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.

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 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 the 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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.”

The company has so far 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.

GlobalData is the parent company of Clinical Trials Arena.