CSA Medical Announces Completion of Enrollment in Mechanism of Action Study utilizing the RejuvenAir® System for COPD Patients with Chronic Bronchitis

May 13, 2021

These results should provide the scientific proof behind the remodeling response and clinical improvements identified in earlier studies

Boston, MA—May 12, 2021: CSA Medical, Inc., today announced ® that all subjects have been enrolled in the RejuvenAir System study Characterizing the Mechanism of Action of Metered Cryospray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis. The aim of this study is to determine the mechanism by which Metered CryoSpray (MCS) reduces the density of goblet cells responsible for over-producing mucus and observe re-growth of healthy cilia in the airways.

Airway Cross Section“In the previous study, we saw meaningful improvements in patient symptoms and quality of life,” said Professor Pallav Shah M.D., from the Royal Brompton, London. “What makes this study different is that we will now be able to provide the cellular rationale for the remodeling response we observed in the feasibility study after treatment with RejuvenAir. In other words, we will prove re-epithelialization and regrowth of healthy airway tissue.

CSA Medical, the developer of the RejuvenAir System, is currently conducting a pivotal study in twenty sites across the United States. 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.

“Together with the final data from the SPRAY-CB pivotal study, we endeavor to understand metered cryospray not only reduces the symptoms of chronic bronchitis, but also how it works to rejuvenate airways for a better quality of life. Current medications only manage those symptoms, we anticipate the RejuvenAir® System will be the first minimally invasive treatment option for this population,” stated Heather V. Nigro, Senior Vice President of Regulatory, Quality and Clinical Affairs at CSA Medical.

About RejuvenAir®

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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