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) reported its second quarter results for 2022, ending with $47.2 million in cash and investments, sufficient to fund operations through 2024. The company noted a cash burn of $4.0 million in the quarter, aligning with expectations. However, net losses rose to $7.1 million, a 197% increase due to higher operating expenses. The ongoing SAVVE pivotal trial aims to evaluate the VenoValve for treating Chronic Venous Insufficiency, targeting approximately 2.4 million affected individuals in the U.S.
enVVeno Medical Corporation has announced that the American Medical Association has issued a new CPT III code for the VenoValve, effective January 1, 2023. This code allows for reimbursement for its procedure to treat Chronic Venous Insufficiency (CVI) in the deep veins of the leg, addressing a significant unmet medical need affecting approximately 2.4 million patients in the U.S. The VenoValve is currently under evaluation in the SAVVE U.S. pivotal trial, aiming to restore proper blood flow and alleviate symptoms caused by CVI.
enVVeno Medical Corporation (Nasdaq: NVNO) reported Q1 2022 financial results, ending the quarter with $51.3 million in cash, expected to fund operations through 2024. Their pivotal SAVVE trial is now active with 20 enrolled sites aiming to conclude patient recruitment by Q1 2023 and provide primary data in H2 2023. Despite a 89% rise in net losses to $5.3 million, company plans include unveiling a second device for venous disease in mid-2022, reinforcing their commitment to addressing chronic venous insufficiency affecting approximately 2.4 million Americans.
enVVeno Medical Corporation announced the issuance of U.S. Patent No. 11,285,243 for the VenoValve, a potential first-in-class treatment for Chronic Venous Insufficiency (CVI). The VenoValve is currently under evaluation in the SAVVE U.S. pivotal trial across major hospitals, addressing a significant unmet medical need for the 2.4 million U.S. patients suffering from deep venous CVI. The patent covers the manufacturing method of the valve's tissue component, enhancing protection for enVVeno's leading product and representing a significant step in its patent strategy.
enVVeno Medical Corporation (NASDAQ: NVNO) announced a strong cash position of $55 million, expected to fund operations through the end of 2024. The company has completed 9 VenoValve surgeries and has 16 clinical sites active in its pivotal SAVVE trial. The VenoValve's long-term safety and efficacy data were presented at a prominent medical meeting, and the company has also received ISO 13485 certification, aiding its commercialization efforts. Despite reporting a net loss of $16.5 million for 2021, cash reserves allow for focused execution of clinical trials.
enVVeno Medical Corporation (NASDAQ: NVNO) announced positive results from its first-in-human study of the VenoValve, showing sustained safety and effectiveness one year post-implantation. The study included 11 patients with severe deep venous Chronic Venous Insufficiency (CVI), revealing a 54% improvement in reflux, 56% in disease manifestations, and 76% in pain. The VenoValve aims to address the shortcomings of existing treatments and is currently under evaluation in the ongoing SAVVE U.S pivotal trial, having received Breakthrough Device Designation from the FDA.
enVVeno Medical Corporation (NASDAQ:NVNO) reported favorable thirty-month outcomes for its VenoValve in first-in-human trials, presented at the 34th Annual Meeting of the American Venous Forum. Key findings include no relapses of Chronic Venous Insufficiency (CVI) or venous ulcers, with significant improvements in reflux (55%), CVI disease manifestations (61%), and pain (81%). The CEO expressed optimism about ongoing trials that may lead to further advancements in treating CVI. As the company gears up for pivotal trials, data showcasing effective solutions for CVI patients continues to grow.
enVVeno Medical Corporation (NASDAQ:NVNO) will present at the Virtual Investor 2022 Top Picks Conference on January 25, 2022, at 1:00 PM ET. CEO Robert Berman will lead the presentation, which includes a corporate overview and an interactive Q&A session. Investors can submit questions live or in advance through the conference website. A live video webcast will be available on the Company’s Events page, with a replay accessible for one year. enVVeno focuses on innovative treatments for venous disease, including its lead product, the VenoValve.
enVVeno Medical Corporation (Nasdaq: NVNO) will host a Virtual Investor Roundtable Event on November 16, 2021, at 1:00 PM ET, featuring CEO Robert Berman and Chief Medical Officer Marc Glickman, M.D. The session will include a presentation, a moderated discussion, and a live Q&A segment.
Investors can submit questions in advance or during the event. A live video webcast will be available on the Company's website, with a replay accessible for one year following the presentation.
