ReCET enrolled 350 patients across approximately 40 clinical sites in the U.S. and Australia. It evaluates the safety and effectiveness of the Endogenex System in adult patients with T2D whose blood glucose levels are inadequately controlled with non-insulin glucose-lowering medications.
The primary endpoint measures the change in HbA1c from baseline at six months following the procedure. Follow-up extends out to 12 months, with participants in the sham arm offered the opportunity to cross over to receive the ReCET procedure after the 12-month observation period.
Minneapolis-based Endogenex designed its endoscopic technology to use electroporation therapy to achieve re-cellularization. It utilizes non-thermogenic pulsed electric fields (PEF) to regenerate duodenal mucosal and submucosal cells.
The platform features a catheter that deploys a flex circuit, which makes appositional contact with the gut wall. Ultra-short pulses of electrical energy cause electroporation of cell membranes and trigger non-thermogenic, apoptotic-like cell death. Then, rapid cellular regeneration follows.
With enrollment completed in the study, Endogenex now plans to focus on follow-up through the six-month primary endpoint and full 12-month observation period. The company recently raised $50 million to support its efforts.
Dr. Barham Abu Dayyeh of the Division of Gastroenterology and Hepatology at Cedars Sinai Medical Center and Dr. Richard Pratley of the AdventHealth Translational Research Institute serve as co-principal investigators for ReCET.
Commentary from Endogenex leadership and investigators
Stacey Pugh, CEO of Endogenex, said:
“Reaching full enrollment in the ReCET study is a defining moment for Endogenex and for the millions of patients living with type 2 diabetes who deserve better options. Even with the best therapies available today, including GLP-1 receptor agonists and SGLT2 inhibitors, the disease often continues to progress because the gut has gone largely untreated. With 350 patients now enrolled across two countries in this rigorous, controlled study, we are focused entirely on generating the randomized evidence needed to bring this therapy to the patients who need it most.”
Dr. Barham Abu Dayyeh said:
“Completing enrollment of this study reflects the significant unmet need in type 2 diabetes and the growing recognition within the clinical community that treatment approaches reaching beyond pharmacotherapy can offer real value to patients. The duodenum’s role in metabolic regulation is well established, and the feasibility data from the REGENT-1 program provided a strong scientific basis for this trial. We now have the opportunity to test that hypothesis at scale in a blinded, controlled design, and the results have the potential to open a new chapter in how clinicians approach the care of this disease.”
Dr. Richard Pratley said:
“For many patients with type 2 diabetes, maintaining adequate blood glucose control remains a substantial challenge despite being on multiple medications. Full enrollment in the ReCET study is an important step toward determining whether targeted restoration of duodenal function can produce durable, clinically meaningful improvements in glycemic control. I look forward to what the results will show and to what they may mean for how we treat this disease going forward.”
