AerWave Medical, an ultrasound pulmonary solutions provider, has completed its first-in-human (FIH) feasibility study of its disease-modifying ultrasound lung denervation therapy.
The study tested the company’s ultrasound lung denervation therapy for chronic obstructive pulmonary disease (COPD) and asthma.
AerWave Medical has also announced the raising of $12m in funding, led by Lucius Partners.
The first-in-human study, announced in April 2023, was conducted on five patients. Its results proved the feasibility and effectiveness of the ultrasound platform. This platform simplifies lung denervation by removing the need for fluoroscopic guidance, oesophageal marker balloons, and multiple catheter exchanges.
AerWave Medical’s approach is said to deliver precise circumferential ablation in a single energy application. It targets airway smooth muscle constriction, addressing the root causes of COPD and asthma rather than just managing symptoms, the medical device company said.
Study investigator David Tchkonia said: “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.”
AerWave Medical’s ultrasound platform is designed to provide precise treatment through a simple, targeted ablation procedure. It avoids sensitive areas like peri-oesophageal nerves and shortens the procedure time.
The single-shot circumferential approach eliminates the need for fluoroscopy and ancillary devices. Additionally, its universal catheter design adapts to various airway anatomies.
The platform extends beyond lung denervation to include conformal lung tumour ablation (LTA) and lung volume reduction (LVR).
Using ultrasound’s precise energy application, these treatments are designed to minimise collateral damage and open new indications.
Conformal LTA spares healthy tissue while enabling larger lesion sizes through pulsed operation. Ultrasound-based LVR offers a non-surgical alternative to valves or coils, reducing emphysematous tissue volume via localiased fibrotic reactions.
Aerwave Medical CEO Patrick Gallagher said: “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.”
