{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-072044","form_type":"8-K","ticker":"ELUT","cik":"0001708527","company_name":"ELUTIA INC.","filed_at":"2024-06-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.685756+00:00","generated_at":"2026-06-01T04:08:11.440492+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Elutia receives FDA clearance for antibiotic-eluting bioenvelope EluPro for cardiac and neuromodulation devices","bullets":["FDA cleared EluPro, first antibiotic-eluting bioenvelope, for pacemakers, defibrillators, neurostimulators, and neuromodulators.","Targets $600M US implantable electronic device protection market; no other biologic competitor currently.","Delivers rifampin and minocycline embedded in extracellular matrix to reduce infection, migration, and erosion complications.","Additional indications expand addressable market to neurostimulation/modulation, estimated at $8B worldwide.","Elutia plans national CIED launch in H2 2024; adjacent neuro markets prioritized for expansion."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-072044","json":"https://secwatch.observer/filing/0001104659-24-072044.json","markdown":"https://secwatch.observer/filing/0001104659-24-072044.md","text":"https://secwatch.observer/filing/0001104659-24-072044.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1708527/000110465924072044/0001104659-24-072044-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1708527/000110465924072044/tm2417396d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T04:08:11.440492+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"}