Achieving a Significant Clinical Milestone in Assessing the ReCET™ System as a Groundbreaking Treatment for Type 2 Diabetes

Endogenex, Inc., a clinical-stage medical device company focused on improving outcomes for patients with type 2 diabetes (T2D),  announced the enrollment of the first patient in the ReCET Clinical Study. This multicenter, prospective, randomized, double-blinded, sham-controlled trial is designed to assess the safety and effectiveness of the ReCET™ System in adult patients whose T2D is inadequately controlled with non-insulin, glucose-lowering medications.

"This milestone is a major step forward in our mission to transform T2D treatment by addressing the underlying causes impacting millions of patients living with T2D," stated Stacey Pugh, CEO of Endogenex. "We are thrilled to have completed the first enrollment and look forward to continued collaboration with our ReCET Clinical Study sites in advancing study enrollment."

The first patient was successfully enrolled at Orlando Health, Orlando, FL, under the leadership of Dr. Andre Teixeira, Medical Director of the Orlando Health Weight Loss and Bariatric Surgery Institute. "We are excited to be part of this landmark study," stated Dr. Teixeira. "Clinical evidence continues to evolve, supporting the central role of the duodenum in regulating glucose metabolism. Therapeutic interventions targeting the upper gastrointestinal tract are demonstrating improved outcomes for patients with type 2 diabetes. The ability to reset pathologic signaling in the duodenum using the ReCET Technology, delivered through an endoscopic procedure, holds great promise for transforming care for T2D patients."

"We are proud to have reached this important milestone in the ReCET pivotal study," stated Dr Richard Pratley, Medical Director of the Advent Health Diabetes Institute in Orlando, FL, and Co-Principal Investigator for the ReCET Study.  "The ReCET Study offers new hope for advancing treatment options and the potential to provide patients a better opportunity to manage their diabetes more effectively."

The ReCET Study is a pivotal trial approved by the U.S. Food and Drug Administration (FDA) under the Investigational Device Exemption (IDE). The study aims to enroll up to 350 patients at approximately 40 sites in the United States and Australia.