enVVeno Medical Announces FDA Not-Approvable Decision On VenoValve PMA Submission

enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it has received a not-approvable letter from the U.S. Food & Drug Administration (FDA) in response to its Premarket Approval (PMA) application for VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI).

The letter indicates that the FDA completed its review of the VenoValve PMA application and determined that it is unable to approve the PMA for the VenoValve in its current form. In particular, the FDA indicated that the favorable revised Venous Clinical Severity Score (rVCSS) data generated by the study to show clinical improvement, together with the improvements in pain scores and venous specific quality of life indicators was not sufficient on its own to determine favorability of the benefit risk profile for the VenoValve. Without a specific hemodynamic measurement that correlates with patient improvement, the FDA raised concerns about bias and the possibility that clinical improvement occurred as a result of the patients being enrolled in a study.

The FDA also focused on safety concerns which were attributed to the VenoValve open surgical procedure, and that required re-hospitalizations. The Company would not expect to see similar safety events with a non-surgical replacement valve.

enVVeno Medical is reviewing the feedback from the FDA and is assessing all options, which may include a meeting to discuss requirements for a potential resubmission of the VenoValve or appeal of the decision along with appropriate next steps. The Company also expects to apply the key learnings from this FDA approval process as it advances enVVe, its non-surgical replacement venous valve for which it is preparing an IDE application.