enVeno Medical Corporation announced that it has achieved full enrollment in SAVVE®?, the 75 person U.S. pivotal trial for the VenoValve®? and the final precursor for seeking FDA pre-market approval of the VenoValve. On July 5, 2023, the Company announced that it had 57 patients enrolled in SAVVE and that it expected to complete full enrollment by the end of 2023.

With full enrollment occurring earlier than expected, initial topline efficacy data from SAVVE is now expected in fourth quarter of this year, initial topline efficacy Data from SAVVE is now expects in second quarter of 2024, and PMA eligibility to file for FDA approval of the VenoValVE is expected to occur in third quarter of 2024. Severe Chronic Venous Insufficiency (CVI) is a debilitating disease that most often occurs when valves inside of the veins of the leg fail, causing blood to flow in the wrong direction (reflux) and increased pressure within the veins of the leg (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and recurrent open sores known as venous ulcers.

The disease can severely impact everyday functions such a sleeping, breathing, and walking, and is known to result high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence and the Company estimates that there are approximately 2.5 million new patients each year in the U.S. that could be candidates for the VenoValve. In addition to the VenoValve, the Company is also developing enVVe, a non-surgical based replacement venous valve that is delivered by transcatheter via a minimally invasive procedure.

The Company expects to be ready for the enVVe pivotal trial in third quarter of 2024.