Revita System Granted Breakthrough Device Designation by FDA

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Revita System (Fractyl Health Inc.) for the maintenance of weight loss after discontinuation of glucagon-like peptide-1 medications. The breakthrough device designation grants priority review by FDA after completion of the REMAIN-1 study, with the potential for early or accelerated decision on reimbursement by the Centers for Medicare and Medicaid Services.

The Revita System is an outpatient procedure that resurfaces the mucosal lining of the duodenum, the first part of the small intestine after the stomach. The duodenum breaks down food into absorbable nutrients, so by targeting the lining, the system makes it easier for the body to maintain healthy metabolism and blood glucose levels.

The REMAIN-1 trial is a randomized, double-blind study of the system compared with sham in individuals who have lost at least 15 percent of total body weight on tirzepatide (Zepound, Mounjaro; Eli Lilly). It is being designed as a pivotal study to support the registration filing for Revita and was set to begin in the second half of 2024.

The company also announced the REVEAL-1 study, which is an open-label cohort that will follow a similar population for open-label data updates as the study progresses.