Fractyl Health's Revita Meets Six-Month Co-Primary Endpoint in Ongoing REMAIN-1 Pivotal Study, With Highly Statistically Significant Reduction in Weight Regain After GLP-1 Discontinuation
Globe Newswire•16/10/2026•07:00 ET
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Key Highlights
- ➤REMAIN-1 met its six-month co-primary endpoint with high statistical significance, p=0.0023
- ➤Revita retained 80% of GLP-1-induced weight loss versus 67% for sham at six months
- ➤Revita participants regained 3.8% body weight versus 8.2% for sham after one procedure
- ➤De Novo marketing application submission planned for late Q4 2026
- ➤Dedicated CPT code 1122T takes effect January 1, 2027, ahead of potential early-2028 U.S. launch
REMAIN-1 met its six-month co-primary endpoint with high statistical significance (p=0.0023; mITT population); demonstrated 80% retention of GLP-1 induced weight loss vs 67% for sham
32% of Revita(®) participants in primary analysis population (mITT) were either weight stable or had further weight loss at 6-months post GLP-1 discontinuation vs 18% for sham (post hoc; nominal p=0.020)
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