Fractyl Laboratories, a private medical technology company based in Lexington, Mass. has started the company’s first U.S. clinical trial for its lead product candidate Revita(TM) DMR for the treatment of Type 2 diabetes and fatty liver disease.
Revita DMR, short for duodenal mucosal resurfacing, is a minimally-invasive, outpatient procedural therapy designed to reverse insulin-resistant metabolic diseases, including Type 2 diabetes and nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH), by addressing their root cause in the intestine.
The Revita DMR procedure harnesses breakthrough insights into the role of the duodenum in causing insulin resistance and metabolic diseases to develop novel interventions designed to restore metabolic health.
The Revita DMR System received a CE mark in the European Union in April 2016. The Revita DMR System may be available for investigational use in other regions.
It has been approved for investigational use by the Food and Drug Administration in the U.S.
“The number of patients with Type 2 diabetes and NAFLD/NASH is increasing at an alarming rate, and new approaches to addressing the epidemic are sorely needed,” said Dr. Lopez-Talavera. “I see that Fractyl’s Revita system, rooted in a new and important scientific insight of the critical role of the gut in causing metabolic disease, offers a paradigm-shifting approach to address this major public health challenge affecting millions of patients around the world.”
The U.S. pilot follows successful clinical trials in the European Union and South America, involving more than 200 patients.
These studies, which include randomized, multicenter trials, showed a single treatment with Revita DMR was well tolerated and appears capable of producing sustained reductions in blood glucose levels, insulin use, insulin resistance, liver fat and inflammation, and weight.
- Fractyl Expands Management Team as Company Initiates U.S. Clinical Trial in Type 2 Diabetes. (2019, March 19) Business Wire. Retrieved: https://www.businesswire.com/news/home/20190318005140/en