Welcome to our dedicated page for Envveno Medical Corporation news (Ticker: NVNO), a resource for investors and traders seeking the latest updates and insights on Envveno Medical Corporation stock.
enVVeno Medical Corporation (NVNO) is a clinical-stage innovator developing bioprosthetic solutions for chronic venous insufficiency. This page aggregates official updates and analysis on the company's progress with its VenoValve surgical implant and transcatheter enVVe device.
Investors and medical professionals will find timely updates on FDA regulatory milestones, including PMA application progress for the VenoValve and pre-clinical developments for enVVe. The curated news collection focuses on clinically significant events: pivotal trial results, regulatory submissions, and technological advancements in venous disease treatment.
Key updates include developments from the company's ongoing GLP studies, IDE application progress, and data publications demonstrating treatment efficacy. All content is verified through primary sources including SEC filings and clinical trial registries.
Bookmark this page for structured access to NVNO's latest medical device developments, with updates organized chronologically for tracking regulatory and clinical progress. Check regularly for new insights into this innovative approach to venous valve replacement therapies.
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.
enVVeno Medical (NASDAQ:NVNO) has announced the pricing of an underwritten public offering of 4,285,715 shares of its common stock (or pre-funded warrants) at $3.50 per share. The company expects to receive gross proceeds of approximately $15.0 million from the offering, excluding underwriting discounts and other expenses. The offering is expected to close around September 30, 2024.
The company plans to use the net proceeds for the continued development of its two lead products, VenoValve and enVVe, and for general corporate purposes. Titan Partners Group is acting as the sole bookrunner for the offering. enVVeno has granted the underwriter a 30-day option to purchase up to an additional 642,857 shares at the public offering price.
enVVeno Medical (NASDAQ:NVNO) has announced a proposed public offering of common stock and pre-funded warrants. The company plans to grant the underwriter a 30-day option to purchase up to an additional 15% of the offered securities. Titan Partners Group, a division of American Capital Partners, is acting as the sole bookrunner for the offering.
The net proceeds will be used primarily for the continued development of enVVeno's two lead products, VenoValve and enVVe, as well as for general corporate purposes. The offering is subject to market conditions, and there is no assurance regarding its completion or terms.
The securities will be offered under a previously filed shelf registration statement. A preliminary prospectus supplement and accompanying base prospectus will be filed with the SEC.
enVVeno Medical (Nasdaq: NVNO) has appointed Sandy Prietto as Vice President of Marketing, strengthening its commercial team ahead of key milestones. The company, focused on treating venous disease, is preparing for the VenoValve monetization and several Q4 2024 events, including:
1. Completion of PMA submission for FDA approval of VenoValve
2. Release of one-year data from VenoValve U.S. Pivotal Study
3. Initiation of GLP pre-clinical study for enVVe
Ms. Prietto brings extensive experience in medical device marketing and successful product launches. enVVeno's lead product, VenoValve, is a surgical replacement venous valve for severe Chronic Venous Insufficiency (CVI). The company is also developing enVVe, a non-surgical transcatheter-based replacement venous valve. With $39.1 million in cash and investments as of Q2, enVVeno is funded through 2025.
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