Aqua Medical Receives FDA IDE Approval for Breakthrough Endoscopic Type 2 Diabetes Treatment
Key Insights
Aqua Medical (search) has secured FDA Investigational Device Exemption approval for its RESTORE-1 pilot trial studying the PIMA procedure (search) using radiofrequency vapor ablation technology.
The minimally invasive endoscopic procedure targets 50-70 cm of the proximal intestine (search) and aims to replicate metabolic benefits of gastric bypass without surgical invasiveness.
The company's RFVA System (search) previously received FDA Breakthrough Device Designation for treating adults with uncontrolled type 2 diabetes (search).
Aqua Medical (search) has achieved a significant regulatory milestone with the U.S. Food and Drug Administration granting Investigational Device Exemption (IDE) approval for its pilot clinical trial of the Proximal Intestinal Mucosal Ablation (PIMA) procedure. The approval enables the company to begin enrolling patients in the U.S. RESTORE-1 pilot trial to study PIMA's potential for delivering durable metabolic control in patients with type 2 diabetes (search).
Revolutionary Endoscopic Approach
The PIMA procedure (search) represents a minimally invasive, outpatient endoscopic treatment that delivers circumferential ablation to 50-70 cm of the proximal intestine (search) using Aqua Medical (search)'s proprietary radiofrequency vapor ablation (RFVA) system. The procedure requires no incisions or fluoroscopy and utilizes a simple, through-the-endoscope RFVA catheter. According to the company, PIMA aims to replicate the metabolic benefits of gastric bypass while avoiding its invasiveness.
"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 (search)," said Dr. Rehan Haidry from Cleveland Clinic London (search), who has collaborated with Aqua Medical (search) from the earliest duodenal ablation efforts through the development of the PIMA procedure (search).
Clinical Trial Leadership and Design
The RESTORE-1 trial will be co-led by Prof. Nicholas J. Shaheen and Prof. John Buse, both at University of North Carolina School of Medicine (search). The researchers expressed enthusiasm about the procedure's potential, noting that "the prospect of a simple, outpatient endoscopic procedure that delivers meaningful and durable metabolic control in T2D is remarkable."
Aqua Medical (search)'s IDE submission was supported by international data demonstrating safety and encouraging metabolic improvements. The company's RFVA System (search) has previously received Breakthrough Device Designation from the U.S. FDA for the treatment of adults with uncontrolled type 2 diabetes (search).
Company Perspective and Next Steps
Lloyd Mencinger, President and CEO of Aqua Medical (search), characterized the IDE approval as "a defining moment for Aqua Medical," stating that 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."
With IDE approval secured, Aqua Medical (search) is now preparing for U.S. site activation and patient enrollment in the RESTORE-1 pilot trial. The study represents the first opportunity to evaluate this endoscopic metabolic restoration approach in U.S. patients with type 2 diabetes (search).