Fractyl Health's Revita meets six-month weight-maintenance endpoint in pivotal trial
GUTS•Fractyl Health said its Revita device met the six-month primary endpoint in the REMAIN-1 trial, reducing weight regain after GLP-1 discontinuation. The company plans to submit a De Novo application to the FDA in late fourth-quarter 2026 and expects one-year results in first-quarter 2027.
1. Trial results and timeline
Fractyl Health reported positive six-month REMAIN-1 results for Revita, showing reduced weight regain following GLP-1 discontinuation. No device- or procedure-related serious adverse events were reported. One-year results, including the second primary endpoint, are expected in first-quarter 2027; the company plans an FDA De Novo marketing application submission in late fourth-quarter 2026, targets potential marketing authorization in late 2027 and a potential U.S. launch in early 2028.
