Background

Type II Diabetes (T2D) pathogenesis is linked to specific duodenal alterations, offering a target for regenerative therapy. The novel Re-Cellularization via Electroporation Therapy (ReCET™) leverages non-thermal pulsed electric fields (PEF) to stimulate intestinal cell regeneration (Figure 1). We synthesize findings from two similar prospective cohort studies.

Methods

Participants aged 18-70 years, with a BMI of 24-40 kg/m2, HbA1c between 7.5%-11.0%, and on 1-4 antidiabetic drugs, were enrolled from 6 centers in Australia and the US. The intervention involved endoscopic application of PEF to the duodenum. Medication regimens remained stable. The primary endpoint was device/procedure-related serious adverse events (SAEs) at 12 weeks. Secondary endpoints included glycemic changes and weight loss.

Results

Seventy-one patients (mean age 53.6 years, 75% male, average BMI 31.7 kg/m2, average T2D duration 5.8 years, baseline HbA1c 8.6%) were treated with two generations of catheters (Gen 1, Gen 2). Gen 2 showed superior duodenal coverage. All procedures were successful, with no device/procedure-related SAEs, and complete mucosal healing at 4 weeks (Figure 1). Gen 2 significantly improved glycemic control, with a mean HbA1c reduction of -1.7%, and weight loss of 7.1% at 24 weeks. HbA1c reduction was doubled and CGM time in range increased by 42% from 23% with the Gen 2 vs. Gen 1 device. Multivariate analysis identified catheter generation as the only significant predictor of HbA1c improvement.

Conclusions

ReCET™, especially with Gen 2 catheter, markedly enhances glycemic control in T2D without serious adverse events, suggesting its potential in improving diabetes management and altering disease course.