AerWave Medical, a portfolio company of Lucius Partners, has treated the first two patients in its First-in-Human (FIH) trial of its ultrasound-based lung denervation system.
The first procedures were conducted at Healthycor in Tbilisi, Georgia, using the company’s novel approach to treat Asthma and Chronic Obstructive Pulmonary Disease (COPD).
The FIH study, designed to enrol five patients, will evaluate the safety and potential efficacy of lung denervation with the company’s advanced time-saving approach.
AerWave said that the study protocols are supported by extensive pre-clinical trials and data on both the safety and efficacy of dosimetry-based ultrasound denervation.
Its technology holds promise for a shorter, more efficacious, and safer clinical lung denervation procedure, said the medical device maker.
FIH trial primary investigator David Tchkonia said: “The ease of use of AerWave’s balloon-based ultrasound platform provides significant advantages over current treatment options for patients.
“The speed of our first procedures is unparalleled as no ancillary devices like marker catheters, oesophageal balloons or fluoroscopic monitoring are required.
“Further, as the technology targets tissue in one energy application and is intentionally distanced from peri-oesophageal nerves; we are optimistic that the approach could confer safety advantages.”
AerWave is using the platform’s efficacy, safety, and speed to deliver ultrasound energy for additional opportunities, including lung tumour ablation (LTA) and lung volume reduction (LVR).
Ultrasound, when used as a treatment option for LTA has significant advantages over currently used radio frequency (RF), Microwave and Cryo approaches, based on its physics.
The heat generated by ultrasound can be directed to reduce lung-lobe volume without removing tissue, or implanting any foreign material, said the company.
AerWave Medical president and chief technology officer Reinhard Warnking said: “We believe that AerWave’s approach, driven by driven by an energy source with complete circumferential coverage, can lead to better efficacy for patients.
“As our proprietary ultrasound denervation approach is designed to deliver energy to secondary bronchi, versus other treatments which focus on the main bronchi, AerWave’s procedure is designed to avoid dangerous oesophageal side effects – a major concern in the interventional pulmonary community.”
