Fractyl Health says Revita met six-month co-primary endpoint in REMAIN-1 pivotal study
Fractyl Health reported topline six-month results from the Pivotal Cohort of its REMAIN-1 study of the Revita DMR System, a randomized, double-blind, sham-controlled trial. The company said Revita met its six-month co-primary endpoint, with participants retaining about 80% of GLP-1-induced weight loss versus 67% for sham, and the company plans a De Novo marketing application to the FDA in late Q4 2026.
Key points
- Six-month co-primary endpoint met in the mITT population (N=308) with p=0.0023; weight regain of 5.1% for Revita versus 8.2% for sham
- Post hoc analysis: participants receiving 20 cm or more of ablation had a mean weight regain of 3.8% (n=47); the second co-primary endpoint at 12 months is expected in Q1 2027
- No device- or procedure-related serious adverse events, no deaths, and no unanticipated adverse device effects as of the September 24, 2026 data cut-off
- Potential U.S. De Novo submission planned for late Q4 2026; potential U.S. launch in early 2028 if authorized
The filing
Written by AI on Nov 9, 2026, 8:38 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 16, 2026.
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