AerWave Medical has announced the successful completion of its first-in-human (FIH) feasibility study evaluating its ultrasound lung denervation therapy for chronic obstructive pulmonary disease (COPD) and asthma. The New York-based company also secured $12 million in funding to further advance the technology.
The FIH study, which involved five patients, demonstrated the feasibility and procedural efficiency of AerWave’s ultrasound platform. The technology aims to simplify and enhance lung denervation by eliminating the need for fluoroscopic guidance, esophageal marker balloons, and multiple catheter exchanges. The approach delivers precise circumferential ablation in a single energy application, seeking to reduce airway smooth muscle constriction, which addresses the underlying drivers of these diseases rather than merely managing symptoms.
Key Advantages of AerWave's Technology
According to AerWave, its platform delivers precise treatment in a single, targeted ablation procedure, avoiding sensitive areas such as peri-esophageal nerves. The shorter procedure utilizes a single-shot, circumferential approach, eliminating the need for fluoroscopy and ancillary devices, with a universal catheter design suitable for diverse airway anatomies.
Dr. David Tchkonia, an interventional pulmonologist and study investigator, stated, "This first-in-human study underscores the transformative potential of AerWave’s technology to redefine the treatment paradigm for COPD and asthma. 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."
Broader Applications and Future Directions
AerWave's platform extends beyond lung denervation to include conformal lung tumor ablation (LTA) and lung volume reduction (LVR). By leveraging ultrasound’s ability to apply energy precisely and avoid collateral damage, these applications open up additional indications. The company believes that conformal lung tumor ablation spares healthy tissue while providing expanded lesion sizes through pulsed operation. Lung volume reduction with ultrasound offers a non-surgical alternative to valves or coils, reducing emphysematous tissue volume via localized fibrotic reactions.
The Unmet Need in Respiratory Care
Asthma and COPD are prevalent chronic diseases, affecting over 600 million people globally. Despite advances in pharmacologic therapies, a significant proportion of patients experience suboptimal control, leading to high healthcare utilization and diminished quality of life. Approximately six million U.S. patients are resistant to drug therapies.
Patrick Gallagher, CEO of Aerwave Medical, noted, "The successful completion of our FIH trial and the accompanying funding are significant milestones for our team. 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."
Reinhard Warnking, Chief Technology Officer of Aerwave Medical, added, "Our approach represents a paradigm shift in interventional pulmonology. 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."
