CryoSpray Therapy Shows Promise for Chronic Bronchitis in Pivotal Trial

The study, which randomized 210 patients in the United States and the United Kingdom, tested the effectiveness of Metered CryoSpray (MCS) therapy against a sham procedure. Participants remained symptomatic despite receiving optimal medical therapy prior to the intervention. After 12 months, those treated with MCS showed a 5.9-point improvement on the St. George's Respiratory Questionnaire, surpassing the 4-point threshold for clinical significance. Similarly, scores on the COPD Assessment Test improved by 3.4 points, exceeding the 2-point benchmark.

Beyond symptom management, the therapy addressed the frequency of severe COPD exacerbations. The researchers noted that MCS treatment resulted in a 38.4% relative reduction in severe events compared to the control group. Regarding safety, the trial reported an acceptable profile, with a 3.6% incidence of pneumothorax, all of which resolved without long-term complications or device-related deaths.

Lead author Gerard J. Criner, MD, of the Lewis Katz School of Medicine at Temple University, noted that the findings highlight a potential breakthrough for patients who fail to find relief through existing medications. The RejuvenAir system functions by delivering liquid nitrogen to the airway lining, promoting a healing response intended to restore epithelial function. While the device currently holds FDA Breakthrough Device Designation, it remains under review and is not yet available for commercial use in the United States.