Fractyl Health, Inc., a metabolic therapeutics company, develops therapies for the treatment of type 2 diabetes (T2D) and obesity. The company develops Revita DMR System (Revita), an outpatient procedural therapy designed to durably modify duodenal dysfunction, a pathologic consequence of a high fat and high sugar diet, which can initiate T2D and obesity in humans. It develops Rejuva, a novel adeno-associated virus delivered pancreatic gene therapy platform that is designed to enable long-term remission of T2D and obesity by durably altering metabolic hormone function in the pancreatic islet cells of patients. Fractyl Health, Inc. was formerly known as Fractyl Laboratories Inc. and changed its name to Fractyl Health, Inc. on June 09, 2021. The company was incorporated in 2010 and is headquartered in Burlington, Massachusetts.
Fractyl Health to Host Virtual Commercial Strategy Day on Tuesday, September 1, 2026: The Potential Path to Commercializing Revita®, a Procedural Therapy for Post-GLP-1 Weight Maintenance
Fractyl Health announced a Virtual Commercial Strategy Day for September 1, 2026, to outline the commercialization pathway for Revita, its procedural therapy designed for weight maintenance after GLP-1 discontinuation.
The announcement recapped positive one-year data from the REMAIN-1 Midpoint Cohort, where Revita-treated participants maintained 84% of their weight loss compared to 46% in the sham group, with the treatment targeting an estimated 30 million U.S. adults on GLP-1 therapy.
Management indicated that topline data from the REMAIN-1 Pivotal Cohort is expected in early Q4 2026, followed by the anticipated submission of a FDA De Novo marketing application in late Q4 2026.