CytoSorbents: FDA appeal hearing set; Health Canada refuses DrugSorb-ATR license

Cytosorbents Corp

FDA confirmed appeal hearing under 21 CFR 10.75; supervisory review expected to complete by end of August 2025.
Health Canada issued Notice of Refusal for DrugSorb-ATR Medical Device License, citing non-compliance with regulations.
Company intends to file Level 1 Request for Reconsideration with Health Canada by July 25, 2025.
DrugSorb-ATR is an FDA Breakthrough Device to reduce bleeding in CABG surgery patients on Brilinta (ticagrelor).
CEO states no approved therapies exist in U.S. or Canada; final regulatory decisions expected by end of 2025.

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