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Fractyl Health Receives FDA Breakthrough Device Designation for Revita in Weight Maintenance for People with Obesity Who Discontinue GLP-1 Based Drugs
Breakthrough Device Designations are granted by the U.S. FDA to expedite review of promising technologies that address high unmet needs and may improve the
About this update from Fractyl Health, Inc.
[{"type":"text","content":"Breakthrough Device Designations are granted by the U.S. FDA to expedite review of promising technologies that address high unmet needs and may improve the lives of people with life-threatening or debilitating conditions REMAIN-1 pivotal study underway to accelerate pathway for weight maintenance indication for Revita®, with anticipated data readouts beginning in Q4 2024 BURLINGTON, Mass., July 30, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat the root cause of obesity and type 2 diabetes (T2D), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Company’s Revita System for use in the maintenance of weight loss after discontinuation of GLP-1 drugs. Breakthrough Device Designation will enable priority regulatory review with the FDA upon successful completion of the REMAIN-1 study, as well as the potential for an early or accelerated decision on reimbursement by the Centers for Medicare & Medicaid Services (CMS). Revita is an outpatient endoscopic procedure that involves resurfacing the mucosal lining of the duodenum, the first part of the small intestine just after the stomach, which is responsible for breaking down food into absorbable nutrients. Revita targets the duodenal lining, which can become thickened by high-fat and high-sugar diets, making it hard for the body to maintain a healthy metabolism and blood glucose levels. By resurfacing and reversing the pathology of the duodenal lining, Revita, if approved, has the potential to become the first disease-modifying therapy that targets a root cause of obesity and T2D. Obesity is a highly prevalent, complex disease that is associated with multiple cardiometabolic complications, including T2D. GLP-1 agonists have become game-changers in the treatment of diabetes and obesity: over 40% of patients with diabetes in the U.S. have tried GLP-1s and over 12 million U.S. adults have used them just to lose weight,1 2 yet they are not providing patients with sustained solutions to these chronic problems. Discontinuation rates are high due to gastrointestinal side effects, cost, access challenges, and other unexplained reasons. Clinical studies have highlighted the risk of substantial weight regain — as much as 66...