Fractyl Health, Inc. announced 6-month follow-up data from its enrolling German real-world registry study of Revita for T2D. The first 14 consented registry participants have now completed at least 6 months of post-Revita follow up. At baseline, prior to Revita, these participants were a median age of 62 years, had a median body weight of 111 kg and advanced T2D with an average of 14 years since diagnosis.

Despite using up to three different glucose lowering medications, participants? T2D remained uncontrolled with a median baseline HbA1c of 9.2%. These 14 participants underwent Revita and experienced an average total body weight loss of 8.1% at 6 months after the procedure, with generally sustained or improved weight loss from month 1 to month 6. These real-world findings further support the potential of Revita for durable maintenance of weight loss.

Fasting blood glucose also improved after the procedure, falling from a baseline median of 153 to 116 mg/dL at 6 months, and HbA1c improved from a median of 9.2 to 7.6%, reflecting better glucose control, despite all patients stabilizing or reducing the number of glucose-lowering medications. No device or procedure-related serious adverse events have been reported to date. To date, 26 of the 33 participants treated with Revita in Germany have consented to participate in the Revita Registry.

Periodic updates on the Revita Registry and real-world clinical outcomes for patients in Germany undergoing Revita treatment will be shared as the study continues to expand and enroll.