Fractyl Laboratories announced today that it received FDA breakthrough device designation for its Revita DMR type 2 diabetes treatment.
Lexington, Mass.-based Fractyl’s Revita DMR treatment is an outpatient endoscopic procedure designed to resurface the upper intestine lining (duodenal mucosa) in metabolic disease for patients with insulin-treated type 2 diabetes. Preliminary clinical findings suggest that the treatment could decrease insulin resistance, improve glucose control, lower weight and reduce liver fat.
Revita DMR has CE mark approval in Europe but up to now was only qualified in the U.S. under FDA investigational device exemption.
“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,” Fractyl co-founder & CEO Dr. Harith Rajagopalan said in a news release. “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 enrolling patients in the Revita-T2Di study that will evaluate a single Revita DMR treatment to allow patients currently on insulin therapy but with inadequate glycemic control to achieve durable insulin-free glycemic control.
The company also announced that CMS approved coverage of routine costs for Medicare patients in the Revita-T2Di trial, with all eligible participants set to receive study-related health assessments at no cost. The decision allows for reimbursement coverage to clinical research centers for certain trial-related expenses.
“Type 2 diabetes is not simply a disease of blood sugar, but a multi-organ pathology that leads to progressive pancreatic beta-cell failure, fundamentally caused by insulin resistance. We know that treatment alternatives to current drug therapy are desperately needed to address the type 2 diabetes epidemic,” Fractyl CMO Dr. Juan Carlos Lopez-Talavera said. “Providing a therapy that could improve glucose to target range while reducing the need for injectable insulin would be a quantum leap forward for patients.
“Fractyl is committed to advancing Revita DMR through the clinical and regulatory process to make a potentially meaningful difference in the lives of patients who are affected by this serious, chronic disease.”