IRVINE, CA / ACCESS Newswire / November 13, 2025 / 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 an unfavorable decision from the U.S. Food & Drug Administration ("FDA") in response to its supervisory appeal of the not-approvable letter it received on August 19, 2025 in response to its Premarket Approval (PMA) application for VenoValve®, a surgical replacement veno ...

Key Takeaways NVNO stock sank 76.1% after the FDA issued a not-approvable letter for VenoValve.The FDA flagged insufficient NVNO's SAVVE study data and raised surgical safety concerns.NVNO eyes an IDE filing for its non-surgical enVVe valve as the next pipeline step.Shares of enVVeno Medical (NVNO) have crashed 76.1% since Aug. 19. The significant decline was due to the FDA’s not-approvable letter in response to its Premarket Approval (“PMA”) application for Veno Valve.The company submitted the PMA applicat ...