Fractyl Health, Inc. shared real‑world two‑year follow‑up data from its Germany Real‑World Registry study, highlighting outcomes after a single Revita procedure. According to the company, nine patients with obesity and poorly controlled type 2 diabetes achieved a median weight loss of 9.6%, maintained from one to two years post‑procedure, with weight holding at approximately 97 kg. The company said that seven of eight evaluable patients realized at least 5% weight reduction, while five achieved reductions of 10% or more. One patient experienced modest 4.5% weight gain, attributed to a history of cortisone therapy.
In addition, the company reported that median HbA1c levels dropped from 9.6% at baseline to around 7.0% over two years, despite participants reducing or maintaining their use of glucose‑lowering medications. The company claims that no device‑ or procedure‑related serious adverse events have been observed to date.
Fractyl Health emphasized that these findings reinforce Revita’s potential as a one‑time, non‑drug intervention capable of delivering durable improvements in metabolic control. The company said that these results add momentum ahead of pivotal REMAIN‑1 trial data expected in the third quarter of 2025, with full primary endpoint data anticipated in the second half of 2026.
Overall, the real‑world data illustrate Revita’s potential to maintain weight and glycemic benefits long term following a single outpatient procedure.
