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.

Fractyl Health，Inc（纳斯达克：GUTS）（以下简称“公司”）是一家代谢治疗公司，专注于开创治疗肥胖和2型糖尿病（T2D）根本原因的新方法，今天宣布，美国食品和药物管理局（FDA）已授予该公司Revita系统突破性设备名称，用于在停用GLP-1药物后维持体重减轻。

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.

突破性的设备指定将在成功完成REMISE-1研究后，与FDA进行优先监管审查，并有可能由医疗保险和医疗补助服务中心（CMS）提前或加速决定报销。Revita是一种门诊内窥镜手术，涉及十二指肠粘膜衬里的表面重建，十二指肠是胃之后小肠的第一部分，负责将食物分解成可吸收的营养物质。

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.

Revita的目标是十二指肠衬里，高脂肪和高糖饮食会使十二指肠衬里增厚，使身体难以维持健康的新陈代谢和血糖水平。通过重新表面和逆转十二指肠衬里的病理，Revita如果获得批准，有可能成为第一种针对肥胖和T2D根本原因的疾病缓解疗法。