Minneapolis-based Endogenex develops the Endogenex ReCET technology, which uses electroporation therapy to achieve re-cellularization. It utilizes non-thermogenic pulsed electric fields (PEF) to regenerate duodenal mucosal and submucosal cells.
Endogenex designed its PEF therapy for endoscopic delivery utilizing a catheter that deploys a flex circuit. The circuit 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.
The novel outpatient procedure “regenerates healthy cells in the mucosal and sub-mucosal layers of the duodenum — the top part of the small intestine, where metabolic coordination occurs,” according to the company. Endogenex says its system aims to deliver a substantial and durable reduction in insulin resistance and improvement in beta cell function.
The company published 48-week results from the REGENT-1 Australia and REGENT-1 US clinical studies in the journal Diabetes, Obesity and Metabolism. It says findings demonstrate the endoscopic procedure’s positive effects on HbA1c reduction, weight loss, with a strong safety profile, too. Findings add to data shared in June 2025 at ADA.
More on the Endogenex data
Endogenex’s integrated analysis evaluated the safety, feasibility and metabolic effects of its PEF system in 71 adults. Subjects had type 2 diabetes with blood sugar not adequately controlled on non-insulin glucose-lowering medications.
The company reported that its study met its primary safety endpoint. It delivered no device- or procedure-related serious adverse events across all 71 participants. The procedure proved technically successful in 100% of cases.
In the study, the highest treatment intensity group used a second-generation catheter with a double application. This group demonstrated the most pronounced and durable improvements at 48 weeks. It recorded a mean HbA1c reduction of 1.5%, a fasting plasma glucose reduction of 2.3 mmol/L (41.4 mg/dL), and body weight loss of 5.4 kg, representing approximately 5 to 6% of baseline body weight.
Continuous glucose monitoring data showed time in range increasing from 55.8% at baseline to 82.1% at 48 weeks. Data also highlighted a dose-response relationship. Higher-energy dosing, double application treatment and the use of the second-generation catheter delivered progressively greater and more sustained metabolic improvements.
No participants required rescue therapy or mandatory initiation of insulin through 48 weeks.
Commentary from company officials and study investigators
Stacey Pugh, Endogenex CEO, said:
“Publication of these data in Diabetes, Obesity and Metabolism gives us important third-party validation of what we have been building toward: a procedure that can meaningfully improve glycemic control, reduce body weight, and sustain those effects for nearly a year. By following the science to the gut, we believe we may redefine what is possible for diabetes care. With our ReCET pivotal study now enrolling, we are focused on generating the randomized controlled evidence needed to bring this therapy to the patients who need it most.”
Dr. David N. O’Neal, corresponding author of the publication, said:
“These results from the integrated REGENT-1 analysis provide the first peer-reviewed evidence demonstrating that non-thermal pulsed electric field-based duodenal therapy can produce clinically meaningful and durable improvements in glycemic control, body weight, and markers of insulin resistance through 48 weeks with a single endoscopic procedure. The dose-response pattern across treatment groups further strengthens the case that duodenal regeneration is driving these metabolic effects.”
Dr. Barham K. Abu Dayyeh, co-author, said:
“This publication provides the most complete view to date of how targeted duodenal treatment with pulsed electric field energy can improve glycemic control, reduce body weight, and restore insulin sensitivity in a single procedure. The dose-response data in particular reinforce that we are modifying the disease biology, not just managing symptoms, and the ReCET trial will test that hypothesis in a controlled design.”
