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Fractyls lead program is. The outer lining of the duodenum is treated to make way for new healthy cells to regenerate.
The purpose of this study is to demonstrate the safety and effectiveness of the Fractyl DMR Procedure using the Revita System compared to a sham.
Revita diabetes treatment. The Revita diabetes treatment works by using hydrothermal ablation technology to deliver treatment to a part of the upper intestine called the duodenum. Revita is a minimally invasive DMR treatment technique developed by US company Fractyl. Patients with poorly controlled type 2 diabetes who underwent a novel minimally invasive endoscopic procedure called Revita duodenal mucosal resurfacing DMR.
The purpose of this study is to demonstrate the efficacy and safety of the Fractyl duodenal mucosal resurfacing DMR Procedure using the Revita System compared to a sham procedure for the treatment of uncontrolled type 2 diabetes. April 2021 issue 4. Improve glycaemic control in patients with type 2 diabetes who have preserved pancreatic beta cell function and whose diabetes is poorly controlled despite oral andor injectable glucose lowering medications andor long-acting insulin therapy reduce liver fat in patients with type 2 diabetes.
March 2021 issue 3. Revita DMR is a minimally invasive procedural therapy designed to rejuvenate the lining of the duodenum. Volume 11 January - December 2020.
A new study shows that duodenal mucosal resurfacing DMR can lead to short-term improvements in hyperglycemia among people with type 2 diabetes. January 2021 issue 1. Fractyls lead program is Revita DMR an outpatient endoscopic procedural therapy designed to treat insulin resistance in type 2 diabetes.
Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks. May 2021 issue 5. Our earlier study Revita-1 with patients that used only oral medication for their diabetes type 2 showed that the effect of a single DMR was comparable to adding one glucose lowering drug.
Revita procedure displays short-term blood glucose improvements in type 2 diabetes. November 2020 issue 11. The Sham treatment arm will cross over to receive the DMR treatment at 24.
December 2020 issue 12. February 2021 issue 2. Research treatment and education of diabetes and related disorders.
Fractyl a life sciences company dedicated to developing novel therapeutic interventions aimed at reversing the metabolic disease epidemic today announced that the US. The Revita-T2Di trial will evaluate a single Revita DMR treatment to allow patients currently on insulin therapy but with inadequate glycemic control to achieve durable insulin-free glycemic control. Food and Drug Administration FDA has granted Breakthrough Device Designation for Revita DMR in patients with insulin-treated type 2 diabetes.
The companys groundbreaking discoveries offer the potential to address other metabolic diseases in the future including nonalcoholic fatty liver diseasenonalcoholic steatohepatitis NAFLDNASH in an effort to reduce the global economic and. Fractyl is pioneering treatments for metabolic diseases based on revolutionary scientific insights into the root causes of metabolic dysfunction. Our lead investigational program Revita DMR takes an innovative approach to treating metabolic disease by addressing the root cause of insulin resistance in the intestine.
LEXINGTON Mass April 27 2021 Fractyl Laboratories Inc. Revita DMR is a minimally-invasive outpatient endoscopic procedure for diabetes patients The Revita T2Di pivotal study is aimed at enrolling patients with inadequately controlled T2D even after taking oral drugs and insulin injections and adopting lifestyle changes. The company will seek to use the trial as the basis of a marketing application to.
The Revita System is a hydrothermal ablation system of the duodenal mucosa with insulin-sensitising properties intended as an adjunct to diet and exercise to. Volume 12 January - May 2021. Revita is a first-in-class intervention designed to target insulin resistance and metabolic disease progression by resetting key pathways in the gut that drive metabolic disease.
Fractyl Laboratories announced today that it enrolled the first patient in the trial for its Revita DMR Type 2 diabetes treatment. The Revita System is being investigated to assess the ability to improve glycemic control in conjunction with diet and exercise in patients with Type 2 diabetes who are inadequately controlled with oral anti-diabetic medications. It opens up the potential to treat type 2 diabetes without the need for daily medication and also reduces the long-term risks of the condition which include heart attacks stroke and even limb.
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