enVVeno Medical Updates Regulatory Status of VenoValve(R)

Core Viewpoint - enVVeno Medical Corporation is seeking to appeal the not-approvable letter from the FDA regarding its VenoValve® device for treating severe deep chronic venous insufficiency [1] Group 1: Company Actions - The company plans to file a request for a supervisory appeal to challenge the FDA's decision received on August 19, 2025 [1] - The appeal will utilize the FDA's internal mechanisms to contest the review staff's decision, which may involve scientific controversies [1] Group 2: Product Information - The VenoValve® is a surgical replacement venous valve designed for the treatment of severe deep chronic venous insufficiency (CVI) [1]