Therapy Areas: Devices
CSA Medical gains FDA's breakthrough device designation and IDE approval for RejuvenAir System for treating COPD with CB
4 April 2019 -

Cryotherapy technology company CSA Medical reported on Wednesdaythat its RejuvenAir System has been designated as a Breakthrough Device by the US Food and Drug Administration (FDA).

Additionally, the company has received unconditional IDE (Investigational Device Exemption) approval to initiate a pivotal clinical study to treat patients with moderate to severe chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB).

The RejuvenAir System delivers a Metered Cryospray of liquid nitrogen at -196 degrees C to targeted areas within the lungs. It is anticipated that the rapid freezing of the epithelial layer of the airway walls will destroy the mucus-producing goblet cells while preserving the extracellular matrix, thereby enabling the regrowth of healthy cells.

COPD, which includes CB, is a long-term, progressive lung disease that over time makes it hard to breathe and is the third leading cause of disease-related deaths in the United States.

The company plans to launch the pivotal, prospective, multi-centre, blinded randomized (2:1) sham controlled trial using the RejuvenAir System across 30 sites in the US, Europe and Canada with up to 330 subjects with moderate to severe COPD with CB.

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