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

Rhea-AI Summary

enVVeno Medical (NASDAQ:NVNO) reported third quarter 2025 results and a corporate update on October 31, 2025.

The company ended Q3 with $31.0 million in cash and investments, which it says could fund operations through Q2 2027 excluding potential VenoValve commercialization and enVVe IDE costs. Q3 cash burn was $4.2 million, in line with the projected $4–5 million quarterly range. Net loss for the three months ended September 30, 2025 was $4.5 million, down 20% from $5.6 million a year earlier.

Regulatory update: enVVeno filed a supervisory appeal of a not-approvable PMA decision for VenoValve, completed an in-person appeal meeting, and expects a decision before year-end 2025. The enVVe program completed final short-term GLP testing and other IDE-related testing and is targeting an IDE filing after clarity from the VenoValve appeal.

Positive

• Cash and investments of $31.0 million
• Cash runway estimated through Q2 2027 excluding commercialization/IDE costs
• Net loss improved 20% to $4.5M year-over-year
• Completed final short-term GLP wave and IDE-related testing for enVVe

Negative

• Not-approvable PMA decision for VenoValve leading to a supervisory appeal
• VenoValve commercialization and enVVe IDE costs currently on hold pending FDA clarity

Insights

Senior Medical Device Analyst

enVVeno reports a neutral operational update: cash runway to Q2 2027 and an ongoing FDA supervisory appeal for the VenoValve with a decision expected by year-end 2025.

enVVeno Medical holds $31.0 million in cash and investments and reported quarterly cash burn of $4.2 million, in line with the stated $4-5 million quarterly range. Net loss narrowed to $4.5 million from $5.6 million, a 20% improvement driven by a $1.3 million reduction in operating expenses. These figures imply the company can fund current operations without commercialization or the IDE study costs through Q2 2027.

The principal dependency is the FDA supervisory appeal outcome for the VenoValve; the company paused commercialization and the enVVe IDE expenses pending clarity. If the appeal fails or requires extensive additional data, expected costs and timelines will rise; if it yields a viable path, the company may resume higher-spend activities. The reported facts show progress on the appeal (in-person meeting, patient and investigator participation) but do not confirm a favorable regulatory result.

Key watch items: the FDA decision expected before year-end 2025, any change to cash burn when commercialization or the IDE restarts, and the final consolidated report for the enVVe preclinical package supporting an IDE filing. Near-term material moves will center on the appeal outcome and any accompanying FDA conditions; monitor those items over the next six months.

- 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
NVNO@jtcir.com
(908) 824-0775

MEDIA CONTACT:
Glenn Silver, FINN Partners
Glenn.Silver@finnpartners.com
(973) 818-8198

SOURCE: enVVeno Medical Corporation

View the original press release on ACCESS Newswire

FAQ

How much cash did enVVeno Medical (NVNO) report at the end of Q3 2025?

The company reported $31.0 million in cash and investments at quarter end.

What is enVVeno's reported cash burn for Q3 2025 and its projected quarterly range?

Q3 cash burn was $4.2 million, within the company's projected $4–5 million per quarter range.

What runway did enVVeno (NVNO) state its cash could cover as of October 31, 2025?

Management said current capital could fund operations through Q2 2027 excluding VenoValve commercialization and enVVe IDE costs.

What is the status of the VenoValve PMA for enVVeno (NVNO) as of October 31, 2025?

enVVeno filed a supervisory appeal of a not-approvable PMA decision, completed an in-person appeal meeting, and expects a decision before year-end 2025.

Has enVVeno completed preclinical work for the enVVe IDE filing?

Yes; the company completed the final short-term GLP wave and other testing required for an IDE filing and is targeting an IDE submission after VenoValve appeal clarity.

How did enVVeno's net loss for Q3 2025 compare to Q3 2024?

Net loss for Q3 2025 was $4.5 million, down from $5.6 million in Q3 2024, a 20% decrease.