HEALTHCARE PROFESSIONALS

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 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.

Healthy Dysfunctional Gut

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.

5 organs of the Metabolic System

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 structural and functional changes to the gut and its potential role in causing obesity and metabolic disease.

Revita Device Prototype Rendering

Revita® is a potential breakthrough solution

The Revita DMR® system consists of a device console and single-use balloon catheter, which is delivered through the mouth with an endoscope to hydrothermally ablate the duodenal mucosa, allowing for regeneration of a new mucosa and potential improvement in metabolic function.

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.

 

Watch the procedure here.

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.

 

Revitalize T2D Program Chart

 

If you are interested in learning more about Revita® or about our clinical studies, please contact us via the form below.

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Publications and Footnotes

2021

Rajagopalan, et al. “A Gut-Centric Model of Metabolic Homeostasis.” Journal of Diabetes Science and Technology, 0:1-08, October 2021.

Mingrone, et al. “Safety and efficacy of hydrothermal duodenal mucosal resurfacing in patients with type 2 diabetes: the randomised, double-blind, sham-controlled, multicentre REVITA-2 feasibility trial.” Gut, 0:1-11, January 2021.

2020

van Baar, et al. “Duodenal mucosal resurfacing combined with GLP-1RA to discontinue insulin in type 2 diabetes: a feasibility study.” Gastrointestinal Endoscopy, 0:1-10, December  2020.

van Baar, et al. “Duodenal mucosal resurfacing: Multicenter experience implementing a minimally invasive endoscopic procedure for treatment of type 2 diabetes mellitus.” Endoscopy International Open; 08: E1683–E1689, October 2020.

van Baar, et al. “Endoscopic duodenal mucosal resurfacing for the treatment of type 2 diabetes mellitus: one year results from the first international, open-label, prospective, multicentre study.” Gut, 69:295-303, January 2020.

2019

van Baar, et al. “Endoscopic duodenal mucosal resurfacing improves glycaemic and hepatic indices in type 2 diabetes: 6-month multicentre results.” JHEP Reports, Volume 1, Issue 6, 429-437, November 2019.

Haidry, et al. “Duodenal mucosal resurfacing: proof-of-concept, procedural development, and initial implementation in the clinical setting.” Gastrointestinal Endoscopy, Volume 90, Issue 4, 673-681.e2, October 2019.

2017

Cherrington, et al. “Hydrothermal Duodenal Mucosal Resurfacing Role in the Treatment of Metabolic Disease.” Gastrointestinal Endoscopy Clinics of North America, 27(2): 299-311, April 2017.

2016

Rajagopalan, et al. “Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study.” Diabetes Care, 39, 1-8, August 2016.

Galvao, et al. “Hydrothermal duodenal mucosal resurfacing: a novel procedural therapy for metabolic disease.” VideoGIE, 1(1), 10-11, September 2016.

2020

Meirling, et al. United European Gastroenterology Week 2020. Virtual, October 2020.

Chouhan, et al. ISMRM & SMRT Virtual Conference & Exhibition. Virtual, August 2020.

Hopkins, et al. Endocrine Online 2020 (ENDO). Virtual, June 2020.

Mingrone, et al. 80th American Diabetes Association Scientific Sessions (ADA). Virtual, June 2020.

Chouhan, et al. European Society of Gastrointestinal and Abdominal Radiology 2020 Virtual Congress (ESGAR). Amsterdam, The Netherlands, May 2020.

Chouhan, et al. European Society of Gastrointestinal and Abdominal Radiology 2020 Virtual Congress (ESGAR). Amsterdam, The Netherlands, May 2020.

2019

Lopez-Talavera, et al. Diabetes Technology Meeting (DTM). North Bethesda, MD, November 2019.

van Baar, et al. Diabetes Technology Meeting (DTM). North Bethesda, MD, November 2019.

West, et al. ObesityWeek 2019. Las Vegas, NV, November 2019.

Bergman, et al. American Association for the Study of Liver Diseases (AASLD). Boston, MA, November 2019.

van Baar, et al. United European Gastroenterology Week 2019 (UEGW). Barcelona, Spain, October 2019.

Meiring, et al. 79th American Diabetes Association Scientific Sessions (ADA). San Francisco, California, USA, June 2019.

Hopkins. 4th World Congress on Interventional Therapies for Type 2 Diabetes (WCITD). New York City, NY, USA, April 2019.

Hopkins, et al. 4th World Congress on Interventional Therapies for Type 2 Diabetes (WCITD). New York City, NY, USA, April 2019.

2018

Haidry, et al. Digestive Disease Week – Monumental Developments in Science & Medicine (DDW). Washington, DC, USA, June 2018.

Ghosh, et al. 78th American Diabetes Association Scientific Sessions (ADA). Orlando, Florida, USA, June 2018.

van Baar, et al. 78th American Diabetes Association Scientific Sessions (ADA). Orlando, Florida, USA, June 2018.

deGravelle, et al. 4th Paris Nash Meeting. Paris, France, July 2018.

Maggs, et al. 4th Paris Nash Meeting. Paris, France, July 2018.

van Baar, et al. United European Gastroenterology Week (UEGW). Vienna, Austria, October 2018.

Maggs, et al. American Association for the Study of Liver Diseases (AASLD). San Francisco, Calif., USA, November 2018.

2017

van Baar, et al. Digestive Disease Week (DDW). Chicago, Illinois, USA, May 2017.

Rajagopalan. 3rd Paris Nash Meeting. Paris, France, July 2017.

van Baar, et al. 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD). Lisbon, Portugal, September 2017.

van Baar, et al. American Association for the Study of Liver Diseases (AASLD). Washington, DC, USA, October 2017.

Sacks, et al. American Heart Association Meeting (AHA). Anaheim, Calif., USA, November 2017.

2016

Rajagopalan, et al. 9th Diabetes Drug Discovery & Development Conference-GTC Diabetes Summit. Boston, Massachusetts, USA, April 2016.

Rajagopalan, et al. The International Liver Congress-European Association for the Study of the Liver (EASL). Barcelona, Spain, April 2016.

Rajagopalan, et al. The International Liver Congress-European Association for the Study of the Liver (EASL). Barcelona, Spain, April 2016.

Galvao Neto, et al. Digestive Disease Week (DDW). San Diego, Calif, USA, May 2016.

Rajagopalan, et al. Digestive Disease Week (DDW). San Diego, Calif, USA, May 2016.

van Baar, et al. Digestive Disease Week (DDW). San Diego, Calif, USA, May 2016

Cherrington, et al. 76th American Diabetes Association (ADA). New Orleans, Louisiana, USA, June 2016. [Oral]

Maggs. The Obesity Society (TOS). New Orleans, LA, USA, October 2016

van Baar, et al. United European Gastroenterology Week (UEGW). Vienna, Austria, October 2016

Rajagopalan, et al. American Association for the Study of Liver Diseases (AASLD). Boston, Massachusetts, USA, November 2016.

van Baar, et al. American Association for the Study of Liver Diseases (AASLD). Boston, Massachusetts, USA, November 2016.

2015

Cherrington, et al. Third World Congress on Interventional Therapies for Type 2 Diabetes (WCITT2D). London, UK, September 2015.

Cherrington, et al. United European Gastroenterology Week (UEGW). Barcelona, Spain, October 2015.

Cherrington, et al. 13th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRS). Los Angeles, Calif., USA, December 2015.

2014

Rajagopalan. 50th Annual Meeting of the European Association for the Study of Diabetes (EASD). Vienna, Austria, September 2014.

Holleman. 50th Annual Meeting of the European Association for the Study of Diabetes (EASD). Vienna, Austria, September 2014.

Rubino. 50th Annual Meeting of the European Association for the Study of Diabetes (EASD). Vienna, Austria, September 2014.

Galvao, et al. World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). Montreal, Canada, August 2014.

2020

Meirling, et al. United European Gastroenterology Week 2020. Virtual, October 2020.

Chouhan, et al. ISMRM & SMRT Virtual Conference & Exhibition. Virtual, August 2020.

Hopkins, et al. Endocrine Online 2020 (ENDO). Virtual, June 2020.

Mingrone, et al. 80th American Diabetes Association Scientific Sessions (ADA). Virtual, June 2020.

Chouhan, et al. European Society of Gastrointestinal and Abdominal Radiology 2020 Virtual Congress (ESGAR). Amsterdam, The Netherlands, May 2020.

Chouhan, et al. European Society of Gastrointestinal and Abdominal Radiology 2020 Virtual Congress (ESGAR). Amsterdam, The Netherlands, May 2020.

2019

Lopez-Talavera, et al. Diabetes Technology Meeting (DTM). North Bethesda, MD, November 2019.

van Baar, et al. Diabetes Technology Meeting (DTM). North Bethesda, MD, November 2019.

West, et al. ObesityWeek 2019. Las Vegas, NV, November 2019.

Bergman, et al. American Association for the Study of Liver Diseases (AASLD). Boston, MA, November 2019.

van Baar, et al. United European Gastroenterology Week 2019 (UEGW). Barcelona, Spain, October 2019.

Meiring, et al. 79th American Diabetes Association Scientific Sessions (ADA). San Francisco, California, USA, June 2019.

Hopkins. 4th World Congress on Interventional Therapies for Type 2 Diabetes (WCITD). New York City, NY, USA, April 2019.

Hopkins, et al. 4th World Congress on Interventional Therapies for Type 2 Diabetes (WCITD). New York City, NY, USA, April 2019.

2018

Haidry, et al. Digestive Disease Week – Monumental Developments in Science & Medicine (DDW). Washington, DC, USA, June 2018.

Ghosh, et al. 78th American Diabetes Association Scientific Sessions (ADA). Orlando, Florida, USA, June 2018.

van Baar, et al. 78th American Diabetes Association Scientific Sessions (ADA). Orlando, Florida, USA, June 2018.

deGravelle, et al. 4th Paris Nash Meeting. Paris, France, July 2018.

Maggs, et al. 4th Paris Nash Meeting. Paris, France, July 2018.

van Baar, et al. United European Gastroenterology Week (UEGW). Vienna, Austria, October 2018.

Maggs, et al. American Association for the Study of Liver Diseases (AASLD). San Francisco, Calif., USA, November 2018.

2017

van Baar, et al. Digestive Disease Week (DDW). Chicago, Illinois, USA, May 2017.

Rajagopalan. 3rd Paris Nash Meeting. Paris, France, July 2017.

van Baar, et al. 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD). Lisbon, Portugal, September 2017.

van Baar, et al. American Association for the Study of Liver Diseases (AASLD). Washington, DC, USA, October 2017.

Sacks, et al. American Heart Association Meeting (AHA). Anaheim, Calif., USA, November 2017.

2016

Rajagopalan, et al. 9th Diabetes Drug Discovery & Development Conference-GTC Diabetes Summit. Boston, Massachusetts, USA, April 2016.

Rajagopalan, et al. The International Liver Congress-European Association for the Study of the Liver (EASL). Barcelona, Spain, April 2016.

Rajagopalan, et al. The International Liver Congress-European Association for the Study of the Liver (EASL). Barcelona, Spain, April 2016.

Galvao Neto, et al. Digestive Disease Week (DDW). San Diego, Calif, USA, May 2016.

Rajagopalan, et al. Digestive Disease Week (DDW). San Diego, Calif, USA, May 2016.

van Baar, et al. Digestive Disease Week (DDW). San Diego, Calif, USA, May 2016

Cherrington, et al. 76th American Diabetes Association (ADA). New Orleans, Louisiana, USA, June 2016. [Oral]

Maggs. The Obesity Society (TOS). New Orleans, LA, USA, October 2016

van Baar, et al. United European Gastroenterology Week (UEGW). Vienna, Austria, October 2016

Rajagopalan, et al. American Association for the Study of Liver Diseases (AASLD). Boston, Massachusetts, USA, November 2016.

van Baar, et al. American Association for the Study of Liver Diseases (AASLD). Boston, Massachusetts, USA, November 2016.

2015

Cherrington, et al. Third World Congress on Interventional Therapies for Type 2 Diabetes (WCITT2D). London, UK, September 2015.

Cherrington, et al. United European Gastroenterology Week (UEGW). Barcelona, Spain, October 2015.

Cherrington, et al. 13th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRS). Los Angeles, Calif., USA, December 2015.

2014

Rajagopalan. 50th Annual Meeting of the European Association for the Study of Diabetes (EASD). Vienna, Austria, September 2014.

Holleman. 50th Annual Meeting of the European Association for the Study of Diabetes (EASD). Vienna, Austria, September 2014.

Rubino. 50th Annual Meeting of the European Association for the Study of Diabetes (EASD). Vienna, Austria, September 2014.

Galvao, et al. World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). Montreal, Canada, August 2014.

Aliluev et al. Nat. Metab. 2021
Angelini et al. Am. J. Physiol. Gastrointest. Liver Physiol. 2020
Baldassano et al. J. Endocrinol. 2013
Dailey et al. Physiol. Behav. 2014
DeMouro et al., Endosc. Int. Open 2019
Dirksen et al. Diab. Care. 2010
Duca et al. Cell. Met. 2015
Galvao et al. Video GIE 2016
Haidry et al. Gastrointest. Endosc. 2019
Hickey, Ann. Surg. 1998
Mah et al. Endocrinol. 2014
Mao et al. Diab. 2013
Meister et al. Obes. Surg. 2017
Mingrone et al. NEJM 2012
Rajagopalan et al. Diab. Care. 2016
Rubino et al. Ann. Surg. 2006
Taylor et al. Nat. 2021
van Baar et al. Endosc. Internat. Open. 2020
Verdam et al., JClinEndocrinolMetab. 2011

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