{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-047762","form_type":"8-K","ticker":"ESTA","cik":"0001688757","company_name":"ESTABLISHMENT LABS HOLDINGS INC.","filed_at":"2023-04-20T23:59:59+00:00","discovered_at":"2026-05-14T18:03:40.047677+00:00","generated_at":"2026-06-16T22:35:49.649558+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Establishment Labs reports 3-year Motiva IDE study data; capsular contracture rate 0.5%","bullets":["3-year follow-up on 451 primary augmentation patients; compliance 92.4%.","Kaplan-Meier risk rates: capsular contracture 0.5%, rupture 0.6%, breast pain 0.7%, infection 0.9%.","Any reoperation 6.1%, any complication 8.4% at 3 years.","Data submitted to FDA as part of final PMA module; device not yet approved in US.","Results consistent from year 2 to year 3 with no increase in capsular contracture or rupture."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-047762","json":"https://secwatch.observer/filing/0001104659-23-047762.json","markdown":"https://secwatch.observer/filing/0001104659-23-047762.md","text":"https://secwatch.observer/filing/0001104659-23-047762.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1688757/000110465923047762/0001104659-23-047762-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1688757/000110465923047762/tm2313294d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-16T22:35:49.649558+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"}