Fractyl Health reports positive 6-month Revita data; 70% weight regain reduction in key subgroup

FRACTYL HEALTH, INC.

Revita-treated patients (n=40) had 4.5% weight regain vs 7.5% sham at 6 months (p=0.07) in REMAIN-1 Midpoint Cohort.
In above-median GLP-1 weight loss subgroup, Revita achieved 70% relative reduction in weight regain vs sham (p=0.004).
Revita improved cardiometabolic markers: HDL +15.5 vs +3.9 mg/dL (p=0.01) and reduced sweet-food cravings (p=0.04).
No serious adverse events related to Revita; no study discontinuations due to adverse events through 6 months.
Fractyl requested FDA feedback on De Novo reclassification for Revita; feedback expected Q2 2026.

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