Envveno Medical Corporation Stock Price, News & Analysis

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.

enVVeno Medical (NASDAQ:NVNO), a company focused on deep venous disease treatment, will participate in the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech. The virtual presentation will be delivered by CEO Robert Berman on Thursday, August 21, 2025, at 2:00 PM ET.

The event is part of a broader virtual conference series for biotech and medical technology companies being held from August 19-21, 2025.

enVVeno Medical (NASDAQ:NVNO) has announced promising results from a health economic study of its VenoValve, a first-in-class surgical replacement venous valve for severe Chronic Venous Insufficiency (CVI). The study demonstrates significant cost-effectiveness, with $32,442 in savings per patient over 5 years compared to standard care.

Key clinical benefits include 2.2 ulcers avoided per patient and 0.33 additional quality-adjusted life years (QALYs) gained. The device could potentially save $5.9 billion annually in healthcare costs for approximately 2.5 million U.S. patients with severe CVI. The company has submitted a PMA application to the FDA, with a decision expected in H2 2025.

enVVeno Medical (NASDAQ:NVNO) participated in a Virtual Investor segment discussing how former President Trump's Chronic Venous Insufficiency (CVI) diagnosis could impact awareness of their VenoValve treatment. The company's CEO Rob Berman and CMO Dr. Marc Glickman discussed the condition's progressive nature and potential treatment options.

The company's VenoValve targets approximately 2.5 million potential patients in the U.S. suffering from severe deep CVI. enVVeno has submitted a pre-market authorization (PMA) application to the FDA, with a decision expected in the second half of 2025.

enVVeno Medical (NASDAQ:NVNO) reported Q2 2025 financial results and provided updates on its deep venous disease treatment programs. The company ended Q2 with $35.1 million in cash and investments, sufficient to fund operations through Q3 2026. Q2 cash burn was $3.8 million, with net losses increasing to $6.7 million, up 35% year-over-year.

Key clinical updates include the VenoValve® PMA application under FDA review with a decision expected in 2H'2025, and the enVVe® program progressing toward IDE submission in 2H'2025. The company presented positive two-year interim data for VenoValve at the SVS 2025 Vascular Annual Meeting and completed pre-clinical studies for enVVe.

enVVeno Medical (NASDAQ:NVNO), a company focused on deep venous disease treatment, announced its participation in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference. CEO Rob Berman presented at the conference, sharing insights about his leadership journey and his passion for the company's products under development.

The presentation is now accessible on-demand through virtualinvestorco.com and the Events section of enVVeno's website.

enVVeno Medical (NVNO) reported positive interim 2-year data from its VenoValve pivotal trial, showing sustained clinical improvements in patients with severe deep venous CVI. Key findings include: 83.3% of subjects maintained clinically meaningful benefit with 3+ point improvement in rVCSS, 9.1 point average rVCSS improvement in responder cohort, and 74% median improvement in leg pain. The trial also demonstrated 60% complete healing of ulcers, with 100% valve patency rate among 30 subjects. The VenoValve, a potential first-in-class surgical replacement venous valve, targets approximately 2.5 million potential new U.S. patients annually. The company has submitted a PMA application to the FDA, with a decision expected in H2 2025.