Fractyl Health announced today that six-month data from a study of its diabetes reversal tech demonstrated improvements in glucose control.
Interim data came from the human clinical experience in Fractyl’s Revita-T2Di long-term, open-label cohort. Revita, a procedure that remodels the duodenal lining via hydrothermal ablation, has FDA breakthrough device designation. The FDA approved an investigational device exemption (IDE) trial for Revita in April 2022.
Lexington, Massachusetts-based Fractyl aims for Revita to improve glycemic control and eliminate insulin needs in type 2 diabetes patients. These patients currently suffer from inadequate control on long-acting insulin. Interim data not only showed improved glycemic control but also stronger metabolic control and reduced insulin requirement.
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