{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-309133","form_type":"8-K","ticker":"RCEL","cik":"0001762303","company_name":"AVITA Medical, Inc.","filed_at":"2022-12-20T23:59:59+00:00","discovered_at":"2026-05-14T18:03:52.027753+00:00","generated_at":"2026-06-21T01:50:37.249775+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"AVITA Medical submits FDA PMA application for RECELL System to treat stable vitiligo","bullets":["PMA submitted to FDA to expand RECELL indication to stable vitiligo; received Breakthrough Device designation.","Pivotal trial met primary endpoint of super-superiority (p<0.025) on repigmentation success rates.","Standard FDA review timeline for PMA is 180 days; full launch anticipated January 2025 if approved.","Vitiligo affects up to 6.5M Americans (~1.3M stable); limited treatment options exist.","This PMA follows original RECELL approval for burns in September 2018."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-309133","json":"https://secwatch.observer/filing/0001193125-22-309133.json","markdown":"https://secwatch.observer/filing/0001193125-22-309133.md","text":"https://secwatch.observer/filing/0001193125-22-309133.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1762303/000119312522309133/0001193125-22-309133-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1762303/000119312522309133/d434009d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-21T01:50:37.249775+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"}