IRVINE, CA - enVVeno Medical Corporation (NASDAQ:NVNO), a medical device company, has reported positive efficacy data from its SAVVE U.S. pivotal trial for the VenoValve, a device aimed at treating severe Chronic Venous Insufficiency (CVI). The trial results, presented at the American Venous Forum Annual Meeting, indicated that 97% of patients experienced clinical improvement as measured by the revised Venous Clinical Severity Score (rVCSS).
The study demonstrated that 74% of patients saw a clinically meaningful benefit, defined by an improvement of 3 or more rVCSS points. The average improvement per patient was 8 points, significantly surpassing the threshold set by the U.S. Food and Drug Administration (FDA) for demonstrating clinical relevance.
The data, which compared six-month follow-up scores to baseline measurements, suggests the VenoValve could offer substantial relief for individuals with CVI who have not responded to conventional treatments.
CVI is often caused by blood clots in the legs' deep veins, leading to symptoms like swelling, pain, and in severe cases, venous ulcers. The disease can severely impact quality of life, and currently, there are limited effective treatments for CVI resulting from valvular incompetence. enVVeno estimates that approximately 2.5 million new U.S. patients each year could be candidates for the VenoValve.
The company plans to file for FDA approval in Q4 2024 after collecting one-year data on all SAVVE patients, which will be completed in September 2024. As of December 31, 2023, enVVeno had sufficient capital to fund operations through the anticipated FDA decision on the VenoValve and until the end of 2025.
The SAVVE trial, a prospective, non-blinded, single-arm study, enrolled 75 CVI patients across 21 U.S. sites. Dr. Cassius Iyad Ochoa Chaar, the primary investigator from Yale School of Medicine, presented the findings. A webcast discussing the results was hosted by enVVeno with Dr. Chaar's participation, emphasizing the significant improvement in patients' conditions.
The VenoValve represents a first-in-class surgical replacement venous valve developed by enVVeno for the treatment of deep venous CVI. The company is also working on a non-surgical, transcatheter-based replacement venous valve called enVVe for deep venous CVI treatment.
This article is based on a press release statement from enVVeno Medical Corporation.
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