Aqua Medical has announced the treatment of the first patient treated on the West Coast of the USA (second overall) in the company’s US Food and Drug Administration (FDA)-approved investigational device exemption RESTORE-I clinical trial evaluating its proximal intestinal mucosal ablation (PIMA) procedure for type 2 diabetes.
The procedure was performed at Hoag Hospital in Newport Beach, USA, one of four US centres participating in the multicentre study. The case was led by Jennifer Phan, interventional endoscopist at Hoag Hospital and vice president of Women in Endoscopy, who becomes the first woman endoscopist in the USA to perform the PIMA procedure. Clinical co-investigators at Hoag Hospital include Kenneth Chang, executive medical director of the Hoag Digestive Health Institute and David T Ahn, endocrinologist and chief of Diabetes Services.
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 company has described that the procedure is designed to address abnormal metabolic signalling 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 or 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,” said Phan.
“We believe this technology could change how metabolic disease is treated,” said Raj Nihalani, 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 programme,” said Bob Haggerty, chief executive officer of Aqua Medical. “Working with world-class centres such as Hoag advances our clinical programme and expands access to the study for patients across western USA.”
According to the company, Phan’s participation also reflects the growing leadership role of women in advanced therapeutic endoscopy. The 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 enrolment is ongoing across participating US study sites.
