Feasibility Study Completed for Ultrasound-Based Asthma, COPD Therapy

AerWave Medical has completed the first-in-human (FIH) feasibility study of its disease-modifying ultrasound lung denervation therapy for chronic obstructive pulmonary disease (COPD) and asthma. The company has also raised $12 million in funding led by Lucius Partners.

“The successful completion of our FIH trial and the accompanying funding are significant milestones for our team,” AerWave Medical CEO Patrick Gallagher stated. “Our technology addresses some of the most pressing challenges in respiratory care and offers a scalable, disease-modifying solution with the potential to improve patient outcomes.”

Conducted in five patients, the study demonstrated the feasibility and procedural efficiency of AerWave’s ultrasound platform, which simplifies and enhances lung denervation by eliminating the need for fluoroscopic guidance, esophageal marker balloons, and multiple catheter exchanges. By delivering precise circumferential ablation in a single energy application, AerWave’s approach is designed to reduce airway smooth muscle constriction, addressing the underlying drivers of disease rather than merely managing symptoms.

Lung denervation has emerged as a promising interventional solution, with radiofrequency-based technologies demonstrating proof of concept but face limitations in procedural complexity, safety, and efficacy. AerWave’s ultrasound platform delivers precise treatment in a single targeted ablation procedure while avoiding sensitive areas like peri esophageal nerves. This is also a shorter procedure with a single-shot circumferential approach, eliminating fluoroscopy and ancillary devices, using a universal catheter design suitable for diverse airway anatomies.

Asthma and COPD are among the most prevalent chronic diseases globally, affecting more than 600 million people. Despite advances in pharmacologic therapies, a significant proportion of patients experience suboptimal control, leading to high healthcare utilization and diminished quality of life. Approximately 6 million U.S. patients are resistant to drug therapies.

“This first-in-human study underscores the transformative potential of AerWave’s technology to redefine the treatment paradigm for COPD and asthma,” said study investigator Dr. David Tchkonia, an interventional pulmonologist and member of the European and World Associations for Bronchology and Interventional Pulmonology, member of the Georgian Respiratory and Endoscopy Associations. “For the first time, we’ve demonstrated that our ultrasound-based denervation performed in lobar bronchi can achieve precise nerve ablation efficiently, and reproducibly without the risk of gastroesophageal or cardiac complications.”

AerWave’s platform extends beyond lung denervation to include conformal lung tumor ablation (LTA) and lung volume reduction (LVR). Leveraging ultrasound’s ability to apply energy precisely and avoid collateral damage, these applications open additional indications. Conformal lung tumor ablation spares healthy tissue while providing expanded lesion sizes through pulsed operation. Lung volume reduction with ultrasound provides a non-surgical alternative to valves or coils, reducing emphysematous tissue volume via localized fibrotic reactions.

“Our approach represents a paradigm shift in interventional pulmonology,” AerWave Chief Technology Officer Reinhard Warnking commented. “By harnessing the advantages of ultrasound energy over heat conducting approaches, we address longstanding challenges in treating airway diseases. Our technology enables targeted interventions that minimize the potential for collateral damage while enhancing procedural efficiency and efficacy. These advancements hold immense promise not only for asthma and COPD but also for emerging applications like lung tumor ablation and lung volume reduction, demonstrating the potential to redefine standards of care in pulmonary medicine.”

AerWave is actively seeking strategic partnerships to advance its lung denervation technology’s development and clinical validation.

AerWave Medical is a medical device company pioneering ultrasound-based therapies for respiratory diseases. With its advanced therapeutic platform, AerWave is transforming the landscape of interventional pulmonology to address unmet medical needs in COPD, asthma, and other diseases.