EnVVeno Medical Corporation Announces Positive Results from VenoValve Pivotal Trial

enVVeno Medical Corporation has disclosed significant clinical improvement in patients from its SAVVE U.S. pivotal trial for the VenoValve, presented at the American Venous Forum Annual Meeting. The trial highlights that 97% of participants noticed clinical enhancement, and 74% reported a clinically meaningful benefit at a six-month interval post-implantation. An average improvement of 8 points in the revised Venous Clinical Severity Score (rVCSS) marks over two and a half times the necessary metric for clinically significant benefit by FDA standards.

The company is geared towards seeking FDA approval for the VenoValve by Q4 2024. Moreover, the results have shown substantial improvements in patients with Chronic Venous Insufficiency (CVI), notably transforming severe cases into milder conditions or full resolution. This development comes as a promising prospect for the approximately 2.5 million new U.S. patients annually suffering from severe CVI caused by deep vein valvular incompetence.

enVVeno Medical plans to collect one year of data from all SAVVE participants, crucial for its FDA Pre-Market Approval (PMA) application, expected by September 2024. The current financial standing, with $46.4 million in cash and investments as of December 2023, positions the company well into the FDA decision timeline, potentially through the end of 2025.