{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-043534","form_type":"8-K","ticker":"CTSO","cik":"0001175151","company_name":"Cytosorbents Corp","filed_at":"2025-05-01T23:59:59+00:00","discovered_at":"2026-05-14T18:02:47.705946+00:00","generated_at":"2026-05-22T23:46:49.757545+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.78,"calibrated_materiality_score":0.78,"confidence":"high","headline":"CytoSorbents receives FDA denial for DrugSorb-ATR De Novo; plans appeal if unresolved","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-043534","json":"https://secwatch.observer/filing/0001104659-25-043534.json","markdown":"https://secwatch.observer/filing/0001104659-25-043534.md","text":"https://secwatch.observer/filing/0001104659-25-043534.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1175151/000110465925043534/0001104659-25-043534-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1175151/000110465925043534/tm2511160d2_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-22T23:46:49.757545+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"}