|Courtesy of Fractyl Laboratories|
Fractyl Laboratories has nabbed a CE mark for its duodenal mucosal resurfacing for metabolic diseases including Type 2 diabetes and fatty liver disease. The announcement came at the European Association for the Study of Liver (EASL) conference in Barcelona, Spain, on April 15.
The CE mark will enable Fractyl to market its Revita DMR System in Europe.
"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 Friedman, dean for therapeutic discovery and chief of the division of liver diseases at the Icahn School of Medicine at Mount Sinai, in a statement. "The results are early, and it will be interesting to see the data from larger clinical trials."
The EASL data reportedly show that one Revita treatment improved metabolic control in patients with both Type 2 diabetes and fatty liver disease. It also lowered hepatic transaminase levels, results that were sustained through 6 months of follow-up. Revita uses hydrothermal ablation to modify the lining of the duodenum.
|Fractyl CEO Dr. Harith Rajagopalan|
The duodenal mucosal resurfacing procedure has its roots in the anecdotal observation that bariatric surgery patients were immediately showing improved HbA1c numbers--right after the surgery and even before they could register any weight loss.
Fractyl was founded in 2011 to create a product that could recreate similar results to improve diabetes control--but with a minimally invasive procedure. It's raised at least $120 million, according to SEC filings, with the latest infusion of a bumped-up $54 million Series C round coming last fall.
"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," said Fractyl co-founder and CEO Dr. Harith Rajagopalan. "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."
- here is the release
Special Report: FierceMedicalDevices' 2015 Fierce 15 - Fractyl Labs