Endogenex, a company focused on developing medical devices for type 2 diabetes management, has shared results from its REGENT-1 clinical study during the Digestive Disease Week (DDW) 2025 event held in San Diego, US.
The study evaluated the safety and feasibility of the Endogenex pulsed electric field system (ReCET system) in the US and Australia.
The system is an investigational endoscopic outpatient procedure that employs non-thermal energy to address inflamed and dysfunctional tissue linked to type 2 diabetic duodenopathy.
This treatment aims to regenerate healthy cells in the mucosal and sub-mucosal layers of the duodenum, which plays a crucial role in metabolic processes.
Endogenex CEO Stacey Pugh said: “The REGENT-1 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.”
The findings from the REGENT-1 Australia study indicated notable enhancements in insulin sensitivity and beta cell function at 12 weeks.
Improvements sustained at 48 weeks in a dose-responsive manner, indicating the “durability” of the treatment, according to the company.
The study reported a procedural success rate of 100%, with no serious adverse events related to the device or the procedure, according to the company
REGENT-1 study lead author Dr Barham Abu Dayyeh said: “These 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.”
In June 2024, Endogenex closed an oversubscribed Series C financing round, securing $88m to complete the ReCET clinical study.
