Pioneering a new approach based on deep understanding of metabolic diseases
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 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.
Role of the gut in the regulation of metabolism
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: Duca et al. Cell Met. 2015
Duodenal dysfunction potentially underlies obesity and metabolic disease
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 the gut and metabolic disease:
West et al. Obesity Week. 2019
Aliluev et al. Nat Metab. 2021
Taylor et al. Nat. 2021
Mah et al. Endocrinol. 2014
Baldassano et al. J Endocrinol. 2013
Mao et al. Diab. 2013
Dailey et al. Physiol Behav. 2014
Revita® is a potential breakthrough solution
Revita® is designed to improve glucose control by targeting the gut
The Revita Duodenal Mucosal Resurfacing (DMR)® system, or 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. Over approximately one hour, the procedure is performed by a trained endoscopist, hydrothermally ablating the mucosal surface resulting in intestinal stem cell-mediated regeneration. The Revita console automates critical steps of the procedure, improving reliability and consistency of treatment.
Patients are generally able to go home the same day and resume normal activities by the following day.
Watch the procedure.
Revitalize T2D clinical development program
The Revitalize T2D program is designed to evaluate Revita® in multiple concurrent clinical studies across a range of T2D patient populations. Our ongoing Revitalize-1 study is a pivotal clinical study of Revita® in patients with inadequately controlled T2D despite being on metformin or multiple antidiabetic agents, and long-acting insulin. Additional planned Revitalize T2D studies will evaluate Revita® in patient populations from prediabetes to pre-insulin T2D patients who qualify for insulin therapy.