CSA Medical is planning to start worldwide pivotal study of RejuvenAir Metered Cryospray system in chronic bronchitis in 2019 as the company reported positive results from its feasibility study.
The feasibility study of the RejuvenAir system demonstrated better safety profile and clinically meaningful improvement on quality of life measures at 6-month follow-up in Chronic Bronchitis patients.
The system is designed to spray liquid nitrogen at -196o C in a circumferential pattern within the airway.
The study involved 30 patients at six month follow up, were treated with RejuvenAir, resulting in clinical improvement in Quality of Life, as measured by Saint George’s Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT).
The Netherlands-based the University Medical Center Groningen Department of Pulmonary Diseases Dirk-Jan Slebos said: “The RejuvenAir therapy appears to have a beneficial response with a decrease in cough and mucus production even in our patients who had optimized medical management.
“The overall improvement in breathing resulted in increased physical activity supporting the potential for RejuvenAir to measurably improve quality of life in chronic bronchitis patients.”
The procedure showed a safety profile and tolerability profile during the study showed minimal adverse effects and serious adverse effect.
Also, there were no pneumothorax or pneumomediastinum events. Patients were discharged from outpatient bronchoscopy suite on day of treatment, CSA claimed.
On SGRQ, patients improved by an average of 10.9 points (p<0.02) at 6-month follow-up. An improvement of 4 points on SGRQ is considered to be clinically meaningful.
On CAT, patients treated with RejuvenAir improved by an average of 3.4 points (p<0.02) at 6-month follow-up.
CSA Medical chief commercial officer Wendelin Maners said: “We are encouraged by these positive safety and feasibility results and we’re moving forward with plans to initiate a worldwide pivotal study of RejuvenAir in chronic bronchitis in 2019.
“We look forward to advancing this novel therapy toward commercialization to provide relief to the millions of patients suffering from COPD with chronic bronchitis.”
CSA Medical develops and manufactures an interventional spray cryotherapy technology platform using properties of liquid nitrogen spray delivered by a software driven device with specialty catheters.