---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-087501"
form_type: "8-K"
ticker: "GUTS"
cik: "0001572616"
company_name: "FRACTYL HEALTH, INC."
filed_at: "2024-07-30T23:59:59+00:00"
generated_at: "2026-05-31T15:17:56.626327+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA grants Breakthrough Device Designation for Fractyl's Revita in weight maintenance after GLP-1 discontinuation

## Summary
- Revita targets duodenal lining; aims to maintain weight loss after stopping GLP-1 drugs.
- Breakthrough Device Designation enables priority FDA review and potential CMS reimbursement support.
- REMAIN-1 pivotal study underway; data readouts expected starting Q4 2024, mid-point analysis Q2 2025.
- Designation based on prior pooled weight data from T2D studies showing durable weight maintenance.

## SEC filing metadata
- accession: 0000950170-24-087501
- form_type: 8-K
- ticker: GUTS
- cik: 0001572616
- company_name: FRACTYL HEALTH, INC.
- filed_at: 2024-07-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1572616/000095017024087501/0000950170-24-087501-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1572616/000095017024087501/guts-20240729.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-087501
- JSON: https://secwatch.observer/filing/0000950170-24-087501.json
- Plain text: https://secwatch.observer/filing/0000950170-24-087501.txt

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