The first patients have been treated in a study evaluating the safety of an ultrasound-based lung denervation technique for treating COPD and asthma.
RT’s Three Key Takeaways:
- Trial Progress: AerWave Medical has completed treatment of the first three patients in its first-in-human trial, which is assessing the safety of the ultrasound-based lung denervation system to treat asthma and COPD.
- Lung Denervation Potential: Research on the role of nerves in the respiratory system suggests that lung denervation could offer a valuable treatment option for patients and clinicians.
- Safety and Efficiency: The company’s ultrasound approach, which avoids peri-esophageal nerves, has shown potential for reducing procedural risks and eliminating the need for additional devices, according to early trial data.
Lucius Partners LLC announced that its portfolio company, AerWave Medical Inc, has completed treatment of its first three patients in its first-in-human trial evaluating the acute safety of patients undergoing lung denervation utilizing AerWave’s novel approach to treat asthma and chronic obstructive pulmonary disease (COPD).
The study is expected to enroll five patients. The protocols are supported by pre-clinical trials and data on both the safety and efficacy of dosimetry-based ultrasound denervation. The company’s technology aims to offer a more efficient, more efficacious, and safer clinical lung denervation procedure.
“We believe that AerWave’s approach confers meaningful safety advantages over current treatments,” says Reinhard Warnking, AerWave Medical’s president and chief technology officer, in a release. “As our proprietary ultrasound denervation approach is designed to be applied a safe distance from peri-esophageal nerves to avoid dangerous esophageal side effects, reducing risks for patients and the interventional pulmonary community.”
AerWave’s first procedures require no ancillary devices like marker catheters, esophageal balloons, or fluoroscopic monitoring.
Ultrasound Denervation Approach
“Ultrasound offers significant procedural and target flexibility as it provides nearly constant power distribution beyond the bronchial wall,” says Pat Gallagher, CEO, in a release. “Based on this adaptability, the team continues to pursue…additional pipeline opportunities [for] lung tumor ablation and lung volume reduction (LVR). For example, in LVR the platform could shrink emphysematous tissue without implanting foreign materials through focal fibrotic resection, a potentially profound improvement in patient care.”
Importantly, the system has, to date, demonstrated the utility of its “one shot denervation” and its integrated diagnostic mode to ensure coupling.
The trial’s primary investigator is David Tchkonia, MD, PhD, interventional pulmonologist, member of the European and World Associations for Bronchology and Interventional Pulmonology, and member of the Georgian Respiratory and Endoscopy Associations. The Trial is being conducted at Healthycore in Tbilisi, Ga.
“We are excited about the continued progress of the company’s FIH trial,” says James Ahern, managing partner at Laidlaw & Company and founding partner of Lucius Partners, in a release. “Our growing data sets suggest that the platform’s unique capabilities could provide an important option for patients and clinicians. The team continues to explore new indications that will leverage our technology and create value for the healthcare system and our shareholders.”
