Welcome to our dedicated page for Envveno Medical news (Ticker: NVNO), a resource for investors and traders seeking the latest updates and insights on Envveno Medical stock.
enVVeno Medical Corporation develops bioprosthetic venous valve devices for severe deep chronic venous insufficiency in the United States. News about NVNO centers on the company’s enVVe System, a minimally invasive transcatheter replacement venous valve, and its TAVVE pivotal study under FDA investigational device exemption approval.
Recurring updates also cover the VenoValve surgical replacement venous valve, FDA communications tied to device review, clinical-development planning, cash runway and operating losses, Nasdaq listing compliance, shareholder-approved capital-structure actions such as the reverse stock split, and investor communications from this late clinical-stage medical device issuer.
enVVeno Medical (NASDAQ:NVNO) received the first-ever FDA IDE approval to begin a U.S. pivotal study (TAVVE) of its minimally invasive enVVe system, a non-surgical replacement venous valve for severe deep Chronic Venous Insufficiency (CVI). Clinical site activation and enrollment are expected later in 2026. The company cites an addressable U.S. population of ~3 million patients and a potential multi-billion-dollar market. enVVeno reported approximately $25 million in cash and investments, funding operations into Q3 2027.
enVVeno Medical (NASDAQ:NVNO) reported full-year 2025 results and strategic progress on its next‑generation enVVe System. Pre-clinical development is complete and the company is in active FDA discussions to initiate a pivotal trial in 2026. Cash and investments were $28.2M at year-end, with an expected 2026 burn of $4–5M per quarter, providing runway into mid‑2027 if key clinical milestones are met. 2025 net loss narrowed to $19.5M from $21.8M in 2024; R&D expense was $10.0M (down 19%), and SG&A was $10.9M.
enVVeno Medical (NASDAQ:NVNO) regained compliance with Nasdaq Listing Rule 5550(a)(2) after its common stock maintained a closing bid of at least $1.00 for 10 consecutive business days, from January 20, 2026 through February 2, 2026. Nasdaq confirmed the matter is closed.
The company reported year-end cash and investments of approximately $28 million as of December 31, 2025 and said it has made meaningful progress on its 2026 strategic plans, with additional details expected in the coming weeks.
enVVeno Medical (NASDAQ:NVNO) announced a reverse stock split at a 1-for-35 ratio, effective 12:01 a.m. ET on January 20, 2026. Post-split trading on The Nasdaq Capital Market under the existing symbol NVNO will begin on January 20, 2026, and the company will use a new CUSIP 29415J205.
Shareholders approved the Reverse Stock Split at the annual meeting on December 11, 2025. The split will combine every 35 pre-split shares into one post-split share, reducing outstanding common stock from approximately 22.9 million to approximately 655 thousand. No fractional shares will be issued; cash will be paid in lieu of fractions. Equity awards and warrants will be adjusted accordingly.
enVVeno Medical (NASDAQ:NVNO) announced that CEO Robert Berman will appear in a Live Virtual Investor CEO Connect segment on Wednesday, December 3, 2025 at 4:00 PM ET. The moderated webcast will include a corporate overview, discussion of recent news and next steps, and a live Q&A where Mr. Berman will answer as many questions as time allows. A live video webcast will be available on the company Events page at www.envveno.com. A replay will be posted two hours after the live event and will remain accessible for 90 days.
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.
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.
enVVeno Medical (NASDAQ:NVNO) announced its CEO Robert Berman's participation in a Virtual Investor "What This Means" segment. During the presentation, Berman discussed the company's recent supervisory appeal request to the FDA following a not-approvable letter for their VenoValve® device.
The not-approvable letter was received on August 19, 2025 from the FDA's Center for Devices and Radiological Health (CDRH) regarding the Premarket Approval (PMA) application for VenoValve®, a surgical replacement venous valve designed to treat severe deep chronic venous insufficiency (CVI).
enVVeno Medical (NASDAQ:NVNO) announced plans to file a supervisory appeal following FDA's not-approvable letter for its VenoValve® Premarket Approval (PMA) application. The appeal must be filed by September 18, 2025, challenging the FDA's August 19 decision regarding this surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI).
The company maintains a positive outlook based on its previous Breakthrough Device Designation and collaborative history with the FDA. The appeal process will involve formal requests, in-person meetings, and multiple interactions. A decision is expected by end of 2025. The VenoValve targets 2.5 to 3.5 million U.S. patients suffering from severe deep venous CVI who currently lack effective treatment options.
enVVeno Medical (NASDAQ:NVNO) has received a not-approvable letter from the FDA for its VenoValve® PMA application, a surgical replacement venous valve designed to treat severe deep chronic venous insufficiency (CVI). The FDA determined that the clinical improvement data was insufficient to establish a favorable benefit-risk profile.
The FDA cited concerns about the lack of specific hemodynamic measurements correlating with patient improvement and raised safety issues related to the surgical procedure requiring re-hospitalizations. Despite showing improvements in revised Venous Clinical Severity Score (rVCSS), pain scores, and quality of life indicators, the FDA suggested potential study bias.
The company is evaluating options, including potential FDA discussions for resubmission or appeal, while continuing development of enVVe, its non-surgical replacement venous valve alternative.