Two research abstracts presented at the World Congress of Bronchology and Interventional Pulmonology (WCBIP) and the American Thoracic Society meetings will provide details about two safety clinical trials conducted using the RejuvenAir System Metered Cryospray technology, which is in development for the treatment of chronic bronchitis. The WCBIP Congress will take place May 8-11 in Florence, Italy. The ATS conference will take place May 13-18 in San Francisco.
According to developer and manufacturer CSA Medical Inc, “the RejuvenAir System is designed to deliver Metered Cryosprays to distinct locations throughout a patient’s lung,” the company’s website reports. “The system consists of a catheter and console with pressure and temperature controls that enable the delivery of liquid nitrogen to meet a predetermined amount of cooling energy for each metered cryospray delivered.”
“These studies represent a major step in our development of the RejuvenAir System as the data supports the safety of delivering this therapy at the deepest lung segment in our anticipated treatment plan,” said Ellen Sheets, MD, CEO of CSA Medical.
One trial, The European Safety Study (NCT02106143), analyzed patients at Galway University Hospital and University Medical Center Groningen who were scheduled within 60 days for a planned lobectomy or pneumonectomy. Eleven patients underwent two sprays per treatable location within the lobe intended for resection. The objectives were to demonstrate the feasibility and safety of delivery of a specific cryospray therapy dose using the RejuvenAir System, and to understand the histologic outcome of the treatment area in the airway in humans. Results will be presented at the WCBIP in Florence.
The second trial, the Canadian Safety Study (NCT02483052) treated patients in Brampton, Ontario, Canada who were scheduled for lobectomy within two to 90 days from date of study treatment. Four patients underwent two sprays per treatable location within the lobe intended for resection. The objectives were to demonstrate safety and to determine the delayed histological effects of the RejuvenAir System treatment in the human airway. Results will be presented at ATS 2016 in May.
RejuvenAir is not yet commercially available, however, CSA currently manufactures and distributes the truFreeze system in the US, which is designed to ablate unwanted benign and malignant tissue by freezing it.
More information is available on the company’s website.