Lucius Partners, LLC (“LP”) today announced that its portfolio company, AerWave Medical, Inc., has completed treatment of its first three patients in its First-in-Human Trial (FIH) conducted at Healthycore in Tbilisi, Georgia. The trial’s Primary Investigator is Univ. Prof. David Tchkonia, MD, PhD, Interventional Pulmonologist, Member of the European and World Associations for Bronchology and Interventional Pulmonology, Member of the Georgian Respiratory and Endoscopy Associations (GRA, GEA).
The study is 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 extensive pre-clinical trials and data on both the safety and efficacy of dosimetry-based ultrasound denervation. The Company’s technology holds promise for a more efficient, more efficacious, and safer clinical lung denervation procedure.
“We believe that AerWave’s approach confers meaningful safety advantages over current treatments,” said Reinhard Warnking, AerWave Medical’s President and Chief Technology Officer. “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.”
The efficiency and logistics of AerWave’s first procedures are unparalleled as no ancillary devices like marker catheters, esophageal balloons or fluoroscopic monitoring are required.
“Ultrasound offers significant procedural and target flexibility as it provides nearly constant power distribution beyond the bronchial wall,” stated Pat Gallagher, CEO. “Based on this adaptability, the team continues to pursue as additional pipeline opportunities 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.
“We are excited about the continued progress of the company’s FIH trial,” said James Ahern, Managing Partner at Laidlaw & Company and Founding Partner of Lucius Partners. “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.”
