PLEASANTON, Calif., July 28, 2026
Aqua Medical, Inc. has achieved a major clinical milestone with 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 its investigational Proximal Intestinal Mucosal Ablation (PIMA) procedure for the treatment of type 2 diabetes. The groundbreaking procedure was performed at UNC Health in Chapel Hill, North Carolina, one of four leading U.S. academic medical centers participating in the multicenter study. Developed using Aqua Medical’s proprietary Radiofrequency Vapor Ablation (RFVA) technology, the minimally invasive endoscopic procedure is designed to restore healthy metabolic signaling by resurfacing a targeted section of the proximal small intestine. The milestone follows encouraging international clinical experience involving 66 patients, supporting the launch of the FDA-authorized U.S. IDE study. As diabetes continues to affect millions worldwide, Aqua Medical’s innovative Endoscopic Metabolic Restoration platform has the potential to introduce a new procedure-based treatment option that bridges the gap between long-term medication therapy and bariatric surgery.
FDA-Authorized IDE Study Evaluates Novel Diabetes Therapy
The FDA-authorized IDE clinical trial is designed to evaluate the safety and effectiveness of Aqua Medical’s investigational PIMA procedure in adults with type 2 diabetes who remain inadequately controlled despite standard medical therapy. Unlike conventional metabolic interventions, the procedure is performed entirely through a standard endoscope using Aqua Medical’s proprietary through-the-working-channel catheter, eliminating the need for fluoroscopy while allowing seamless integration into existing outpatient endoscopy suites. The technology gently applies radiofrequency vapor ablation (RFVA) to the proximal intestinal mucosa, promoting tissue regeneration and restoring metabolic signaling associated with improved insulin sensitivity. By targeting one of the underlying biological mechanisms linked to insulin resistance, the investigational therapy seeks to provide a minimally invasive treatment alternative capable of delivering meaningful metabolic improvements while reducing dependence on chronic pharmacological therapies.
Early Clinical Results Support Continued Development
Prior to initiating the U.S. IDE study, Aqua Medical completed an international clinical development program in which 66 patients underwent the investigational procedure outside the United States. According to the company, these early clinical experiences generated encouraging safety and efficacy findings, including reductions in hemoglobin A1c levels and complete insulin elimination in selected treated patients, providing the scientific rationale for advancing into U.S. clinical evaluation. The first American procedure was led by internationally recognized gastroenterologist Dr. Nicholas Shaheen, National Principal Investigator of the study, in collaboration with renowned endocrinologist Dr. John B. Buse, Co-Principal Investigator. Their leadership brings extensive expertise in gastroenterology, endoscopy, and diabetes care to the multicenter investigation, supporting rigorous clinical evaluation of this innovative endoscopic treatment strategy for metabolic disease.
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Endoscopic Innovation Could Transform Type 2 Diabetes Care
Aqua Medical’s Endoscopic Metabolic Restoration platform represents an emerging category of procedure-based metabolic therapies designed to complement existing diabetes treatment options. The company believes its proprietary PIMA procedure could provide physicians with a scalable outpatient intervention that addresses the underlying pathophysiology of type 2 diabetes rather than solely managing symptoms through medication. Patient enrollment continues across participating U.S. clinical sites as investigators evaluate the procedure’s long-term safety, effectiveness, and potential role within future diabetes treatment pathways. If clinical outcomes continue to demonstrate favorable results, the technology may offer a valuable alternative for patients seeking minimally invasive therapies capable of improving metabolic function while reducing medication dependence. The successful treatment of the first U.S. patient marks an important step toward advancing innovative endoscopic medical technologies that could reshape future management of metabolic disease through precision, minimally invasive intervention.
Source: Aqua Medical press release
