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Cryotherapy Spray For COPD Approved FDA
In more FDA approval news, the U.S. Department Food and Drug Administrations (FDA) has designated a cryotherapy spray designed for the subset of patients with moderate to severe chronic obstructive pulmonary disease (COPD) who suffer from chronic bronchitis. Known as the RejuvenAir system, the device sprays liquid nitrogen at -196 degrees Celsius, aiming to rapidly freeze the epithelial layer of airway walls, destroying mucus-producing goblet cells while preserving the extracellular matrix that can regrow healthy cells.
The move by the FDA may signal acceleration of the availability of new treatments that leverage advanced technology. Use of these cryo-devices, which are meant to destroy unwanted tissue through the application of extreme cold, has been spreading across disease areas.
The FDA also gave RejuvenAir’s maker, CSA Medical, a separate unconditional investigational device exemption approval, which means the company can move forward with a study.
CSA Medical completed a feasibility study in 2018 and said in a press release that it plans to conduct a randomized, sham-controlled trial across 30 sites in the U.S., Europe and Canada with up to 330 patients. Small-scale initial safety data was published in the American Journal of Respiratory and Critical Care Medicine in 2017.
Cryotherapy has been safely used for some time in various medical procedures. The RejuvenAir System radial spray cryotherapy is for conditions associated with abnormal bronchial function, such as chronic bronchitis.
“We are eager to begin this pivotal trial and build on the successful data that was generated from the feasibility study of RejuvenAir,” Heather Nigro, senior vice president of regulatory, quality, and clinical affairs at CSA Medical, said in a press release. “Receiving the Breakthrough Device designation from the FDA further highlights the unmet clinical need for this patient population and we are excited to drive the solution for moderate to severe COPD patients with chronic bronchitis,” she said.
CSA Medical's already markets its truFreeze spray kit for use in patients with acid reflux, esophogeal cancer and other conditions.
With 8.6 million US diagnoses in the past year alone, chronic bronchitis is the most common disease to fall under the CPOD umbrella. Inflamed bronchial tubes lead to heavy mucus production and prolonged cough, and in some cases fatigue, shortness of breath and fever, which can be treated with a range of medications, oxygen therapy or surgical removal of damaged lung tissue.
