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Statistically significant and clinically meaningful BATURA Phase III trial results provide new evidence for AIRSUPRA as standard of care for as-needed rescue treatment in asthma
Statistically significant and clinically meaningful BATURA Phase III trial results provide new evidence for AIRSUPRA as standard of care for as-needed rescue treatment in asthma

Yahoo

time19-05-2025

  • Health
  • Yahoo

Statistically significant and clinically meaningful BATURA Phase III trial results provide new evidence for AIRSUPRA as standard of care for as-needed rescue treatment in asthma

AIRSUPRA demonstrated a 47% reduction in the risk of severe exacerbations in mild asthma compared with albuterol alone Full results published in the New England Journal of Medicine and presented at ATS 2025 International Conference WILMINGTON, Del., May 19, 2025--(BUSINESS WIRE)--Positive full results from the BATURA Phase IIIb trial showed AstraZeneca's anti-inflammatory reliever rescue therapy, AIRSUPRA (albuterol/budesonide), demonstrated statistically significant and clinically meaningful improvements in all primary and secondary endpoints compared to albuterol in patients with mild asthma.1,2 These data were published in the New England Journal of Medicine and presented today at the American Thoracic Society (ATS) 2025 International Conference in San Francisco, CA.1 The trial measured as-needed AIRSUPRA compared to as-needed albuterol, the most commonly used rescue medicine in the US.3 The BATURA trial demonstrated treatment with AIRSUPRA significantly reduced the risk of a severe exacerbation by 47% (5.1% , 9.1%, hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.39, 0.73; p<0.001) when compared with albuterol alone. The overwhelming efficacy of AIRSUPRA at a pre-specified interim analysis led to the early stop of the BATURA trial as recommended by the Independent Data Monitoring Committee.4 BATURA builds upon the previous Phase III MANDALA and DENALI trials and in totality, the clinical program demonstrates the benefit of as-needed AIRSUPRA in reducing the risk of severe exacerbations across all asthma severities compared to albuterol alone.3,5 This BATURA data also aligns to the latest global recommendations from the Global Initiative for Asthma which recommends an anti-inflammatory reliever combination therapy taken as-needed as the preferred reliever therapy in mild asthma.6 Mild asthma, affecting 50% to 70% of patients, is often assumed to be low-risk, yet can result in severe or even fatal exacerbations.7,8 People with mild asthma or infrequent asthma symptoms represent up to 30% of all reported asthma-related exacerbations and deaths.7,8 Craig LaForce, MD, Medical Director of North Carolina Clinical Research, said: "The unprecedented BATURA trial results provide an opportunity to change 50 years of clinical practice in asthma. For decades, millions of patients have relied on albuterol-only rescue treatment in asthma, leaving them unprotected against the increasing airway inflammation that could lead to a more serious attack. The results from the AIRSUPRA BATURA trial add to a wide body of evidence on the value of the anti-inflammatory reliever rescue approach to not only provide immediate relief from symptoms, but also reduce inflammation to prevent future and more severe exacerbations for patients living with asthma across all severities." Tonya Winders, President of Global Allergy and Airways Patient Platform (GAAPP), said: "Patients who live with asthma are often at risk for unexpected exacerbations. Using an anti-inflammatory reliever therapy can transform every use of a rescue inhaler into an opportunity for early intervention to address the underlying inflammation of asthma, helping to prevent attacks and reduce exposure to systemic steroids. This is especially important for patients with mild asthma whose risk for severe exacerbations is often underestimated." Sharon Barr, Executive Vice-President and Head of BioPharmaceuticals R&D, AstraZeneca, said: "The exciting results from the BATURA trial, coupled with the findings from MANDALA and DENALI, clearly demonstrate the superiority of AIRSUPRA over albuterol alone across all asthma severities. We hope these comprehensive results accelerate the use of anti-inflammatory rescue therapy as the preferred standard of care, in line with recommendations from the Global Initiative for Asthma." In a key secondary endpoint, adults and adolescents ages 12 and older receiving AIRSUPRA had 63% lower exposure to total systemic corticosteroids (SCS) (p<0.001) over the treatment period compared with albuterol-alone, thereby reducing known risks from cumulative exposure to SCS. Similar reductions in all primary and secondary endpoints were seen in a prespecified subgroup of adult patients (≥18 years) on treatment. SCS are commonly used to control inflammation in asthma, treatment of exacerbations, however as few as 1-3 short courses of SCS are associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia and fracture.9 Safety findings in the BATURA trial demonstrated the safety and tolerability of AIRSUPRA was consistent with its well-established safety profile. There were no clinically meaningful differences in safety results between the AIRSUPRA and albuterol groups. AIRSUPRA is the first and only anti-inflammatory rescue medication approved in US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. The US approval was based on results from the MANDALA and DENALI Phase III trials.3,5 AIRSUPRA is also being studied in adolescents with asthma (12 to <18 years old) in the ACADIA Phase III trial and in patients in China in the BAIYUN Phase III trial.10,11 AIRSUPRA was developed by AstraZeneca and Avillion. Outside of the US, AIRSUPRA is approved in the United Arab Emirates, Kuwait, Bahrain, Qatar and Oman. Summary of Results: BATURA Time to First Severe Exacerbation (Primary Endpoint) Treatment Group Number (%) of participants with a severe exacerbation Comparison vs. albuterol 180 μg Hazard Ratio 95% CI P-value Full analysis set, age ≥12 years Albuterol/budesonide 180/160 µg (n=1209) 62 (5.1) 0.53 (0.39, 0.73) <0.001 Albuterol 180 µg (n=1212) 110 (9.1) – – – Annualised severe exacerbation rate (Secondary Endpoint) Treatment group Number of severe exacerbations Time at risk (pt-years) Annualised rate, estimate (95% CI) Comparison vs. albuterol 180 μg Rate ratio (95% CI) P-value Full analysis set, age ≥12 years Albuterol/budesonide 180/160 µg (n=1209) 83 845.8 0.15 (0.11, 0.20) 0.47 (0.34, 0.64) <0.001 Albuterol 180 µg (n=1212) 160 823.8 0.32 (0.25, 0.41) – – Full analysis set, age ≥18 years Albuterol/budesonide 180/160 µg (n=1180) 82 825.7 0.15 (0.12, 0.20) 0.46 (0.33, 0.63) <0.001 Albuterol 180 µg (n=1173) 159 797.4 0.33 (0.26, 0.43) – – Systemic corticosteroid use (Secondary Endpoint) Treatment group Mean (SD) total amount per participant of SCS exposure, mg/year Comparison vs. albuterol 180 μg Difference in arithmetic means % difference in arithmetic means P-value Full analysis set, age ≥12 years Albuterol/budesonide 180/160 µg (n=1204) 23.2 (142.90) −38.7 −62.5 <0.001 Albuterol 180 µg (n=1203) 61.9 (662.09) – – – Full analysis set, age ≥18 years Albuterol/budesonide 180/160 µg (n=1175) 23.0 (142.38) −40.0 −63.5 <0.001 Albuterol 180 µg (n=1164) 63.0 (672.28) – – – *According to the non-parametric Wilcoxon rank sum test. CI, confidence interval; SCS, systemic corticosteroid; SD, standard deviation. Notes AsthmaAsthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide,3 including over 25 million in the US.12 Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency.6 These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.13,14 There are an estimated 136 million asthma exacerbations globally per year,15 including more than 10 million in the US;12 these are physically threatening and emotionally significant for many patients16 and can be fatal.12,17 Inflammation is central to both asthma symptoms13 and exacerbations.18 Many patients experiencing asthma symptoms use a SABA (e.g. albuterol) as a rescue medicine;19-21 however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations,22 which can result in impaired quality of life,23 hospitalization24 and frequent oral corticosteroid (OCS) use.25 Treatment of exacerbations with as few as 1-3 short courses of OCS are associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia and fracture.9 International recommendations from the Global Initiative for Asthma no longer recommend SABA alone as the preferred rescue therapy.8 Phase IIIb BATURA trialBATURA was a Phase IIIb, US, randomized, double-blind, parallel-group, event-driven trial, comparing the efficacy and safety of using inhaled albuterol/budesonide (180mcg/160mcg) as an as-needed rescue medication in response to symptoms compared to as-needed albuterol (180mcg) for up to 12 months. Patients recruited were aged 12 years and over with intermittent or mild persistent asthma and must have been using as-needed albuterol, or as-needed SABA on a background of either low-dose inhaled corticosteroids (ICS) or leukotriene receptor antagonists (LTRA) maintenance therapy.25 Participants (n=2421) were randomized and treated 1:1 with AIRSUPRA (n=1209) or albuterol as needed (n=1212) for 12-52 weeks. Two efficacy analysis populations were defined: the on-treatment population (data collected on-treatment before randomized treatment discontinuation or step-up maintenance therapy) and the intent-to-treat (ITT) population (all data, regardless of these events).1 The primary efficacy endpoint was the time to first severe asthma exacerbation during the study period. Secondary endpoints included severe exacerbation rate and total systemic corticosteroid use. A severe exacerbation was defined as a worsening of symptoms resulting in three or more days of SCS use, an emergency department, urgent care visit or hospitalization for asthma or death.1 BATURA was a first-ever decentralized, patient-centric design allowed participants to accommodate trial-related activities around their daily lives and was intended to remove logistical barriers, thereby lowering participant burden and increasing efficiency and equitable access to the study.1 AIRSUPRAAIRSUPRA (albuterol/budesonide), formerly known as PT027, is a first-in-class SABA/ICS rescue treatment for asthma in the US, to be taken as needed. It is an inhaled, fixed-dose combination rescue medication containing albuterol (also known as salbutamol), a SABA, and budesonide, a corticosteroid, and has been developed in a pressurized metered-dose inhaler (pMDI) using AstraZeneca's Aerosphere delivery technology. AstraZeneca's Collaboration with Avillion In March 2018, AstraZeneca and Avillion signed an agreement to advance AIRSUPRA through a global clinical development program for the treatment of asthma. Under the terms of the agreement, Avillion became the trial sponsor responsible for executing and funding the global, multicentre clinical trial program for AIRSUPRA through NDA filing to a regulatory decision in the US. Following the successful approval of AIRSUPRA, AstraZeneca is commercializing the medicine. AstraZeneca extended its agreement with Avillion in 2022 to undertake the BATURA Phase IIIb trial to further assess the role of AIRSUPRA in reducing the risk of asthma exacerbations. AstraZeneca in Respiratory & ImmunologyRespiratory & Immunology, part of AstraZeneca BioPharmaceuticals is a key disease area and growth driver to the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases. AstraZenecaAstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit and follow the Company on social media @AstraZeneca. References LaForce, C, et al. As-needed Albuterol–Budesonide in Mild Asthma. Engl J Med. 2025; Available at: Bonini M, et al. Minimal clinically important difference for asthma endpoints: an expert consensus report. Eur Respir Rev. 2020; 29: 190137. Chipps BE, et al. Efficacy and safety of albuterol/budesonide (PT027) in mild-to-moderate asthma: Results of the DENALI study. Am J Respir Crit Care Med. 2022; 205: A3414. AstraZeneca news release. Airsupra demonstrated statistically significant and clinically meaningful reduction in the risk of severe exacerbations in patients with intermittent or mild persistent asthma in BATURA Phase III trial. Available at: [Last accessed: May 2025]. Papi A, et al. Albuterol–Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med. 2022; 386 (22): 2071-2083. Global Initiative for Asthma. Global strategy for asthma management and prevention, 2022. Available at: [Last accessed: May 2025]. Lugogo n, et al. Exacerbation burden in patients treated as intermittent or mild-persistent asthma using short-acting β2-agonist rescue. Annals of Allergy, Asthma & Immunology, Volume 134, Issue 5, 2025, Pages 539-547.e1, ISSN 1081-1206, [Last accessed: May 2025]. Cicco M, et al. Intermittent and mild persistent asthma: how therapy has changed. Acta Biomed. 2021 Nov 29;92(S7):e2021523. doi: 10.23750/abm.v92iS7.12422. PMID: 34842585; PMCID: PMC9431889. [Last accessed: May 2025]. Price DB, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy. 2018; 11: 193–204. Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma (ACADIA). Available at [Last accessed: May 2025]. A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma (BAIYUN). Available at [Last accessed: May 2025]. CDC. Most Recent National Asthma Data. [Online]. Available at: [Last accessed: May 2025]. Price D, et al. Asthma control and management in 8,000 European patients: the Recognise Asthma and Link to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 24: 14009. Papi A, et al. Relationship of inhaled corticosteroid adherence to asthma exacerbations in patients with moderate-to-severe asthma. J Allergy Clin Immunol Pract. 2018; 6 (6): 1989-98.e3. AstraZeneca Pharmaceuticals. Data on File. 2024. Budesonide/formoterol Data on File: Annual Rate of Asthma Exacerbations Globally. (REF-173201). Sastre J, et al. Insights, attitudes, and perceptions about asthma and its treatment: a multinational survey of patients from Europe and Canada. World Allergy Organ J. 2016; 9: 13. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014; 40 (4): 364-372. Wark PA, et al. Asthma exacerbations 3: pathogenesis. Thorax. 2006; 61 (10): 909-15. Johnson DB, Merrell BJ, Bounds C. (2022). Albuterol. StatPearls [Internet]. Treasure Island, Florida: StatPearls Publishing. Montemayor T, et al. Albuterol: Often Used and Heavily Abused. Respiratory Care. November 2021; 66 (Suppl 10): 3603775. Albuterol: Drug Usage Statistics, US 2013 – 2020. Available at: [Last accessed: May 2025]. Nwaru BI, et al. Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme. Eur Respir J. 2020; 55 (4): 1901872. Lloyd A, et al. The impact of asthma exacerbations on health-related quality of life in moderate to severe asthma patients in the UK. Prim Care Respir J. 2007; 16 (1): 22-7. Bourdin A, et al. ERS/EAACI statement on severe exacerbations in asthma in adults: facts, priorities and key research questions. Eur Respir J. 2019; 54 (3): 1900900. A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma (BATURA). Available at [Last accessed: May 2025]. Last Updated 5/25 View source version on Contacts Media Inquiries Fiona Cookson, +1 212 814 3923Jillian Gonzales, +1 302 885 2677US Media Mailbox: usmediateam@ Sign in to access your portfolio

Climate change increases severity of obstructive sleep apnea: Study
Climate change increases severity of obstructive sleep apnea: Study

Hans India

time18-05-2025

  • Health
  • Hans India

Climate change increases severity of obstructive sleep apnea: Study

A new large study on Sunday claimed that rising temperatures increase the severity of obstructive sleep apnea (OSA). Published at the 'ATS 2025 International Conference,' the study also found that, under the most likely climate change scenarios, the societal burden of OSA is expected to double in most countries over the next 75 years. In addition to highlighting the critical importance of limiting global warming, the findings also emphasise the immediate need for strategies to alleviate the health and economic impacts of OSA as it becomes more common and severe, researchers said. 'This study really highlights the societal burden associated with the increase in OSA prevalence due to rising temperatures,' said Bastien Lechat, a senior research fellow at FHMRI: Sleep Health at Flinders University. Previous cross-sectional studies identified a link between ambient temperature and OSA severity. However, this is the first to explain and describe that connection in detail. For the study, researchers analysed a consumer database of more than 116,000 worldwide users of an under-mattress sensor validated to estimate OSA severity. The dataset included around 500 repeat measurements per user. Researchers then analysed this data against 24-hour ambient temperatures extracted from climate models. Overall, higher temperatures were associated with a 45 per cent increased likelihood of a sleeper experiencing OSA on a given night. However, these findings varied by region, with people in European countries seeing higher rates of OSA when temperatures rise than those in Australia and the United States. 'We were surprised by the magnitude of the association between ambient temperature and OSA severity,' Dr Lechat noted. Researchers then sought to estimate how burdensome the increase in OSA prevalence due to rising temperature is to society in terms of wellbeing and economic loss. They conducted modelling including disability-adjusted-life-years, productivity losses, and health economics to estimate the OSA burden under several climate scenarios. They found that any scenario that involved temperatures rising 2 degrees Celsius or higher would result in a 1.5-fold to 3-fold increase to the OSA burden by the year 2100. They estimated that climate change has already increased the OSA burden by 50 percent to 100 percent since the year 2000. In addition to providing further evidence of the major threat of climate change to human health and wellbeing, Dr. Lechat said the study highlighted the importance of developing effective interventions to diagnose and manage OSA. 'The high prevalence undiagnosed and untreated OSA amplifies the effect of global warming on the societal burden associated with OSA,' he said. 'Higher rates of diagnosis and treatment is likely to reduce the health and productivity burden due to rising temperature and increased OSA prevalence.'

Xenon MRI Featured Prominently at ATS 2025 Across Broad Clinical Spectrum
Xenon MRI Featured Prominently at ATS 2025 Across Broad Clinical Spectrum

Associated Press

time15-05-2025

  • Business
  • Associated Press

Xenon MRI Featured Prominently at ATS 2025 Across Broad Clinical Spectrum

DURHAM, NC and LONDON, May 15, 2025 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX) ('Polarean' or the 'Company'), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ('MRI') of the lungs, will be featured at the American Thoracic Society's (ATS) 2025 Respiratory Innovation Summit (RIS), taking place May 16–17 at the Marriott Marquis in San Francisco, California. Polarean will also attend the ATS 2025 International Conference from May 18–21, continuing its active engagement with leaders across pulmonary medicine. Polarean's selection as a featured company at RIS 2025 underscores the growing recognition of the company's Xenon MRI platform as an innovative tool for both clinical imaging and pharmaceutical drug development. RIS brings together key innovators, investors, clinicians, and patient advocacy groups for cross-sector dialogue on the future of respiratory care. At the ATS 2025 International Conference, Xenon MRI will be featured in over 30 posters and presentations from more than 10 leading clinical sites. This robust presence reinforces the sustained momentum behind Xenon MRI as a powerful and enduring technology in pulmonary medicine. The breadth and depth of research presented this year further demonstrate its expanding role in both clinical care and clinical trials—signaling that Xenon MRI is not just innovative, but a lasting part of the respiratory care landscape. The presentations listed below will highlight Xenon MRI's versatility across a wide spectrum of respiratory conditions, including asthma, bronchopulmonary dysplasia, COPD, COVID-19, cystic fibrosis, pulmonary arterial hypertension, radiation-induced lung injury, and post-transplant lung monitoring. Polarean representatives will be on-site throughout RIS and the ATS International Conference to connect with clinicians, researchers, industry partners, and patient advocates. As excitement continues to build around functional lung imaging, Polarean remains at the forefront — visualizing hidden disease, personalizing treatment, and accelerating the future of respiratory medicine. Christopher von Jako, PhD, CEO of Polarean, said: 'We are honored to return as a featured company at the Respiratory Innovation Summit. RIS and the ATS International Conference provide vital opportunities to engage with thought leaders, strengthen partnerships, and highlight the growing body of clinical evidence supporting Xenon MRI. With over 30 presentations this year, it's clear that Xenon MRI is not only gaining traction—it's shaping the future of functional lung imaging and respiratory care.' See the listing below for details on the presentation title, abstract number, session time, and location. About Polarean Polarean is a revenue-generating medical imaging technology company revolutionizing pulmonary medicine through direct visualization of lung function by introducing the power and safety of MRI to the respiratory healthcare community. This community is in desperate need of modern solutions to accurately assess lung function. The Company strives to optimize lung health and prevent avoidable loss by illuminating hidden disease, addressing the global unmet medical needs of more than 500 million patients worldwide suffering from chronic respiratory disease. Polarean is a leader in the field of hyperpolarization science and has successfully developed the first and only hyperpolarized Xenon MRI inhaled contrast agent, XENOVIEW™, which is now FDA-approved in the United States. Polarean is dedicated to researching, developing, and commercializing innovative imaging solutions with its non-invasive and radiation-free pulmonary functional MRI platform. This comprehensive drug-device platform encompasses the proprietary Xenon gas blend, gas hyperpolarization system, as well as software and accessories, facilitating fully integrated modern respiratory imaging operations. Founded in 2012, with offices in Durham, NC, and London, United Kingdom, Polarean is committed to increasing global awareness of and broad access to its XENOVIEW MRI technology platform. For the latest news and information about Polarean, please visit XENOVIEW IMPORTANT SAFETY INFORMATION Indication XENOVIEW®, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging. CONTRAINDICATIONS None. Warnings and Precautions Risk of Decreased Image Quality from Supplemental Oxygen: Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold. Risk of Transient Hypoxia: Inhalation of an anoxic gas such as XENOVIEW may cause transient hypoxemia in susceptible patients. Monitor all patients for oxygen desaturation and symptoms of hypoxemia and treat as clinically indicated. Please see full prescribing information at Contact Information: Polarean: Chuck Osborne Chief Financial Officer +1 (919) 206-7900, ext. 117 [email protected] [email protected] [email protected] General inquiries: [email protected] Follow Polarean on LinkedIn here Polarean: Chuck Osborne Chief Financial Officer +1 (919) 206-7900, ext. 117 [email protected] Polarean Investors: Anna Dunphy / Phillip Marriage +44 (0)20 7933 8780 [email protected] Polarean Media Contact: Alexis Opp +1 (919) 206-7900, ext. 145 [email protected] General inquiries: [email protected]

Xenon MRI Featured Prominently at ATS 2025 Across Broad Clinical Spectrum
Xenon MRI Featured Prominently at ATS 2025 Across Broad Clinical Spectrum

Yahoo

time15-05-2025

  • Business
  • Yahoo

Xenon MRI Featured Prominently at ATS 2025 Across Broad Clinical Spectrum

30+ studies across diverse conditions illuminate the unique value of functional lung imaging with Xenon MRI DURHAM, NC and LONDON, May 15, 2025 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX) ('Polarean' or the 'Company'), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ("MRI") of the lungs, will be featured at the American Thoracic Society's (ATS) 2025 Respiratory Innovation Summit (RIS), taking place May 16–17 at the Marriott Marquis in San Francisco, California. Polarean will also attend the ATS 2025 International Conference from May 18–21, continuing its active engagement with leaders across pulmonary selection as a featured company at RIS 2025 underscores the growing recognition of the company's Xenon MRI platform as an innovative tool for both clinical imaging and pharmaceutical drug development. RIS brings together key innovators, investors, clinicians, and patient advocacy groups for cross-sector dialogue on the future of respiratory care. At the ATS 2025 International Conference, Xenon MRI will be featured in over 30 posters and presentations from more than 10 leading clinical sites. This robust presence reinforces the sustained momentum behind Xenon MRI as a powerful and enduring technology in pulmonary medicine. The breadth and depth of research presented this year further demonstrate its expanding role in both clinical care and clinical trials—signaling that Xenon MRI is not just innovative, but a lasting part of the respiratory care presentations listed below will highlight Xenon MRI's versatility across a wide spectrum of respiratory conditions, including asthma, bronchopulmonary dysplasia, COPD, COVID-19, cystic fibrosis, pulmonary arterial hypertension, radiation-induced lung injury, and post-transplant lung monitoring. Polarean representatives will be on-site throughout RIS and the ATS International Conference to connect with clinicians, researchers, industry partners, and patient advocates. As excitement continues to build around functional lung imaging, Polarean remains at the forefront — visualizing hidden disease, personalizing treatment, and accelerating the future of respiratory medicine. Christopher von Jako, PhD, CEO of Polarean, said: 'We are honored to return as a featured company at the Respiratory Innovation Summit. RIS and the ATS International Conference provide vital opportunities to engage with thought leaders, strengthen partnerships, and highlight the growing body of clinical evidence supporting Xenon MRI. With over 30 presentations this year, it's clear that Xenon MRI is not only gaining traction—it's shaping the future of functional lung imaging and respiratory care.' See the listing below for details on the presentation title, abstract number, session time, and location. ATS Abstract Title Presentation Time Format Session Location Clinical Focus Area Distinguishing Dose-dependent Radiation Lung Injury Using Hyperpolarized 129Xe Magnetic Resonance Spectroscopy May 18, 202511:30 AM – 1:15 PM Poster Board # P893 Area G, Hall F (North Building, Exhibition Level), Moscone Center Radiation Induced Lung Injury (RILI) 129Xe Gas Exchange MRI in Obesity-associated Asthma: Clinical Correlates and Regional Patterns May 18, 202511:30 AM – 1:15 PM Poster Board # P873 Area G, Hall F (North Building, Exhibition Level), Moscone Center Asthma Same-session Repeatability of 129Xe MRI/MRS Measures of Gas Exchange in Idiopathic Pulmonary Fibrosis May 18, 202511:30 AM – 1:15 PM Poster Board # P885 Area G, Hall F (North Building, Exhibition Level), Moscone Center Idiopathic Pulmonary Fibrosis (IPF) Assessment of Regional Ventilation by Hyperpolarized 129Xe MRI in Patients With Idiopathic Pulmonary Fibrosis and Asthma May 18, 202511:30 AM – 1:15 PM Poster Board # P894 Area G, Hall F (North Building, Exhibition Level), Moscone Center Asthma, Idiopathic Pulmonary Fibrosis (IPF) Regional Patterns of Obstruction and Air-trapping Before and After Exacerbation in Severe Asthma May 18, 20252:15 PM – 4:15 PM Poster Board # 503 Room 3010/3012 (West Building, Level 3), Moscone Center Asthma Utilizing Hyperpolarized 129Xe MRI as a Biomarker for Asthmatics on Biologic Treatments May 18, 20252:15 PM – 4:15 PM Poster Board # 506 Room 3010/3012 (West Building, Level 3), Moscone Center Asthma Investigating the Effects of Vaping on Lung Structure-Function With 129Xe MRI and CT May 19, 20259:15 AM – 11:15 AM Poster Board # 924 Room 3009/3011 (West Building, Level 3), Moscone Center Vaping Data-Efficient Lung Segmentation Using Foundational Models: Improving Clinical Workflow With Segment Anything Model (SAM) for Hyperpolarized Gas MRI May 19, 20259:15 AM – 11:15 AM Poster Board # 909 Room 3009/3011 (West Building, Level 3), Moscone Center Clinical Workflow Mapping the Chemical Shift of 129Xe in Red Blood Cells as a Biomarker for Pulmonary Hypertension May 19, 20259:15 AM – 11:15 AM Poster Board # 407 Room 301-302 (South Building, Level 3), Moscone Center Pulmonary Hypertension (PH) Hyperpolarized 129Xe MRI Captures Elevated Regional Ventilation Heterogeneity in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-cell Transplantation in Children May 19, 20259:15 AM – 4:15 PM Poster Board# P341 Area C, Hall F (North Building, Exhibition Level), Moscone Center Hematopoietic Stem Cell Transplantation (HSCT), Bronchiolitis Obliterans Syndrome (BOS) Xenon Gas Magnetic Resonance Imaging to Characterize Viable Regions of Ventilation and Perfusion Prior to Removal of Endobronchial Valves May 19, 20259:15 AM – 4:15 PM Poster Board # P141 Area B, Hall F (North Building, Exhibition Level), Moscone Center Endobronchial Valves (EBV) Xe MRI Imaging Findings in the TRANSPIRE Cohort May 19, 202512:48 PM – 1:00 PM Mid-day Symposium Room 3000/3002/3004 (West Building, Level 3), Moscone Center Hematopoietic Stem Cell Transplantation (HSCT) Exploring the Impact of Inflammation on Gas Exchange Efficiency in Cannabis-smoking Individuals Using 129XeMRI May 19, 2025 4:03 PM – 4:15 PM Mini Symposium Room 2005/2007 (West Building, Level 2), Moscone Center Cannabis Smoking Characterization of Pulmonary Dysfunction in Children With Systemic Juvenile Idiopathic Arthritis Using Xe MRI May 20, 2025 9:15 AM – 11:15 AM Poster Board # 901 Room 3009/3011 (West Building, Level 3), Moscone Center Systemic Juvenile Idiopathic Arthritis (sJIA) Single-breath Fractional Ventilation Derived From 129Xe MRI: Repeatability in Idiopathic Pulmonary Fibrosis May 20, 2025 9:15 AM – 11:15 AM Poster Board # 920 Room 3009/3011 (West Building, Level 3), Moscone Center Idiopathic Pulmonary Fibrosis (IPF) Hyperpolarized129Xe MRI Membrane Uptake Associates With 12-month Changes in Lung Function in Patients With Idiopathic Pulmonary Fibrosis Initiating Therapy May 20, 2025 9:15 AM – 11:15 AM Poster Board # 616 Room 2002/2004 (West Building, Level 2), Moscone Center Idiopathic Pulmonary Fibrosis (IPF) Lung Volume Correction Increases Repeatability of 129Xe Gas Exchange MRI in IPF May 20, 2025 9:15 AM – 11:15 AM Poster Board # 919 Room 3009/3011 (West Building, Level 3), Moscone Center Idiopathic Pulmonary Fibrosis (IPF) Dynamic Imaging of Physiological Dead Space and Effective Alveolar Ventilation in Patients Undergoing Endobronchial Valve Therapy Using Hyperpolarized Xenon May 20, 2025 11:30 AM – 1:15 PM Poster Board # P357 Area C, Hall F (North Building, Exhibition Level), Moscone Center Endobronchial Valves (EBV) Image-guided Bronchoscopy in Severe Asthma Reveals Inflammatory and Epithelial Remodeling in Post-exacerbation Ventilation Defects May 20, 2025 2:15 PM – 4:15 PM Poster Board # 301 Room 213-214 (South Building, Level 2), Moscone Center Asthma Pulmonary 129Xe Ventilation MRI Predicts Severe Exacerbations in People With CF May 20, 20252:39 PM – 2:51 PM Mini Symposium Room 211-212 (South Building, Level 2), Moscone Center Cystic Fibrosis (CF) MRI-based Ventilation-perfusion (V/Q) Matching Using Hyperpolarized Xenon and Dynamic Contrast-enhanced MRI in Long COVID Patients May 21, 20258:15 AM – 10:15 AM Poster Board # 609 Room 2002/2004 (West Building, Level 2), Moscone Center Long-COVID Analyzing the Impact of Fitted Transit Time on Simulated Alveolar Septal Wall Thickness Measurements With Hyperpolarized Xenon-129 MRI May 21, 20258:15 AM – 10:15 AM Poster Board# 621 Room 2002/2004 (West Building, Level 2), Moscone Center Cellular Mechanisms Assessment of Dyspnea of Unknown Origin With Hyperpolarized Xenon-129 Gas MRI: A Case Series May 21, 20258:15 AM – 10:15 AM Poster Board # 202 Room 207-208 (South Building, Level 2), Moscone Center Unexplained Dyspnea Pulmonary Regional Differences Highlight Profibrotic Airway Epithelial Cell Signaling in Obese Asthma May 21, 2025 9:15 AM – 9:27 AM Mini Symposium Room 3014/3016/3018 (West Building, Level 3), Moscone Center Asthma Continued Lung Ventilation Improvement in People With Cystic Fibrosis Receiving Highly Effective Modulator Therapy May 21, 2025 9:39 AM – 9:51 AM Mini Symposium Room 3006/3008 (West Building, Level 3), Moscone Center Cystic Fibrosis (CF) Precision Imaging Meets Lung Transplantation: Hyperpolarized Gas Magnetic Resonance Imaging and Transcriptomic Signatures Transform Rejection Detection May 21, 202511:00 AM – 1:00 PM Poster Board # 1018 Room 3022/3024 (West Building, Level 3), Moscone Center Lung Transplantation Assessing Post-Transplant Lung Function Alterations Using Free-Breathing Hyperpolarized Xenon MRI May 21, 202511:00 AM – 1:00 PM Poster Board # 401 Room 301-302 (South Building, Level 3), Moscone Center Lung Transplantation Comparison of Healthy Reference Models for 129Xe Pulmonary Gas Exchange May 21, 202511:00 AM – 1:00 PM Poster Board # 403 Room 301-302 (South Building, Level 3), Moscone Center Healthy Lung XeLHC: Initial Impressions From Hyperpolarized 129Xe MRI Measurements of Regional Lung Health in Participants From the Lung Health Cohort May 21, 202511:00 AM – 1:00 PM Poster Board # 408 Room 301-302 (South Building, Level 3), Moscone Center Healthy Lung Multi-site Analysis of Functional Gas Exchange Measures on 129Xe MRI Among Healthy Volunteers May 21, 202511:00 AM – 1:00 PM Poster Board # 411 Room 301-302 (South Building, Level 3), Moscone Center Healthy Lung The Age-dependent Upper Limit of Normal for Hyperpolarized 129Xe MRI Ventilation Defect Percent in Healthy Individuals Using a Multi-center Database May 21, 202511:00 AM – 1:00 PM Poster Board # 421 Room 301-302 (South Building, Level 3), Moscone Center Healthy Lung Multifunctional Xe MRI to Assess Alveolar Microstructure and Gas-exchange in Women With Lymphangioleiomyomatosis May 21, 2025 11:48 AM – 12:00 PM Mini Symposium Room 3006/3008 (West Building, Level 3), Moscone Center Lymphangioleio-myomatosis (LAM)About Polarean Polarean is a revenue-generating medical imaging technology company revolutionizing pulmonary medicine through direct visualization of lung function by introducing the power and safety of MRI to the respiratory healthcare community. This community is in desperate need of modern solutions to accurately assess lung function. The Company strives to optimize lung health and prevent avoidable loss by illuminating hidden disease, addressing the global unmet medical needs of more than 500 million patients worldwide suffering from chronic respiratory disease. Polarean is a leader in the field of hyperpolarization science and has successfully developed the first and only hyperpolarized Xenon MRI inhaled contrast agent, XENOVIEW™, which is now FDA-approved in the United States. Polarean is dedicated to researching, developing, and commercializing innovative imaging solutions with its non-invasive and radiation-free pulmonary functional MRI platform. This comprehensive drug-device platform encompasses the proprietary Xenon gas blend, gas hyperpolarization system, as well as software and accessories, facilitating fully integrated modern respiratory imaging operations. Founded in 2012, with offices in Durham, NC, and London, United Kingdom, Polarean is committed to increasing global awareness of and broad access to its XENOVIEW MRI technology platform. For the latest news and information about Polarean, please visit XENOVIEW IMPORTANT SAFETY INFORMATION IndicationXENOVIEW®, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. Limitations of UseXENOVIEW has not been evaluated for use with lung perfusion imaging. CONTRAINDICATIONSNone. Warnings and PrecautionsRisk of Decreased Image Quality from Supplemental Oxygen: Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold. Risk of Transient Hypoxia: Inhalation of an anoxic gas such as XENOVIEW may cause transient hypoxemia in susceptible patients. Monitor all patients for oxygen desaturation and symptoms of hypoxemia and treat as clinically indicated. Please see full prescribing information at Contact Information:Polarean: Chuck Osborne Chief Financial Officer +1 (919) 206-7900, ext. 117 cosborne@ Polarean Investors: Anna Dunphy / Phillip Marriage +44 (0)20 7933 8780 polarean@ Media Contact: Alexis Opp +1 (919) 206-7900, ext. 145 aopp@ General inquiries: info@ Follow Polarean on LinkedIn here CONTACT: Polarean: Chuck Osborne Chief Financial Officer +1 (919) 206-7900, ext. 117 cosborne@ Polarean Investors: Anna Dunphy / Phillip Marriage +44 (0)20 7933 8780 polarean@ Polarean Media Contact: Alexis Opp +1 (919) 206-7900, ext. 145 aopp@ General inquiries: info@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Gossamer Bio to Present Preclinical Data at the American Thoracic Society (ATS) 2025 International Conference
Gossamer Bio to Present Preclinical Data at the American Thoracic Society (ATS) 2025 International Conference

Business Wire

time07-05-2025

  • Business
  • Business Wire

Gossamer Bio to Present Preclinical Data at the American Thoracic Society (ATS) 2025 International Conference

SAN DIEGO--(BUSINESS WIRE)-- Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), today announced that the Company will present a poster at the American Thoracic Society (ATS) 2025 International Conference, taking place from May 16 th through 21 st, in San Francisco, California. Poster Presentation Title: Seralutinib in Pulmonary Arterial Hypertension: Exploring Mechanisms of Reverse Remodeling Versus Vasodilation Poster Number: P920 Session: A76 Finger on the Pulse: Cardiopulmonary Dysfunction in Lung Disease Date: Sunday, May 18 th Time: 11:30am – 1:15pm PDT Location: Area G, Hall F (North Building, Exhibition Level), Moscone Center Following its presentation at the ATS 2025 International Conference, the poster will also be made available on the 'Posters & Publications' section of the Gossamer Bio website at Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement. About Gossamer Bio Gossamer Bio is a late-stage, clinical biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension.

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