CSA Medical has submitted a premarket approval (PMA) application for its RejuvenAir System, a device-based therapy intended to treat chronic bronchitis in patients with chronic obstructive pulmonary disease (COPD).
Submitted to the US Food and Drug Administration (FDA), the application is based on positive data from the sham-controlled, multi-centre, randomised SPRAY-CB study.
This trial assessed the effectiveness and safety of metered cryospray (MCS) therapy delivered bronchoscopically through RejuvenAir. The therapy removes damaged cells to promote a restorative healing process.
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CSA Medical reported that the study achieved its primary endpoint and several secondary endpoints with statistical significance and showed an encouraging safety profile.
RejuvenAir is developed for interventional pulmonologists to treat diseased airway tissue in chronic bronchitis, leaving no implant in the patient.
The company noted that the system works alongside current medical treatments. It also aims to address underlying chronic cough and issues with mucus production and clearance in chronic bronchitis.
RejuvenAir secured breakthrough device designation from the FDA because of its potential benefits compared to existing treatments for a broad patient group.
Chronic bronchitis is the most common subgroup within COPD. It is diagnosed by the presence of cough with productive sputum for at least three months over two consecutive years.
CSA Medical president and CEO Wendelin Maners said: “Today marks a major inflection point for RejuvenAir and for patients with chronic bronchitis who currently lack FDA-approved, device-based treatment options.
“With the PMA submission complete, we look forward to continuing our collaborative review with the FDA and advancing RejuvenAir toward potential US commercialisation.”
In September 2024, CSA Medical raised $53m in Series D stock equity financing to advance the commercialisation of its RejuvenAir cryotherapy system for treating chronic bronchitis.
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