CSA Medical announced today that it completed patient enrollment in a pivotal trial for its RejuvenAir spray cryotherapy system.
Boston-based CSA enrolled 210 patients worldwide in its SPRAY-CB pivotal trial for treating chronic obstructive pulmonary disease (COPD). The double-blind, sham-controlled, prospective, randomized clinical trial evaluates RejuvenAir for COPD with chronic bronchitis.
CSA Medical said its study completed enrolling patients nearly two months ahead of schedule. The company enrolled nearly a quarter of participants over the last four months. Heather Nigro, SVP of clinical and regulatory affairs, said it highlights significant interest in the RejuvenAir device therapy.
RejuvenAir applies a precise thermal dose, or metered cryospray, of extremely cold (-196°C) liquid nitrogen to targeted areas within the lungs through a minimally invasive, outpatient procedure. It ablates damaged cells in chronic bronchitis patients to enable a rejuvenating, healing response.
CSA Medical’s therapy targets the underlying cause in a minimally invasive outpatient or same-day bronchoscopic procedure. The company says that offers something no other drug or device on the market does today. RejuvenAir carries CE mark but remains investigational in the U.S.
“The completion of enrollment in our SPRAY-CB pivotal trial is a critical achievement for CSA Medical as we strive to bring a new, first of its’ kind medical device therapy to the millions of COPD patients struggling with the debilitating symptoms of chronic bronchitis,” said Wendelin Maners, CEO of CSA Medical. “We want to thank the clinical trial participants, investigators, and sites whose significant interest in this breakthrough device therapy drove strong recruitment.”
