Endogenex™ Announces First Patient Enrolled in the ReCET Clinical Study

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

MINNEAPOLIS, Oct. 15, 2024 /PRNewswire/ -- Endogenex, Inc., a clinical-stage medical device company focused on improving outcomes for patients with type 2 diabetes (T2D), today 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.

About the ReCET™ Procedure
ReCET is a novel, endoscopic outpatient procedure that targets the cellular pathology of the duodenum. This pathology may contribute to the development and progression of type 2 diabetes.

The ReCET System aims to initiate the body's natural regenerative process by applying highly controlled, non-thermal pulsed electric fields to the mucosa and sub-mucosa duodenal tissue. This approach may help restore proper cellular signaling from the duodenum and improve metabolic function, including better control of blood glucose levels. 

The ReCET System has been evaluated in feasibility clinical studies, such as REGENT-1 US, REGENT-1 Australia, and EMINENT in the Netherlands. These studies assessed the safety and efficacy of the treatment in adults with type 2 diabetes whose blood glucose levels were inadequately controlled despite using insulin and non-insulin medications. Preliminary outcomes from these studies have been presented at medical conferences globally.

About Endogenex
Endogenex, founded in partnership with Mayo Clinic, aims to revolutionize treatment options for individuals with type 2 diabetes (T2D). The company's innovations focus on resetting the body's metabolic signaling system by harnessing its natural regenerative capabilities to improve metabolic function. Through the development of the ReCET System and the novel application of precise, controlled, non-thermal pulsed electric fields, Endogenex is establishing a new era in T2D therapy, helping patients regain control of their blood glucose levels and slow disease progression.

For more information, please visit www.endogenex.com or www.recetstudy.com.

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