Aqua Medical Secures FDA IDE to Study its Breakthrough Endoscopic Technology for the treatment of Type 2 Diabetes

PLEASANTON, Calif., Nov. 4, 2025 /PRNewswire/ -- Aqua Medical, a company advancing Endoscopic Metabolic Restoration for type 2 diabetes, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for its pilot clinical trial of the Proximal Intestinal Mucosal Ablation (PIMA) procedure using the company's proprietary radiofrequency vapor ablation (RFVA) system. Aqua Medical's RFVA System has received Breakthrough Device Designation from the U.S. FDA for the treatment of adults with uncontrolled type 2 diabetes.

The IDE approval marks a pivotal milestone for Aqua Medical, allowing the company to begin enrolling patients in the U.S. RESTORE-1 pilot trial and study PIMA's potential to deliver durable metabolic control for patients with type 2 diabetes (T2D).

PIMA is a minimally invasive, outpatient endoscopic procedure that delivers circumferential ablation to 50–70 cm of the proximal intestine using a simple, through-the-endoscope RFVA catheter with no incisions or fluoroscopy required. The procedure aims to replicate the metabolic benefits of gastric bypass while avoiding its invasiveness.

"I've worked collaboratively with Aqua Medical from the earliest duodenal ablation efforts through the development of the PIMA procedure," said Dr. Rehan Haidry, Cleveland Clinic London. "The through-the-scope RFVA catheter is elegant in its simplicity, and PIMA's results to date are truly best-in-class — representing a major leap forward for metabolic endoscopy and the treatment of type 2 diabetes."

RESTORE-1 will be co-led by Prof. Nicholas J. Shaheen and Prof. John Buse, both at University of North Carolina School of Medicine. "The prospect of a simple, outpatient endoscopic procedure that delivers meaningful and durable metabolic control in T2D is remarkable," they noted. "We're excited to co-lead RESTORE-1 to support the FDA approval process."

Aqua Medical's IDE submission was supported by international data demonstrating safety and encouraging metabolic improvements. With IDE approval in place, the company is now preparing for U.S. site activation and patient enrollment.

"This IDE approval is a defining moment for Aqua Medical," said Lloyd Mencinger, President and CEO. "It validates years of foundational research and global clinical experience, and opens the door to studying this important procedure in U.S. patients for the first time."

Media Contact:
Deborah Ball
deborah@marketcraft.ai 

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SOURCE Aqua Medical Inc.