Endogenex Highlights 48-Week REGENT-1 Clinical Study Results at Digestive Disease Week 2025

Novel Endoscopic Procedure Demonstrates Substantial and Durable Reduction in Insulin Resistance and Improvement in Beta Cell Function for People with Type 2 Diabetes

MINNEAPOLIS, May 03, 2025 (GLOBE NEWSWIRE) — Endogenex, a clinical-stage medical device company dedicated to improving outcomes in individuals with type 2 diabetes (T2D), presented significant results from its REGENT-1 Australia clinical study at Digestive Disease Week (DDW) 2025 in San Diego.

REGENT-1 assessed the safety and feasibility of the Endogenex Pulsed Electric Field System (the ReCET System) in the U.S. and Australia. The ReCET System is an investigational, endoscopic outpatient procedure that uses non-thermal energy to treat the inflamed and dysfunctional tissue associated with type 2 diabetic duodenopathy. The treatment 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 REGENT-1 Australia study results showed significant improvements in insulin sensitivity and beta cell function at 12 weeks. 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.

“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, AdventHealth Translational Research Institute in Orlando, FL. “The results are promising for the millions of people living with type 2 diabetes who are seeking new approaches for improving their metabolic health.”

“These findings reinforce that the duodenal mucosa and submucosa are critical therapeutic targets for advancing type 2 diabetes treatment and disease management,” said Dr. Barham K. Abu Dayyeh, lead author of the REGENT-1 study. “These results lay the groundwork for further studies, and we are eager to expand the clinical evidence base.”

“The REGENT-1 study continues to deliver promising results, reinforcing the ReCET System’s potential as a transformative treatment for type 2 diabetes,” said Stacey Pugh, CEO of Endogenex. “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.”

About DDW

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases nearly 6,000 abstracts and over 1,000 invited talks on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

About Endogenex™

Founded in partnership with Mayo Clinic, Endogenex is pioneering a treatment for type 2 diabetes that targets what research now points to as a likely cause: a damaged duodenum. The company’s novel, outpatient endoscopic procedure uses non-thermal pulsed electric fields (PEF) energy to treat inflamed and dysfunctional tissue associated with type 2 diabetic duodenopathy. A specialized Endogenex catheter delivers PEF to the mucosa and sub-mucosa duodenal tissue initiating the body’s natural process of cell regeneration. Our goal is to restore the gut to a healthier state, so we may help patients do more than manage their symptoms — and potentially slow, or even stop, their disease progression. By following the science to the gut, we hope to redefine what’s possible for diabetes care.

For more information – including about the ReCET Study, which is currently enrolling new patients – please visit www.endogenex.com and www.recetstudy.com.

Media Inquiries:

Ashley Biladeau
Biladeau Consulting for Endogenex
ashley@biladeauconsulting.com

Krissy Wright
Chief Financial Officer
kwright@endogenex.com