{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-034531","form_type":"8-K","ticker":"ICU","cik":"0001831868","company_name":"SeaStar Medical Holding Corp","filed_at":"2026-11-03T13:30:35+00:00","discovered_at":"2026-11-03T13:35:00.268578+00:00","generated_at":"2026-11-03T13:35:23.352164+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.72,"calibrated_materiality_score":0.72,"confidence":"high","headline":"FDA Confirms SeaStar Medical's QUELIMMUNE SAVE Registry Fulfilled Post-Approval Requirements","bullets":["FDA's CBER determined the QUELIMMUNE Pediatric SAVE Surveillance Registry met post-approval study requirements under the original Humanitarian Device Exemption.","SAVE Registry data showed 90-day survival of 65.1% for QUELIMMUNE patients (N=43) versus 47.5% for KID cohorts (N=196), P=0.043.","Registry patients showed no device-related adverse events; results were presented as a late-breaker at ASN Kidney Week 2026.","FDA's decision lets hospitals use QUELIMMUNE without SAVE Registry research infrastructure, expanding access at centers that previously could not participate.","CEO Eric Schlorff noted these children typically have about a 50% survival rate with traditional supportive care alone."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-034531","json":"https://secwatch.observer/filing/0001437749-26-034531.json","markdown":"https://secwatch.observer/filing/0001437749-26-034531.md","text":"https://secwatch.observer/filing/0001437749-26-034531.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1831868/000143774926034531/0001437749-26-034531-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1831868/000143774926034531/icu20261102_8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-11-03T13:35:23.352164+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"}