CSA Medical Presents Positive Feasibility Study Results for its RejuvenAir® System at the 2019 European Respiratory Society International Congress in Madrid
Results demonstrate a strong safety profile and clinically meaningful improvement in quality of life measures in chronic bronchitis patients at 12-month follow-up
RejuvenAir® recently achieved Breakthrough Device Designation by the U.S. FDA and will begin a U.S. Pivotal Study in 2020
BOSTON, Oct. 3, 2019 /PRNewswire/ -- CSA Medical, Inc., presented positive 12-month results of its feasibility study for the RejuvenAir Metered Cryospray™ system yesterday at the 2019 European Respiratory Society (ERS) International Congress in Madrid, Spain.
In the session entitled, "Bronchoscopic Treatment of COPD: Hot News," Dr. Justin Garner (Essex, United Kingdom) presented 12-month follow-up data on all patients treated with Metered Cryospray ("MCS") utilizing the RejuvenAir System. The RejuvenAir System is a revolutionary cryosurgical device that applies spray liquid nitrogen to the central airways through a minimally invasive bronchoscopic procedure. The extreme-cold flash freezes damaged surface area lung cells which results in a rejuvenative healing process.
Thirty-five patients were enrolled in this safety and feasibility trial (NCT02483637) and all have completed their treatments. The data presented showed clinically meaningful improvements in multidimensional measures of cough, sputum production, breathlessness, and Quality of Life (QoL), as measured by Saint George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT). MCS is designed to address the underlying causes of Chronic Bronchitis, the over-production of mucus and damaged cilia.
The one-year data showed superior scores in QoL measures versus pharmacologic standard of care regimens. Dirk-Jan Slebos, M.D., Ph.D. of the Department of Pulmonary Diseases, at the University Medical Center Groningen, The Netherlands reported that "Metered Cryospray 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 is safe and well-tolerated for patients suffering from COPD with Chronic Bronchitis.
About RejuvenAir®
The RejuvenAir® Metered Cryospray™ System is designed to spray liquid nitrogen at -196◦C in a circumferential pattern within the airway. It is anticipated that the rapid freezing of the epithelial layer of the airway walls will destroy the mucus-producing goblet cells while preserving the extracellular matrix, thereby enabling the regrowth of healthy cells. The RejuvenAir® System is under clinical investigation in the United States.
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 12.7 – 14.7 million people with COPD, and in 2011 approximately 11 million people sought medical attention for 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.
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. To learn more about our technology, please visit www.csamedical.com
For further information contact:
Wendelin Maners, CSA Medical
[email protected]
SOURCE CSA Medical
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