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) has reported significant developments in its VenoValve and enVVe clinical programs. In 2022, the company achieved over half enrollment in the pivotal SAVVE trial of VenoValve, currently totaling 43 patients. The firm ended the year with $39.1 million in cash, remaining on track to sustain operations through the end of 2024. While Q4 cash burn was $3.6 million, net losses for the year declined to $16.5 million. Upcoming milestones include topline safety data from SAVVE expected before the end of 2023 and the initiation of the enVVe trial upon regulatory approval.
enVVeno Medical Corporation (NASDAQ:NVNO) will present at Cowen's 43rd Annual Health Care Conference on March 8, 2023, at 9:10 AM ET. During this event, CEO Robert Berman will discuss the company's innovative solutions for treating venous disease, highlighting their lead product, VenoValve, a first-in-class surgical replacement venous valve aimed at addressing Chronic Venous Insufficiency (CVI). The presentation will be accessible via a live video webcast on the company's website, available for 90 days post-event. enVVeno's advancements, including the upcoming TAVVE trial for their non-surgical enVVe valve, signify a commitment to improving venous care.
enVVeno Medical Corporation (Nasdaq: NVNO) has announced the promotion of Dr. Hamed Alavi to Senior Vice President and Chief Technology Officer. Dr. Alavi has been instrumental in the development of enVVe, a transcatheter-based replacement venous valve, moving it from concept to readiness for human testing in a short timeframe. His role will now focus on integrating innovative technologies, such as artificial intelligence, into existing products and preparing for the commercialization of the VenoValve. These devices aim to improve treatment for chronic venous insufficiency (CVI), a condition affecting leg veins.
enVVeno Medical Corporation (NASDAQ:NVNO) announced promising results at the 49th Annual VEITH Symposium regarding its VenoValve clinical trial. Three years post-implantation, VenoValve recipients show no relapses of severe Chronic Venous Insufficiency (CVI) or venous ulcers. Average improvements in reflux, CVI manifestations, and pain are stable at 63%, 52%, and 84%, respectively. The trial involved eight patients with an average age of 68. The VenoValve aims to restore proper blood flow in patients with CVI, a condition affecting approximately 2.5 million people in the U.S.
enVVeno Medical Corporation announced the successful preliminary safety review by the FDA for its VenoValve, as part of the ongoing SAVVE U.S. pivotal study. The first 20 patients enrolled showed minimal adverse events, allowing the trial to proceed without changes. Currently, 33 patients are enrolled, with full enrollment expected by Q2 2023. The company reported $42.7 million in cash to sustain operations through 2024, including the upcoming release of pivotal trial data.
enVVeno Medical Corporation (NASDAQ:NVNO) reported its third-quarter 2022 financial results, ending with $42.7 million in cash and investments, providing a runway through 2024. The burn rate was $4.5 million for the quarter. Notably, the company is advancing its SAVVE pivotal trial with strong enrollment and is set to begin the TAVVE first-in-human study in early 2023. However, net losses increased to $6.1 million, up 154% year-over-year, primarily due to higher operating expenses, including a 140% rise in SG&A costs.
enVVeno Medical Corporation (NASDAQ:NVNO) announced CEO Rob Berman will participate in a fireside chat at the Ladenburg Thalmann 2022 Healthcare Conference on September 29, 2022, in New York, NY. Investors can join one-on-one meetings with management. A live video webcast will be available on the Company's website for 90 days post-event. enVVeno specializes in innovative solutions for venous disease, with its lead product, the VenoValve, in pivotal studies and awaiting approval for a non-surgical alternative, enVVe.
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