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
