{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-303948","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2026-07-15T10:00:36+00:00","discovered_at":"2026-07-15T10:10:00.292070+00:00","generated_at":"2026-07-15T10:10:25.632097+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Fractyl Health reports positive one-year REMAIN-1 data: Revita maintains 81% of GLP-1 weight loss after discontinuation","bullets":["Single Revita procedure reduced weight regain by ~40% vs sham at one year (7.8% vs 13.0% regain in mITT, N=45).","Complete duodenal ablation (>14 cm) maintained ~81% of GLP-1-induced weight loss vs 48% sham (4.8% vs 13.0% regain).","Optimized patients (≥17.5% run-in loss) maintained ~84% vs 46% (4.1% vs 13.5% regain); responder rate 73% mITT, 91% complete ablation.","No device/procedure-related serious adverse events; TEAE rates comparable (24% Revita vs 25% sham).","Next milestones: topline Pivotal Cohort data early Q4 2026; potential FDA De Novo submission late Q4 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-303948","json":"https://secwatch.observer/filing/0001193125-26-303948.json","markdown":"https://secwatch.observer/filing/0001193125-26-303948.md","text":"https://secwatch.observer/filing/0001193125-26-303948.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000119312526303948/0001193125-26-303948-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000119312526303948/guts-20260715.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-07-15T10:10:25.632097+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"}