Productive Cough

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, [email protected] SOURCE CSA Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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. Continue Reading RejuvenAir Metered Cryospray "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

LONDON, UK I September 06, 2024 I GSK plc (LSE/NYSE: GSK) today announced positive headline results of MATINEE, the phase III clinical trial evaluating Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5) in adults with chronic obstructive pulmonary disease (COPD). The trial recruited COPD patients with broad clinical presentations of chronic bronchitis and/or emphysema, who were receiving optimised inhaled maintenance therapy. Participants were also required to have evidence of type 2 inflammation characterised by raised blood eosinophil count. 1 MATINEE met its primary endpoint with the addition of Nucala to inhaled maintenance therapy, and study results showed a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations versus placebo with patients treated for up to 104 weeks. The preliminary safety results are consistent with the known safety profile of Nucala . Further analysis of these data is ongoing. COPD affects more than 300 million people globally with up to 40% of patients exhibiting type 2 inflammation characterised by raised blood eosinophil count, that drives exacerbations. 3,4 IL-5 is a key messenger protein (cytokine) in type 2 inflammation. 5 Recurrent exacerbations lead to damage to the lungs, progressive lung function decline and risk of hospitalisation. This can result in a vicious cycle of deterioration in overall physical health, which leads to worsening of symptoms and quality of life, and increased mortality. 6,7 The full results of MATINEE will be presented at a future scientific congress and will inform ongoing discussions with regulatory authorities. Nucala is currently not indicated for COPD anywhere in the world. About the mepolizumab development programme for COPD The mepolizumab program in COPD is comprised of three clinical trials. The first two studies, METREX and METREO, completed in 2017. MATINEE was designed to supplement METREX and METREO, building on our learnings from these studies and IL-5 science to identify the patients who could benefit the most from Nucala and support future submissions and approvals for use in this indication. 3 MATINEE is a multi-centre, randomised, placebo controlled, double-blind, parallel group study. The trial is designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in 806 COPD participants who were randomised to receive mepolizumab, or a placebo, as an add on to their optimised maintenance COPD therapy for at least 52 weeks and up to a maximum of 104 weeks. 1 About Nucala First approved in 2015 for severe asthma with an eosinophilic phenotype in the US, mepolizumab is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation. Nucala has been developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation. For product and important safety information please consult the country relevant summary of product characteristics. EU and UK available at: https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf About chronic obstructive pulmonary disease (COPD) COPD is the third leading cause of death worldwide with exacerbations accounting for the greatest proportion of the total COPD burden on the healthcare system. 2 Patients with COPD have chronic inflammation leading to persistent respiratory symptoms such as breathlessness and a productive cough. The daily impact on patients’ lives can lead to anxiety and depression. 6 Exacerbations are acute episodes of worsening COPD symptoms and can result in hospitalisation, irreversible and cumulative lung damage or death. 6 Many patients continue to experience exacerbations despite standard treatment meaning that there is a need for targeted therapies that address the underlying pathobiology. 6,10,11 Up to 40% of patients have evidence of type 2 inflammation that drives exacerbations. 3,4 Blood eosinophil count is a biomarker for type 2 inflammation that can be easily measured by a simple blood test and indicates a patient’s risk of exacerbation and deterioration, and response to treatment in COPD. 6 IL-5 is a core cytokine in type 2 inflammation. It is a major protein responsible for the growth, maturation, activation and survival of eosinophils, a type of white blood cell implicated in the pathogenesis of type 2 inflammatory diseases. Evidence indicates that IL-5 has an impact on other cell types beyond eosinophils, including those that contribute to inflammation, lung remodelling and disease progression. 12-16 About GSK in respiratory GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care, and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics and inhaled medicines, we are focused on improving outcomes and the lives of people living with all types of asthma and COPD along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim to modify underlying disease dysfunction and prevent disease progression. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. References SOURCE: GlaxoSmithKline