Envveno Medical Corporation Stock Price, News & Analysis

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.