Pivotal SPRAY-CB Trial of RejuvenAir® Published in American Journal of Respiratory and Critical Care Medicine

Randomized, blinded, sham-controlled pivotal trial demonstrates clinically meaningful improvements in quality of life and COPD symptoms, with a 38.4% relative reduction in severe exacerbation rates

BOSTON, Sept. 23, 2026 /PRNewswire/ -- CSA Medical, Inc., a medical device company focused on interventional pulmonary therapies, today announced the publication in the American Journal of Respiratory and Critical Care Medicine (AJRCCM) of results from SPRAY-CB (NCT03893370), the pivotal randomized, blinded, sham-controlled trial evaluating Metered CryoSpray™ (MCS) therapy with the RejuvenAir® System in patients with moderate-to-severe COPD and symptomatic chronic bronchitis.

SPRAY-CB randomized 210 patients with moderate-to-severe COPD and symptomatic chronic bronchitis in the United States and United Kingdom. Patients remained highly symptomatic despite optimal medical therapy.

The trial met its primary effectiveness endpoint. At 12 months, MCS-treated patients demonstrated a 5.9-point greater improvement in St. George's Respiratory Questionnaire (SGRQ) score compared with control (p=0.0422), exceeding the established 4-point threshold for a clinically meaningful treatment benefit. MCS-treated patients also demonstrated a 3.4-point greater improvement in COPD Assessment Test (CAT) score compared with control (p=0.005), exceeding the established 2-point threshold. Between-group differences on both validated measures were statistically significant and exceeded established thresholds for clinically meaningful improvement. 

Importantly, MCS treatment was also associated with fewer severe COPD exacerbations—serious clinical events that can require emergency department care or hospitalization and are a major driver of disease burden in patients with COPD. In a supportive analysis of severe exacerbations occurring more than 30 days following treatment, MCS-treated patients experienced a 38.4% relative reduction in the incidence rate of severe exacerbations compared with control.

"Patients enrolled in SPRAY-CB remained highly symptomatic despite receiving optimal medical therapy, underscoring the significant unmet need in chronic bronchitis," said Gerard J. Criner, MD, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University and lead author of the study. "In this rigorous randomized, sham-controlled trial, Metered CryoSpray demonstrated clinically meaningful improvements in quality of life and overall COPD symptoms through 12 months. The findings, together with the lower incidence of severe COPD exacerbations observed with MCS, support the potential for a bronchoscopic therapy that directly targets the airways affected by chronic bronchitis to provide an important new treatment option for these patients."

"The publication of the SPRAY-CB results represents the culmination of more than a decade of research, development and clinical investigation of RejuvenAir," said Wendelin Maners, President and CEO of CSA Medical. "These pivotal results support the potential for RejuvenAir to become the first interventional therapy developed specifically for chronic bronchitis and to establish an entirely new category of treatment for these patients."

The clinical benefits observed with MCS were achieved with an acceptable procedural safety profile. The principal procedural risk was pneumothorax, occurring in 3.6% of MCS procedures. All pneumothoraces resolved, none occurred after discharge, and there were no device- or procedure-related deaths or unanticipated adverse device effects.

RejuvenAir represents a new interventional approach to chronic bronchitis: a minimally invasive bronchoscopic therapy designed to directly target the airways affected by the disease rather than relying solely on medications to manage symptoms. RejuvenAir delivers precisely metered doses of medical-grade liquid nitrogen to the airway lining, enabling a nonscarring healing response intended to restore healthier airway epithelium and improve mucociliary function.

About RejuvenAir

The RejuvenAir System is a medical device therapy designed to address chronic cough and dysfunctional production and clearance of mucus associated with chronic bronchitis. Metered CryoSpray therapy ablates damaged airway epithelium, 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. The RejuvenAir System is currently under FDA review and is not commercially available in the United States.

About COPD with Chronic Bronchitis

Chronic bronchitis is a major disease phenotype of chronic obstructive pulmonary disease (COPD) and is characterized by chronic productive cough, mucus hypersecretion and impaired mucus clearance. Patients with chronic bronchitis can experience substantial symptom burden, recurrent exacerbations and impaired quality of life despite optimized medical therapy. In the United States, there are an estimated 16 million people with COPD, of whom more than 9 million have been estimated to have chronic bronchitis.

About CSA Medical

CSA Medical is focused on developing interventional pulmonary therapies that address significant unmet needs in patients with COPD and chronic bronchitis. The Company is advancing its core liquid nitrogen spray technology, RejuvenAir, to target abnormal airway epithelium associated with chronic cough, mucus hypersecretion and impaired mucus clearance. By selectively ablating damaged airway tissue without creating scar tissue, Metered CryoSpray is designed to enable regrowth of healthier, normally functioning airway epithelium.

SOURCE CSA Medical