enVVeno Medical Corporation announced that positive preliminary device related Material Adverse Event (MAE) safety data from the SAVVE U.S. pivotal trial for the VenoValve is being presented at the 50th Annual VEITH symposium in New York. The preliminary device related MAE rate for the fully enrolled 75 subject study is reported to be eight% (8%). MAEs for the SAVVE study are defined as all-cause mortality, pulmonary embolisms (PEs), ipsilateral deep vein thromboses (DVTs), bleeding, and deep wound infections, occurring within thirty (30) days of enrollment in the study.

The report on MAEs presented at the conference indicates no deaths, no pulmonary embolisms, and six (6) deep vein thrombosing (DVTs), from the fully enrolled cohort of 75 patients. MAEs for the SAVve study are adjudicated by an independent Clinical Events Committee (CEC) and the overall safety of SAVVE is monitored by an independent Data Safety Monitoring Board (DSMB). As to the clinical impact of the DVT MAEs, three (3) of the patients have shown significant clinical improvement when comparing most recent rVCSS values to baseline scoring, two (2) of the patients have not yet reached the thirty (90) day visit where clinical change is evaluated, and one (1) patient voluntary withdrew from the study after thirty (30) days.

The preliminary topline MAE related safety data from SAVVE also includes a higher-than-expected procedure related bleeding rate for a small sub-group of contiguous patients, all of which occurred within the first two (2) weeks after surgery, were deemed to be moderate in severity by the CEC, and resulted from anticoagulation medication, as well as an expected rate of wound infections at the site of the skin incisions. All safety and associated clinical data for these patients is unaudited, and subject to change. The CEC will continue to adjudicate safety events and the DSMB will continue to monitor the overall safety of SAVve throughout the duration of the study.

All safety events will also be evaluated by the U.S. Food and Drug Administration (FDA), as part of the Company's application seeking pre-market approval (PMA) for the VenoValve. The Company plans to present initial topline efficacy data from the SAVVE study in second quarter of 2024 and expects to be ready to file the PMA application for the VenoValve with the FDA in fourth quarter of 2024. Severe Chronic Venous Insufficiency is a debilitating disease that most often occurs when valves inside 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, bathing, and walking, and is known to be known to have a number of patients with the FDA in fourth quarter.