Fractyl’s Latest Milestone: Breakthrough Device Designation

Fractyl Laboratories has won breakthrough device designation for a treatment that has the potential to eliminate the need for daily insulin.

The Lexington, MA-based company is developing the Revita DMR. The therapy uses thermal ablation to ablate a portion of the duodenum mucosa, which executives believe can improve glucose control in patients struggling to manage diabetes

“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,” said Juan Carlos Lopez-Talavera, M.D., Ph.D., Chief Medical Officer of Fractyl. “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.”

The designation follows on the heels of Fractyl enrolling the first patient in a REVITA-T2Di pivotal study of the therapy. The trial is set to enroll 300 patients at up to 35 sites around the world. Fractyl won a nod from FDA for the REVITA-T2Di pivotal study in June of 2020.

The company said the Centers for Medicare and Medicaid Services has approved coverage of routine costs for Medicare patients in the REVITA-T2Di trial. All eligible participants will receive study-related health assessments at no cost; this CMS decision allows for reimbursement coverage to clinical research centers for certain trial-related expenses.

Fractyl was able to obtain significant support from investors during the pandemic. In August of 2020, the company raised $55 million in a series E round. The proceeds are being used to support the pivotal trial.