Type 2 Diabetes Therapies Reinvented

We’re developing a unique portfolio of approaches to address the organ level root causes of type 2 diabetes

Fractyl Health’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 product candidate, the Revita DMR System, or Revita^®, is a first-in-class procedural therapy designed to target the duodenum as a root cause of type 2 diabetes. For people with advanced type 2 diabetes, the main form of therapy to control HbA1c today is insulin dose escalation and lifestyle interventions. 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 being developed as a minimally invasive, outpatient, endoscopic procedural therapy. It is designed to be performed approximately one 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 Health 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 DMR procedure uses SureLift^TM 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 lining within a matter of days.

The Revita DMR 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 via the balloon.

Revita’s purpose-built hardware and software automate key elements of the treatment, enhancing the procedure’s reproducibility.

To date, we have conducted clinical testing of Revita outside of the United States 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).

Fractyl Health is currently developing Rejuva, a novel pancreatic gene therapy platform, to enable long-term remission of T2D.

Our novel Rejuva gene therapy platform is designed to restore insulin production capacity in the pancreas via endoscopic, locally delivered adeno-associated virus, or AAV, mediated gene therapy of key metabolic hormones necessary for proper insulin production in the beta cells of the pancreas.

We anticipate nominating our first gene therapy candidate under our Rejuva program in 2023.