Fractyl Health reported positive six-month topline results from the REMAIN-1 pivotal cohort, a randomized, double-blind, sham-controlled study of the Revita DMR System in adults with obesity after tirzepatide-induced weight loss.
According to the company, in the modified intention-to-treat population (N=308) Revita participants maintained approximately 80% of their glp-1–induced weight loss at six months versus 67% for sham, with least-squares mean weight regain of 5.1% versus 8.2% (p=0.0023).
Fractyl claims 32% of Revita participants were weight stable or had further loss at six months versus 18% for sham (post hoc; nominal p=0.020). In post hoc analyses by ablation length, the company reports a dose-dependent effect, with 20 cm or greater duodenal ablation showing mean regain of 3.8% versus 8.2% for sham (53% reduction; nominal p=0.003).
Revita was generally well tolerated with no device- or procedure-related serious adverse events as of the 24 September 2026 data cut-off.
Revita has FDA Breakthrough Device designation, plans to submit a De Novo marketing application in late Q4 2026, anticipates topline 12-month data in Q1 2027, and cites a potential U.S. launch in early 2028 with CPT code 1122T effective 1 January 2027.
