Endogenex has enrolled the first patient in the Re-Cellularization via Electroporation Therapy (ReCET) clinical study, multi-centre, prospective, randomised, double-blinded, sham-controlled trial that 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.
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 procedure designed to reduce blood sugar levels and improve glycemic control in adults with type 2 diabetes. During the procedure, a doctor introduces a small camera through the mouth to place a specialized catheter in the duodenum. The catheter then delivers highly controlled electric energy to the lining of the duodenum. This energy triggers the body’s natural process to regenerate healthy cells that can help control blood sugar levels. The camera and catheter are then removed, and nothing is left inside the body. Following routine observation, the patient can return home the same day and resume normal activities shortly after.
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. Clinical evidence continues to evolve, supporting the central role of the duodenum in regulating glucose metabolism,” said Teixeira. “Therapeutic interventions targeting the upper gastrointestinal tract are demonstrating improved outcomes for patients with type 2 diabetes. The ability to reset pathologic signalling in the duodenum using the ReCET Technology, delivered through an endoscopic procedure, holds great promise for transforming care for T2D patients."
The ReCET Study is a pivotal trial approved by the FDA under the Investigational Device Exemption (IDE). The study aims to enrol up to 350 patients at approximately 40 sites in the US and Australia.
"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," said 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 enrolment."
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.
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