Endogenex Gets IDE OK for ReCET Study for Type 2 Diabetes

Endogenex, a clinical-stage company, has been granted investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a clinical study of its ReCET system to treat type 2 diabetes in adults inadequately controlled by non-insulin, glucose-lowering medications.
 
ReCET is an endoscopic procedure that targets underlying cell pathology in the duodenum that could contribute to type 2 diabetes development and progression. It applied controlled, non-thermal pulsed electric fields to initiate the natural regenerative process, in order to restore correct cell signaling from the duodenum and boost metabolic function—including better blood glucose control.
 
The clinical study will enroll patients at up to 30 sites in the U.S. and up to 10 sites in Australia.
 
“Endogenex is excited to achieve this important clinical milestone,” said Endogenex CEO Stacey Pugh. “This is a critical next step in advancing the ReCET Procedure as a treatment that addresses the underlying causes of T2D that are not targeted by current diabetes medications.”
 
Richard Pratley, MD is co-principal investigator for the ReCET study, as well as the medical director of the Advent Health Diabetes Institute in Orlando, Fla. He explained that many patients with type 2 diabetes have trouble controlling blood sugar levels, even while taking modern glucose lowering medications.
 
“Preliminary results of the ReCET Procedure have been very encouraging, so we look forward to participating in this study and expanding the understanding of how it may fulfill a significant need in the care of this patient population,” he said.
 
ReCET has been evaluated as part of feasibility clinical studies including REGENT-1 US, REGENT-1 Australia, and EMINENT in the Netherlands. It’s also claimed breakthrough status from the FDA to treat type 2 diabetes patients.