What is organ editing?

Organ editing is the process of targeting and modifying the duodenum and the pancreas directly as a means of addressing the organ-level root causes of T2D.

We believe that blood sugar is a symptom of T2D, not the disease itself. The underlying problem that leads to T2D is caused by the dysfunction of key metabolic organs, leading to insulin resistance and insulin insufficiency.

Recent advances in our understanding of the dysfunction of key metabolic organs in the intestine and in the pancreas have enabled the development of new approaches aimed at reversing T2D. We have developed what we believe to be broadly accessible therapies that target the gut and the pancreas directly. This approach, known as organ editing, can transform T2D treatment from chronic blood glucose management to disease-modifying therapies that focus on the organ-level root causes of disease.

Our approach involves identifying diseased metabolic organs at the root of the T2D disease process and designing disease-modifying treatments that aim to reverse the core pathology in these organs that is driving the disease process. We believe that addressing the diseased organs in a manner that is designed to restore their metabolic health and function offers the potential for disease eradication in a manner that current approaches, focused on lifestyle intervention or pharmacological management, have not been able to achieve. We call this approach “organ editing.”

REVITA® Duodenal Mucosal Resurfacing


Revita, our lead product candidate, targets duodenal dysfunction, which we believe to be a driver of insulin resistance in T2D, via a minimally invasive endoscopic procedure. In this outpatient procedure, the Revita catheter is introduced through the mouth and into the duodenum. The catheter is designed to isolate the mucosa from the deeper layers of the duodenum, to separate these layers, and then hydrothermally ablate the excess surface layers of the duodenal lining. In the days following the ablation procedure, the duodenal mucosa regenerates, which we believe leaves the duodenal lining revitalized and better able to function in a manner that has the potential to improve metabolic health.

Orientation-PhantomDuodPrf1-focusedMerge-wOverlay

We believe the function of the duodenum is negatively impacted by diets high in fat and sugars.

Revita is designed to remodel the duodenal lining via hydrothermal ablation.

THE REVITA DMR® SYSTEM

The Revita DMR system comprises (i) the Revita console that houses our proprietary technology and software and (ii) a single-use Revita catheter and single-use lineset. The image seen here depicts a prototype rendering of the modular Revita console with the current touchscreen user interface.

Learn more about Revita

REVITALIZE T2D CLINICAL DEVELOPMENT PROGRAM

Led by our ongoing Revitalize-1 pivotal study, we have initiated a broad clinical program, Revitalize T2D, which is designed to evaluate Revita in multiple concurrent clinical studies across a range of patient populations from prediabetes to T2D patients on long-acting insulin.

Organ Editing

We are now enrolling patients in the Revitalize-1 clinical study. Revitalize-1 is evaluating the effectiveness and safety of Revita for people with inadequately controlled type 2 diabetes despite being on standalone metformin or multiple antidiabetic agents and long-acting insulin.

Learn more about Revitalize-1

In Development: ReJuva®


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

The Rejuva platform is our pipeline program that is designed to restore insulin production capacity in the pancreas in people with advanced type 2 diabetes. Our approach involves an endoscopic, locally administered adeno-associated virus (AAV) to the pancreas to enable local gene therapy. Our platform is designed to enable the local production of key metabolic hormones that are known to be necessary for proper insulin production in the beta cells of the pancreas.

Revita Publications

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.

You are now leaving the Fractyl.com website

You are leaving Fractyl’s main website to go to Fractyl’s U.K. site.

By selecting Continue you will be directed to Fractyl’s U.K. site. If you would like to remain on Fractyl’s main site, select the Cancel button.

ContinueCancel