Endogenex Announces Full Enrollment of the ReCET Clinical Study

350 Patients Enrolled Across Sites in the United States and Australia, Advancing the Path to FDA Approval of a Novel Endoscopic Treatment for Type 2 Diabetes

MINNEAPOLIS, July 07, 2026 (GLOBE NEWSWIRE) -- Endogenex, a clinical-stage medical device company dedicated to improving outcomes in individuals with type 2 diabetes (T2D), announced that the ReCET Clinical Study has reached full enrollment. A total of 350 patients have been enrolled across approximately 40 clinical sites in the United States and Australia.

The ReCET Study (NCT06267391) is a multicenter, prospective, randomized, double-blinded, sham-controlled trial assessing the safety and effectiveness of the Endogenex System in adult patients with T2D whose blood glucose levels are inadequately controlled with non-insulin, glucose-lowering medications. The primary endpoint measures the change in HbA1c from baseline at six months following the procedure. All participants will be followed for 12 months, with participants in the sham arm offered the opportunity to cross over to receive the ReCET procedure after the 12-month observation period.

"Completing enrollment of this study reflects the significant unmet need in type 2 diabetes and the growing recognition within the clinical community that treatment approaches reaching beyond pharmacotherapy can offer real value to patients," said Barham Abu Dayyeh, MD, MPH, Division of Gastroenterology and Hepatology at Cedars Sinai Medical Center and Co-Principal Investigator for the ReCET Study. "The duodenum's role in metabolic regulation is well established, and the feasibility data from the REGENT-1 program provided a strong scientific basis for this trial. We now have the opportunity to test that hypothesis at scale in a blinded, controlled design, and the results have the potential to open a new chapter in how clinicians approach the care of this disease."

"For many patients with type 2 diabetes, maintaining adequate blood glucose control remains a substantial challenge despite being on multiple medications," said Richard Pratley, MD, Senior Investigator and Diabetes Program Lead | AdventHealth Translational Research Institute and Co-Principal Investigator for the ReCET Study. "Full enrollment in the ReCET study is an important step toward determining whether targeted restoration of duodenal function can produce durable, clinically meaningful improvements in glycemic control. I look forward to what the results will show and to what they may mean for how we treat this disease going forward."

"Reaching full enrollment in the ReCET study is a defining moment for Endogenex and for the millions of patients living with type 2 diabetes who deserve better options," said Stacey Pugh, Chief Executive Officer of Endogenex. "Even with the best therapies available today, including GLP-1 receptor agonists and SGLT2 inhibitors, the disease often continues to progress because the gut has gone largely untreated. With 350 patients now enrolled across two countries in this rigorous, controlled study, we are focused entirely on generating the randomized evidence needed to bring this therapy to the patients who need it most."

With enrollment now complete, Endogenex will focus on patient follow-up through the six-month primary endpoint and the full 12-month observation period.

About the ReCET Clinical Study

The ReCET Clinical Study (NCT06267391) is a multicenter, prospective, randomized, double-blinded, sham-controlled study assessing the safety and effectiveness of the Endogenex System for the treatment of type 2 diabetes in adults whose blood glucose levels are inadequately controlled on non-insulin, glucose-lowering medications. The primary endpoint is the change in HbA1c from baseline at six months. Secondary endpoints include the proportion of participants achieving HbA1c of 7.0% or below without rescue medication, time in range, total body weight loss, and the incidence of adverse events. The study received IDE approval from the FDA in November 2023.

About the Endogenex Procedure

The Endogenex procedure is a novel, minimally invasive, outpatient endoscopic procedure that targets the cellular pathology of the duodenum, the first section of the small intestine. Growing evidence suggests that when the duodenum 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 dysfunction may worsen or even contribute to the cause of type 2 diabetes.

The Endogenex System applies highly controlled, nonthermal pulsed electric fields to the mucosa and submucosa of the duodenal tissue, supporting healthy cell regeneration and aiming to restore proper metabolic signaling from the gut. The system has been evaluated in feasibility studies including REGENT-1 US, REGENT-1 Australia, and EMINENT in the Netherlands, with results published in Diabetes, Obesity and Metabolism and presented at medical conferences globally.

The Endogenex System has received FDA Breakthrough Device Designation for treating type 2 diabetes in adults whose blood glucose levels are inadequately controlled by glucose-lowering medications.

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: damage to the 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.

Inquiries:

Greg Chodaczek greg@gilmartinir.com

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.