Aqua Medical Treats First West Coast Patient in FDA-Approved IDE Trial of Investigational PIMA Procedure for Type 2 Diabetes

Hoag Hospital joins Aqua Medical's multi-center RESTORE-I study as its Irvine Hoag team, led by Dr. Jennifer Phan, delivers a milestone procedure and Dr. Phan becomes the first woman interventional endoscopist in the U.S. to perform it.

PLEASANTON, Calif., Aug. 18, 2026 /PRNewswire/ -- Aqua Medical, Inc., a clinical-stage medical technology company advancing Endoscopic Metabolic Restoration, today announced 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 U.S. centers participating in the multicenter IDE study. The case was led by Jennifer Phan, M.D., interventional endoscopist at Hoag and Vice President of Women in Endoscopy, who becomes the first woman endoscopist in the United States to perform the PIMA procedure. Clinical co-investigators at Hoag include Kenneth Chang, M.D., Executive Medical Director of the Hoag Digestive Health Institute and David T. Ahn, M.D., Endocrinologist and Chief of Diabetes Services at Hoag.

Aqua Medical's investigational PIMA procedure uses the company's radiofrequency vapor 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 signaling 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.

"Initiating this clinical trial enables us to deliver cutting-edge endoscopic metabolic interventions, giving patients access to pioneering, low-burden procedures being evaluated for their potential to improve metabolic outcomes. We are thrilled that Hoag is contributing to this milestone study, bringing our clinical team into the front lines of advancing innovative, minimally invasive metabolic therapies." Jennifer Phan, M.D., Interventional Endoscopist, Hoag Hospital

"We believe this technology could change how metabolic disease is treated," said Raj Nihalani, M.D., Chief Medical Officer of Aqua Medical. "A procedure delivered through the working channel of a standard endoscope, with no fluoroscopy required, has the potential to make advanced metabolic therapy accessible to far more patients. Early clinical experience has been encouraging, and this study is designed to evaluate those observations rigorously."

"Hoag's privademic model, which blends rigorous academic research with agile, patient-centric delivery, made them a strong partner for this stage of our clinical program," said Bob Haggerty, Chief Executive Officer of Aqua Medical. "Working with world-class centers such as Hoag advances our clinical program and expands access to the study for patients across the western United States."

Dr. Phan's participation also reflects the growing leadership role of women in advanced therapeutic endoscopy. 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, with the goal of assessing the potential role of this minimally invasive, device-based approach in the management of type 2 diabetes. Patient enrollment is ongoing across participating U.S. study sites.

About Aqua Medical 

Aqua Medical is a clinical-stage medical technology company advancing a minimally invasive, through the working channel of the scope technology to address type 2 diabetes. Using its proprietary radiofrequency vapor ablation (RFVA) system for the Proximal Intestinal Mucosal Ablation (PIMA) procedure, the company aims to deliver scalable, device-based approach intended to address mechanisms associated with type 2 diabetes and potentially improve metabolic outcomes.

The RFVA system is FDA-cleared for marketing for its indicated use in the gastrointestinal tract. Use of the RFVA system for the PIMA procedure is investigational. The safety and effectiveness of the RFVA system for the PIMA procedure have not yet been established.

Forward-Looking Statements

This press release contains forward-looking statements regarding Aqua Medical's investigational technology, clinical development activities, and future expectations. Actual results may differ materially.

Media Contact: 

Dr. Aradhana Mariam Philips

[email protected]

SOURCE Aqua Medical Inc.