{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-24-033362","form_type":"8-K","ticker":"NUWE","cik":"0001506492","company_name":"Nuwellis, Inc.","filed_at":"2024-07-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.297314+00:00","generated_at":"2026-05-31T20:11:25.155578+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Nuwellis announces first commercial sale of QUELIMMUNE therapy for pediatric AKI/sepsis","bullets":["First commercial sale of QUELIMMUNE to Cincinnati Children's Hospital for pediatric AKI/sepsis patients.","QUELIMMUNE (Selective Cytopheretic Device) developed by SeaStar Medical; early data show 77% survival rate.","Sale under exclusive US distribution agreement with SeaStar Medical (ICU); FDA Humanitarian Device Exemption.","Dr. Stuart Goldstein, principal investigator, will integrate QUELIMMUNE as standard of care at Cincinnati Children's.","CEO Nestor Jaramillo: milestone advances Nuwellis' pediatric business development strategy."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-24-033362","json":"https://secwatch.observer/filing/0001140361-24-033362.json","markdown":"https://secwatch.observer/filing/0001140361-24-033362.md","text":"https://secwatch.observer/filing/0001140361-24-033362.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1506492/000114036124033362/0001140361-24-033362-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1506492/000114036124033362/ef20032543_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T20:11:25.155578+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"}