NEWS
enVVeno Medical Provides Update on FDA Premarket Approval Application Status for VenoValve(R)
enVVeno Medical has made significant progress in its FDA premarket approval (PMA) application for the VenoValve, a surgical replacement venous valve. The company has successfully submitted, and the FDA has approved, four out of five modules required for the PMA application. The fifth and final module, containing clinical data from the SAVVE U.S. pivotal trial, is expected to be filed in Q4 2024.
The VenoValve is being developed as a potential treatment for severe Chronic Venous Insufficiency (CVI), a debilitating disease affecting approximately 2.5 million new patients annually in the U.S. The SAVVE study, involving 75 CVI patients across 21 U.S. sites, is currently collecting one-year clinical data to support the final PMA module submission.
As of June 30, 2024, enVVeno Medical had $39.1 million in cash and investments, which is expected to fund operations through the FDA's decision on the VenoValve PMA application.
enVVeno Medical has made significant progress in its FDA premarket approval (PMA) application for the VenoValve, a surgical replacement venous valve. The company has successfully submitted, and the FDA has approved, four out of five modules required for the PMA application. The fifth and final module, containing clinical data from the SAVVE U.S. pivotal trial, is expected to be filed in Q4 2024.
The VenoValve is being developed as a potential treatment for severe Chronic Venous Insufficiency (CVI), a debilitating disease affecting approximately 2.5 million new patients annually in the U.S. The SAVVE study, involving 75 CVI patients across 21 U.S. sites, is currently collecting one-year clinical data to support the final PMA module submission.
As of June 30, 2024, enVVeno Medical had $39.1 million in cash and investments, which is expected to fund operations through the FDA's decision on the VenoValve PMA application.
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