CytoSorbents receives FDA denial for DrugSorb-ATR De Novo; plans appeal if unresolved

Cytosorbents Corp

FDA issued denial letter on April 25, 2025 for DrugSorb-ATR De Novo Request, citing remaining deficiencies.
DrugSorb-ATR is a Breakthrough Device to reduce bleeding in CABG surgery patients on Brilinta.
CytoSorbents has met with FDA and will continue discussions; formal appeal due within 60 days if unresolved.
CEO expects final regulatory decision still in 2025 despite the denial.
No therapies currently approved in U.S. for this indication; tens of thousands of patients at risk annually.

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