enVVeno Medical Corporation has successfully passed a preliminary safety review by the U.S. Food and Drug Administration (FDA) for the first twenty (20) patients enrolled in the ongoing SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal study for the VenoValve. The FDA had requested that enVVeno submit preliminary safety data at thirty (30) days post VenoValve implantation for the first twenty (20) patients enrolled in the study. The preliminary safety data submitted by the Company included one (1) device related (mild) and two (2) procedure related (moderate) adverse events.

After review by the FDA, the study was cleared to continue without modification or interruption. The Company currently has thirty-three (33) patients enrolled in the trial and based upon the current pace of enrollment, expects to be fully enrolled by the end of the second quarter of 2023. With $42.7 million of cash and investments reported at the end of the third quarter of 2022, the Company has sufficient cash to sustain operations through the end of 2024, including past the expected release of thirty (30) day primary safety and one hundred eighty (180) day primary efficacy endpoint data from the study.

The SAVVE Trial is a prospective, non-blinded, single arm, multi-center study of 75 CVI patients. The trial's primary safety endpoint is based on the number of major adverse events (MAEs) at 30 days post implantation. MAEs are defined as mortality, deep wound infection, major bleeding, ipsilateral deep vein thrombosis or pulmonary embolism.

The VenoValve is surgical replacement venous valve that is being evaluated as a potential treatment for deep venous CVI. The VenoValve is intended to restore proper directional blood flow for patients with CVI of the deep veins of the leg. CVI occurs when the natural valves inside of the veins fail, causing blood to flow in the wrong direction (reflux), and creating increased pressure inside of the veins of the leg (venous hypertension).

CVI can cause the leg to swell, and blood vessels to break, resulting in discoloration, pain, and the breakdown of the skin leading to venous ulcers (open sores) which are difficult to heal. Patients with severe CVI have limited mobility and often experience difficulty standing, walking, and completing everyday tasks. The Company estimates that approximately 2.5 million people in the U.S. suffer from the debilitating impacts of severe deep venous CVI who would be candidates for the VenoValve.

Patients suffering from lower leg swelling, pain, non-healing leg sores, enlarged veins, and/or brownish or blueish skin discoloration - who may also have leg pain when standing or walking - may be candidates for the SAVVE trial.