While multiple diabetes associations have recommended bariatric surgery as a standard treatment for some diabetics, it’s still unsuitable for the mass treatment of patients. Enter Fractyl Labs, which just reported data from the first-in-human study of its endoscopic duodenal mucosal resurfacing treatment.
Fractyl’s Revita duodenal mucosal resurfacing (DMR) device uses balloon catheters to “rejuvenate” the lining of the duodenum in a bid to change gut signaling in patients with metabolic diseases caused by insulin resistance, such as diabetes. It is an outpatient treatment administered via oral endoscope, and takes about an hour.
The study, involving 39 Type 2 diabetics who were failing oral medications, investigated the safety and durability of the Revita DMR treatment. At 6 months, the treatment had improved glycemic control in patients, primarily reducing fasting hyperglycemia, or high blood glucose. It was well tolerated and caused minimal gastrointestinal symptoms after treatment, according to a statement.
“This study is part of a growing body of evidence that suggests Revita DMR may address the underlying metabolic complications of insulin resistance and could represent a new treatment option for patients with type 2 diabetes who are failing oral medications or have evidence of fatty liver disease,” said Fractyl CEO Dr. Harith Rajagopalan, in the statement.
While the American Diabetes Association and other organizations recommended metabolic, or bariatric, surgery as a treatment for some patients, less invasive procedures, which harness the mechanisms of major surgery and reproduce some of its beneficial effects could provide a real opportunity for improvement of diabetes care,” said Dr. Francesco Rubino, chair of bariatric surgery at King’s College London and Consultant Surgeon at King’s College Hospital in London, in the statement. “The early results with Revita DMR are quite encouraging in this regard.”
The Revita DMR device received a CE mark in April this year, but Fractyl did not detail a timeline for FDA submission.
- here's the statement
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