Endogenex today reported positive findings from studies of its endoscopic procedure aimed at transforming diabetes care.
Minneapolis-based Endogenex shared findings in poster presentations at the American Diabetes Association’s 85th Scientific Sessions in Chicago.
The Endogenex ReCET technology uses electroporation therapy to achieve re-cellularization. It utilizes non-thermogenic pulsed electric fields (PEF) to regenerate duodenal mucosal and submucosal cells.
Endogenex designed its PEF therapy for endoscopic delivery utilizing a catheter that deploys a flex circuit. The circuit makes appositional contact with the gut wall. Ultra-short pulses of electrical energy cause electroporation of cell membranes and trigger non-thermogenic, apoptotic-like cell death. Then, rapid cellular regeneration follows.
The novel outpatient procedure “regenerates healthy cells in the mucosal and sub-mucosal layers of the duodenum — the top part of the small intestine, where metabolic coordination occurs,” according to the company. Endogenex says its system aims to deliver a substantial and durable reduction in insulin resistance and improvement in beta cell function.
A look at the ADA poster presentations from Endogenex
In the study — REGENT-1 — investigators evaluated the endoscopic PEF therapy in adults with type 2 diabetes for less than or equal to 10 years on 1-4 non-insulin glucose-lowering medications. The study modeled mixed meal tolerance test (MMTT) data to assess the metabolic effects of PEF therapy on insulin sensitivity, β-cell function and deposition index.
The investigators reported significantly improved insulin sensitivity, β-cell function and disposition index. They cited large improvements in insulin sensitivity and disposition index in particular. These were energy dose-dependent, suggesting the regenerative effect to a depth of the submucosa is important in explaining the findings, according to the poster presentation.
REGENT-1 also assessed energy dose responsiveness with its second-generation catheter. The Gen 2 catheter increases the treated surface area with a larger diameter flex circuit and expanded circumferential coverage. It delivered double treatment (mucosa and submucosa), indicating a second PEF application at the same duodenal location to enhance consistency of treatment.
Investigators found that double treatment induced by PEF proved feasible and safe. It led to improvements in glycemic, weight and lipid parameters. The energy dose-dependent response suggested the importance of the uniformity and depth of penetration of PEF.
Finally, the study looked at CGM data from different energy delivery treatment groups. Endogenex says the dose-dependent PEF improved CGM glycemic parameters and reduced glycemic variability. The greatest improvement came with the Gen 2 treatment.
Medical Design & Outsourcing: How the minimally invasive ReCET system delivers pulsed field energy in the gut
