{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-065280","form_type":"8-K","ticker":"CTSO","cik":"0001175151","company_name":"Cytosorbents Corp","filed_at":"2025-07-02T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.489802+00:00","generated_at":"2026-05-18T09:35:03.492487+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"CytoSorbents: FDA appeal hearing set; Health Canada refuses DrugSorb-ATR license","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-065280","json":"https://secwatch.observer/filing/0001104659-25-065280.json","markdown":"https://secwatch.observer/filing/0001104659-25-065280.md","text":"https://secwatch.observer/filing/0001104659-25-065280.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1175151/000110465925065280/0001104659-25-065280-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1175151/000110465925065280/tm2519729d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T09:35:03.492487+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}