CSA Medical announced today that study data support the use of its RejuvenAir system for treating chronic bronchitis.
Boston-based CSA Medical designed its metered cryospray (MCS) treatment using the RejuvenAir System. RejuvenAir, a proprietary interventional liquid nitrogen spray cryotherapy system, utilize software-driven dosimetry and specialty catheter.
Together, this enables the delivery of cryogen spray inside the airways to flash freeze and destroy damaged cells. The company designed it to allow for a rejuvenative pattern of healing.
According to a news release, data came from the first randomized, controlled study of MCS with RejuvenAir for chronic bronchitis. Data was presented by Dr. Christopher Orton (Royal Brompton Hospital, London) at the International Congress of the European Respiratory Society in Barcelona.
Patient-reported symptom scores (measured by SGRQ and CAT) were statistically significant and clinically meaningful, respectively. The sham group of the study saw quality of life continue to decline, CSA said. Sham subjects were offered treatment crossover at six months and all 32 subjects have now completed treatment.
The team at Royal Brompton reported strong safety and clinically meaningful 24-month results from a previous open-label trial. With the new cohort, the team has now performed more than 100 MCS treatments with zero pneumothoraces.
“This first randomized controlled study data reinforces previous feasibility results showing quality of life improvement in patients with chronic bronchitis,” Imperial College (London) professor of respiratory medicine Pallav Shah said. “RejuvenAir metered cryospray is both safe and effective in a patient population with multiple co-morbidities, in a disease with no established therapies.”
CSA is currently enrolling in SPRAY-CB,a pivotal study for RejuvenAir in patients with COPD with chronic bronchitis as well.
