Endogenex, Inc., a clinical stage medical device company dedicated to improving outcomes in patients with Type 2 Diabetes (T2D), announced that the U.S. Food and Drug Administration (FDA) granted an Investigational Device Exemption (IDE) to initiate a clinical study of the ReCET System for the treatment of T2D in adult patients, inadequately controlled by non-insulin, glucose lowering medications.

The ReCET Clinical Study is a multicenter, prospective, randomized, double blinded, sham controlled study assessing the safety and effectiveness of the ReCET™ System. The pivotal study will enroll up to 350 patients at clinical sites in the United States and Australia. 

"Endogenex is excited to achieve this important clinical milestone," said Stacey Pugh, Endogenex CEO. "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."

"Many people living with T2D struggle to remain in control of their blood sugar levels, even while using modern glucose lowering medications. This presents a significant challenge for patients and their care providers," stated Richard Pratley, MD, Medical Director of the Advent Health Diabetes Institute in Orlando, Florida and Co-Principal Investigator for the ReCET Study. "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."

"The role of the duodenum in metabolic function and signaling is well-established," stated Dr. Barham Abu Dayyeh, MD, MPH, the Director of Advanced and Metabolic Endoscopy at Mayo Clinic in Rochester, Minnesota, and Co-Principal Investigator for the ReCET Study. "Regenerating duodenal tissue through the ReCET Procedure has the potential to target underlying pathophysiologic factors associated with Type 2 Diabetes. The evaluation of this procedure within the ReCET Study may pave the way for a novel treatment approach to this disease."

The ReCET Clinical Study will be enrolling patients at up to 30 sites in the United States and up to 10 sites in Australia.

The ReCET™ Procedure:
ReCET is a novel, endoscopic, outpatient procedure that targets the underlying cellular pathology of the duodenum that may contribute to the development and progression of Type 2 Diabetes.

Through the application of highly controlled, non-thermal pulsed electric fields, the ReCET System is designed to initiate the body's natural regenerative process to restore proper cellular signaling from the duodenum and improve metabolic function, including better control of blood glucose levels.

The ReCET System has been evaluated as part of feasibility clinical studies including REGENT-1 US, REGENT-1 Australia, and EMINENT in the Netherlands. The clinical studies assessed safety and efficacy in adults with Type 2 Diabetes whose blood glucose levels were inadequately controlled, despite the use of insulin and non-insulin medications. Publication of preliminary study outcomes has been presented at clinical conferences globally.

The ReCET System has received Breakthrough Device Designation from the FDA for treatment of Type 2 Diabetes in adult patients inadequately controlled by glucose lowering medications.