{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-22-130934","form_type":"8-K","ticker":"VCEL","cik":"0000887359","company_name":"Vericel Corp","filed_at":"2022-12-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:53.879107+00:00","generated_at":"2026-06-20T22:13:17.020344+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Vericel gets FDA approval for NexoBrid to treat severe thermal burns in adults","bullets":["FDA approved NexoBrid (anacaulase-bcdb) for eschar removal in adults with deep partial- and full-thickness thermal burns.","Approval based on Phase 3 DETECT study meeting primary endpoint of complete eschar removal vs placebo.","NexoBrid showed shorter time to eschar removal and lower incidence of surgical removal vs standard of care.","Commercial launch expected in Q2 2023; company plans to establish it as new standard of care.","Expands Vericel's target addressable market beyond sports medicine into severe burn care."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-22-130934","json":"https://secwatch.observer/filing/0001104659-22-130934.json","markdown":"https://secwatch.observer/filing/0001104659-22-130934.md","text":"https://secwatch.observer/filing/0001104659-22-130934.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/887359/000110465922130934/0001104659-22-130934-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/887359/000110465922130934/tm2233709d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-20T22:13:17.020344+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"}