Aqua Medical Advances PIMA Trial for Type 2 Diabetes

PLEASANTON, Calif., August 18, 2026

PIMA Procedure Enters Multicenter Clinical Trial

The procedure at Hoag Hospital was led by Jennifer Phan, M.D., an interventional endoscopist who became the first woman endoscopist in the United States to perform the PIMA procedure. Hoag is one of four U.S. centers participating in the RESTORE-I IDE study, which is designed to evaluate the safety and effectiveness of Aqua Medical’s investigational approach. Clinical co-investigators at the center 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. Patient enrollment remains ongoing across participating U.S. clinical sites. The study represents an important step in evaluating whether an endoscopic intervention could become a new device-based treatment option for people with type 2 diabetes who remain inadequately controlled using conventional medical therapy.

Minimally Invasive Technology Targets Metabolic Signaling

Aqua Medical’s investigational PIMA procedure uses the company’s proprietary radiofrequency vapor ablation (RFVA) platform, which is delivered through the working channel of a standard endoscope. The technology is designed to resurface a targeted section of the proximal small intestine with the goal of influencing abnormal metabolic signaling associated with insulin resistance and promoting mucosal regeneration. Unlike surgical interventions, the procedure is intended to be performed as a minimally invasive outpatient treatment, without surgery or fluoroscopy. Because the system is delivered through a standard endoscope, Aqua Medical believes the procedure could potentially integrate into existing endoscopy suites and established clinical workflows. The approach reflects growing interest in device-based metabolic therapies that seek to address physiological mechanisms associated with type 2 diabetes rather than relying exclusively on pharmacological treatment. However, the PIMA procedure remains investigational, and its safety and effectiveness for this indication have not yet been established.

FDA-Approved IDE Study Evaluates Safety and Effectiveness

The RESTORE-I study is evaluating the potential role of PIMA in adults with inadequately controlled type 2 diabetes despite standard medical therapy. The FDA-approved IDE provides the regulatory framework for investigating the device-based procedure in a controlled clinical setting and generating evidence on its safety and effectiveness. Aqua Medical describes the study as part of its broader effort to advance Endoscopic Metabolic Restoration, a minimally invasive approach intended to address mechanisms involved in metabolic disease. The company’s RFVA system is FDA-cleared for marketing for its indicated use in the gastrointestinal tract, but its use specifically for the PIMA procedure remains investigational. The first West Coast treatment expands access to the clinical program for patients in the western United States and represents a meaningful milestone in the development of endoscopic metabolic technology. As enrollment continues, results from RESTORE-I will help determine whether PIMA can provide a clinically meaningful and durable metabolic benefit for patients with type 2 diabetes. The study also highlights the expanding role of medical devices, interventional endoscopy and minimally invasive technologies in the development of new treatment strategies for chronic metabolic diseases.

Source: Aqua Medical press relese