Peer-Reviewed Data Show Durable HbA1c Reduction, Significant Weight Loss, and a Favorable Safety Profile Through 48 Weeks Following a Single Endoscopic Procedure for Type 2 Diabetes
MINNEAPOLIS, March 17, 2026 (GLOBE NEWSWIRE) -- Endogenex, a clinical-stage medical device company dedicated to improving outcomes in individuals with type 2 diabetes (T2D), announced the publication of 48-week results from its REGENT-1 Australia and REGENT-1 US clinical studies in Diabetes, Obesity and Metabolism.
Growing evidence suggests that type 2 diabetes may start in the gut. When the duodenum, the uppermost segment of the small intestine, is inflamed and damaged, it disrupts the gut's ability to sense and communicate with the organs that regulate blood sugar, appetite, digestion, and metabolism. This gut dysfunction may worsen or even contribute to the cause of type 2 diabetes. Endogenex's treatment targets the disease right where research is pointing us: the gut.
The integrated analysis evaluated the safety, technical feasibility, and metabolic effects of the Endogenex Pulsed Electric Field System in 71 adults with T2D whose blood sugar was not adequately controlled on non-insulin glucose-lowering medications. The Endogenex System delivers non-thermal, pulsed electric field energy through a minimally invasive, outpatient endoscopic procedure to treat inflamed and dysfunctional tissue in the duodenum. The procedure is designed to support healthy cell regeneration in both the mucosal and submucosal layers of the duodenum, where metabolic signaling and coordination occur. Our goal is to restore the gut to a healthier state so that patients may do more than manage symptoms and potentially alter the course of their disease.
The publication reports that the primary safety endpoint was met, with no device- or procedure-related serious adverse events observed across all 71 participants. The procedure was technically successful in 100% of cases. The highest treatment intensity group, which used the second-generation catheter with a double application, demonstrated the most pronounced and durable metabolic improvements at 48 weeks. This group achieved 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 from this same group showed time in range increasing from 55.8% at baseline to 82.1% at 48 weeks. The data also demonstrated a dose-response relationship, with higher energy dosing, double application treatment, and use of the second-generation catheter producing progressively greater and more sustained metabolic improvements. No participants required rescue therapy or mandatory initiation of insulin through 48 weeks.
"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," said Dr. David N. O'Neal, Department of Medicine at the University of Melbourne and St. Vincent's Hospital Melbourne, and corresponding author of the publication. "The dose-response pattern across treatment groups further strengthens the case that duodenal regeneration is driving these metabolic effects."
"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," said Dr. Barham K. Abu Dayyeh, Division of Gastroenterology and Hepatology at Cedars Sinai Medical Center and co-author of the study. "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."
"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," said Stacey Pugh, Chief Executive Officer of Endogenex. "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."
The full publication is available online at Diabetes, Obesity and Metabolism (DOI: 10.1111/dom.70533).
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
