REMAIN-1 met its six-month co-primary endpoint with high statistical significance (p=0.0023; mITT population); demonstrated 80% retention of GLP-1 induced weight loss vs 67% for sham
32% of Revita® participants in primary analysis population (mITT) were either weight stable or had further weight loss at 6-months post GLP-1 discontinuation vs 18% for sham (post hoc; nominal p=0.020)
Post hoc analyses demonstrated that patients receiving a single complete duodenal ablation with Revita (>=20 cm length) regained 3.8% total body weight vs 8.2% in sham, reflecting a 53% reduction in weight regain between Month 1 and Month 6 (nominal p=0.003)
Revita has been generally well-tolerated with no device- or procedure-related serious adverse events
Revita received FDA Breakthrough Device Designation for Post-GLP-1 weight maintenance; De Novo marketing application submission to the FDA planned for late Q4 2026; anticipated topline one-year data from the REMAIN-1 Pivotal Cohort and second co-primary endpoint planned for Q1 2027
Dedicated CPT code 1122T for the Revita procedure takes effect January 1, 2027, well ahead of a potential U.S. launch in early 2028
Investor webcast today at 8:00 a.m. ET
BURLINGTON, Mass., Oct. 16, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced positive topline six-month results from the Pivotal Cohort of its ongoing REMAIN-1 study (Pivotal Cohort), a 308-participant, multicenter, randomized, double-blind, sham-controlled study of the Revita DMR System (Revita) for weight maintenance in adults with obesity following discontinuation of GLP-1 therapy. REMAIN-1 met its pre-specified six-month co-primary endpoint of weight loss retention, as patients treated with a single Revita procedure demonstrated a highly statistically significant reduction in weight regain compared to sham (p=0.0023). The second prespecified co-primary endpoint, the percentage of participants who maintain 5% or greater total body weight loss, will be assessed at 12 months. We believe these 6-month results reinforce the potential of Revita to be the first durable procedural therapy for post-GLP-1 weight maintenance and support the Company’s planned De Novo marketing application submission in late Q4 2026.