Aqua Medical treats first patient in IDE trial for minimally invasive diabetes therapy

Aqua Medical has treated the first U.S. patient in its FDA investigational device exemption (IDE) trial evaluating its minimally invasive procedure for type 2 diabetes.

The company’s proximal intestinal mucosal ablation (PIMA) procedure uses radiofrequency vapor ablation through a standard endoscope to target the duodenum without fluoroscopy. The outpatient approach is designed to address the underlying biology of type 2 diabetes and could offer an alternative to ongoing medication or bariatric surgery.

The first procedure was performed at UNC Health, marking a key milestone as Aqua Medical advances its clinical program toward potential regulatory approval. The company previously treated 66 patients outside the U.S. and reported positive 12-month follow-up results.

“We believe this technology could fundamentally change how metabolic disease is treated,” said 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, has the potential to make advanced metabolic therapy accessible to millions of people living with type 2 diabetes.”