Envveno Medical Corporation Stock Price, News & Analysis

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.

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) reported its Q1 2025 financial results, showing a cash position of $38.9 million and a quarterly cash burn of $4.0 million, in line with projections. The company reduced its net loss to $4.5 million from $5.0 million in Q1 2024. The company is awaiting an FDA decision on its VenoValve PMA application in H2 2025, targeting approximately 2.5 million potential U.S. patients annually, including 1.5 million with active venous ulcers. For its enVVe device, the company completed the shorter-term phase of its 6-month pre-clinical GLP study and plans to file for IDE approval in mid-2025. Current cash reserves are expected to fund operations through the FDA decision, initial commercialization, and the start of the enVVe pivotal trial.

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.