PLEASANTON, Calif., July 28, 2026 /PRNewswire/ — Aqua Medical, Inc., a clinical-stage medical technology company pioneering Endoscopic Metabolic Restoration, today announced the successful treatment of the first U.S. patient in its U.S. Food and Drug Administration (FDA)-authorized Investigational Device Exemption (IDE) clinical trial evaluating the company’s proprietary Proximal Intestinal Mucosal Ablation (PIMA) procedure for the treatment of type 2 diabetes.

The landmark procedure was performed at UNC Health in Chapel Hill, North Carolina, one of only four leading U.S. academic medical centers selected to participate in the multicenter IDE clinical study. The procedure was led by Nicholas Shaheen, M.D., MPH, internationally recognized gastroenterologist, endoscopist, and National Principal Investigator of the study. The trial is being conducted in close collaboration with John B. Buse, M.D., Ph.D., one of the world’s leading endocrinologists and Co-Principal Investigator, whose pioneering work has helped shape modern diabetes care.

Aqua Medical’s investigational PIMA procedure utilizes the company’s proprietary radiofrequency vapor ablation (RFVA) platform delivered through-the-working-channel-of-the-scope catheter to gently resurface a targeted segment of the proximal small intestine. By addressing abnormal metabolic signaling associated with insulin resistance, the procedure is designed to promote regeneration of healthy intestinal mucosa and restore normal metabolic function signaling through a minimally invasive outpatient approach.

To date, Aqua Medical has treated 66 patients outside the United States through its international clinical development program, generating encouraging safety and clinical data that supported initiation of the FDA-authorized U.S. IDE study.

Unlike conventional interventional therapies, the Aqua Medical platform is performed entirely through a standard endoscope, requires no fluoroscopy, and integrates seamlessly into existing endoscopy suites as a minimally invasive outpatient procedure.

“We believe this technology could fundamentally change how metabolic disease is treated,” said Raj Nihalani, M.D., Chief Medical Officer of Aqua Medical. “A proprietary, through-the-working-channel-of-the-scope procedure requiring no fluoroscopy, combined with encouraging early clinical data demonstrating complete insulin elimination in treated patients, has the potential to make advanced metabolic therapy accessible to millions of people living with type 2 diabetes.”

“Treating the first patient in the U.S. IDE Study represents an important milestone in the clinical evaluation of this novel endoscopic approach to metabolic disease,” said Nicholas Shaheen, M.D., MPH, National Principal Investigator of the study and Professor of Medicine at the University of North Carolina School of Medicine. “Our team is excited to help evaluate a technology designed to address the underlying biology of type 2 diabetes through a minimally invasive procedure.”

“This achievement marks the beginning of an exciting new chapter for Aqua Medical,” said Lloyd Mencinger, Chief Executive Officer of Aqua Medical. “Reaching the first treated patient in our FDA-authorized IDE study is the culmination of years of scientific innovation, engineering, and collaboration. Having internationally respected leaders such as Dr. Nicholas Shaheen and Dr. John Buse leading our U.S. clinical program underscores both the scientific foundation of our technology and its potential to transform the treatment paradigm for type 2 diabetes. We are proud to partner with UNC Health as we continue enrolling patient and advancing this important clinical program.”

“Reaching the first treated patient in our U.S. FDA-authorized IDE study is the culmination of years of scientific innovation, engineering, and collaboration. This adds to the success already demonstrated in the 66 patients we treated in Chile with results including hemoglobin A1c reduction and insulin elimination. And having internationally respected leaders such as Dr. Nicholas Shaheen and Dr. John Buse leading our U.S. clinical program underscores both the scientific foundation of our technology and its potential to transform the treatment paradigm for type 2 diabetes. We are proud to partner with UNC Health as we continue enrolling patients and advancing this important clinical program.”

The IDE clinical trial is evaluating the safety and effectiveness of Aqua Medical’s investigational PIMA procedure in adults with inadequately controlled type 2 diabetes despite standard medical therapy. Patient enrollment is ongoing across participating U.S. study sites. The study represents an important step toward developing a scalable, minimally invasive treatment that could bridge the gap between chronic pharmacologic therapy and bariatric surgery while expanding treatment options for patients and physicians.

About Aqua Medical

Aqua Medical is a clinical-stage medical technology company advancing Endoscopic Metabolic Restoration through its proprietary Radiofrequency Vapor Ablation (RFVA) platform. The company’s minimally invasive, through-the-working-channel-of-the-scope technology is designed to treat the underlying pathophysiology of type 2 diabetes by restoring healthy metabolic signaling in the proximal intestine. Aqua Medical’s vision is to deliver scalable, procedure-based therapies that reduce medication dependence and improve long-term metabolic outcomes for millions of patients worldwide.

The Aqua Medical RFVA System is FDA-cleared for its indicated use in the gastrointestinal tract. Use of the RFVA System for the Proximal Intestinal Mucosal Ablation (PIMA) procedure is investigational. The safety and effectiveness of the RFVA System for the PIMA procedure have not been established.

Forward-Looking Statements

This press release contains forward-looking statements regarding Aqua Medical’s investigational technology, clinical development activities, and future expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated.

Media Contact:

Deborah Ball
MarketCraft
deborah@marketcraft.ai

View original content to download multimedia:https://www.prnewswire.com/news-releases/aqua-medical-treats-first-us-patient-for-type-2-diabetes-at-unc-health-using-investigational-through-the-scope-endoscopic-therapy-302835317.html

SOURCE Aqua Medical Inc.