Pleasanton, California, U.S., September 24, 2026
Aqua Medical, Inc. has announced the closing of a Series B financing led by Relevance Ventures to advance the U.S. clinical development of its investigational Proximal Intestinal Mucosal Ablation (PIMA) procedure for adults with Type 2 diabetes. Announced on September 24, 2026, the financing will support completion of the company’s ongoing RESTORE-1 U.S. pilot study and operational preparations for a planned U.S. pivotal clinical trial, subject to regulatory authorization. Aqua Medical is developing PIMA as a minimally invasive, through-the-endoscope procedure designed to treat targeted mucosa in the proximal small intestine using its proprietary radiofrequency vapor ablation (RFVA) technology. The company said the financing will help advance its U.S. clinical program and generate additional evidence for this device-based approach to Type 2 diabetes management.
Series B Supports U.S. Clinical Development
The Series B financing provides funding for the next stage of Aqua Medical’s clinical development strategy. The company said proceeds will be used to complete the RESTORE-1 pilot study and prepare the operational infrastructure required for a larger planned pivotal study. The pivotal trial remains subject to regulatory authorization, meaning the financing announcement represents preparation for future clinical development rather than authorization to market PIMA for diabetes. Aqua Medical’s U.S. program is being conducted under an FDA Investigational Device Exemption (IDE), and four patients had undergone the investigational procedure in the United States at the time of the announcement. Outside the U.S., the company reported that 66 patients have been treated with PIMA, providing clinical experience that is being used to support continued development of the technology.
PIMA Uses Through-the-Scope RF Vapor Ablation
Aqua Medical’s PIMA procedure is designed to be delivered through the working channel of a standard endoscope. The company’s RFVA platform generates heated water vapor using a radiofrequency generator and delivers the vapor through an endoscopic catheter to perform targeted ablation. Aqua Medical describes the approach as an Endoscopic Metabolic Restoration strategy for Type 2 diabetes, focusing on the proximal intestinal mucosa rather than relying solely on pharmacological treatment or conventional surgery. The technology is designed for an outpatient, minimally invasive procedure and does not require fluoroscopy, according to the company. Aqua Medical’s clinical program includes studies evaluating the safety, tolerability and effectiveness of RF vapor ablation for improving glycemic parameters in people with Type 2 diabetes.
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Clinical Evidence and Regulatory Status
The company has reported clinical findings from earlier studies involving PIMA, including follow-up data presented in 2026. Aqua Medical’s clinical publications include results from the STEAM-IE trial, which investigated duodenal mucosal RF vapor ablation in insulin-treated adults with Type 2 diabetes, as well as earlier first-in-human research. The company’s clinical-trial information states that these studies are intended to evaluate outcomes such as glycemic control and the potential for reducing or eliminating insulin use. However, these investigational findings do not constitute FDA approval of PIMA for diabetes. Aqua Medical specifically states that its RFVA System is FDA-cleared for use in the gastrointestinal tract, but that the system is not cleared for Type 2 diabetes and is not currently available for sale for that indication.
The new financing therefore represents a significant development in Aqua Medical’s medical-device clinical program, supporting the company’s efforts to move its investigational diabetes procedure through U.S. clinical development. If the planned pivotal trial receives the necessary regulatory authorization, it could provide additional evidence regarding the safety and effectiveness of PIMA in people with Type 2 diabetes. For now, the procedure remains under clinical investigation, and further studies will be required to establish its clinical benefits and risks. Aqua Medical’s work illustrates continued innovation in interventional metabolic medicine, with endoscopic technologies being investigated as potential device-based approaches for chronic metabolic diseases.
Source: Aqua Medical press release
