CytoSorbents Issues Regulatory Update For DrugSorb-ATR

(RTTNews) - CytoSorbents (CTSO) issued a regulatory update on its marketing applications for DrugSorb-ATR with the FDA and Health Canada. On June 27, 2025, the FDA confirmed the scheduling of an appeal hearing date for the company's requested supervisory review. The company continues to believe remaining deficiencies in its De Novo Request can be effectively resolved through this supervisory review process. Also, 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.

Phillip Chan, CEO of CytoSorbents, said: "We remain confident in the strength of our regulatory submissions and are committed to working through the appeals processes in a timely manner with both FDA and Health Canada. We continue to expect final regulatory decisions by the end of this year."

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