Fractyl Health, Inc. (GUTS) announced FDA approval of a pivotal Investigational Device Exemption to study Revita's efficacy in maintaining weight loss following the discontinuation of GLP-1 receptor agonist drug therapy. The IDE approval launches the Remain-1 study, set to begin in the second half of 2024.
Revita is an outpatient endoscopic procedure that targets the duodenum and is designed to reverse pathology in the duodenal lining that is a root cause of obesity and T2D. Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases.
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