Endogenex has secured an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) for its ReCET System, clearing the path for the commencement of a clinical study involving patients with Type 2 diabetes (T2D).

ReCET is an outpatient procedure intended to be performed endoscopically. It is designed to target the cellular pathology of the duodenum, which could potentially influence the onset and advancement of Type 2 diabetes.

According to Endogenex, ReCET utilises precisely controlled, non-thermal pulsed electric fields.

The goal of the system is to trigger the body’s innate regenerative mechanisms, thereby restoring optimal cellular signalling in the duodenum and enhancing metabolic function. This is expected to lead to improved regulation of blood glucose levels.

Endogenex CEO Stacey Pugh said: “Endogenex is excited to achieve this important clinical milestone.

“This is a critical next step in advancing the ReCET Procedure as a treatment that addresses the underlying causes of T2D that are not targeted by current diabetes medications.”

The multicentre, prospective, randomised, double blinded, sham controlled study will feature adult patients whose glucose levels are not adequately controlled by non-insulin, glucose-lowering medications.

It will assess the safety and effectiveness of the system in up to 350 patients at clinical sites across the US and Australia.

Advent Health Diabetes Institute in Orlando, Florida medical director Richard Pratley, who is the co-principal investigator for the ReCET study, said: “Many people living with T2D struggle to remain in control of their blood sugar levels, even while using modern glucose lowering medications. This presents a significant challenge for patients and their care providers.

“Preliminary results of the ReCET Procedure have been very encouraging, so we look forward to participating in this study and expanding the understanding of how it may fulfill a significant need in the care of this patient population.”

The FDA had granted breakthrough device designation to the ReCET System for the treatment of Type 2 diabetes in adults whose glucose levels are not adequately controlled by glucose-lowering medications.

The system has been assessed as part of feasibility clinical studies such as REGENT-1 US, REGENT-1 Australia, and EMINENT in the Netherlands.