First Randomized Controlled Study with RejuvenAir® for Chronic Bronchitis shows Clinically Significant Results
06 Sep 2022
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Metered Cryospray treats damaged airways enabling a rejuvenative healing response
BOSTON, Sept. 6, 2022 /PRNewswire/ -- CSA Medical, Inc., today announced results from the first randomized, controlled study of Metered Cryospray (MCS) utilizing the RejuvenAir® System for the treatment of Chronic Bronchitis. The data was presented at the International Congress of the European Respiratory Society in Barcelona, Spain by Christopher Orton, MD, of The Royal Brompton Hospital, London, UK.
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SGRQ and CAT, the gold standard measurement for patient reported symptom scores, were statistically significant and clinically meaningful, respectively. Chronic Bronchitis, the largest subset of COPD, is a progressive, irreversible disease with no cure. Medications merely manage symptoms, but over time, chronic productive cough and breathlessness worsen. As expected, quality of life in the sham group continued to decline. However, sham subjects were offered cross-over to treatment at 6 months and to date, all 32 subjects have completed treatment.
RejuvenAir goes beyond medical management addressing the underlying cause of Chronic Bronchitis, damaged airways.
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The Royal Brompton team previously reported strong safety and clinically meaningful 24 month results, from an open-label trial, now 36 months out. Together with this new cohort, they have performed over 100 Metered Cryospray treatments with zero pneumothoraces. "This first randomized controlled study data reinforces previous feasibility results showing Quality of Life improvement in patients with chronic bronchitis. RejuvenAir® Metered Cryospray is both safe and effective in a patient population with multiple co-morbidities, in a disease with no established therapies," summarized Pallav Shah, Professor of Respiratory Medicine, Imperial College, London.
The RejuvenAir System is designed to address the underlying cause of Chronic Bronchitis, the damaged cilia and mucus-producing goblet cells lining the airways and enable a rejuvenative healing response. SPRAY-CB, the pivotal study of the RejuvenAir System in patients with COPD with Chronic Bronchitis, is actively enrolling.
About COPD with 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. 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. 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.
About CSA Medical
CSA Medical, Inc. develops and manufactures proprietary interventional liquid nitrogen spray cryotherapy systems that utilize software-driven dosimetry and specialty catheters that enable delivery of cryogen spray inside the airways to flash freeze and destroy damaged cells allowing for a rejuvenative pattern of healing.
The RejuvenAir System is approved in the EU and under clinical investigation in the United States. To learn more about our technology or clinical trials, please visit www.rejuvenair.com or www.clinicaltrials.gov [Identifiers: NCT03893370 and NCT03892694].
SOURCE CSA Medical
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