enVVeno provides update on FDA premarket approval application for VenoValve

enVVeno Medical provided an update on the U.S. Food and Drug Administration premarket approval application status for its lead product, a surgical replacement venous valve called the VenoValve. Four out of five modules that comprise the VenoValve PMA application have now been submitted, reviewed and approved by the FDA, with the fifth and final module containing the clinical data from the SAVVE U.S. pivotal trial for the VenoValve expected to be filed in the fourth quarter of this year. The enVVeno Medical PMA application seeking FDA approval for the VenoValve consists of five sections including: Module 1 — Sterilization, Packaging, and Packaging Shelf-Life Testing; Module 2 — Non-clinical and Device Shelf-Life Testing; Module 3 — Biocompatibility, Animal Study, and Tissue Sourcing; Module 4 — Manufacturing Information; Module 5 – Clinical Data and Proposed Labeling; The first four modules have now been submitted, reviewed, and approved by the FDA. The Company is in the process of collecting one-year clinical data for each patient in the SAVVE study, to support the filing of the fifth and final module of the PMA application for the VenoValve, which the Company expects to file in Q4 of this year. As of June 30, 2024, the Company had cash and investments of $39.1 million on hand, which the Company expects to be sufficient capital to fund operations through an FDA decision on the PMA application for the VenoValve.