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enVVeno Medical Announces the Development of a Transcatheter Based Replacement Venous Valve for the Treatment of Chronic Venous Insufficiency
Potential relief to approximately 3.5 million CVI sufferersDesigned to be used by an expansive network of physiciansInitial bench testing and animal testing
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Potential relief to approximately 3.5 million CVI sufferersDesigned to be used by an expansive network of physiciansInitial bench testing and animal testing successfully completedAwaiting regulatory approval to begin first-in-human testing, which is expected by end of 2022Company to host conference call with live audio webcast today, Wednesday, September 21st at 4:30 PM ETIRVINE, CA / ACCESSWIRE / September 21, 2022 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced the development of a non-surgical transcatheter based replacement venous valve called enVVe™, for the treatment of Chronic Venous Insufficiency (CVI) of the deep veins of the leg. Preliminary bench testing and animal testing for enVVe have already been successfully completed and the Company has filed an application seeking approval to begin first-in-human (FIH) testing, which it expects to receive by the end of 2022. The Company's surgical replacement venous valve, called the VenoValve®️, is currently being evaluated in the SAVVE U.S. pivotal trial. As previously announced, enVVeno will host a conference call and webcast today, Wednesday, September 21, 2022 at 4:30 PM ET (details below)."In addition to potentially appealing to an even larger pool of CVI patients, our plan is to eventually make enVVe available through a substantially larger number of doctors, which includes the thousands of physician interventionalists across the world," said Robert Berman, enVVeno Medical's Chief Executive Officer. "As the replacement venous valve market develops over time, we want to be the leader for both surgical valves, and non-surgical valves, and by developing both the VenoValve and enVVe, we will have the products that we need to help establish and maintain enVVeno Medical as the preeminent company for the treatment of venous disease."The enVVe first-in-human trial, which will take place in Colombia, will be known as the Transcatheter Anti-reflux, Venous Valve Endoprosthesis (TAVVE) FIH study. The initial phase of the TAVVE-FIH study will seek to enroll 3 to 5 patients across multiple sites. Several parameters will be evaluated over the course of the study including safety and technical success of the enVVe venous valve delivery system, and the safety and clinical performance of the enVVe ...
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