CSA Medical has secured CE mark approval for its RejuvenAir system to treat chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB).
RejuvenAir Metered Cryospray system has been developed to spray liquid nitrogen at -196◦C in a circumferential pattern within the airway.
The advanced cryosurgical device applies metered cryospray (MCS) of liquid nitrogen at -196◦C to targeted areas within the lungs via the minimally invasive bronchoscopic procedure.
The extreme cold flash is said to freeze damaged surface area lung cells to induce a rejuvenative healing process.
Chronic bronchitis affects over 11 million Americans and is the third major cause of disease-related deaths, as per the American Lung Association.
RejuvenAir system is currently under clinical investigation in the US
The EU approval of RejuvenAir was based on data from the prospective, multi-centre, open-label, safety and efficacy study.
According to the company, the 35-patient study led to a significant improvement in patient-reported health-related quality of life, at least up to one year.
The rapid freezing of the epithelial layer of the airway walls is believed to ruin the mucus-producing goblet cells while preserving the extracellular matrix, helping to support the regrowth of healthy cells.
RejuvenAir system is currently under clinical investigation in the US.
CSA Medical regulatory, quality and clinical affairs senior vice president Heather Nigro said: “While pharmaceutical options can decrease cough and mucus production, the RejuvenAir System offers the only treatment able to address the underlying cause of CB – while simultaneously treating the debilitating symptoms.
“This patient population now has an option that can dramatically improve their quality of life – that’s exciting!”
In October last year, CSA Medical secured $23m in venture debt and equity financing to advance its two cryospray therapy platforms, truFreeze and Rejuvenair.
Horizon Technology Finance provided the $15m venture loan facility along with $8m in equity investment sourced from existing CSA shareholders.
In November, Grifols introduced a new cheek swab, AlphaID, for the screening of Alpha-1, the most common genetic form of COPD.
