20 March 2019 - - US-based medical technology company Fractyl Laboratories Inc. (Fractyl) has hired Margaret Borys as chief commercial officer and Juan Carlos Lopez-Talavera, M.D., Ph.D., as chief medical officer, the company said.

These additions come as Fractyl is preparing for commercialization efforts outside the US and has started the company's first US clinical trial for its lead product candidate Revita DMR for the treatment of type 2 diabetes and fatty liver disease.

Revita DMR (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 US pilot follows successful clinical trials in the European Union and South America, involving more than 200 patients.

These studies, which include randomised, 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.

Borys brings more than 26 years of industry experience to her new role, having held positions in corporate strategy, commercial operations, global brand management, business technology, finance, and business consulting.

She has direct experience with Fractyl's core market of metabolic diseases; most recently leading Sanofi's multibillion dollar US diabetes biologics business.

Prior to Sanofi, Borys worked for Pfizer, Wyeth, and Arthur Andersen.

Dr. Lopez-Talavera has more than 20 years of experience in drug development for liver and gastrointestinal diseases.

Prior to joining Fractyl, Dr. Lopez-Talavera was chief medical officer at Enterome Biosciences.

Before these industry roles, Dr. Lopez-Talavera was assistant professor with the Divisions of Gastroenterology and Hepatology, and Endocrinology and Pathology at the University of Pittsburgh Medical Center.

He has been an author on more than 120 research publications and abstracts in hepatology and liver diseases.

Fractyl Laboratories is a private medical technology company based in Lexington, Mass. Fractyl is developing Revita DMR, a same-day, minimally invasive procedure to treat two highly prevalent metabolic diseases: type 2 diabetes and NAFLD/NASH.

The Revita DMR procedure harnesses breakthrough insights in 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. It has been approved for investigational use by the Food and Drug Administration in the United States. The Revita DMR System may be available for investigational use in other regions.