enVVeno Medical initiates six-month pre-clinical GLP study of enVVe

enVVeno announced the start to its six-month pre-clinical GLP study for enVVe, its transcatheter-delivered replacement venous valve. The first wave of implants, for the long-term subjects, was successfully completed, with the final wave for the shorter-term subjects scheduled for December. The GLP study is a prerequisite to enVVeno seeking IDE approval from the U.S. Food and Drug Administration to begin the enVVe U.S. pivotal study. The Company expects to be in a position to file for IDE approval for the enVVe pivotal trial mid-next year. enVVeno’s lead product is the VenoValve, a surgical replacement venous valve for patients suffering from severe Chronic Venous Insufficiency caused by incompetent valves in the deep venous system. The Company estimates that there are approximately 2.5 million candidates each year in the U.S. for the VenoValve. enVVe, a next-generation, transcatheter based replacement venous valve, would appeal to an even larger market in terms of both patients and physicians. Severe deep venous CVI is a debilitating disease that is most often caused by blood clots in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase. Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, 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. enVVeno expects to file its PMA application seeking approval from the U.S. Food and Drug Administration to market and sell the VenoValve, and to release the definitive data that supports the PMA application in Q4 of this year. Beginning early next year, the Company will begin to implement its plans to transition from being a development stage company to a commercial entity, and to complete all of the additional non-clinical testing for enVVe that is necessary to file for IDE approval.