---
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"
generated_at: "2026-05-31T09:19:53.481877+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Fractyl Health Q2 2024 net loss $17.2M; Revita gets FDA Breakthrough Device designation

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-096983
- JSON: https://secwatch.observer/filing/0000950170-24-096983.json
- Plain text: https://secwatch.observer/filing/0000950170-24-096983.txt

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