Pleasanton, California-based Aqua Medical designed its Proximal Intestinal Mucosal Ablation (PIMA) procedure to use its proprietary RFVA system. PIMA, a minimally invasive outpatient endoscopic procedure, delivers circumferential ablation to 50-70 cm of the proximal intestine.
The procedure uses a simple, through-the-endoscope RFVA catheter with no incisions or fluoroscopy required. It aims to replicate the metabolic benefits of gastric bypass while avoiding the invasiveness of the procedure. PIMA aims to restore metabolic signaling and address the root drivers of insulin resistance.
Aqua Medical’s RFVA system features the Aqua RF Vapor Generator, Aqua RF Vapor Catheters, saline delivery tubing and syringe. The generator delivers bipolar RF energy to the single-use catheter, creating heated saline vapor in the catheter tip for ablation.
The Aqua Medical RFVA system is not for sale and not authorized for diabetes patients. However, it has FDA 510(k) clearance for coagulation and ablation of bleeding and non-bleeding sites in the gastrointestinal (GI) tract of adults. That includes but is not limited to the esophagus. The company announced FDA investigational device exemption (IDE) for the diabetes procedure in November 2025.
Now, presenting data at Digestive Disease Week (DDW) 2026, Aqua says findings highlight the potential in treating type 2 diabetes.
A look at the data shared by Aqua Medical
Aqua Medical said its findings demonstrated clinically meaningful and sustained improvements in glycemic control across multiple patient populations. That included patients on oral therapies, insulin-requiring individuals and those previously treated with duodenal mucosal ablation.
Outcomes included up to a 2.6% reduction in HbA1c at 12 months and 100% elimination of exogenous insulin in treated patients. Additionally, 80% of patients remained insulin-free without additional medications. The 60-minute outpatient procedure had a safety profile with no required fluoroscopy.
According to investigators, findings support the hypothesis that targeting the proximal intestine can restore key metabolic pathways.
“The data presented at DDW 2026 represent a major milestone for Aqua Medical and the field of metabolic endoscopy, especially in an ASC,” said Lloyd Mencinger, CEO of Aqua Medical, Inc. “We believe RF vapor ablation has the potential to redefine how type 2 diabetes is treated shifting from chronic dependence on escalating medications to a single-shot durable outpatient intervention.”
