NASDAQ — Healthcare: Manufacturing, Biotechnology: Surgical & Medical Instruments & Apparatus
fractyl.comGUTS announced the expected completion of the clinical trial for the Revita DMR Treatment Paradigm 1, targeting Type 2 diabetes patients, on December 1, 2026. Sponsored by the Academisch Medisch Centrum - Universiteit van Amsterdam, the trial aims to evaluate the feasibility, safety, and efficacy of the DMR treatment against a sham procedure. The results may demonstrate an improvement in glucose regulation and reductions in HbA1c levels, with secondary goals of enhancing cardiovascular and metabolic health. The trial will enroll 18 participants and is currently listed as not yet recruiting.
Clinical Trial CompletionFractyl Health Inc. is set to complete its REVITA DMR clinical trial (REMAIN-1) on September 30, 2027. The trial is designed to evaluate the efficacy of Revita® Duodenal Mucosal Resurfacing (DMR) in maintaining body weight in individuals with obesity who have already lost at least 15% of their body weight on GLP-1 based therapy, specifically tirzepatide. The completion of this pivotal trial is crucial as it may enhance treatment options for obesity, which poses significant health risks and increases healthcare costs. Approximately 865 participants are involved, and the anticipated outcomes could materially affect GUTS’s market positioning and financial performance depending on the trial's results.
clinical trial completion