CSA Medical, Inc. Announces Cooper University Health Care is the 20th Clinical Site to Join the SPRAY-CB Pivotal Study for the treatment of Chronic Bronchitis
BOSTON, April 19, 2021 /PRNewswire/ -- CSA Medical, Inc., today announced that Wissam Abouzgheib, MD, chief of pulmonary medicine at Cooper University Health Care, Camden, New Jersey, has joined the SPRAY-CB Study investigating a new device treatment for COPD with Chronic Bronchitis.
The SPRAY-CB Study is actively enrolling subjects who suffer from the debilitating symptoms of Chronic Bronchitis. COPD is a long-term, progressive, irreversible lung disease that, over time, makes it difficult to breathe. Chronic Bronchitis (CB), the largest subset of COPD, is characterized by a chronic productive cough. The SPRAY-CB study is investigating a minimally invasive device therapy, Metered Cryospray (MCS), which utilizes the RejuvenAir® System, a revolutionary cryosurgical device which applies a precise thermal dose of extremely cold, -196◦C liquid nitrogen to targeted areas within the lungs through an outpatient bronchoscopic procedure. Unlike inhalers, which provide temporary relief for shortness of breath, RejuvenAir is designed to address the over-production of mucus and chronic cough associated with Chronic Bronchitis.
"We see many chronic bronchitis patients in our practice and believe that, as we emerge out of COVID-19, patients will be more focused on their lung health. We are excited to be part of the SPRAY-CB study and anticipate our patients will see meaningful improvements in their quality of life," said Dr. Abouzgheib.
"We are delighted to add Cooper Health to our list of twenty prestigious clinical study sites across the U.S and build on the successful data generated from Feasibility," stated Heather Nigro, Senior Vice President of Regulatory, Quality and Clinical Affairs at CSA Medical.
The RejuvenAir Metered Cryospray System is designed to spray liquid nitrogen in a circumferential pattern within the airways. It is anticipated that the rapid freezing of the epithelial layer of the airway walls will destroy the damaged cilia and mucus-producing goblet cells while preserving the extracellular matrix, thereby enabling the regrowth of healthy cells. The RejuvenAir System has received CE mark in the EU and 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 defined as inflammation of the bronchial airways, while chronic bronchitis is defined by cough with productive sputum of three months duration for two consecutive years. In addition to chronic inflammation, cough and increased production of mucus, chronic bronchitis may or may not present with obstructed or partially blocked airways due to swelling and excess mucus in the bronchi, or shortness of breath (dyspnea). In the United States, the CDC reported 9 million Americans were diagnosed with chronic bronchitis in 2019. Additionally, 700,000 people every year are hospitalized due to symptoms/exacerbations of chronic bronchitis.
About CSA Medical
CSA Medical, Inc. develops and manufactures a proprietary interventional liquid nitrogen spray cryotherapy system that utilizes 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 has been designated a Breakthrough Device by the FDA and is currently under clinical investigation in the United States. To learn more about our technology or clinical trials, please visit www.rejuvenair.com, https://spray-cb.com/ or www.clinicaltrials.gov [Identifiers: NCT03893370 and NCT03892694]
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SOURCE CSA Medical