Minneapolis-based Endogenex said its endoscopic system uses nonthermal energy to treat inflamed and dysfunctional tissue associated with type 2 diabetic duodenopathy. (ReCET stands for Re-Cellularization via Electroporation Therapy.)
The device developer — founded in partnership with Mayo Clinic — is scheduled to present the findings from its Regent-1 Australia study at Digestive Disease Week (DDW) 2025 in San Diego.
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,” the company said in a statement shared with MassDevice ahead of the presentation.
“The Regent-1 Australia study results showed significant improvements in insulin sensitivity and beta cell function at 12 weeks,” the company continued. “Improvement persisted at 48 weeks in an energy dose-responsive fashion, suggesting durability of the treatment effect. Procedural success was achieved in 100% of cases, with no device- or procedure-related serious adverse events.”
The lead author of the Regent-1 study, Dr. Barham K. Abu Dayyeh, said in the advance statement that the findings “reinforce that the duodenal mucosa and submucosa are critical therapeutic targets for advancing type 2 diabetes treatment and disease management. These results lay the groundwork for further studies, and we are eager to expand the clinical evidence base.”
Endogenex is led by CEO Stacey Pugh, a former Medtronic executive, who said the study “continues to deliver promising results, reinforcing the ReCET System’s potential as a transformative treatment for type 2 diabetes.”“We have known for some time that the duodenum plays an important role in type 2 diabetes, and these new data — along with other cutting-edge analyses being presented here at DDW — illuminate and reinforce the duodenum as a novel target in the treatment of type 2 diabetes,” she continued.
“This first-of-its-kind study demonstrates that non-thermal pulsed electric field energy treatment of the duodenum can significantly and durably improve the core physiologic mechanisms that underlie type 2 diabetes: specifically, insulin resistance and beta cell function,” said Dr. Richard Pratley, medical director of the AdventHealth Diabetes Institute and senior investigator and diabetes program lead at AdventHealth Translational Research Institute in Orlando, Florida. “The results are promising for the millions of people living with type 2 diabetes who are seeking new approaches for improving their metabolic health.”