Fractyl Health’s REMAIN-1 Study Meets Six-Month Co-Primary Endpoint With High Statistical Significance; Demonstrates 80% Retention Of GLP-1 Induced Weight Loss Vs 67% For Sham

Fractyl Health's REMAIN-1 study has successfully met its six-month co-primary endpoint with a statistically significant p-value of 0.0023, showing 80% retention of GLP-1 induced weight loss compared to 67% for the sham group. The study involved 308 participants and demonstrated that those treated with the Revita procedure had a 53% reduction in weight regain. The company plans to submit a De Novo marketing application to the FDA in late Q4 2026, with topline one-year data expected in Q1 2027. A dedicated CPT code for the Revita procedure will take effect on January 1, 2027, ahead of a potential U.S. launch in early 2028.