Fractyl’s groundbreaking research and biological insights have led to a new understanding of the origins of type 2 diabetes. Based on these discoveries, we are advancing new approaches to the treatment of type 2 diabetes and other metabolic diseases that are designed to be disease-modifying and broadly accessible, to have the greatest possible impact on improving the lives of patients and society.
Our lead program is Revita DMR, a first-in-class procedural therapy targeting the root cause of type 2 diabetes. For people with advanced type 2 diabetes, the only treatment option today is insulin dose escalation. We have developed and are investigating Revita DMR with the goal of providing an important treatment alternative to people living with type 2 diabetes whose blood sugar levels remain uncontrolled despite being on insulin therapy.
Revita DMR is a minimally invasive, outpatient, endoscopic, one-time procedural therapy. It is performed in about an hour in an outpatient endoscopy setting, offering a potential non-surgical alternative for the treatment of type 2 diabetes.
Revita DMR has been developed on the basis of research conducted by Fractyl and others that has shown that an area of the intestine called the duodenum plays a key role in the development of insulin resistance. Diets high in fat and sugar cause thickening of the duodenal lining over time. The Revita DMRSM procedure uses SureLiftTM technology, which delivers fluid to expand the duodenal tissue, and targeted thermal energy to remove the excess layers of the duodenal lining. After treatment, the duodenum begins to regenerate a new, healthy lining within a matter of days.
The duodenum is malfunctioning as a metabolic controller due to thickening of the duodenal lining
The duodenum regenerates a new lining with the potential to restore improved metabolic signaling
The Revita System consists of a specially designed control console and a novel single-use balloon catheter. The console is used to monitor the procedure, while the physician uses the catheter to apply heat to the duodenum.
Revita’s purpose-built hardware and software automate key elements of the treatment, enhancing the procedure’s reproducibility.
To date, we have conducted rigorous clinical testing of Revita in close to 300 patients with a variety of metabolic disorders and varying degrees of insulin resistance, including type 2 diabetes, nonalcoholic steatohepatitis (NASH), and polycystic ovarian syndrome (PCOS).
We are now enrolling patients in the REVITA-T2Di clinical study. REVITA-T2Di is evaluating the efficacy of Revita DMR for people with type 2 diabetes who are currently on insulin therapy but with inadequate glycemic control.