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 Corporation (NASDAQ:NVNO) has appointed Jennifer Bright as Chief Financial Officer, effective May 19, 2025. Bright brings over 25 years of financial and strategic leadership experience from companies like Biolase, Spectrum Pharmaceuticals, and Teleflex Medical. She succeeds Craig Glynn, who will remain available in an advisory capacity.
The company is developing two devices for deep venous CVI treatment: the VenoValve®, a surgical replacement valve currently under FDA review with a decision expected in H2 2025, and enVVe®, a non-surgical replacement valve. enVVeno estimates a U.S. market of 2.5 million potential patients annually, including 1.5 million with active venous ulcers. The company plans to file an IDE for enVVe pivotal trial in Q3 2025.
enVVeno Medical (NASDAQ:NVNO) has published promising three-year data from its first-in-human VenoValve® trial in the Annals of Vascular Surgery. The VenoValve, a surgical replacement venous valve for severe deep venous CVI, demonstrated continued safety and effectiveness after three years of implantation. Key findings from the study of 11 subjects include:
- 79% primary patency rate at three years
- 7-point improvement in Venous Clinical Severity Score
- 84% reduction in pain on the Visual Analog Scale
The company estimates 2.5 million potential new U.S. patients annually could benefit from VenoValve. A PMA application has been submitted to the FDA, with a decision expected in H2 2025.
enVVeno Medical (NASDAQ:NVNO) announced that its VenoValve® will be featured at the 47th Annual Charing Cross Symposium in London from April 23-25, 2025. Dr. David Dexter from Sentara Hospital and Eastern Virginia Medical School will present on 'Progress to date and future prospects for invasive correction of deep venous reflux' on April 24.
The VenoValve is positioned as a first-in-class surgical replacement venous valve for severe deep venous CVI patients, with an estimated 2.5 million potential new patients annually in the U.S. The company 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) has announced its participation in the Virtual Investor Closing Bell Series scheduled for Tuesday, April 22nd, 2025 at 4:00 PM ET. Robert Berman, the company's Chief Executive Officer, will lead the presentation.
During the live webcast, Berman will provide a corporate overview and discuss enVVeno's innovative portfolio, including their VenoValve® and enVVe® technologies - novel implantable replacement venous valve solutions designed for treating severe deep venous CVI. The event will feature a moderated discussion followed by a live Q&A session.
Investors can access the live video webcast through the Events page on www.envveno.com. A replay will be available two hours after the live event and remain accessible for 90 days.
enVVeno Medical (NASDAQ: NVNO) announced that its abstract on the VenoValve® will be presented at the Society for Clinical Vascular Surgery 52nd Annual Symposium in Austin, TX. Dr. Cassius Iyad Ochoa Chaar from Yale School of Medicine will present 'Impact of the VenoValve on Patients with Primary and Thrombotic Deep Venous Reflux' on April 2, 2025.
The VenoValve is a potential first-in-class surgical replacement venous valve for severe deep venous CVI patients. The company estimates 2.5 million potential new patients annually in the U.S. could be candidates for the treatment. 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) has reported its Q4 and full-year 2024 financial results, highlighting progress towards VenoValve FDA approval expected in H2 2025. The company ended 2024 with $43.2 million in cash and investments, sufficient to fund operations through VenoValve approval and enVVe pivotal trial initiation.
Key financial metrics include a Q4 cash burn of $5.2 million, with projected increases to $5-7 million per quarter in 2025. Net losses decreased 7% to $21.8 million in 2024 from $23.5 million in 2023.
Clinical highlights for VenoValve show strong two-year follow-up data with 78% of subjects maintaining significant clinical benefits, including 75% pain reduction. The SAVVE trial demonstrated 85% of patients experiencing meaningful improvement at one year. For enVVe, the company is on track for IDE application submission by mid-2025, pending GLP study completion in Q1 2025.
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.
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