Envveno Medical Corporation - NVNO STOCK NEWS

enVVeno Medical (NASDAQ: NVNO), a company focused on venous disease treatment, has participated in the Virtual Investor 'Top 5 for '25' On-Demand Conference. During the event, CEO Robert Berman presented the top five reasons why investors and industry professionals should monitor the company in 2025. The presentation is now available for viewing online through the conference platform and on the company's website in the Investors section under Events.

enVVeno Medical (NASDAQ:NVNO) announced one-year follow-up data from the VenoValve U.S. pivotal trial, showing sustained improvements in venous-specific quality-of-life indicators across 75 subjects. The data will be presented at the 37th Annual Meeting of the American Venous Forum.

The company has submitted a pre-market authorization (PMA) application for VenoValve to the FDA, with a decision expected in the second half of 2025. The VenoValve aims to be the first FDA-approved treatment for deep venous CVI, a debilitating disease affecting millions of patients with no effective treatment options.

Severe CVI, often caused by blood clots in deep leg veins, results in symptoms including leg swelling, pain, edema, and venous ulcers. The condition significantly impacts daily activities and costs the U.S. healthcare system over $4 billion annually.

enVVeno Medical (Nasdaq: NVNO) announced interim two-year follow-up data from the VenoValve U.S. pivotal trial, showing sustained clinical improvement in treating venous disease. Key findings include: 78% of subjects maintained clinically meaningful benefit with an average improvement of 8.2 points in rVCSS at 24 months, a median 75% reduction in pain, and sustained improvements across all venous quality-of-life indicators.

The company submitted a pre-market authorization (PMA) application for VenoValve to the FDA in November 2024, with a decision expected in second half of 2025. Among subjects with core lab-evaluable data at 24 months, a 100% device patency rate was observed in all 27 subjects. The data will be presented at the VESS 2025 Annual Winter Meeting by Dr. Matthew Smeds.

enVVeno Medical (Nasdaq: NVNO) announced the successful completion of final implants in its six-month pre-clinical GLP study for enVVe, their transcatheter-delivered replacement venous valve. The company maintains its timeline for IDE application submission to FDA by mid-2025, pending successful study results. The enhanced enVVe crimping and delivery system has demonstrated consistent performance throughout the study.

The company recently submitted a PMA application for their lead product, VenoValve, seeking FDA approval for U.S. market distribution. They estimate approximately 2.5 million potential new patients annually in the U.S. could be candidates for VenoValve. Beginning early next year, enVVeno will transition from development to commercial stage for VenoValve while completing necessary testing for enVVe.

enVVeno Medical has launched a recap website showcasing its participation at the 51st Annual VEITH Symposium. The website features interviews with patients and Principal Investigators from the VenoValve U.S. Pivotal Trial, along with presented data. The company's CEO, Robert Berman, emphasized the importance of sharing first-hand experiences from physicians and patients. VenoValve is positioned as a potential first-in-class surgical replacement venous valve for severe deep venous CVI, targeting approximately 2.5 million potential new U.S. patients annually. The company is also developing enVVe, a transcatheter-based replacement venous valve.

enVVeno Medical presented one-year data from the VenoValve U.S. pivotal trial at the 51st Annual VEITH Symposium, supporting their recent FDA pre-market authorization application. Key findings include: 85% of subjects achieved clinically meaningful benefit with a 3+ point improvement in revised Venous Clinical Severity Score (rVCSS), 7.91 point average rVCSS improvement among responders, 97% target vein patency rate, 75% median pain reduction, and 87% median ulcer area reduction.

The VenoValve demonstrated effectiveness across all CEAP diagnostic classes, with positive correlation between rVCSS improvement and systemic reflux time. The safety profile showed minimal adverse events, with 94% of subjects experiencing adverse events still achieving clinical meaningful benefit at one year.

enVVeno Medical has submitted its PMA application to the FDA for the VenoValve, seeking marketing and sales approval in the United States. Four out of five modules have been approved, with the final module containing clinical data from the SAVVE pivotal trial and proposed labeling. The FDA-designated breakthrough device aims to treat severe deep venous Chronic Venous Insufficiency (CVI), targeting an estimated 2.5 million U.S. candidates annually. A decision is expected in the second half of 2025. The company is also developing enVVe, a next-generation transcatheter-based replacement venous valve, with pivotal trials expected mid-2025.

enVVeno Medical (NASDAQ:NVNO) reported Q3 2024 financial results and progress on its VenoValve and enVVe programs. The company has submitted 4 out of 5 modules for VenoValve's FDA premarket approval (PMA) application, with the final module containing clinical data scheduled for Q4 2024. The company ended Q3 with $48.4 million in cash and investments after raising $13.6 million in September. Q3 net loss increased 12% to $5.6 million, with quarterly cash burn at $4.3 million. The GLP study for enVVe is underway, with IDE approval filing expected mid-2025.

enVVeno Medical has successfully initiated its six-month pre-clinical GLP study for enVVe, their transcatheter-delivered replacement venous valve. The first wave of implants was completed successfully, with final wave scheduled for December. The company is on track to file for IDE approval for the enVVe pivotal trial by mid-2025. The updated delivery system performed well, with improvements to crimping and delivery systems resulting in consistent valve deployment. The company plans to file its PMA application for VenoValve and release supporting data in Q4 2024, marking its transition from development to commercial stage.