BOSTON | January 7, 2026 — CSA Medical, a U.S.-based medical device company focused on interventional pulmonary therapies, has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its RejuvenAir® System, following positive results from the pivotal SPRAY-CB clinical trial. The submission marks a major regulatory milestone for a first-of-its-kind bronchoscopic, device-based therapy intended to treat chronic bronchitis in patients with chronic obstructive pulmonary disease (COPD), an area with limited FDA-approved interventional options.
Science Significance
The scientific importance of the PMA submission lies in the novel mechanism of action behind the RejuvenAir® System. The device delivers Metered CryoSpray (MCS) therapy, a bronchoscopic application of liquid nitrogen designed to ablate diseased airway cells without leaving an implant behind. This controlled cryoablation triggers a rejuvenative healing response, enabling regrowth of healthy, functional airway tissue. In the SPRAY-CB trial, a multicenter, randomized, sham-controlled pivotal study, the therapy met its primary endpoint and multiple secondary endpoints with statistical significance, while demonstrating a favorable safety profile. These results provide strong clinical evidence supporting RejuvenAir as a new therapeutic category within pulmonary intervention, bridging a gap between pharmacologic management and invasive surgical approaches.
Regulatory Significance
From a regulatory standpoint, PMA submission represents the highest level of FDA scrutiny for medical devices, underscoring the maturity and robustness of the RejuvenAir clinical and technical data package. The PMA is supported by pivotal GCP-compliant clinical evidence, extensive safety data, and manufacturing controls aligned with FDA quality system requirements. RejuvenAir’s prior FDA Breakthrough Device Designation further emphasizes its potential to provide meaningful advantages over existing therapies for a large, underserved patient population. For cGxP professionals, this milestone highlights the complexity of device-based clinical development, where clinical outcomes, risk management, and design controls converge to support regulatory approval.
Business Significance
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Strategically, the PMA submission positions CSA Medical at a critical inflection point as it moves toward potential U.S. commercialization. Success would establish RejuvenAir as a category-defining MedTech solution for chronic bronchitis, expanding CSA Medical’s footprint in interventional pulmonology. The ability to complement existing medical management creates opportunities for adoption by specialized pulmonary centers, while also supporting long-term growth through reimbursement discussions and post-market clinical expansion. For the broader MedTech sector, the program illustrates how pivotal trial success paired with Breakthrough Device designation can accelerate regulatory pathways and strengthen investor and partner confidence.
Patients’ Significance
For patients, particularly those suffering from COPD with chronic bronchitis, the potential impact is substantial. Millions of individuals experience persistent cough, mucus overproduction, and reduced quality of life, with limited options beyond chronic pharmacologic therapy. RejuvenAir offers a non-implant, minimally invasive bronchoscopic option that targets the underlying airway pathology rather than symptoms alone. If approved, the therapy could reduce disease burden, improve daily functioning, and provide new hope for patients who remain inadequately managed with current treatments.
Policy Significance
At a policy level, the advancement of RejuvenAir aligns with broader healthcare priorities focused on innovation for chronic respiratory diseases, which impose significant clinical and economic burdens. The PMA review process reinforces the importance of rigorous clinical evidence, patient safety, and post-market accountability in approving high-impact medical technologies. Additionally, the Breakthrough Device framework continues to demonstrate its value in encouraging early regulatory engagement while maintaining stringent approval standards, supporting faster access to transformative therapies without compromising oversight.
The PMA submission for the RejuvenAir® System represents a major regulatory and clinical milestone for CSA Medical and the field of interventional pulmonology. Backed by statistically significant pivotal trial data and a strong safety profile, RejuvenAir has the potential to redefine how chronic bronchitis in COPD patients is treated. For the cGxP community, this development underscores the critical role of quality systems, clinical rigor, and regulatory strategy in advancing innovative MedTech solutions from investigational concepts to potential standards of care.
Source: CSA Medical press release
