LEXINGTON, Mass., April 11, 2017 /PRNewswire/ -- CSA Medical, Inc., a company focused on developing spray cryotherapy devices that selectively freeze and ablate unwanted tissue inside the body, today announced publication of a Research Letter in the American Journal of Respiratory and Critical Care Medicine (AJRCCM), which highlights the initial safety data for the RejuvenAir® System.
This data supports the safety of using Liquid Nitrogen Metered Cryospray (MCS) in the lobar and first segmental airways of the human bronchial system. Published by principal investigators Drs. D-J Slebos, D Breen and K Irshad, the data set encompasses 16 patients presenting for peripheral lung nodule resection in two separate studies. In total, 32 MCS were successfully delivered without device related adverse events in these distal airways, which supports the safety of delivering Liquid Nitrogen MCS with the RejuvenAir System.
The results of these two initial studies led to the initiation of a clinical trial investigating the safety and feasibility of delivering Liquid Nitrogen MCS therapy in chronic bronchitis patients. This study (NCT02483637) is ongoing.
The Research Letter can be found at: http://dx.doi.org/10.1164/rccm.201611-2220LE
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. 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[1], and in 2011 approximately 10 million people sought medical attention for chronic bronchitis, a subset of COPD[2]. Approximately 700,000 people are hospitalized for symptoms/exacerbations of chronic bronchitis every year[3].
In Europe, there are approximately 23 million people with COPD[4]. There are approximately 1.5 million hospitalizations per year for COPD[5].
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, please visit www.csamedical.com.
RejuvenAir is a registered trademark of CSA Medical, Inc.
[1] American Lung Association, Trends in COPD: Morbidity and Mortality.
http://www.lung.org/finding-cures/our-research/trend-reports/copd-trend-report.pdf
[2] ibid
[3] CDC/NCHS National Hospital Discharge Survey, 2010.
[4] Health at a Glance: Europe (2012 and 2014 reports) http://www.oecd-ilibrary.org/social-issues-migration-health/health-at-a-glance-europe-2012_9789264183896-en
[5] erswhitebook.org
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SOURCE CSA Medical
