Aqua Medical has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for its pilot clinical trial evaluating the Proximal Intestinal Mucosal Ablation (PIMA) procedure.
The study will assess the company’s proprietary Radiofrequency Vapor Ablation (RFVA) system for treating type 2 diabetes (T2D). The RFVA system also holds Breakthrough Device Designation from the FDA.
The IDE approval enables Aqua Medical to initiate the RESTORE-1 pilot trial in the United States, studying PIMA’s potential to provide durable metabolic control in patients with uncontrolled T2D.
PIMA is a minimally invasive endoscopic procedure designed to ablate 50–70 cm of the proximal intestine using a through-the-endoscope RFVA catheter. The outpatient procedure requires no incisions or fluoroscopy and aims to deliver metabolic effects comparable to gastric bypass without surgical intervention.
Dr. Rehan Haidry of Cleveland Clinic London, who collaborated with Aqua Medical during PIMA’s development, described the technology as “elegant in its simplicity” and called the results “best-in-class.”
The RESTORE-1 trial will be co-led by Prof. Nicholas J. Shaheen and Prof. John Buse from the University of North Carolina School of Medicine. Both emphasized the significance of a less invasive, outpatient procedure capable of achieving “meaningful and durable metabolic control” in diabetes patients.
Aqua Medical’s IDE submission was backed by international safety and efficacy data showing promising metabolic outcomes. With FDA approval secured, the company is preparing to begin U.S. site activation and patient enrollment.
Lloyd Mencinger, President and CEO of Aqua Medical, called the milestone “a defining moment” for the company, noting that it “validates years of foundational research and global clinical experience.