Fractyl Health, Inc., also known as GUTS, recently announced they have received FDA approval for a critical Investigational Device Exemption to study the effectiveness of Revita, specifically in maintaining weight loss after the stopping of GLP-1 receptor agonist drug treatment. The approval signifies the beginning of the Remain-1 study, slated to start in the latter half of 2024.
Revita is an outpatient endoscopic procedure that focuses on the duodenum and is engineered to reverse the pathology in the duodenal lining, which is a primary cause of obesity and Type 2 Diabetes. The company, Fractyl Health, is a metabolic therapeutic business that pioneers innovative approaches to treating metabolic diseases.
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