The SPRAY-CB trial marks the first pivotal study of a medical device therapy targeting the underlying cause of Chronic Bronchitis.
Boston,MA. – October 22, 2020: CSA Medical Inc., a developer of medical devices advancing the power of liquid nitrogen spray cryotherapy, today announced the first patient treated in the SPRAY-CB, U.S. pivotal trial utilizing the RejuvenAir® System for COPD with Chronic Bronchitis at Temple University.
Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University (LKSOM) and Director of the Temple Lung Center, and principal investigator completed the procedure on October 14th. “We are pleased to have performed the first procedure in this landmark pivotal trial, building on the European data in which patients achieved meaningful improvements in their cough and overall quality of life,” said Dr. Criner. “RejuvenAir Metered Cryospray is a promising new interventional tool that has the potential to reduce emergency hospital visits due to chronic bronchitis symptoms. This definitive intervention may provide a long-term benefit to millions of adults suffering with Chronic Bronchitis.”
The RejuvenAir System is a revolutionary cryosurgical device which applies a precise thermal dose or “metered cryospray” of extremely cold, -196°C liquid nitrogen to targeted areas within the lungs through a minimally invasive, often outpatient procedure. After successful completion of the 35 patient European Feasibility Study and receiving Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), the SPRAY-CB trial marks the first pivotal study of a medical device therapy targeting the underlying cause of Chronic Bronchitis, the over-production and clearance of mucus. In Chronic Bronchitis patients, the airways have been damaged and the tiny hair-like cells lining the lungs that help move mucus and debris out of the airway, become dysfunctional. The RejuvenAir System ablates these damaged cells enabling a rejuvenative healing response.
“Today marks an important milestone in the treatment of COPD with Chronic Bronchitis. The RejuvenAir System is designed to be the first therapy which goes beyond addressing symptoms and treats the underlying disease itself,” said Wendelin Maners, CSA Medical’s President and CEO.
The SPRAY-CB trial is a double-blind, sham controlled, prospective, randomized, clinical trial and is currently enrolling across the United States.
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About COPD with Chronic Bronchitis
Chronic Bronchitis is the largest disease subset of Chronic Obstructive Pulmonary Disease (COPD). Bronchitis isinflammation 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 peopleare 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].
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