CSA Medical today released early results from a feasibility study exploring the use of its RejuvenAir Metered Cryospray system in treating patients with chronic bronchitis, touting improvements in quality of life for patients treated with the system.
Results from the trial were presented at the 2018 European Respiratory Society Congress in Paris, the Boston-based company 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,” chief commercial officer Wendelin Maners said in a prepared statement.
Data came from an analysis of 30 patients during their six-month follow-up visits, and indicated improvements in quality of life, as measured by Saint George’s Respiratory Questionnaire and COPD Assessment Test. Results also indicated a strong safety profile, and that the treatment was well tolerated, CSA Medical said.
Patients saw an average improvement on average of 10.9 points on the SGRQ, with an improvement of four points on the scale considered to be clinically meaningful, the company said. Average improvements on the CAT were reported to be 3.4 points at six months, with improvements of two points considered clinically meaningful, the company added.
“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. RejuvenAir Metered Cryospray can be safely delivered in patients with COPD and demonstrates clinical meaningful improvements in quality of life and symptom scores out to 6 months and is a promising new therapy for the millions of people who suffer from chronic bronchitis,” Dr. Dirk-Jan Slebos of The Netherland’s University Medical Center Groningen said in a prepared statement.
Last October, CSA Medical said that the first patient was treated using the company’s new rapid AV spray catheter for the management of persistent symptomatic esophageal cancer and associated dysplastic Barrett’s disease.