First US patient treated with Proximal Intestinal Mucosal Ablation for the treatment of T2DM

Aqua Medical has announced the successful treatment of the first US patient in its FDA authorised Investigational Device Exemption (IDE) clinical trial evaluating the company's proprietary Proximal Intestinal Mucosal Ablation (PIMA) procedure for the treatment of type 2 diabetes.

Aqua Medical is investigating a new diabetes procedure called proximal intestinal mucosal ablation (Illustration courtesy of Aqua Medical)

Aqua Medical's investigational PIMA procedure utilises the company's proprietary radiofrequency vapor ablation (RFVA) platform delivered through-the-working-channel-of-the-scope catheter to gently resurface a targeted segment of the proximal small intestine. By addressing abnormal metabolic signalling associated with insulin resistance, the procedure is designed to promote regeneration of healthy intestinal mucosa and restore normal metabolic function signalling through a minimally invasive outpatient approach. Unlike conventional interventional therapies, the Aqua Medical platform is performed entirely through a standard endoscope, requires no fluoroscopy, and integrates seamlessly into existing endoscopy suites as a minimally invasive outpatient procedure.

The landmark procedure was performed at UNC Health in Chapel Hill, NC, one of only four leading US academic medical centres selected to participate in the multicentre IDE clinical study. The procedure was led by Dr Nicholas Shaheen, a gastroenterologist, endoscopist and National Principal Investigator of the study. The trial is being conducted in close collaboration with Dr John B Buse, one of the world's leading endocrinologists and Co-Principal Investigator, whose pioneering work has helped shape modern diabetes care.

"Treating the first patient in the U.S. IDE Study represents an important milestone in the clinical evaluation of this novel endoscopic approach to metabolic disease," said Shaheen. "Our team is excited to help evaluate a technology designed to address the underlying biology of type 2 diabetes through a minimally invasive procedure."

To date, Aqua Medical has treated 66 patients outside the US through its international clinical development program, generating encouraging safety and clinical data that supported initiation of the IDE study.

"We believe this technology could fundamentally change how metabolic disease is treated," said Dr Raj Nihalani, Chief Medical Officer of Aqua Medical. "A proprietary, through-the-working-channel-of-the-scope procedure requiring no fluoroscopy, combined with encouraging early clinical data demonstrating complete insulin elimination in treated patients, has the potential to make advanced metabolic therapy accessible to millions of people living with type 2 diabetes."

The Aqua Medical RFVA System is FDA-cleared for its indicated use in the gastrointestinal tract. Use of the RFVA System for the Proximal Intestinal Mucosal Ablation (PIMA) procedure is investigational. The safety and effectiveness of the RFVA System for the PIMA procedure have not been established.