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 (NASDAQ: NVNO) is an Irvine, California-based, late clinical-stage medical device company developing bioprosthetic, tissue-based venous valves for deep venous disease. This news page aggregates company announcements, press releases, and market disclosures related to enVVeno’s clinical programs, regulatory interactions, and corporate actions.
Readers can follow updates on VenoValve®, enVVeno’s first-in-class surgical replacement venous valve for severe deep chronic venous insufficiency and deep venous insufficiency, as well as enVVe®, its non-surgical, transcatheter-based replacement venous valve for deep venous CVI. News items include information on pivotal clinical studies, health economic analyses, and the company’s discussions with the U.S. Food & Drug Administration, such as the not-approvable letter for the VenoValve PMA application and the subsequent supervisory appeal process.
In addition to clinical and regulatory developments, this feed covers financial and corporate news, including quarterly financial updates, capital-raising arrangements like the at-the-market equity program, and shareholder matters disclosed in proxy statements and Form 8-K filings. Announcements about investor presentations, virtual investor segments, and other outreach events featuring enVVeno’s leadership are also reflected here.
For investors and observers tracking NVNO, the news page offers a centralized view of how enVVeno is progressing its venous valve technologies, responding to regulatory feedback, and managing its capital structure through actions such as a board-approved reverse stock split. Regularly reviewing this page can help users understand the evolving context around enVVeno’s development pipeline, regulatory milestones, and key corporate decisions.
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 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.