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Fractyl begins clinical trial of Revita DMR system

Fractyl Laboratories has started the enrollment of patients in its multicenter clinical trial of Revita Duodenal Mucosal Resurfacing (DMR) system.

Revita-I trial is being carried out in Europe and South America to assess the safety and performance of the DMR system.

Revita is claimed to be the first non-invasive and implant free duodenal resurfacing procedural therapy that is designed to directly treat the digestive causes of insulin resistance in patients with uncontrolled type 2 diabetes.

Fractyl Laboratories founder and CEO Dr Harith Rajagopalan said: "The Revita-1 study will expand our understanding of the safety and efficacy of the Revita DMR procedure in patients with type 2 diabetes.

"It will also guide our plans for multi-arm pivotal trials, along with data from our earlier, proof-of-concept human studies that we plan to publish this year."

According to the firm, around 10 patients were treated in the first phase of the Revita-I trial and it will enrol up to 50 patients across ten international sites.

The primary efficacy endpoint of the trial will be change in HbA1c in patients with uncontrolled type 2 diabetes, determined as having poor glucose control on oral medications and an HbA1c of 7.5% to 10%.

Fractyl will enroll up to 240 patients in a double-blinded and sham-controlled second phase of the study, which is expected to start in 2016.