Aqua Medical Inc, a clinical-stage medical technology company advancing Endoscopic Metabolic Restoration, announced on Tuesday the treatment of the first West Coast patient (second overall in the US) in the company's FDA-approved Investigational Device Exemption (IDE) RESTORE-I clinical trial evaluating its investigational Proximal Intestinal Mucosal Ablation (PIMA) procedure for type 2 diabetes.
The procedure was performed at Hoag Hospital in Newport Beach, California, one of four US centres participating in the multicentre IDE study. The case was led by Jennifer Phan, M.D., interventional endoscopist at Hoag and vice president of Women in Endoscopy.
Aqua Medical's investigational PIMA procedure uses the company's radiofrequency vapour ablation (RFVA) platform, delivered through the working channel of a standard endoscope, to resurface a targeted segment of the proximal small intestine. The procedure is designed to address abnormal metabolic signalling associated with insulin resistance with the goal of promoting mucosal regeneration and evaluating its effects on metabolic control. Performed as a minimally invasive outpatient intervention, it requires no surgery and no fluoroscopy, and integrates into existing endoscopy suites and standard endoscopic workflows.
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