---
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"
generated_at: "2026-07-15T10:10:25.632097+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Fractyl Health reports positive one-year REMAIN-1 data: Revita maintains 81% of GLP-1 weight loss after discontinuation

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-303948
- JSON: https://secwatch.observer/filing/0001193125-26-303948.json
- Plain text: https://secwatch.observer/filing/0001193125-26-303948.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.