{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-304486","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2025-12-02T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.792577+00:00","generated_at":"2026-05-16T15:44:32.751041+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Fractyl Health reports positive 6-month REVEAL-1 data for Revita in post-GLP-1 weight maintenance","bullets":["Participants who lost ~24% body weight on GLP-1 drugs had mean 1.5% weight change at 6 months after Revita (n=17), vs ~10% regain in literature.","HbA1c change was 0.04% after Revita vs ~0.4% increase in STEP-1 extension; no procedure-related serious adverse events.","Upcoming catalysts: Jan 2026 REMAIN-1 6-month randomized data; H2 2026 pivotal topline data and potential PMA filing.","Revita received FDA Breakthrough Device designation for post-GLP-1 weight maintenance.","Average ablation length ~16 cm, consistent with prior experience, supporting scalability."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-304486","json":"https://secwatch.observer/filing/0001193125-25-304486.json","markdown":"https://secwatch.observer/filing/0001193125-25-304486.md","text":"https://secwatch.observer/filing/0001193125-25-304486.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000119312525304486/0001193125-25-304486-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000119312525304486/guts-20251202.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T15:44:32.751041+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"}