CytoSorbents Corporation has announced updates on its ongoing regulatory reviews for DrugSorb™-ATR, a breakthrough blood purification device designed to reduce bleeding severity in patients undergoing coronary artery bypass grafting surgery on the antiplatelet drug Brilinta®. The U.S. FDA has scheduled an appeal hearing for the company's requested supervisory review, aiming to resolve outstanding deficiencies in its De Novo Request by the end of August 2025. Concurrently, Health Canada issued a Notice of Refusal for the Medical Device License application, citing regulatory non-compliance. CytoSorbents plans to file a "Request for Reconsideration" by July 25, 2025, to directly address these issues. The company remains optimistic about bringing this critical therapy to market by the end of the year, pending successful regulatory outcomes in both the U.S. and Canada.