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 (NASDAQ: NVNO) will host a conference call and live audio webcast on September 21, 2022, at 4:30 PM ET. Interested parties can join by calling (877) 407-9708 (domestic) or (201) 689-8259 (international) using conference ID: 13732870. The live webcast will be available on the enVVeno website and archived for 90 days. The company focuses on innovative bioprosthetic solutions for venous disease, with its lead product, the VenoValve, currently in evaluation for treating Chronic Venous Insufficiency.
enVVeno Medical Corporation (Nasdaq: NVNO) announced CEO Robert Berman's participation at the H.C. Wainwright 24th Annual Global Investment Conference in New York from September 12-14, 2022. The event will include virtual one-on-one meetings with investors. A video webcast of the presentation will be live from September 12 at 7:00 AM ET, with a replay available for 90 days on their website. enVVeno focuses on innovative solutions for venous disease, including its lead product, the VenoValve, which is currently evaluated in the SAVVE pivotal study.
enVVeno Medical Corporation (NASDAQ: NVNO) has appointed Kevin Belteau as Vice President of Clinical Operations. Belteau brings over 23 years of experience from Medtronic, where he managed clinical operations for significant studies. enVVeno expects to engage in multiple clinical trials to support the adoption of its VenoValve device, aimed at treating Chronic Venous Insufficiency (CVI). The VenoValve is currently under evaluation in the SAVVE U.S. pivotal trial for safety and effectiveness, addressing a condition affecting around 2.4 million U.S. individuals.
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.
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