SPRAY-CB met its primary endpoint and multiple secondary endpoints with statistical significance, FDA review underway

BOSTON, Jan. 7, 2026 /PRNewswire/ — CSA Medical, Inc., a medical device company focused on interventional pulmonary therapies, today announced the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its RejuvenAir System for the treatment of chronic bronchitis in patients with chronic obstructive pulmonary disease (COPD).

The PMA submission is supported by positive results from SPRAY-CB, a multicenter, randomized, sham-controlled pivotal clinical trial evaluating the safety and effectiveness of Metered CryoSpray (MCS) therapy delivered bronchoscopically using the RejuvenAir System. The study met its primary endpoint and multiple secondary endpoints with statistical significance and demonstrated a favorable safety profile.

“Today marks a major inflection point for RejuvenAir and for patients with chronic bronchitis who currently lack FDA-approved, device-based treatment options,” said Wendelin Maners, President and CEO of CSA Medical. “With the PMA submission complete, we look forward to continuing our collaborative review with the FDA and advancing RejuvenAir toward potential U.S. commercialization.”

Developed for interventional pulmonologists, RejuvenAir is a first-of-its-kind, bronchoscopic, device-based therapy that targets diseased airway tissue in chronic bronchitis, with no implant left behind. By complementing existing medical management, RejuvenAir has the potential to define a new category within pulmonary intervention.

About RejuvenAir

The RejuvenAir System is a medical device therapy designed to target the underlying chronic cough and dysfunctional production and clearance of mucus in Chronic Bronchitis. Metered CryoSpray therapy ablates the damaged cells enabling a rejuvenative healing response. RejuvenAir received FDA Breakthrough Device Designation, reflecting its potential to provide meaningful advantages over existing medical therapies for a large and underserved patient population.

About COPD with Chronic Bronchitis

Chronic Bronchitis is the largest disease subset of Chronic Obstructive Pulmonary Disease (COPD). 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.

About CSA Medical

CSA Medical is committed to developing spray cryotherapy devices that improve the lives of people suffering from COPD with Chronic Bronchitis. We are advancing our core liquid nitrogen spray technology, RejuvenAir, to target the underlying chronic cough, dysfunctional mucus production and clearance, in chronic bronchitis patients. By targeting and destroying these damaged cells without creating scar tissue, the body can begin the rapid regrowth of new, healthy normal functioning cells in the lung. The RejuvenAir System is an investigational device and not currently commercially available in the United States.

SOURCE CSA Medical

Underlying proof of rejuvenative healing indicative of airway remodeling corresponds with clinical efficacy and improved quality of life

Boston, MA—Oct 8, 2024: /PRNewswire/ — CSA Medical, Inc., a leader in developing spray cryotherapy solutions for the treatment of airway diseases, today announced data correlating the positive clinical outcomes following Metered CryoSpray (MCS), using the RejuvenAir^® System, with evidence of airway tissue remodeling in chronic bronchitis subjects. In a session at the American College of Chest Physicians (CHEST) conference in Boston entitled “Beyond Bronchodilators: Bronchoscopic Management of COPD”, Dr. Robert Browning, Jr., Professor of Medicine, Walter Reed National Military Medical Center, described the evolution of bronchoscopic Metered CryoSpray (MCS) treatment and shared the latest peer-reviewed and published data.

Interestingly, early RNA gene analysis data suggests Metered CryoSpray therapy remodels airway tissues in a way that is disease-modifying.  Recently, scientists at the National Heart and Lung Institute (NHLI), Imperial College London, presented key genomics findings suggesting improvements in lung architecture with increased epithelial cell progenitor growth; improvement in cilial function; increased integrity of the apical junctional complex; a reduction in airway inflammation; and a reduction in the Epithelial to Mesenchymal Transition (EMT) post Metered CryoSpray therapy.  These changes in cellular populations, indicative of airway remodeling, build upon previously published clinical results showing statistically significant improvements in quality of life.

The RejuvenAir System is a medical device therapy designed to target the underlying chronic cough and dysfunctional production and clearance of mucus in Chronic Bronchitis. Metered CryoSpray therapy ablates the damaged cells, enabling a rejuvenative healing response. “While the medical definition of chronic bronchitis is simplistic, the genomics reveal the underlying disease is multifactorial. We are encouraged by the rejuvenative changes in the airways we are seeing after treatment with RejuvenAir and anticipate we will continue to see positive clinical data from our larger SPRAY-CB pivotal trial next year,” said Wendelin Maners, Chief Executive Officer of CSA Medical.

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.

About CSA Medical

CSA Medical is committed to developing spray cryotherapy devices that improve the lives of people suffering from COPD with Chronic Bronchitis. We are advancing our core liquid nitrogen spray technology, RejuvenAir, to target the underlying chronic cough, dysfunctional mucus production and clearance in chronic bronchitis patients. By targeting and destroying these damaged cells without creating scar tissue, the body can begin the rapid regrowth of new, healthy normal functioning cells in the lung. RejuvenAir is an investigational device and not currently commercially available in the United States.

SOURCE CSA Medical

The RejuvenAir System is a minimally invasive medical device therapy which aims to target the underlying cause of COPD with Chronic Bronchitis

BOSTON, Feb. 7, 2024 /PRNewswire/ — CSA Medical Inc., a developer of medical devices advancing the power of liquid nitrogen spray cryotherapy, today announced its 500^th 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 500^th 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 our home page

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.

SOURCE CSA Medical