Endogenex Inc. has raised $50 million in an extension to its series C financing round to fund the completion of its pivotal Recet clinical study, which is evaluating the use of the company’s non-thermal pulsed electric field system for remodeling the duodenal tissue in adults with type 2 diabetes. The new capital will also be used to support the company's regulatory pathway toward U.S. FDA approval.
The FDA has granted breakthrough device designation to Fractyl Laboratories Inc. for Revita DMR, a duodenal mucosal resurfacing treatment for patients with type 2 diabetes. The company recently launched the pivotal REVITA-T2Di clinical trial to evaluate the treatment in this population, in hopes it will offer a new option for people with the metabolic disease.
Improving metabolic disorders without major changes in diet and exercise is typically seen as impossible, unless bariatric surgery is involved. But that’s precisely what Fractyl Laboratories Inc. aims to do. It plans to start a pivotal trial of its duodenal mucosal resurfacing system, Revita DMR, before year end.
