enVVeno Medical Corporation, based in Irvine, California, is a medical device firm founded in 1999 that is currently in its clinical development phase. The company's primary objective is to pioneer advanced bioprosthetic, tissue-engineered solutions intended to significantly elevate the existing standards of care for patients suffering from venous conditions. Their flagship product is the VenoValve, a specialized replacement venous valve developed for the management of chronic venous insufficiency. This device requires an open surgical procedure for implantation, which involves making a 5-to-6-inch incision in the patient's upper thigh to facilitate placement into the femoral vein. In addition to the VenoValve, enVVeno Medical is actively developing the enVVe system. This innovative system represents a non-surgical, transcatheter approach to venous valve replacement, comprising the enVVe valve itself, a dedicated delivery mechanism, and various supplementary accessories. The company previously operated under the name Hancock Jaffe Laboratories, Inc., before officially rebranding to enVVeno Medical Corporation in October 2021.
Independent Health Economic Study Recently Published in Journal of Vascular Surgery Reports Economic Dominance of enVVeno Medical's Replacement Venous Valve Therapy Compared to Standard of Care Treatments
A peer-reviewed health economic analysis published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders found enVVeno Medical's venous valve replacement therapy to be economically dominant over standard of care treatments.
The study projects average healthcare savings of more than $32,000 per patient over five years and estimates $5.9 billion in annual savings system-wide with broader adoption of the technology.
CEO Robert Berman stated the publication provides compelling evidence to support future coverage determinations for the enVVe system, which is currently being evaluated in the TAVVE pivotal trial.