{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-215608","form_type":"8-K","ticker":"ICU","cik":"0001831868","company_name":"SeaStar Medical Holding Corp","filed_at":"2025-09-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:45.210236+00:00","generated_at":"2026-05-17T05:48:30.501281+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"SeaStar Medical DSMB recommends continue NEUTRALIZE-AKI trial; enrollment target raised to 339","bullets":["DSMB reports zero device-related safety issues in first 100 patients; recommends continuation of pivotal AKI trial.","Enrollment target increased from 200 to 339 patients to meet statistical power; 137 patients enrolled to date.","Estimated enrollment completion near end of 2026 based on current rate and new site additions.","QUELIMMUNE pediatric registry shows 75% 28-day survival and no device-related safety events in first 20 patients.","Company highlights potential clinical benefit signal; plans to manage capital to support milestones."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-215608","json":"https://secwatch.observer/filing/0001193125-25-215608.json","markdown":"https://secwatch.observer/filing/0001193125-25-215608.md","text":"https://secwatch.observer/filing/0001193125-25-215608.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1831868/000119312525215608/0001193125-25-215608-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1831868/000119312525215608/icu-20250924.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:48:30.501281+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"}