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Shifting the therapeutic focus to the root causes of T2D and obesity

FRACTYL HEALTH ASSETS ARE POTENTIALLY POSITONED TO TARGET PREVIOUSLY UNADDRESSABLE CATEGORIES IN T2D AND OBESITY

1. FDA Draft Guidance: Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention February 2008 (withdrawn), Section V.B.5 Prevention of Type 2 Diabetes Mellitus 2. Buse et al Diabetes Care. 2009 32:2133-2135. 3. FDA Guidance for Industry Developing Products for Weight Management February 2007. 4. Adapted from Hatoum et al JAMA Surgery Feb 2016.

OUR PRESENTATIONS, SCIENTIFIC POSTERS, AND PUBLICATIONS

PresentationPublication
2024
A Prospective Post-market Clinical Follow-up Registry to Evaluate Real-world Effectiveness of Duodenal Mucosal Resurfacing in Patients with Type 2 Diabetes
DDG, 2024

A Prospective Post-market Clinical Follow-up Registry to Evaluate Real-world Effectiveness of Duodenal Mucosal Resurfacing in Patients with Type 2 Diabetes

Martin, et al, presented poster at German Diabetes Association (DDG) Annual Meeting, 2024, Berlin, Germany, May 2024

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Duodenal Mucosal Resurvacing (DMR): A treatment Approach for Type 2 Diabetes Mellitus
Duodenal Mucosal Resurvacing (DMR): A treatment Approach for Type 2 Diabetes Mellitus Video
WIley

A Look at duodenal mucosal resurfacing: Rationale for targeting the duodenum in type 2 diabetes

Jonah A. Hoyt, et al

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insulin Sensitivity and beta cell function
Gastrointest Endosc

Insulin Sensitivity and Beta Cell Function After Duodenal Mucosal Resurfacing (DMR): An Open-Label, Mechanistic, Pilot Study

Celine B E Busch, et al

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Bariatrics and endoscopic therapies
Diabetes Res Clin Pract.

Bariatrics and Endoscopic Therapies for the Treatment of Metabolic Disease: Past, Present, and Future

Geltrude Mingrone, et al

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2023
ADA, 2023

Glycemic Improvement, Insulin Reductions, and Improved Body Weight 48 Weeks after Revita Duodenal Mucosal Resurfacing in T2D patients with Previously Inadequately Controlled Glucose Despite Multiple Glucose-Lowering Agents Including Insulin

Fonseca, et al. presented poster at American Diabetes Association 2023, San Diego, CA, June 2023

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DDW, 2023

Duodenal Mucosal Resurfacing Procedure Training and Implementation

Galvani, et al. presented poster at Digestive Disease Week (DDW) 2023, Chicago, IL USA, May 2023

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2022
UEGW, 2022

Enhanced β-cell function and improved insulin sensitivity after Revita® Duodenal Mucosal Resurfacing in patients with T2D

Busch, et al. presented poster at United European Gastroenterology Week (UEGW), Vienna, Austria, Oct 2022

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DDW, 2022

Improvements In Insulin Sensitivity Seen In Patients With Type 2 Diabetes After Revita® DMR Are Associated With A Decrease In Glucagon, Glucose, And GIP After A Mixed Meal Tolerance Test

Meiring, et al. presented at Digestive Disease Week (DDW) 2022, San Diego, CA, USA, May 2022

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Cardiovascular Diabetology, 2022.

Eliminating exogenous insulin therapy in patients with type 2 diabetes by duodenal ablation and GLP-1 RA decreases risk scores for cardiovascular events

Meiring, et al.

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Diabetes Research and Clinical Practice, 13 January 2022.

Durable metabolic improvements 2 years after duodenal mucosal resurfacing (DMR) in patients with type 2 diabetes (REVITA-1 Study)

van Baar, et al. 

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American Journal of Physiology, Endocrinology and Metabolism, 31 January 2022.

Duodenal mucosal resurfacing with a GLP-1 receptor agonist increases postprandial unconjugated bile acids in patients with insulin-dependent type 2 diabetes

Meiring, et al.

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Frontiers in Clinical Diabetes and Healthcare, 05 July 2022.

A Changed Gut Microbiota Diversity Is Associated With Metabolic Improvements After Duodenal Mucosal Resurfacing With Glucagon-Like-Peptide-1 Receptor Agonist in Type 2 Diabetes in a Pilot Study

Meiring, et al.

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2021
Journal of Diabetes Science and Technology, October 2021.

A Gut-Centric Model of Metabolic Homeostasis

Rajagopalan, et al.

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DDW, May 2021

Changes in Incretins Bile acids and the Microbiome after duodenal mucosal resurfacing in patients with Type 2 Diabetes

Meiring, et al. presented at Digestive Disease Week (DDW) 2021, Virtual, May 2021

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Gut, January 2021.

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

Mingrone, et al.

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2020
Gastrointestinal Endoscopy, December 2020.

Duodenal mucosal resurfacing combined with GLP-1RA to discontinue insulin in type 2 diabetes: a feasibility study

van Baar, et al.

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UEG, 2020.

Duodenal mucosal resurfacing combined with GLP-1RA may eliminate insulin treatment in type 2 diabetes while improving glycaemic control and metabolic health

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

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Endoscopy International Open; 08: E1683–E1689, October 2020.

Duodenal mucosal resurfacing: Multicenter experience implementing a minimally invasive endoscopic procedure for treatment of type 2 diabetes mellitus

van Baar, et al.

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ISMRM & SMRT, 2020.

Proton-density fat fraction-derived R2* liver iron concentration – an exploratory study of Revita-2 phase II trial data

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

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ENDO, June 2020.

Mixed-meal tolerance test (MMTT) results from REVITA-2, the first randomized, sham-controlled, double-blind, prospective, multicenter study of duodenal mucosal resurfacing (DMR) safety and efficacy in patients with suboptimally controlled type 2 diabetes (T2D)

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

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ADA, 2020.

Durable Glycemic Improvements After Duodenal Mucosal Resurfacing (DMR) in Patients with Type 2 Diabetes (T2D): 48-week Results From the REVITA-2 European Cohort

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

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ESGAR, 2020.

MRI liver proton density fat fraction in patients with the type 2 diabetes mellitus following treatment with Duodenal Mucosal Resurfacing – results from a randomised, double-blind, sham-controlled, prospective, multicenter study

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

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ESGAR, 2020.

Serum ferritin levels in patients with non-elevated Proton-Density Fat Fraction-derived R2* Liver Iron concentration – an explanatory study of Revita-2 phase II trial data

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

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Gut, January 2020.

Endoscopic duodenal mucosal resurfacing for the treatment of type 2 diabetes mellitus: one year results from the first international, open-label, prospective, multicentre study

van Baar, et al.

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2019
DTM, 2019

Duodenal Mucosal Resurfacing (DMR) for the Treatment of Type 2 Diabetes

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

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DTM, 2019

Durable Glycemic and Hepatic Improvements After Duodenal Mucosal Resurfacing in Patients With Type 2 Diabetes

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

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ObesityWeek, 2019

Diet-Induced Intestinal Mucosal Disequilibrium Contributes to Insulin-Resistant Metabolic Disease

West, et al. presented poster at ObesityWeek 2019. Las Vegas, NV, November 2019.

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AASLD, 2019.

Topline results from REVITA-2: The first randomized, double-blind, sham-controlled, prospective, multicenter study of duodenal mucosal resurfacing (DMR) efficacy, safety, and impact on NASH biomarkers in T2D

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

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JHEP Reports, November 2019.

Endoscopic duodenal mucosal resurfacing improves glycaemic and hepatic indices in type 2 diabetes: 6-month multicentre results

van Baar, et al.

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UEGW, 2019

Duodenal mucosal resurfacing combined with GLP-1 eliminates insulin therapy and improves metabolic health in type 2 diabetes

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

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Gastrointestinal Endoscopy, October 2019

Duodenal mucosal resurfacing: proof-of-concept, procedural development, and initial implementation in the clinical setting

Haidry, et al.

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ADA, June 2019

Duodenal mucosal resurfacing (DMR) combined with GLP-1 receptor agonism may eliminate insulin treatment while maintaining glycemic control and improving overall metabolic health in type 2 diabetes

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

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WCITD, April 2019.

Endoscopic Duodenal Mucosal Resurfacing

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

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WCITD, 2019

Duodenal Mucosal Resurfacing Improves Glycemic, Lipid and Hepatic Fat Fraction Measures in Type 2 Diabetes

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

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2018
AASLD, November 2018

Reduction in Liver Fat in Patients with Type 2 Diabetes Following Treatment with Duodenal Mucosal Resurfacing

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

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UEGW, 2018.

Single Duodenal Mucosal Resurfacing Elicits Improvements in Glycaemic and Hepatic Parameters in Type 2 Diabetes Mellitus: Complete 1 Year Results from the First Prospective Multicentre Study

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

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NASH, July 2018.

Duodenal mucosal resurfacing improves lipotoxic stress, mitochondrial function, aerobic metabolism, and gluconeogenic drive in type 2 diabetes

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

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NASH, July 2018.

Duodenal Mucosal Resurfacing Reduces Liver Fat in Patients with Type 2 Diabetes

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

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DDW, June 2018.

Successful Implementation Of Duodenal Mucosal Resurfacing Endoscopic Procedure Across Multiple Centers in a Study of Type 2 Diabetes Subjects

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

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ADA, June 2018.

Westernized Diet-induced Insulin Resistance in Mice is Associated with Focal Duodenal Hyperplasia Westernized Diet-induced Insulin Resistance in Mice is Associated with Focal Duodenal Hyperplasia

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

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ADA, June 2018

Duodenal Mucosal Resurfacing Elicits Improvement in Glycemic and Hepatic Parameters in Type 2 Diabetes: 1 Year Multicenter Study Results

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

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2017
AHA, November 2017

The Economic Burden of Insulin Resistance, Obesity, and Cardiovascular Disease in Medicare Beneficiaries 65 Years of Age and Older

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

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AASLD, October 2017

Improvement in Hepatic Transaminases Over 12 Months After Single Procedure Duodenal Mucosal Resurfacing in Type 2 Diabetes Patients

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

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EASD, September 2017

Duodenal Mucosal Resurfacing demonstrates sustained improvement in glycaemic parameters in type 2 diabetes: 12 month data

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

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NASH, July 2017

Duodenal Mucosa: A Target for Treating Metabolic Liver Disease in NASH and T2D

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

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DDW, May 2017.

Single Catheter for Duodenal Mucosal Resurfacing Demonstrates Similar Safety Profile With Improved Procedure Time When Compared to Original Dual Catheter: Multicenter Study of Subjects With Type 2 Diabetes

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

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Gastrointestinal Endoscopy Clinics of North America, 27(2): 299-311, April 2017.

Hydrothermal Duodenal Mucosal Resurfacing Role in the Treatment of Metabolic Disease

Cherrington, et al.

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2016
AASLD, November 2016.

Endoscopic duodenal mucosal resurfacing (DMR) improves insulin sensitivity, hepatic transaminase levels and anti-inflammatory markers in subjects with type 2 diabetes

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

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AASLD, November 2016

A single endoscopic duodenal mucosal resurfacing procedure exerts a sustained improvement in hepatic transaminase levels in a cohort of type 2 diabetes patients

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

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TOS, October 2016

Duodenal mucosal hydrothermal ablation: a new procedure designed for metabolic gain

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

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UEGW, October 2016

Endoscopic Duodenal Mucosal Resurfacing treatment for type 2 diabetes: Early multicenter experience

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

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VideoGIE, 1(1), 10-11, September 2016.

Hydrothermal duodenal mucosal resurfacing: a novel procedural therapy for metabolic disease

Galvao, et al.

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Diabetes Care, 39, 1-8, August 2016.

Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study

Rajagopalan, et al.

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ADA, June 2016

Endoscopic Duodenal Mucosal Resurfacing (DMR) Improves Metabolic Measures in Type 2 Diabetes: First-in-Human Study 6-Month Data

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

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DDW, May 2016.

Endoscopic Duodenal Mucosal Resurfacing (DMR) Improves Glycemic and Hepatic Parameters in Patients with Type 2 Diabetes: Data from a First-in-Human Study

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

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DDW, May 2016

Early experience of Duodenal Mucosal Resurfacing treatment for Type 2 Diabetes when expanding from single to multiple sites

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

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EASL, April 2016.

Endoscopic duodenal mucosal resurfacing (DMR) improves metabolic measures including hepatic transaminase levels in patients with type 2 diabetes (T2D): Data from a first-in-human study

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

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GTC Diabetes Summit, April 2016.

Duodenal mucosa: a target for treating metabolic disease

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

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EASL, April 2016.

Endoscopic Duodenal Mucosal Resurfacing (DMR) Improves Metabolic Measures, Including Hepatic Transaminase Levels, in Patients with Type 2 Diabetes: Data from a First-in-Human Study

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

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2015
WCIRS, December 2015.

Early clinical experience of duodenal mucosal resurfacing (DMR), a new endoscopic approach to treating type 2 diabetes

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

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UEGW, October 2015.

Duodenal mucosal resurfacing (DMR) as a new endoscopic treatment for type 2 diabetes (T2D): Safety and proof-of principle cohort study

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

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WCITT2D, September 2015.

Duodenal mucosal resurfacing (DMR) as a new endoscopic treatment for type 2 diabetes (T2D): Safety and proof-of principle cohort study

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

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2014
EASD, September 2014.

Evaluation of the Duodenal Mucosal Resurfacing (DMR) for the Treatment of Type 2 Diabetes

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

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EASD, September 2014.

Metabolic Surgery for Type 2 Diabetes – Window into Pathophysiology

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

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IFSO, August 2014.

Duodenal Mucosal Resurfacing A New Procedural Therapy for Type 2 Diabetes

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

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PresentationPublication
2024
ADA, 2024

Single-Dose GLP-1-Based Pancreatic Gene Therapy Durably Maintains Body Composition and Glycemia After Semaglutide Withdrawal in a Murine Model of Obesity

Rajagopalan, et al, presented at the American Diabetes Association’s 84th Scientific Sessions

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DDW, 2024

Single-dose GLP-1-based Pancreatic Gene Therapy Maintains Weight Loss After Semaglutide Withdrawal and Reduces Hepatic Triglycerides in a Murine Model of Obesity

Rajagopalan, et al, presented at Digestive Disease Week, Washington, D.C., May 2024

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2023
WCIRDC, 2023

Single-dose GLP-1-based Pancreatic Gene Therapy Maintains Weight Loss After Semaglutide Withdrawal in a Murine Model of Obesity

Liou, et.al. presented at World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease, Universal City, CA, Dec 2023

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EASD, 2023

Pancreatic Gene Therapy Durably Improves Glycaemia and Delays Disease Progression in a Murine Model of Type 2 Diabetes

Rajagopalan, et al. presented at European Association for the Study of Diabetes (EASD) 2023, Hamburg, German, October 2023

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ADA, 2023

Pancreatic Gene Therapy Durably Improves Glycemia and Delays Disease Progression in a Murine Model of Type 2 Diabetes

Rajagopalan, et al. presented at American Diabetes Association 2023, San Diego, CA, June 2023

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ASGCT, 2023

A Pancreatic Gene Therapy Delivery Platform for the Treatment of Type 2 Diabetes

Rajagopalan, et al. presented at American Society of Gene and Cell Therapy, Los Angeles, CA, May 2023

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ASGCT, 2023

Local Delivery and Tissue Restricted Expression to Optimize Therapeutic Profile for Pancreatic Gene Therapy

Rajagopalan, et al. presented at American Society of Gene and Cell Therapy, Los Angeles, CA, May 2023

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2022
WCIRDC, 2022

AAV-Mediated Pancreatic Gene Therapy for Type 2 Diabetes

Liou, et al. presented at World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC), Universal City, CA, Dec 2022

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2017
AHA, November 2017

The Economic Burden of Insulin Resistance, Obesity, and Cardiovascular Disease in Medicare Beneficiaries 65 Years of Age and Older

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

View Poster

Erase T2D

Advancing research on the role of the gut in metabolic disease

Led by world-renowned experts in metabolic disease, the EraseT2D task force shares Fractyl Health’s mission to build evidence, understand, and ultimately eradicate metabolic disease.

The Erase T2D task force builds on decades of discovery that have clearly identify the critical role of the gut as a regulator of metabolic disease. The signaling mechanisms between the gut and the rest of the body are numerous and not yet fully understood. The task force is charged with advancing research on the role of the gut in metabolic disease to catalyze future discoveries that may inform how diabetes can be better understood and ultimately erased.
This initiative, funded by Fractyl Health, is meant to spur the kind of innovative thinking and fundamental breakthroughs that will point the way toward a world without type 2 diabetes.

Erase Task Force

The ERASE T2D Task Force is comprised of the following members:

Alan Cherrington,
Ph.D.
(co-chair)

Professor of Molecular Physiology & Biophysics, Professor of Medicine, and Jacquelyn A. Turner and Dr. Dorothy J Turner Chair in Diabetes Research at Vanderbilt University School of Medicine

Harith Rajagopalan,
M.D., Ph.D.
(co-chair)

Co-founder and CEO of Fractyl Health

Dave D’Alessio,
M.D.

Professor of Medicine and Chief of Division of Endocrinology and Metabolism at Duke University School of Medicine

Geltrude Mingrone,
M.D., Ph.D.

Professor of Diabetes and Nutrition at King’s College, London; Associate Professor of Internal Medicine at Catholic University of Rome

Randy Seeley,
Ph.D.

Professor of Surgery and Director of Michigan Nutrition Obesity Research Center at Michigan School of Medicine

Timothy Kieffer,
Ph.D.

Chief Scientific Officer of Fractyl Health