CSA Medical‘s RejuvenAir System received the designation of Breakthrough Device by the U.S. Food and Drug Administration (FDA) for the treatment of patients with chronic obstructive pulmonary disease (COPD).
The FDA also gave the company an unconditional Investigational Device Exemption (IDE) approval to test the system in patients with moderate to severe COPD with chronic bronchitis in an upcoming pivotal clinical trial.
RejuvenAir is a medical device designed to destroy cells on the surface of the airways that are producing excessive mucus. The device releases extremely cold liquid nitrogen (-196°C, about -321°F) in specific areas of the lungs. The procedure uses a bronchoscope through the patient’s mouth to reach the lungs, and is performed in an operating room under general anesthesia.
FDA’s Breakthrough Devices Program is intended to facilitate and speed up the clinical development and review of new medical devices that offer a therapeutic advantage over existing technologies in the treatment or diagnosis of life-threatening or chronic diseases. Manufacturers from technologies receiving this designation receive regular feedback from FDA experts to facilitate the development process and regulatory approval of the product.
“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.
Besides emphysema, chronic bronchitis is one of the most common lung conditions associated with COPD. It is characterized by cough, shortness of breath, and inflammation of the airways, caused by the excessive production of mucus in the lungs.
CSA Medical is planning to launch the prospective, blind, randomized, sham-controlled trial (NCT03893370) in 30 sites across the U.S., Canada, and Europe. It will enroll up to 330 COPD patients, ages 40-80, who will be randomized to undergo treatment using the RejuvenAir Metered Cryospray System or a sham procedure.
Researchers will evaluate the treatment’s ability to rapidly freeze and destroy cells that produce mucus, while leaving components of the airways’ extracellular matrix (the network that surrounds and supports cells as they grow) and healthy cells unharmed. The team will also assess changes in the frequency of COPD flares (exacerbations) and lung function over 12 months.
“We are especially encouraged that the FDA approved the IDE unconditionally. The study approval and device designation will allow us to greatly impact the lives of chronic bronchitis patients worldwide, and collect significant clinical data surrounding our novel system,” said Wendelin Maners, president of CSA Medical.