enVVeno Medical to file request for appeal of CDRH non-approvable letter

enVVeno Medical (NVNO) will file a request for supervisory appeal of the not-approvable letter from the Center for Devices and Radiological Health of the U.S. Food & Drug Administration received on August 19, 2025, in response to its Premarket Approval application for the VenoValve, a surgical replacement venous valve for treating severe deep chronic venous insufficiency. The FDA provides several internal informal and formal mechanisms to challenge lower review staff decisions, including scientific controversies. One mechanism is a request for supervisory review in which an appeal is made to the next line of supervision. Supervisory appeals are required to be filed within 30 days of the decision being appealed, which is on or before September 18, 2025. These appeals involve a formal substantive request, an in-person meeting, and a decision. It also often includes multiple interactions even after an initial appeal decision is made. “Due to our interaction with FDA to obtain our Breakthrough Device Designation, in which the FDA determined that the VenoValve will meet an unmet clinical need, and our clinical trial negotiations to obtain our Investigational Device Exemption, as well as during our PMA submission interactions, we have established a productive and collaborative working relationship with the FDA over the past several years. We view this supervisory appeal as an opportunity to extend that relationship,” said Robert Berman, CEO. “Bringing a true first-in-class device through the PMA regulatory process raises unique challenges, and it is not unusual to have sequential collaborative discussions with the Agency to address issues that arise during the review process. We are committed to our continuing interactions with the FDA and to the goal of bringing the VenoValve to the 2.5 to 3.5 million patients suffering from severe deep venous CVI in the U.S. and who have no effective treatment options.” Internal Agency reviews are based on information already in the administrative file. Due to the variety of both physician reported and patient reported data generated by the VenoValve pivotal study and which is already a part of the file, the Company is confident that explaining this data to supervisory management in a focused appeal setting will lead to a positive outcome, with a decision expected by the end of 2025.