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Product approval

Fractyl’s Revita DMR System gains CE Mark approval

Company presents new data in patients with type 2 diabetes and fatty liver disease

Fractyl Laboratories has announced that it’s Revita DMRTM System, used to perform minimally invasive duodenal mucosal resurfacing for the treatment of metabolic diseases (Revita DMRprocedure), has received European CE Mark approval.  The announcement was made during a company presentation of new data in liver disease at the 2016 International Liver Conference of the European Association for the Study of Liver (EASL) in Barcelona, Spain. 

“Both CE Mark approval and the first opportunity to share our early results in liver disease are major milestones for Fractyl and for our clinical and research partners.  This is the first of several presentations on Revita DMR that will take place over the next two months across the major endocrinology, GI and diabetes conferences,” said Dr Harith Rajagopalan, Co-Founder and CEO of Fractyl.

Revita DMR

Revita DMR is a minimally-invasive procedure designed to safely alter the inner surface of the duodenum and change how the body absorbs and processes sugar. The procedure is an endoscopic procedure that thermal ablates the duodenal mucosa.  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 Revita device allows physicians to easily separate the mucosal layer of the duodenum from the sub-muscosa

CE Mark approval gives Fractyl the opportunity to commercialize Revita DMR in the European Union for the treatment of metabolic diseases such as type 2 diabetes and fatty liver disease.  CE Marking confirms  that Revita DMR has met the requirements of the European Medical Devices Directive.

After the mucosal layer is separated, the ablation balloon catheter is delivered into the duodenum

In 2015, Fractyl announced results from 39 patients with poorly controlled type 2 diabetes in a single-site, proof-of-concept study in which beneficial changes in blood sugar were observed following Revita DMR.  The data presented at EASL from the same population expands on this previously announced data and suggests beneficial changes in markers of fatty liver disease following Revita DMR. In their presentation, Fractyl’s presentation, 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,” included new data that a single Revita DMR treatment improved metabolic control in patients with both type 2 diabetes and fatty liver disease.  The results presented included a lowering of hepatic transaminase levels, sustained through six months of follow up.

“The potential for a new type of intervention that may impact both fatty liver disease and type 2 diabetes is an exciting prospect. These conditions are becoming more prevalent and need new treatment options,” said Dr Scott L Friedman, Dean for Therapeutic Discovery and Chief of the Division of Liver Diseases at the Icahn School of Medicine at Mount Sinai. “The results are early, and it will be interesting to see the data from larger clinical trials.”

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