Fractyl Laboratories has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Revita duodenal mucosal resurfacing (DMR) in patients with insulin-treated type 2 diabetes (T2D).
Revita DMR is a first-in-class intervention designed to target the role of the intestine in metabolic disease.
It is an outpatient procedural therapy, which uses heat to resurface the lining of the upper intestine that plays an integral role in metabolic regulation.
According to the company, the preliminary clinical findings have indicated that treatment with Revita DMR may decrease insulin resistance, improve glucose control, lower weight and reduce liver fat.
Fractyl has also stated that the Centers for Medicare and Medicaid Services (CMS) has approved CMS coverage of routine costs for Medicare patients in the REVITA-T2Di study.
Fractyl co-founder and CEO Harith Rajagopalan said: “We are thrilled to work closely with the FDA to accelerate the introduction of a potentially significant therapy for patients with type 2 diabetes who continue to struggle with the burden and risks of their disease.
“Breakthrough Designation provides recognition from the FDA of the potential value that Revita DMR can bring to patients and an opportunity for accelerated access for patients who need better treatment options.”
Fractyl is currently recruiting patients in the REVITA-T2Di trial to assess the effectiveness of Revita DMR in improving glucose control while reducing or eliminating the need for insulin.
The data from the trial will serve as the basis for a premarket submission to the FDA in the insulin-treated T2D patient population.
The prospective, randomised, double-blind and sham-controlled study will recruit up to 300 patients at around 35 sites across the world.
