EnVVeno Medical Commences Pre-Clinical Study for enVVe Valve

enVVeno Medical Corporation has launched a pre-clinical GLP study for its enVVe replacement venous valve. The first wave of implants using the updated delivery system has been completed successfully. This study is essential for seeking IDE approval from the FDA, with aims to apply mid-2025 for the enVVe pivotal trial.

CEO Robert Berman emphasized the technical challenges of creating a valve that fits a catheter just 0.17 inches in diameter, noting improvements in crimping and delivery systems. The upcoming GLP study results will determine the valve's efficacy.

enVVeno's main product, the VenoValve®, targets patients with severe Chronic Venous Insufficiency (CVI), a market estimated at 2.5 million candidates annually in the U.S. The enVVe valve aims for a broader reach, leveraging transcatheter technology for treatment.