enVVeno Medical presents efficacy data from SAVVE U.S. trial for VenoValve

enVVeno Medical announced the presentation of topline efficacy data showing significant clinical improvement from the SAVVE U.S. pivotal trial for the VenoValve at the 2024 American Venous Forum Annual Meeting in Tampa, Florida. The data being presented today shows that overall, 97% of the study patients receiving the VenoValve have shown clinical improvement as measured by revised Venous Clinical Severity Score, 74% of the study patients have improved the 3 or more rVCSS points needed to demonstrate the VenoValve’s clinically meaningful benefit, and the average amount of per patient improvement for patients showing clinically meaningful benefit is 8 points, more than two and a half times the amount of rVCSS improvement required by the U.S. Food and Drug Administration to show that the VenoValve provides clinically meaningful benefit. All of the reported data was derived by comparing rVCSS patient evaluations at six months to baseline readings taken prior to VenoValve implantation. In assessing the benefit and risk of a novel technology such as the VenoValve, which addresses an unmet medical need, the FDA considers a variety of factors including whether a medical device provides a clinically meaningful benefit compared to existing technologies. Patients who were enrolled in the SAVVE study all showed little or no improvement after at least three months of conventional treatment with existing technologies. For severe CVI patients, an improvement in the rVCSS of 3 or more points is considered by the FDA to be evidence of clinically meaningful benefit. The rVCSS is an objective grading system used by vascular specialists throughout the world to report clinical outcomes and responses to treatments for venous diseases such as CVI. The score consists of 10 categories graded from 0 to 3 and includes patient reported outcomes and physician assessments. The FDA has asked the Company to collect a minimum of one year of data on all SAVVE patients prior to filing its PMA application seeking FDA approval, which the Company will have completed collecting in September of 2024. As of December 31, 2023, the Company had cash and investments of $46.4 million on hand, which should be sufficient capital to fund operations through an FDA decision on the VenoValve and the end of 2025. The Surgical Anti-reflux Venous Valve Endoprosthesis U.S. pivotal study for the VenoValve is a prospective, non-blinded, single arm, multi-center study of seventy-five CVI patients enrolled at 21 U.S. sites.