CSA Medical Announces the Completion of Treatments in the RejuvenAir Safety and Feasibility Study for patients with Chronic Bronchitis
LEXINGTON, Mass., March 1, 2018 /PRNewswire/ -- CSA Medical, Inc. announced the completion of the treatment phase for its ongoing study The Safety and Feasibility Study of RejuvenAir for Treating Chronic Bronchitis Patients (NCT02483637). This prospective, open label, single arm study of COPD patients with known chronic bronchitis is being conducted at three sites in The Netherlands, United Kingdom, and Canada. The study strongly supports the feasibility of using Liquid Nitrogen Metered Cryospray(TM) (MCS) throughout the central airways to ablate inflamed bronchial epithelium allowing non-inflamed tissue to regenerate after treatment.
The final patient treatment was completed at the University Medical Center Groningen, The Netherlands by Dr. Dirk-Jan Slebos, M.D., PhD of the Department of Pulmonary Diseases, who reported that "The Liquid Nitrogen Metered Cryospray therapy is very well tolerated by our patients and appears to have a beneficial response with a decrease in their cough and mucus production as well as an improvement in breathing, resulting in increased physical activity."
Professor Pallav Shah, M.D., FRCP from the Royal Brompton, London, further notes, "The ability to deliver a highly tolerable treatment with such a remarkable safety profile means that Liquid Nitrogen Metered Cryospray has the potential to quickly change the course of the disease for the millions of people who suffer from chronic bronchitis."
The 35 patient study completed treatment without device related adverse events. "The ability to deliver Liquid Nitrogen MCS treatments in a bronchoscopy suite without issues speaks to the procedure's safety," stated Ellen Sheets, M.D., CEO at CSA Medical. "Additionally, early data on treatment response from patient reported outcome instruments remains strongly positive, supporting RejuvenAir as a potential procedure for patients suffering from chronic bronchitis."
About Chronic Bronchitis
Chronic Bronchitis is the largest disease subset of Chronic Obstructive Pulmonary Disease (COPD). Bronchitis is inflammation of the bronchial airways. A chronic bronchitis diagnosis is defined by cough with productive sputum of three months duration for two consecutive years.
About CSA Medical
CSA Medical, Inc. develops and manufactures a proprietary interventional spray cryotherapy technology platform utilizing unique properties of liquid nitrogen spray delivered by a software driven device with specialty catheters that enable delivery of spray cryogen inside the body to flash freeze and destroy unwanted tissue allowing for a rejuvenative pattern of healing.
The RejuvenAir System is currently under clinical investigation and is not commercially available.
To learn more about our technology, visit www.csamedical.com.
RejuvenAir is a registered trademark of CSA Medical, Inc.
For further information contact:
Amy Sarli, CSA Medical
+1-781-538-4779 / asarli@csamedical.com
View original content with multimedia:http://www.prnewswire.com/news-releases/csa-medical-announces-the-completion-of-treatments-in-the-rejuvenair-safety-and-feasibility-study-for-patients-with-chronic-bronchitis-300606899.html
SOURCE CSA Medical
