RevitaTM DMR Procedure
New findings in metabolic science show that alterations in the hormones produced by the intestine can contribute to insulin resistance. Fractyl is developing an investigational, device-based, minimally invasive, trans-oral procedure—Revita™ duodenal mucosal resurfacing (DMR)†—that aims to directly address this impairment.
Performed using Fractyl’s proprietary Revita™ System, the DMR procedure uses hydrothermal ablation to modify the lining of the duodenum.
We believe that modifying the duodenal mucosa with our resurfacing procedure has the potential to alter the body’s ability to respond to sugar, improve glycemic control and restore metabolic health by targeting the underlying metabolic defect—insulin resistance—associated with many metabolic diseases.
Fractyl’s proprietary Revita™ System consists of a console and a novel single-use balloon catheter. The console is used to monitor and control the procedure, while the catheter is designed to access the duodenum and perform the DMR procedure.
The Revita™ System is currently under clinical investigation and is not commercially available.
Our Clinical Trialstop
We are currently engaged in clinical trials designed to investigate the effects of our Revita™ DMR procedure on insulin resistance and glucose control, with the aim of restoring metabolic health. If you are a physician interested in Fractyl’s clinical trials, please contact us.
The First-in-Human Study of Revita™ DMR was performed in a single center in Santiago, Chile to demonstrate procedural safety, tolerability and feasibility. The study included patients with type 2 diabetes who had an HbA1c > 7.5%, taking at least one oral glucose lowering medication, but not insulin or GLP-1. The treatment and one year follow up portion of the study is completed. Data from the FIH trial have been presented at several meetings. The final study report is being prepared.
The Revita-1 Study is being conducted to further evaluate the safety and potential benefits of Revita™ DMR in patients with type 2 diabetes who have sub-optimal glycemic control on oral medications. This study is being conducted in several leading academic medical centers in Europe, as well as one site in Santiago, Chile. Patient enrollment is closed. The treatment portion of the study is complete and patients are undergoing follow up.
Revita-2 is a randomized double blind, sham-controlled further investigation of the effects of DMR on glycemic control on subjects with type 2 diabetes sub-optimally controlled on 2 or more oral anti-diabetic medications. The study is conducted at nine leading endoscopic medical centers in Europe and two in Brazil. Screening for new subjects is now closed.
US Pilot Study
The Revita™ US Pilot Study is a randomized, double-blind sham-controlled prospective multicenter clinical investigation, conducted to assess the safety of the Fractyl Revita™ System for the treatment of subjects with type 2 diabetes (T2D) suboptimally controlled on 2 oral antidiabetic medications (OADs) and to assess the effect of Duodenal Mucosal Resurfacing (DMR) versus Sham procedures on glycemic endpoints 24 weeks after the procedure. This study will be conducted in a total of 5 institutions throughout the US. Patient enrollment is ongoing.
Publications from Fractyl’s Revita™ DMR clinical trials
- Cherrington, et al. “Hydrothermal Duodenal Mucosal Resurfacing Role in the Treatment of Metabolic Disease.” Gastrointestinal Endoscopy Clinics of North America, 27(2), 299-311, 2017
- 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. August, 2016.
- Galvao, et al. “Hydrothermal duodenal mucosal resurfacing: a novel procedural therapy for metabolic disease.” VideoGIE. September, 2016.
Data from Fractyl’s Revita™ DMR clinical trials have been presented at the following scientific meetings:
- van Baar, et al. Digestive Disease Week (DDW) 2017. Chicago, Illinois, USA, May 2017.
- Rajagopalan, et al. The International Liver Congress (ILC/EASL). Barcelona, Spain, April 2016.
- Cherrington, et al. 13th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. Los Angeles, Calif., USA, December 2015.
- Cherrington, et al. Third World Congress on Interventional Therapies for Type 2 Diabetes. London, UK, September 2015.
- Galvao, et al. 19th World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). Montreal, Canada, August 2014.