CSA Medical Completes Enrollment in SPRAY-CB, a U.S. Pivotal Trial of The RejuvenAir System for the Treatment of Chronic Bronchitis

2024-07-08

临床研究

The RejuvenAir®

System, utilizing Metered Cryospray, delivers a minimally invasive medical device therapy which aims to target the underlying cause of COPD with Chronic Bronchitis

BOSTON, July 8, 2024 /PRNewswire/ -- CSA Medical Inc., developer of The RejuvenAir® System, a medical device advancing the power of liquid nitrogen spray cryotherapy, today announced the completion of patient enrollment in its SPRAY-CB pivotal trial. The SPRAY-CB study is a double-blind, sham-controlled, prospective, randomized, clinical trial for the treatment of COPD with Chronic Bronchitis. The trial enrolled 210 patients worldwide and completed enrollment nearly two months ahead of schedule. The RejuvenAir System has already obtained CE Mark and UKCA approval for use outside the U.S.

"We enrolled almost 25% of the study in the last four months reflecting the strong interest in a device therapy that goes beyond pharmaceutical management of the disease," said Heather Nigro, CSA Medical's SVP of Clinical and Regulatory Affairs.

The RejuvenAir System is a revolutionary cryosurgical device that 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.

"The completion of enrollment in our SPRAYCB 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, Chief Executive Officer 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."

The RejuvenAir System is a medical device therapy targeting the underlying cause of Chronic Bronchitis, the over-production and clearance of mucus. In Chronic Bronchitis patients, the airways have been damaged and the tiny hair-like cells lining the lungs that help move mucus and debris out of the airway, become dysfunctional. The RejuvenAir System ablates these damaged cells enabling a rejuvenative healing response. The RejuvenAir System offers a unique solution that is aimed at treating the underlying cause of the disease through a minimally invasive, outpatient or same-day bronchoscopic procedure; something no drug or device on the market does today.

About COPD with Chronic Bronchitis

Chronic Bronchitis is the largest disease subset of Chronic Obstructive Pulmonary Disease (COPD). Bronchitis is inflammation of the bronchial airways. A chronic bronchitis diagnosis is defined by cough with productive sputum of three months duration for two consecutive years. In addition to chronic inflammation, cough, and increased production of mucus, Chronic Bronchitis may or may not present with obstruction/partially blocked airways due to swelling and excess mucus in the bronchi, or shortness of breath (dyspnea). In the United States, there are an estimated 16 million people with COPD, of which over 9 million have a diagnosis of Chronic Bronchitis, a subset of COPD. Approximately 700,000 people are hospitalized for symptoms/exacerbations of Chronic Bronchitis every year. In Europe, there are approximately 23 million people with COPD and approximately 1.5 million hospitalizations per year for COPD.

About CSA Medical

CSA Medical is committed to developing spray cryotherapy devices that improve the lives of people suffering from COPD with Chronic Bronchitis. We are advancing our core liquid nitrogen spray technology, RejuvenAir, to target the underlying cause of Chronic Bronchitis – the over production of mucus and damaged cilia within the airways. By targeting and destroying these damaged cells without creating scar tissue, the body can begin the rapid regrowth of new, healthy normal functioning cells in the lung.

RejuvenAir is an investigational device and not currently commercially available in the United States.

SOURCE CSA Medical