Fractyl Health Reports Potent and Durable Two-Year Real-World Outcomes with Revita® Showing Sustained Weight Loss and Improved Glucose Control After a Single Procedure

Two-year follow-up in Germany Real-World Registry study showed median 9.6% weight loss and 1.6% HbA1c reduction after a single Revita procedure in participants with type 2 diabetes, with no device- or procedure-related serious adverse events to date

New real-world findings are consistent with prior two-year clinical data from studies conducted outside the United States, reinforcing Revita’s potential for long-term metabolic control ahead of pivotal REMAIN-1 readouts

Company anticipates key data readouts from randomized Revita studies in post-GLP-1 weight maintenance starting in Q3 2025

BURLINGTON, Mass., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a metabolic therapeutics company focused on pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced 2-year follow-up data from the Germany Real-World Registry study that showed a single Revita procedure led to durable weight loss and improved glucose control in people with obesity and advanced T2D. These data underscore Revita’s potential to provide a potent and durable non-drug alternative for patients struggling with long-term metabolic control.

Two-Year Data in Germany Show Sustained Weight Loss and Glycemic Improvement in Patients with Obesity and Advanced T2D

The Germany Real-World Registry study is a prospective, post-market, clinical follow-up study to evaluate the Revita procedure in patients with inadequately controlled T2D. Participants had a baseline HbA1c between 7–10% (inclusive), BMI ≤45 kg/m², and were on at least one glucose-lowering agent (GLA).

At baseline, the first 9 participants with 2 years of follow-up had a median age of 62 years, median weight of 104 kg (229 lbs.; BMI 32 kg/m²), and a median HbA1c of 9.6%, despite being on up to three GLAs.

After a single Revita procedure, these 9 participants achieved a median weight loss of 9.6% with weight decreasing from 104 kg to 97 kg at 1 year, a result that was sustained throughout 2 years. Notably, 7 of 8 participants experienced at least a