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Revita DMR can benefit liver disease

Revita DMR can benefit both NAFLD, NASH and type 2 diabetes

Minimally invasive therapy lowered hepatic fat by 36% and Hb1AC levels by 1% in patients with non-alcoholic fatty liver disease and type 2 diabetes

Fractyl Laboratories has announced new clinical data showing its same-day therapeutic procedure - Revita Duodenal Mucosal Resurfacing (DMR) procedure - can generate significant improvements in both nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and type 2 diabetes (T2DM) in people with both conditions. The data was presented at The International Liver Congress, the EASL annual meeting, in Vienna, Austria.

NAFLD, NASH and T2D have both reached epidemic levels in the US and around the world. Of particular concern are the estimated 18 million Americans who have both conditions, which greatly increases their risk of negative outcomes. There are currently no FDA-approved treatments for NAFLD/NASH and no same-day procedure that strikes at the intersection of the two diseases.

“There are no FDA-approved treatments for NAFLD/NASH, and type 2 diabetes can be difficult to treat effectively, due to issues with compliance and drug side effects,” said Dr Arun Sanyal, Professor of Medicine, Physiology and Molecular Pathology at Virginia Commonwealth University and past president of the American Association for Study of Liver Diseases. “We have long surmised a key role of the duodenum in contributing to metabolic diseases. A potent therapy targeting the duodenum that can strike at both NAFLD/NASH and type 2 diabetes would be potentially transformative for millions of patients.”

The Revita DMR procedure is a novel endoscopic therapy that uses heat to ablate the lining of the duodenum. The procedure designed to safely alter the inner surface of the duodenum and change how the body absorbs and processes sugar. The procedure thermal ablates the duodenal mucosa and the company claims procedure has the potential to delay the need for insulin therapy and free patients from the burdens associated with managing type 2 diabetes, particularly when oral medications have failed.

 The approach aims to reset key metabolic pathways arising from the duodenum. Earlier studies have demonstrated sustained improvements in blood glucose levels and insulin resistance measures through one year of follow-up in patients with T2D. The latest data showed the metabolic benefits extend to NAFLD/NASH, lowering liver fat by 36%. Nearly 95% of treated patients showed improvement in either glucose or liver fat, with 88% of patients showing improvement in both within three months of treatment. Additional benefits from the therapy were improvement in cardiovascular risk (lowering triglyceride/HDL ratio by 28%), and in weight, with 3.1 kg weight loss unaided by any lifestyle intervention. As with earlier clinical studies, Revita DMR was well-tolerated and proved to be safe in this study of patients with NAFLD/NASH and T2DM.

“Data from our clinical studies thus far demonstrate that our minimally invasive, same-day procedure can be an efficient therapeutic approach with significant clinical benefit for patients at high risk of complications from their metabolic diseases,” said Dr Harith Rajagopalan, co-founder and CEO of Fractyl. “We are heartened by these results and look forward to data from the randomized studies to be reported later this year that will form the basis for commercialisation and upcoming US pivotal studies.”

The Revita DMR System received a CE mark in the European Union in April 2016. It has been approved for investigational use by the FDA in the US. The Revita DMR System may be available for investigational use in other regions.

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