Fractyl Laboratories Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Revita® DMR in patients with insulin-treated type 2 diabetes (T2D).
Revita DMR (duodenal mucosal resurfacing) is a first-in-class intervention targeting the role of the intestine in metabolic disease. It is an outpatient procedural therapy that uses heat to resurface the lining of the upper intestine, an organ which plays an integral role in metabolic regulation. Fractyl’s preliminary clinical findings suggest that treatment with Revita DMR may decrease insulin resistance, improve glucose control, lower weight and reduce liver fat.
The goal of the Breakthrough Device program is to provide patients and health care providers with timely access to certain medical devices that deliver more effective treatment of life-threatening or irreversibly debilitating diseases or conditions by speeding up their development, assessment and review.