Fractyl Snags CE Mark Approval for Revita DMR

Fractyl Announces CE Mark Approval for Revita DMR(TM) at EASL 2016

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

WALTHAM, Mass. & BARCELONA, Spain--(BUSINESS WIRE)--

Fractyl Laboratories, Inc. (Fractyl) announced today that the Company’s Revita DMR^TM 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. 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.

“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 Harith Rajagopalan, MD, PhD, Co-Founder and CEO of Fractyl.

CE Mark approval gives Fractyl the opportunity to commercialize Revita DMR^TM 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.

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.

“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.”

Upcoming Revita DMR presentations in the second quarter of 2016 will include:

• Digestive Disease Week, San Diego, CA, May 22-24
• American Association of Clinical Endocrinologists, Orlando, FL, May 25-29
• American Diabetes Association, New Orleans, LA, June 10-14

About Fatty Liver Disease and NASH

Nonalcoholic fatty liver disease (NAFLD) is a condition in which fat accumulates in the liver in association with common manifestations of metabolic disease, such an altered lipid profile and insulin resistance. NAFLD can progress to nonalcoholic steatohepatitis (NASH) and lead to liver inflammation and fibrosis, which can place NASH patients at higher risk of developing cirrhosis, liver failure and liver cancer. In both NAFLD and type 2 diabetes, insulin resistance is a key driver of both disease processes. Approximately 50 percent of patients with NASH also have type 2 diabetes. There are currently no available pharmaceutical or procedural therapies specifically approved for NAFLD or NASH.

About Fractyl and the Revita™ Duodenal Mucosal Resurfacing (DMR) System

Fractyl Laboratories, Inc. is a private, clinical-stage medical technology company based in Waltham, MA. Fractyl is developing Revita DMR, a same-day, minimally invasive, device-based procedure to treat insulin resistance, the underlying metabolic cause of type 2 diabetes and NASH (nonalcoholic steatohepatitis). Fractyl aims to alleviate the daily burdens of disease management for patients and physicians with a safe and reliable therapeutic treatment for insulin resistance and lower the tremendous health and financial burden of metabolic disease. The Revita DMR procedure and device are currently being evaluated in clinical trials. For more information, visit www.fractyl.com or www.twitter.com/FractylLabs, or www.RevitaTrial.com. Revita is for investigational use only in the United States.

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• type 2 diabetes
• fatty liver disease
• liver disease