SPRAY-CB met its primary endpoint and multiple secondary endpoints with statistical significance, FDA review underway

BOSTON, Jan. 7, 2026 /PRNewswire/ — CSA Medical, Inc., a medical device company focused on interventional pulmonary therapies, today announced the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its RejuvenAir System for the treatment of chronic bronchitis in patients with chronic obstructive pulmonary disease (COPD).

The PMA submission is supported by positive results from SPRAY-CB, a multicenter, randomized, sham-controlled pivotal clinical trial evaluating the safety and effectiveness of Metered CryoSpray (MCS) therapy delivered bronchoscopically using the RejuvenAir System. The study met its primary endpoint and multiple secondary endpoints with statistical significance and demonstrated a favorable safety profile.

“Today marks a major inflection point for RejuvenAir and for patients with chronic bronchitis who currently lack FDA-approved, device-based treatment options,” said Wendelin Maners, President and CEO of CSA Medical. “With the PMA submission complete, we look forward to continuing our collaborative review with the FDA and advancing RejuvenAir toward potential U.S. commercialization.”

Developed for interventional pulmonologists, RejuvenAir is a first-of-its-kind, bronchoscopic, device-based therapy that targets diseased airway tissue in chronic bronchitis, with no implant left behind. By complementing existing medical management, RejuvenAir has the potential to define a new category within pulmonary intervention.

About RejuvenAir

The RejuvenAir System is a medical device therapy designed to target the underlying chronic cough and dysfunctional production and clearance of mucus in Chronic Bronchitis. Metered CryoSpray therapy ablates the damaged cells enabling a rejuvenative healing response. RejuvenAir received FDA Breakthrough Device Designation, reflecting its potential to provide meaningful advantages over existing medical therapies for a large and underserved patient population.

About COPD with Chronic Bronchitis

Chronic Bronchitis is the largest disease subset of Chronic Obstructive Pulmonary Disease (COPD). 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.

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 chronic cough, dysfunctional mucus production and clearance, in chronic bronchitis patients. 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. The RejuvenAir System is an investigational device and not currently commercially available in the United States.

SOURCE CSA Medical

Underlying proof of rejuvenative healing indicative of airway remodeling corresponds with clinical efficacy and improved quality of life

Boston, MA—Oct 8, 2024: /PRNewswire/ — CSA Medical, Inc., a leader in developing spray cryotherapy solutions for the treatment of airway diseases, today announced data correlating the positive clinical outcomes following Metered CryoSpray (MCS), using the RejuvenAir^® System, with evidence of airway tissue remodeling in chronic bronchitis subjects. In a session at the American College of Chest Physicians (CHEST) conference in Boston entitled “Beyond Bronchodilators: Bronchoscopic Management of COPD”, Dr. Robert Browning, Jr., Professor of Medicine, Walter Reed National Military Medical Center, described the evolution of bronchoscopic Metered CryoSpray (MCS) treatment and shared the latest peer-reviewed and published data.

Interestingly, early RNA gene analysis data suggests Metered CryoSpray therapy remodels airway tissues in a way that is disease-modifying.  Recently, scientists at the National Heart and Lung Institute (NHLI), Imperial College London, presented key genomics findings suggesting improvements in lung architecture with increased epithelial cell progenitor growth; improvement in cilial function; increased integrity of the apical junctional complex; a reduction in airway inflammation; and a reduction in the Epithelial to Mesenchymal Transition (EMT) post Metered CryoSpray therapy.  These changes in cellular populations, indicative of airway remodeling, build upon previously published clinical results showing statistically significant improvements in quality of life.

The RejuvenAir System is a medical device therapy designed to target the underlying chronic cough and dysfunctional production and clearance of mucus in Chronic Bronchitis. Metered CryoSpray therapy ablates the damaged cells, enabling a rejuvenative healing response. “While the medical definition of chronic bronchitis is simplistic, the genomics reveal the underlying disease is multifactorial. We are encouraged by the rejuvenative changes in the airways we are seeing after treatment with RejuvenAir and anticipate we will continue to see positive clinical data from our larger SPRAY-CB pivotal trial next year,” said Wendelin Maners, Chief Executive Officer of CSA Medical.

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.

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 chronic cough, dysfunctional mucus production and clearance in chronic bronchitis patients. 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

Research reveals rejuvenative changes in cellular populations indicative of airway remodeling correspond with clinical efficacy and improved quality of life

BOSTON, Sept. 16, 2024 /PRNewswire/ —CSA Medical, Inc., today announced multiple presentations at the European Respiratory Society (ERS) Congress in Vienna detailing new clinical science supporting Metered CryoSpray (MCS) with the RejuvenAir^® System for the treatment of Chronic Bronchitis.  In a session entitled, “Cutting-edge concepts in interventional pulmonology: the future is here!” Dr. Christopher Orton, Consultant Respiratory Physician at Royal Brompton Hospital, London U.K, presented research characterizing potential mechanisms of action of bronchial epithelial resurfacing and remodeling utilizing MCS for the treatment of patients with COPD with chronic bronchitis. In addition to confirming the clinical efficacy of Metered CryoSpray to reduce the symptoms associated with chronic bronchitis, he and his colleagues found a reduction in air-trapping and changes in cellular populations indicative of airway remodeling or “rejuvenation”.

The RejuvenAir System is a medical device therapy targeting the underlying chronic cough, dysfunctional mucus production and clearance in Chronic Bronchitis. The RejuvenAir System ablates these damaged cells enabling a rejuvenative healing response.

Building on the mechanism of action dataset, Dr. Orton’s co-investigators at the National Heart and Lung Institute (NHLI), Imperial College London presented further evidence of rejuvenative healing after MCS treatment concluding, the metered cryospray procedure reduced abnormal lung epithelium morphology and altered DNA methylation pathways suggesting a link between the regeneration of epithelial tissues in large airways and improvements in quality of life. “Our initial transcriptomic analyses suggest that these increases in quality of life post MCS treatment may be associated with an improvement in cilia function and lung repair mechanisms and reduced epithelial to mesenchymal transition leading to an enhancement in epithelial barrier integrity,” shared Dr. Pankaj Bhavsar, scientific lead at the NHLI.

“We want to thank the clinicians and researchers at Imperial College London investigating the science behind tissue rejuvenation in chronic bronchitis patients who received Metered CryoSpray therapy with RejuvenAir. The science reinforces the statistically significant clinical outcomes from previous studies and we look forward to seeing more positive data from our larger SPRAY-CB pivotal trial next year,” said Wendelin Maners, Chief Executive Officer of CSA Medical.

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.

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 chronic cough, dysfunctional mucus production and clearance in chronic bronchitis patients. 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.

Media Contact:  Wendelin Maners, wmaners@csamedical.com

TVM Capital Life Science and Yonjin Venture co-led the round, joined by a strong syndicate of existing investors

BOSTON, Sept. 9, 2024 /PRNewswire/ — CSA Medical Inc., developer of The RejuvenAir® System, a Breakthrough Medical Device advancing the power of liquid nitrogen spray cryotherapy for the treatment of chronic bronchitis, today announced the completion of an oversubscribed $53 million Series D preferred stock equity financing. This round will fund the company though expected U.S. Food and Drug Association (FDA) premarket approval (PMA) and the building of a comprehensive commercialization strategy for successful U.S. launch. TVM Capital Life Science and Yonjin Ventures co-led the round, joined by a strong syndicate of existing shareholders SV Health Investors, Ascension Ventures, First Analysis, Blue Heron, and Intersouth Partners. In conjunction with the financing, Dr. Luc Marengere of TVM and Dr. Deng Mao of Yonjin Ventures will join CSA Medical’s Board of Directors.

“We’re excited to bring new partners on board as we approach the next significant milestone of submitting the RejuvenAir System for regulatory approval,” said Wendelin Maners, CSA Medical CEO. “This new investment further validates the enormous market potential for the RejuvenAir therapeutic platform in this under-served patient population.” The RejuvenAir System is a medical device therapy aimed at treating the underlying cause of the chronic bronchitis, something no drug or device on the market does today.

“This successful funding round is a testament to our confidence in the Company’s team, vision and impact RejuvenAir will make in treating chronic bronchitis around the world,” said Dr. Luc Marengere, Managing Partner at TVM Capital Life Science. “I am excited to join the Board of CSA and look forward to see the upcoming data from the U.S. pivotal study.”

On behalf of Yonjin Ventures, Dr. Deng Mao expressed enthusiasm about the partnership, stating “Our investment is driven by the clear and significant impact the RejuvenAir technology will have on chronic bronchitis patients worldwide.”

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.

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

The RejuvenAir System is a minimally invasive medical device therapy which aims to target the underlying cause of COPD with Chronic Bronchitis

BOSTON, Feb. 7, 2024 /PRNewswire/ — CSA Medical Inc., a developer of medical devices advancing the power of liquid nitrogen spray cryotherapy, today announced its 500^th Metered CryoSpray Procedure utilizing the RejuvenAir System.

Jonathan S. Kurman, MD, MBA, and Director of Interventional Pulmonology for the Froedtert & Medical College of Wisconsin health network, performed the procedure as part of the U.S. pivotal trial, SPRAY-CB, investigating the RejuvenAir^® System for treatment of COPD with Chronic Bronchitis. “Our team is excited to be part of this landmark trial to support FDA approval, and to have performed the 500^th procedure is just a bonus,” said Dr. Kurman. “We hope to build on the results out of Europe which showed statistically significant and clinically meaningful improvements in patient symptoms and overall quality of life. Finding a definitive intervention for the millions of Americans who suffer from chronic bronchitis, despite triple medical therapy, is a game changer for this patient population.”

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, often outpatient procedure.  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 SPRAY-CB study is a double-blind, sham-controlled, prospective, randomized, clinical trial currently enrolling across the United States. RejuvenAir is an investigational device and not currently commercially available in the United States. To watch an educational video or to find center a near you, please visit our home page

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, Inc. develops and manufactures proprietary interventional liquid nitrogen spray cryotherapy systems that utilize software-driven dosimetry and specialty catheters that enable delivery of cryogen spray inside the airways to flash freeze and destroy damaged cells allowing for a rejuvenative pattern of healing. The RejuvenAir System is approved in the EU and under clinical investigation in the United States. To learn more about our technology or clinical trials, please visit www.rejuvenair.com or www.clinicaltrials.gov [Identifiers: NCT03893370 and NCT03892694].

RejuvenAir is a registered trademark of CSA Medical, Inc.

SOURCE CSA Medical

Metered Cryospray treats damaged airways enabling a rejuvenative healing response

BOSTON, Sept. 6, 2022 /PRNewswire/ — CSA Medical, Inc., today announced results from the first randomized, controlled study of Metered Cryospray (MCS) utilizing the RejuvenAir® System for the treatment of Chronic Bronchitis. The data was presented at the International Congress of the European Respiratory Society in Barcelona, Spain by Christopher Orton, MD, of The Royal Brompton Hospital, London, UK.

SGRQ and CAT, the gold standard measurement for patient reported symptom scores, were statistically significant and clinically meaningful, respectively. Chronic Bronchitis, the largest subset of COPD, is a progressive, irreversible disease with no cure. Medications merely manage symptoms, but over time, chronic productive cough and breathlessness worsen. As expected, quality of life in the sham group continued to decline. However, sham subjects were offered cross-over to treatment at 6 months and to date, all 32 subjects have completed treatment.

RejuvenAir goes beyond medical management addressing the underlying cause of Chronic Bronchitis, damaged airways.

The Royal Brompton team previously reported strong safety and clinically meaningful 24 month results, from an open-label trial, now 36 months out. Together with this new cohort, they have performed over 100 Metered Cryospray treatments with zero pneumothoraces. “This first randomized controlled study data reinforces previous feasibility results showing Quality of Life improvement in patients with chronic bronchitis. RejuvenAir® Metered Cryospray is both safe and effective in a patient population with multiple co-morbidities, in a disease with no established therapies,” summarized Pallav Shah, Professor of Respiratory Medicine, Imperial College, London.

The RejuvenAir System is designed to address the underlying cause of Chronic Bronchitis, the damaged cilia and mucus-producing goblet cells lining the airways and enable a rejuvenative healing response. SPRAY-CB, the pivotal study of the RejuvenAir System in patients with COPD with Chronic Bronchitis, is actively enrolling.

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 a 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. 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, Inc. develops and manufactures proprietary interventional liquid nitrogen spray cryotherapy systems that utilize software-driven dosimetry and specialty catheters that enable delivery of cryogen spray inside the airways to flash freeze and destroy damaged cells allowing for a rejuvenative pattern of healing.

The RejuvenAir System is approved in the EU and under clinical investigation in the United States. To learn more about our technology or clinical trials, please visit www.rejuvenair.com or www.clinicaltrials.gov [Identifiers: NCT03893370 and NCT03892694].

SOURCE CSA Medical