---
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"
generated_at: "2026-05-16T15:44:32.751041+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Fractyl Health reports positive 6-month REVEAL-1 data for Revita in post-GLP-1 weight maintenance

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-304486
- JSON: https://secwatch.observer/filing/0001193125-25-304486.json
- Plain text: https://secwatch.observer/filing/0001193125-25-304486.txt

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