Company Profile

enVVeno Medical (Nasdaq: NVNO) is an Irvine, California-based, late clinical-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. The Company’s lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe®. CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal and become chronic. The Company estimates that there are approximately 2.5 million to 3.5 million people in the United States with severe CVI caused by malfunctioning valves. Both the VenoValve® and enVVe® can potentially help these patients and are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve® is currently being evaluated in the SAVVE® U.S. pivotal trial and the Company has reported initial positive topline efficacy data showing significant clinical improvement and clinical meaningful benefit at six months. The company is currently performing the final testing necessary to seek approval for the enVVe® pivotal trial. 

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The VenoValve® and enVVe® are investigational medical devices currently in development. Neither device is approved or cleared for any indication in any market. The VenoValve® is only available for use in the United States in pre-market clinical studies.