CSA Medical completed enrolment in its SPRAY-CB trial ahead of schedule and believe this reflects the strong interest in device therapy for COPD. Credit: Marko Aliaksandr/Shutterstock.com

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.

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The SGRQ is designed to measure health impairment in patients with COPD or asthma.

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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.