AerWave Medical, Inc. has treated its first two patients in the first-in-human trial for its ultrasound-based lung denervation system aimed at treating COPD and asthma. The company received an allowance from the Georgian Ministry of Health to initiate the study earlier this year. David Tchkonia, MD, PhD, interventional pulmonologist and member of the European and World Associations for Bronchology and Interventional Pulmonology, is the trial’s primary investigator.
“The use of AerWave’s balloon-based ultrasound platform provides significant advantages over current treatment options for patients,” Dr. Tchkonia said. “The speed of our first procedures is unparalleled as no ancillary devices like marker catheters, esophageal ballons or fluoroscopic monitoring are required. Further, as the technology targets tissue in one energy application and is intentionally distanced from periesophageal nerves, we are optimistic that the approach could confer safety advantages.”
The study is evaluating patients undergoing lung denervation utilizing AerWave’s treatment approach. The protocols are supported by extensive pre-clinical trials and data on both the safety and efficacy of disometry-based ultrasound denervation. Reinhard Warnking, president and chief technology officer for AerWave, said the company’s technology holds promise for a shorter, more efficacious and safer lung denervation procedure.
“We believe that AerWave’s approach, driven by an energy source with complete circumferential coverage, can lead to better efficacy for patients,” Warnking said. “Our proprietary ultrasound denervation approach is designed to deliver energy to secondary bronchi, versus other treatments which focus on the main bronchi. AerWave’s procedure is designed to avoid dangerous esophageal side effects — a major concern in the interventional pulmonary community.”
