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.
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SOURCE CSA Medical