enVVeno Receives Unfavorable Appeal Decision from the FDA for the VenoValve
Rhea-AI Summary
enVVeno Medical (NASDAQ:NVNO) announced an unfavorable FDA supervisory appeal decision dated November 13, 2025, upholding a not-approvable letter issued on August 19, 2025 for its surgical VenoValve device because it did not meet the standard of reasonable assurance of safety and effectiveness.
The company said it will shift focus to its next-generation transcatheter valve, enVVe, which it views as having a different safety profile and as ready for human testing pending alignment with the FDA on endpoints. The company reported $31.5 million in cash and investments at Q3-end and a quarterly cash burn of $4–5 million, which it says funds operations into 2027.
Positive
- Cash and investments of $31.5M at Q3-end
- Quarterly cash burn of $4–5M, runway into 2027
- Plan to advance enVVe toward human testing pending FDA alignment
Negative
- FDA supervisory appeal upheld not-approvable decision for VenoValve
- VenoValve failed to meet FDA standard for reasonable assurance of safety and effectiveness
News Market Reaction – NVNO
On the day this news was published, NVNO declined 35.68%, reflecting a significant negative market reaction. Argus tracked a trough of -37.8% from its starting point during tracking. Our momentum scanner triggered 14 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $7M from the company's valuation, bringing the market cap to $13M at that time. Trading volume was elevated at 2.7x the daily average, suggesting increased selling activity.
Data tracked by StockTitan Argus on the day of publication.
IRVINE, CA / ACCESS Newswire / November 13, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it has received an unfavorable decision from the U.S. Food & Drug Administration ("FDA") in response to its supervisory appeal of the not-approvable letter it received on August 19, 2025 in response to its Premarket Approval (PMA) application for VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI). The supervisory appeal upheld the review staff decision in the not-approvable letter that the VenoValve did not meet the standard of reasonable assurance of safety and effectiveness.
"Although the appeal decision was not the result we are looking for, it did provide valuable insight into the criteria that would be necessary for approval of enVVe, our next generation transcatheter based replacement venous valve," said Robert Berman, enVVeno Medical's Chief Executive Officer. "enVVe should have a different safety profile than an open surgical device and is ready for human testing. Assuming that we can reach alignment with the Agency on achieveble endpoints for enVVe, it makes sense to turn our attention and devote our resources to enVVe. We will continue to interact with the FDA on enVVe and will provide periodic updates on our progress."
The Company reported
Severe, deep venous Chronic Venous Insufficiency (CVI) is a debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. The disease can severely impact everyday functions such as sleeping, bathing, dressing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence. Estimates indicate that there are approximately 2.5 million to 3.5 million patients with severe deep venous CV I in the U.S. including approximately 1.5 million patients that develop venous leg ulcers (C6 patients). The average patient seeking treatment of a venous ulcer spends as much as
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 is developing surgical and non-surgical replacement venous valves for the treatment of deep venous CVI.
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
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
What did enVVeno (NVNO) announce on November 13, 2025 about the VenoValve?
How much cash did enVVeno (NVNO) report and how long is the runway?
What is enVVeno's next regulatory plan after the FDA decision on VenoValve (NVNO)?
Did the FDA approve VenoValve for severe deep chronic venous insufficiency (NVNO)?
What clinical unmet need does enVVeno (NVNO) target with its valves?
Will enVVeno (NVNO) provide updates on enVVe development?
