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), based in Irvine, California, is a late-stage clinical medical device company dedicated to developing innovative bioprosthetic (tissue-based) solutions for treating venous disease. The company's flagship product, the VenoValve®, is a first-in-class surgical replacement venous valve designed to treat severe deep venous Chronic Venous Insufficiency (CVI). CVI occurs when leg vein valves fail, leading to blood reflux, pooling, venous hypertension, severe pain, leg swelling, and recurrent ulcers.
The VenoValve is currently undergoing evaluation in the SAVVE U.S. pivotal study, where it has shown promising results, with 97% of patients demonstrating clinical improvement and 74% achieving a clinically meaningful benefit after six months. The company plans to file for FDA pre-market approval in Q4 2024. Additionally, enVVeno is developing the enVVe™, a non-surgical, transcatheter-based replacement venous valve, expected to enter pivotal trials in Q4 of 2024.
In recent updates, enVVeno presented positive preliminary safety data from the SAVVE study at the 50th Annual VEITH Symposium and shared encouraging topline efficacy data at the American Venous Forum and Charing Cross International Symposium. Financially, the company reported ending the first quarter of 2024 with $42.9 million in cash and investments, sufficient to fund operations through 2025.
enVVeno's mission is to address the unmet needs of approximately 2.5 million new CVI patients annually in the U.S. with no effective current treatments. For more information on their groundbreaking products, visit enVVeno.com.
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.
enVVeno Medical Corporation (NASDAQ: NVNO) announced its third-quarter 2021 financial results, highlighting a net loss of $2.4 million, reflecting a 21% increase in losses year-over-year. The company successfully completed the first VenoValve surgery in the pivotal SAVVE trial, aimed at treating severe deep venous Chronic Venous Insufficiency (CVI). A recent $20 million direct offering strengthened its cash position, ending the quarter with $57.9 million in cash. The trial expects to enroll up to 75 patients across multiple centers, with topline data anticipated by late 2022.
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