enVVeno Medical Corporation announced that new interim venous ulcer healing data from the VenoValve U.S. pivotal trial will be presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting (VAM2024) being held June 18-22, 2024 in Chicago, IL. The presentation, entitled "The Impact of VenoValve Implantation on Venous Ulcer Healing in Patients with Deep Venous Reflux," will be made on June 21, 2024 by primary investigator Dr. Cassius Iyad Ochoa Chaar MD, MS, RPVI, Associate Professor of Surgery, Division of Vascular Surgery, Yale School of Medicine, the top enrolling site for the trial. The data to be presented will include venous ulcer healing and improvement rates for venous ulcer patients who have now reached the one-year milestone in the Company's Surgical Anti-reflux Venous Valve Endoprosthesis (SAVVE) U.S. pivotal study for the VenoValve.

Overall healing or improvement rate data for thirty-one ulcers among twenty-one patients will be presented, and the presentation will also include sub-categories for ulcers that existed for more than one year and less than one year prior to the VenoValve surgery. Recurrence rate data for any venous ulcers that fully healed, and then recurred, will also be presented. In assessing the benefit and risk of a novel technology such as the VenoValve, which addresses an unmet medical need, the U.S. Food and Drug Administration (FDA) considers whether a medical device provides a clinically meaningful benefit compared to existing technologies.

Subjects with venous ulcers who were enrolled in the SAVVE study all received at least three (3) months of conventional treatment with existing technologies (compression therapy, leg elevation, and wound care) and many also received vein ablations for superficial venous disease, and venous stenting for obstruction, if indicated. As a result, the venous ulcer patients in the SAVVE study are the most difficult to treat, having venous ulcers that remained after at least three and as many as five types of existing treatments. 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 as sleeping, bathing, and walking, and is known to result in 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.

The FDA has asked the Company to collect one year data on all SAVVE patients to support its PMA application seeking FDA approval to market and sell the VenoValve, which the Company expects to file in fourth quarter of this year.