Boston – September 23, 2026 -- CSA Medical, Inc. announced publication in the American Journal of Respiratory and Critical Care Medicine of pivotal SPRAY-CB trial results showing its RejuvenAir System reduced severe COPD exacerbation rates by 38.4% versus a sham control.
Trial enrolled 210 patients across the US and UK despite optimal medical therapy
The randomized, blinded, sham-controlled SPRAY-CB trial (NCT03893370) tested Metered CryoSpray (MCS) therapy in patients with moderate-to-severe COPD and symptomatic chronic bronchitis who remained highly symptomatic despite receiving standard-of-care medication.
MCS therapy met primary effectiveness endpoint at 12 months
MCS-treated patients showed a 5.9-point greater improvement in St. George's Respiratory Questionnaire score than controls (p=0.0422), surpassing the 4-point clinical significance threshold. On the COPD Assessment Test, MCS patients improved 3.4 points more than controls (p=0.005), exceeding the 2-point benchmark for meaningful benefit.
Severe exacerbations dropped 38.4% in supportive analysis
In exacerbations occurring more than 30 days post-treatment, MCS-treated patients experienced a 38.4% relative reduction in severe exacerbation incidence compared with the sham-control group—events that typically require emergency care or hospitalization.
Procedural safety profile showed 3.6% pneumothorax rate
All pneumothorax cases resolved without occurring after discharge, and the trial recorded no device- or procedure-related deaths or unanticipated adverse device effects.
Temple University physician calls findings evidence of unmet need
Gerard J. Criner, MD, Chair of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University and the study's lead author, said patients enrolled in SPRAY-CB remained highly symptomatic despite optimal medical therapy, underscoring significant unmet need in chronic bronchitis. He said the rigorous sham-controlled design demonstrated clinically meaningful improvements in quality of life and COPD symptoms through 12 months.
CSA Medical CEO frames results as new treatment category
Wendelin Maners, President and CEO of CSA Medical, said the publication represents the culmination of more than a decade of research and clinical investigation, positioning RejuvenAir as a potential first interventional therapy developed specifically for chronic bronchitis.
RejuvenAir remains under FDA review, holds Breakthrough Device Designation
The bronchoscopic system delivers metered doses of medical-grade liquid nitrogen to ablate damaged airway epithelium, targeting a disease affecting an estimated 9 million of the 16 million COPD patients in the United States who have chronic bronchitis. RejuvenAir is not yet commercially available in the US.