CSA Medical Inc., a developer of medical devices advancing the power of liquid nitrogen spray cryotherapy, today announced its 500th Metered CryoSpray Procedure utilizing the RejuvenAir System.
Jonathan S. Kurman, MD, MBA, and Director of Interventional Pulmonology for the Froedtert & Medical College of Wisconsin health network, performed the procedure as part of the U.S. pivotal trial, SPRAY-CB, investigating the RejuvenAir® System for treatment of COPD with Chronic Bronchitis. "Our team is excited to be part of this landmark trial to support FDA approval, and to have performed the 500th procedure is just a bonus," said Dr. Kurman. "We hope to build on the results out of Europe which showed statistically significant and clinically meaningful improvements in patient symptoms and overall quality of life. Finding a definitive intervention for the millions of Americans who suffer from chronic bronchitis, despite triple medical therapy, is a game changer for this patient population."
The RejuvenAir System is a revolutionary cryosurgical device that 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.
The RejuvenAir System is 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.
The SPRAY-CB study is a double-blind, sham-controlled, prospective, randomized, clinical trial currently enrolling across the United States. RejuvenAir is an investigational device and not currently commercially available in the United States. To watch an educational video or to find center a near you, please visit https://rejuvenair.com/.
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 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 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].
RejuvenAir is a registered trademark of CSA Medical, Inc.