{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-087501","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2024-07-30T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.590858+00:00","generated_at":"2026-05-31T15:17:56.626327+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA grants Breakthrough Device Designation for Fractyl's Revita in weight maintenance after GLP-1 discontinuation","bullets":["Revita targets duodenal lining; aims to maintain weight loss after stopping GLP-1 drugs.","Breakthrough Device Designation enables priority FDA review and potential CMS reimbursement support.","REMAIN-1 pivotal study underway; data readouts expected starting Q4 2024, mid-point analysis Q2 2025.","Designation based on prior pooled weight data from T2D studies showing durable weight maintenance."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-087501","json":"https://secwatch.observer/filing/0000950170-24-087501.json","markdown":"https://secwatch.observer/filing/0000950170-24-087501.md","text":"https://secwatch.observer/filing/0000950170-24-087501.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000095017024087501/0000950170-24-087501-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000095017024087501/guts-20240729.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T15:17:56.626327+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"}