CytoSorbents appeals FDA denial of DrugSorb-ATR De Novo request; decision expected ~60 days

Cytosorbents Corp

Appeal filed June 18, 2025 under 21 CFR 10.75; FDA denial letter dated April 25, 2025.
DrugSorb-ATR designed to reduce bleeding risk in CABG patients on Brilinta; had Breakthrough Device Designation.
Supervisory review includes formal hearing with CDRH senior management; final decision typical within 60 days.
Health Canada review remains ongoing; company expects a regulatory decision in 2025.

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