Fractyl Health reports positive 6-month REVEAL-1 data for Revita in post-GLP-1 weight maintenance

FRACTYL HEALTH, INC.

Participants who lost ~24% body weight on GLP-1 drugs had mean 1.5% weight change at 6 months after Revita (n=17), vs ~10% regain in literature.
HbA1c change was 0.04% after Revita vs ~0.4% increase in STEP-1 extension; no procedure-related serious adverse events.
Upcoming catalysts: Jan 2026 REMAIN-1 6-month randomized data; H2 2026 pivotal topline data and potential PMA filing.
Revita received FDA Breakthrough Device designation for post-GLP-1 weight maintenance.
Average ablation length ~16 cm, consistent with prior experience, supporting scalability.

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