November 11, 2020
CSA Medical, Inc., today announced that over half of the subjects in a 32 patient study, characterizing the mechanism of action of Metered Cryospray (MCS) with the RejuvenAir System in patients with Chronic Bronchitis, have been enrolled.
Professor Pallav Shah, M.D., F.R.C.P. from the Royal Brompton, London, who was a principal investigator in the safety and efficacy study, performed the procedures. “We know from the feasibility study that patients achieved meaningful improvements in their cough and overall quality of life. This study will provide a cellular rationale for the remodeling response observed after metered cryospray and clinical improvements identified in the previous study.” said Professor Shah.
The RejuvenAir System received CE mark last year, and this post-market study aims to identify molecular and cellular targets in the central airways of patients before and after MCS treatment to determine the mechanism which enables metered cryospray to rejuvenate damaged airways in Chronic Bronchitis patients. The RejuvenAir System is a revolutionary cryosurgical device which applies a precise thermal dose of extremely cold (-196◦C) liquid nitrogen to targeted areas within the lungs through a minimally invasive, often outpatient, bronchoscopic procedure.
“The team is excited to advance our Chronic Bronchitis program and believe that understanding the mechanism to rejuvenative healing in the airways will accelerate the adoption of this first-of-its-kind therapy,” said Wendelin Maners, President and CEO of CSA Medical, Inc. “Both this study and the SPRAY-CB pivotal trial in the United States are drawing strong interest from patients and are actively enrolling.”
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. In addition to a chronic inflammation, cough and increased production of mucus, chronic bronchitis may or may not present with obstruction/partially blocked airways due to swelling and excess mucus in the bronchi, or shortness of breath (dyspnea). In the United States, there are an estimated 16 million people with COPD, of which over 9 million have a diagnosis of chronic bronchitis, a subset of COPD. Approximately 700,000 people are hospitalized for symptoms/exacerbations of chronic bronchitis every year. In Europe, there are approximately 23 million people with COPD and approximately 1.5 million hospitalizations per year for COPD.