Aqua Medical Secures Breakthrough Device IDE from FDA for Endoscopic Diabetes Ablation

Aqua Medical has obtained Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration to begin a pilot clinical trial of its Proximal Intestinal Mucosal Ablation (PIMA) procedure for people with type 2 diabetes. 

The technology uses the company’s radiofrequency vapour ablation (RFVA) system, which already holds Breakthrough Device status for adults with poorly controlled type 2 diabetes.

The approval enables the start of RESTORE-1, a U.S. pilot study that will evaluate whether PIMA can provide sustained improvements in metabolic control. 

The procedure is performed endoscopically as an outpatient treatment, delivering controlled ablation to a section of the upper intestine without the need for incisions or fluoroscopy. 

It is intended to offer some of the metabolic benefits associated with gastric bypass surgery, but with far less invasiveness.

The RFVA system has been developed over several years alongside earlier clinical work in duodenal ablation. Evidence from international studies has shown a favourable safety profile and encouraging results in blood glucose control.

With regulatory clearance now in place, Aqua Medical is preparing to activate U.S. clinical sites and begin patient enrolment. 

The company views this step as an important move towards offering a new therapeutic option for individuals living with type 2 diabetes.