The study is designed to determine the safety and efficacy of lung denervation with the AerWave device in patients with COPD and asthma.

RT’s Three Key Takeaways: 

  1. The ultrasound-based lung denervation system has begun its first-in-human trial to assess its safety and potential efficacy in treating chronic obstructive pulmonary disease (COPD) and asthma.
  2. AerWave has treated the first two patients in its First-in-Human trial in Georgia.
  3. Beyond treating COPD and asthma, the platform’s design opens opportunities for lung tumor ablation and lung volume reduction.

AerWave Medical Inc has treated its first two patients in its first-in-human trial (FIH) for its ultrasound-based lung denervation system for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.

The study is expected to enroll five patients and will evaluate the safety and potential efficacy of lung denervation with the system. The protocols are supported by pre-clinical trials and data on both the safety and efficacy of dosimetry-based ultrasound denervation. 

“The ease of use of AerWave’s balloon-based ultrasound platform provides significant advantages over current treatment options for patients,” says David Tchkonia, MD, PhD, interventional pulmonologist, and the trial’s primary investigator member. “The speed of our first procedures is unparalleled as no ancillary devices like marker catheters, esophageal balloons, or fluoroscopic monitoring are required. Further, as the technology targets tissue in one energy application and is intentionally distanced from peri-esophageal nerves; we are optimistic that the approach could confer safety advantages.”

Expanding Potential Applications

AerWave is leveraging the platform’s design to multiple additional pipeline opportunities, including lung tumor ablation and lung volume reduction. Ultrasound as a potential treatment option for lung tumor ablation has advantages over currently used radio frequency, microwave, and cryo approaches, according to a release from the company. Further, ultrasound-generated heat can be directed to reduce lung-lobe volume without removing tissue or implanting any foreign material (valves, coils, etc).

“We believe that AerWave’s approach, driven by an energy source with complete circumferential coverage, can lead to better efficacy for patients,” says Reinhard Warnking, AerWave Medical’s president and chief technology officer. “As 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.”

The procedures are being conducted at Healthycor in Tbilisi, Georgia.

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