Aqua Medical says it has successfully treated the first type 2 diabetes patient with its proximal intestinal mucosal ablation (PIMA) procedure in an FDA investigational device exemption (IDE) trial.
The clinical-stage medtech developer uses radiofrequency vapor ablation (RFVA) through a standard endoscope without fluoroscopy for the minimally-invasive, outpatient PIMA procedure in the duodenum.
The FDA approved the IDE in November to evaluate PIMA in adults with inadequately controlled type 2 diabetes despite standard medical therapy. The treatment could give patients an alternative to pharmaceutical therapy and bariatric surgery.
“We believe this technology could fundamentally change how metabolic disease is treated,” Aqua Medical Chief Medical Officer Raj Nihalani said in a statement shared with MassDevice ahead of an official announcement. “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 first procedure was performed at UNC Health in Chapel Hill, North Carolina, by Dr. Nicholas Shaheen, the study’s national principal investigator.
“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,” Shaheen said. “Our team is excited to help evaluate a technology designed to address the underlying biology of type 2 diabetes through a minimally invasive procedure.”
Read more about the technology at Medical Design & Outsourcing.
Aqua Medical said it has so far treated 66 patients outside the U.S. in cases to generate evidence supporting its IDE application and reported positive 12-month follow-up results in May.
Now that the first IDE case is complete, Aqua Medical CEO Lloyd Mencinger called it “the beginning of an exciting new chapter for Aqua Medical … the culmination of years of scientific innovation, engineering, and collaboration.”
He continued, “Having internationally respected leaders such as Dr. Nicholas Shaheen and Dr. John Buse leading our U.S. clinical program underscores both the scientific foundation of our technology and its potential to transform the treatment paradigm for type 2 diabetes. We are proud to partner with UNC Health as we continue enrolling patient and advancing this important clinical program.”
Buse is a leading endocrinologist who’s serving as co-principal investigator on the IDE.
Aqua Medical’s RFVA system comprises of the Aqua RF Vapor Generator, Aqua RF Vapor Catheters, saline delivery tubing and syringe. The generator delivers bipolar radiofrequency energy to the single-use catheter, which has two silicone-coated nitinol discs that create an ablation zone for heated saline vapor.
The Aqua Medical RFVA system is not for sale and not authorized for diabetes patients. However, it has FDA 510(k) clearance for coagulation and ablation of bleeding and non-bleeding sites in the gastrointestinal (GI) tract of adults. That includes, but is not limited to, the esophagus.
Other companies targeting the duodenum to address diabetes and obesity include Endogenex, Morphic Medical and Fractyl.
— Senior Editor Sean Whooley contributed to this report.