{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-096983","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2024-08-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.591143+00:00","generated_at":"2026-05-31T09:19:53.481877+00:00","sec_items":["2.02","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Fractyl Health Q2 2024 net loss $17.2M; Revita gets FDA Breakthrough Device designation","bullets":["Net loss of $17.2M vs $30.2M in Q2 2023; cash and equivalents $102.4M as of June 30, 2024.","FDA Breakthrough Device designation for Revita in weight maintenance after GLP-1 discontinuation.","REMAIN-1 pivotal study for Revita initiated; open label data expected Q4 2024; midpoint analysis Q2 2025.","REVITALIZE-1 on track to report topline data mid-2025 in expanded T2D population (protocol amendment approved).","Chairman Allan Will stepped down; Ajay Royan appointed new Chair effective August 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-096983","json":"https://secwatch.observer/filing/0000950170-24-096983.json","markdown":"https://secwatch.observer/filing/0000950170-24-096983.md","text":"https://secwatch.observer/filing/0000950170-24-096983.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000095017024096983/0000950170-24-096983-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000095017024096983/guts-20240814.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T09:19:53.481877+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"}