CytoSorbents provides FDA, Health Canada regulatory update for DrugSorb-ATR

CytoSorbents (CTSO) provided a regulatory update on its marketing applications for DrugSorb-ATR with the U.S. FDA and Health Canada. DrugSorb-ATR is an FDA-designated Breakthrough Device designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting surgery within 2 days of stopping the antiplatelet drug Brilinta, a commonly used blood thinner. U.S. FDA Update: On June 27, 2025, the FDA confirmed the scheduling of an appeal hearing date for the company’s requested supervisory review under 21 CFR 10.75. The company continues to believe remaining deficiencies in its De Novo Request can be effectively resolved through this supervisory review process that enables direct interaction and engagement with FDA senior leadership and our external experts, which is expected to complete by the end of August 2025. Health Canada Update: On June 26, 2025, Health Canada issued a Notice of Refusal of the Company’s Medical Device License application, citing non-compliance with certain Medical Devices Regulations. As part of Health Canada’s prescribed reconsideration process, the company intends to file a Level 1 “Request for Reconsideration” with the Medical Devices Directorate Bureau Director by July 25, 2025. The prescribed reconsideration process allows for supervisory review and provides the opportunity to directly address issues raised in the Notice of Refusal with staff not involved in the original review and may include input from qualified external subject matter experts. If marketing authorization is not received as part of the reconsideration process, the company can then file a formal Appeal with the Director General of the Medical Devices Directorate.