Fractyl Health reports positive one-year REMAIN-1 data: Revita maintains 81% of GLP-1 weight loss after discontinuation

FRACTYL HEALTH, INC.

Single Revita procedure reduced weight regain by ~40% vs sham at one year (7.8% vs 13.0% regain in mITT, N=45).
Complete duodenal ablation (>14 cm) maintained ~81% of GLP-1-induced weight loss vs 48% sham (4.8% vs 13.0% regain).
Optimized patients (≥17.5% run-in loss) maintained ~84% vs 46% (4.1% vs 13.5% regain); responder rate 73% mITT, 91% complete ablation.
No device/procedure-related serious adverse events; TEAE rates comparable (24% Revita vs 25% sham).
Next milestones: topline Pivotal Cohort data early Q4 2026; potential FDA De Novo submission late Q4 2026.

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