Core Viewpoint - enVVeno Medical Corporation has received an unfavorable decision from the FDA regarding its VenoValve® application, which indicates that the product does not meet the necessary safety and effectiveness standards [1] Company Summary - enVVeno Medical Corporation focuses on developing treatments for deep venous disease [1] - The company aimed to gain Premarket Approval (PMA) for its VenoValve®, a surgical replacement venous valve designed for severe deep chronic venous insufficiency (CVI) [1] Regulatory Summary - The FDA issued a not-approvable letter on August 19, 2025, which was upheld in a supervisory appeal [1] - The decision indicates that the VenoValve® failed to provide reasonable assurance of safety and effectiveness [1]

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]