Fractyl Health posts REMAIN-1 midpoint cohort presentation on Revita weight maintenance after GLP-1 discontinuation
GUTS•Safety remained clean and pivotal cohort remains on track
The safety profile remained clean through 12 months, with no device-related serious adverse events; any treatment-emergent adverse events were similar to sham.
REMAIN-1 pivotal cohort is fully randomized, with topline 6-month data targeted for early Q4 2026 and a potential FDA De Novo submission in late Q4 2026.
Midpoint cohort data show better weight-loss retention with Revita
Fractyl Health highlighted one-year REMAIN-1 midpoint cohort data showing higher post-GLP-1 weight-loss retention with Revita than sham.
- The optimized subgroup showed up to 84% of weight loss retained with Revita versus 46% with sham at 12 months.
- Complete ablation over 14 cm drove durability, with 81% retention in Revita versus 48% in sham in that population.
