CSA Medical has completed enrolment in its SPRAY-CB trial (NCT03893370) for patients with chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB).
The double-blind, sham-controlled trial will measure the effect of the Boston-based company’s RejuvenAir System on improving patient outcomes.
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RejuvenAir is a cryospray that delivers liquid nitrogen via a radial head catheter to targeted areas within the lungs. It received a CE mark in Europe and breakthrough device designation and investigational device exemption (IDE) from the US Food and Drug Administration (FDA) in 2019.
The system is designed to induce a regenerative effect on endobronchial tissue and to address the underlying cause of CB and enable a healing response in damaged cilia and mucus-producing goblet cells.
CSA’s primary trial outcome is to measure change in the St. George Respiratory Questionnaire (SGRQ) score from baseline to 12 months.
The SGRQ is designed to measure health impairment in patients with COPD or asthma.
Secondary outcome measures include the reduction of cough and sputum in patients from baseline through 12 months.
CSA Medical CEO Wendelin Maners commented: “The completion of enrolment 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.”
To date, the company has raised approximately $125m from venture financing.
According to GlobalData, the COPD market stood at a value of around $18.5bn in 2023 and is forecast to reach a value of around $28bn by 2028.
