaiting the final consolidated study report

• Targeting IDE filing for enVVe pivotal trial following clarity gained from VenoValve appeal process

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 deep 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®. 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.

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

MEDIA CONTACT:

Glenn Silver, FINN Partners

[email protected]

(973) 818-8198

SOURCE: enVVeno Medical Corporation