Duodenal Mucosal Resurfacing System (DMR) for Healthcare Professionals - Medical / Health Care
Fractyl Health was founded in 2011 with a dedication to developing novel therapeutic interventions that have the potential to help reverse the metabolic disease epidemic. Despite advances in treatment over the past 50 years, metabolic diseases in general, and type 2 diabetes (T2D) in particular, continue to be a principal and rapidly growing driver of morbidity and mortality in the 21st century. Our goal is to transform T2D treatment from chronic blood glucose management to disease-modifying therapies that target the organ-level root causes of the disease.
Our lead product candidate, the Revita DMR® system (Revita®), is designed to remodel the duodenal lining via hydrothermal ablation in order to edit abnormal intestinal nutrient sensing and signaling mechanisms that we believe are a root cause of metabolic diseases. Revita has been granted Breakthrough Device Designation by the US FDA to improve glycemic control and eliminate insulin needs in T2D patients who are inadequately controlled on long-acting insulin and has obtained a CE Mark in Europe. Clinical studies of Revita thus far have been conducted in close to 300 patients at centers around the world. These clinical studies have evaluated the feasibility and tolerability of the device as well as its impact on glucose control, weight, and other metabolic parameters in patients with T2D.
In recent years, there has been an increase in research linking intestinal health to a range of diseases throughout the body —from obesity to T2D to dementia. Not only is the lining of the gut a protective barrier, but it also serves as an early warning system for the brain and the body. Advances in our understanding have begun to reveal the role of the intestine as the body’s largest endocrine organ with a central role in the body’s ability to regulate metabolism.
Learn more about the role of the gut in the regulation of metabolism.
We believe that an important root cause of metabolic disease is related to the impact of modern diets on the structure and function of the proximal intestine, including the duodenum. Recent findings have demonstrated that the chronic exposure of the intestine to high levels of fats and sugars may lead to structural and functional changes of the lining of the proximal gut. We believe these diets alter nutrient sensing and signaling to the brain and body, and therefore lead to metabolic diseases.
Learn more about structural and functional changes to the gut and its potential role in causing obesity and metabolic disease.Revita® is designed to improve glucose control by targeting the gut non-invasively
Revita is designed to be a minimally invasive, outpatient, endoscopic procedural therapy using a proprietary balloon catheter that is uniquely designed to ablate the duodenal mucosa. The procedure is performed by a trained endoscopist in approximately one hour and targets the mucosal surface for ablation and intestinal stem cell-mediated regeneration. With the help of the Revita console, certain steps of the procedure are designed to be highly automated, which we believe improves the reliability and consistency of the procedure. Patients are generally able to go home the same day and resume normal activities by the following day.