• Fractyl Health reported positive six-month REMAIN-1 results for Revita on October 16, 2026, showing reduced weight regain following GLP-1 discontinuation.
• The trial met its six-month primary endpoint; no device- or procedure-related serious adverse events were reported.
• A De Novo marketing application submission to the FDA is planned for late fourth-quarter 2026.
• One-year results, including the second primary endpoint, are expected in first-quarter 2027.
• Potential FDA marketing authorization is targeted for late 2027, with a potential U.S. commercial launch in early 2028.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Fractyl Health Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202610160700PRIMZONEFULLFEED9847005) on October 16, 2026, and is solely responsible for the information contained therein.