True to its namesake geometric figure, Fractyl Health’s Type 2 diabetes treatment program now comprises multiple components that all share overarching characteristics—namely, a goal of reversing disease and preventing recurrence.
Fractyl’s diabetes treatment previously took a single-pronged approach with its flagship Revita therapy, an endoscopic procedure that blasts away thickened areas of the duodenal lining in the small intestine to improve the organ’s function, addressing what may be a root cause of Type 2 diabetes.
Now, however, the company has added a second prong, in the form of a telehealth program that aims to inspire behavioral changes alongside the intestinal resurfacing of the Revita procedure.
Fractyl unveiled the new addition, dubbed Revita+, on Tuesday. The telehealth program is meant to be used in combination with and as a way to compound the effects of the original Revita treatment. It does so by helping users build new behavioral habits—particularly those relating to diet—that can reduce glucose spikes and therefore users’ reliance on insulin injections.
“Revita+ shows the promise that a new treatment paradigm that focuses on addressing duodenal dysfunction in combination with nutritional modification aimed at preventing excessive insulin spikes may be beneficial for patients,” Stephan Martin, M.D., said in Fractyl’s announcement. “We know that weight loss and metabolic improvements are achievable for people with T2D, but Revita+ represents a treatment approach that I believe may allow durable maintenance of metabolic benefit.”
Martin is the director of the West German Diabetes and Health Centre, which created Revita+ in partnership with Fractyl.
The introduction of Revita+ comes as Fractyl debuted the first data to come out of its Revita Real World Registry. According to a case study of the first patient enrolled in the registry—which launched earlier this year, at a handful of German hospitals to start—by three months after the Revita procedure, the patient had seen their HbA1c levels drop from a starting point of 7.6% to 5.3%, back below the “normal” cutoff of 5.7%.
The patient also lost about 20 pounds during that time, saw their cholesterol, triglycerides and liver transaminase counts improve and was able to stop taking the metformin, DPP4 inhibitor and long-acting insulin they were previously prescribed to help regulate glucose levels.
Fractyl suggested in the release that adding behavioral telehealth support to the mix could further boost those results and help sustain them by guiding patients to build long-term habits that prevent the recurrence of Type 2 diabetes.
To date, Revita is only available in Europe, where it’s been CE marked since 2016. It has also caught the FDA’s eye in the years since, having earned the regulator’s breakthrough device designation and, most recently, separate approvals to begin two clinical studies in the U.S.—targeting people with Type 2 diabetes who do and don’t take insulin, respectively.