Polarean Imaging plc
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XENOVIEW® 3T coil passes Philips compatibility testing
Globenewswire· 2025-12-01 14:04
Core Insights - Polarean Imaging plc has achieved a significant milestone with its FDA-cleared XENOVIEW® 3T Chest Coil, confirming compatibility with Philips' latest 3T MRI platforms, which is expected to enhance clinical reach and adoption of advanced pulmonary imaging [1][2][3] Group 1: Product Development and Integration - The XENOVIEW® 3T Chest Coil has successfully completed compatibility testing with Philips MRI systems, allowing integration starting in early 2026 [2][3] - This development follows the introduction of Xenon MRI compatibility by Philips in 2022, expanding access to advanced pulmonary imaging and supporting functional lung assessment [2][3] - The coil's integration with Philips systems is anticipated to simplify workflow for clinicians, thereby accelerating market penetration and growth opportunities for Polarean [4] Group 2: Market Position and Strategic Goals - The compatibility of the XENOVIEW® 3T Chest Coil with major Philips MRI systems positions Polarean to enhance its market penetration and commercial value globally [3][4] - Polarean aims to optimize lung health and address the unmet medical needs of over 500 million patients suffering from chronic respiratory diseases through innovative imaging solutions [5] - The company is committed to increasing global awareness and access to its XENOVIEW MRI technology platform, which includes a proprietary gas blend and hyperpolarization system [5]
Korean distributor agreement with DK Healthcare in South Korea
Globenewswire· 2025-11-24 14:15
Core Insights - Polarean Imaging has signed an exclusive distribution agreement with DK Healthcare for its Xenon MRI platform in South Korea, marking its second international distribution partnership and enhancing its commercial presence in the Asia-Pacific region [1][2]. Company Overview - Polarean Imaging is a leader in functional MRI technology for lung imaging, focusing on the direct visualization of lung function and addressing the unmet medical needs of over 500 million patients with chronic respiratory diseases globally [5]. - The company has developed the first and only hyperpolarized Xenon MRI inhaled contrast agent, XENOVIEW™, which is FDA-approved in the United States [5]. Partnership Details - The partnership with DK Healthcare aims to facilitate the regulatory clearances necessary for the commercial launch of the Xenon MRI platform in South Korea, a market known for its advanced medical imaging capabilities [2][4]. - DK Healthcare, a prominent provider of diagnostic radiology systems in Korea, has a strong reputation for delivering innovative imaging solutions and support [3][6]. Market Potential - South Korea's focus on early detection and precision medicine positions it as an ideal growth market for Polarean's technology, which enhances lung function assessment and aims to improve outcomes for patients with conditions such as lung cancer and COPD [4].
FDA expands XENOVIEW® indication to include children from six years of age
Globenewswire· 2025-06-02 12:31
Core Insights - The FDA has approved Polarean Imaging's Supplemental New Drug Application to expand the indication of XENOVIEW, lowering the minimum patient age from 12 to 6 years, thus increasing the number of eligible patients by approximately one million [1][2][3] Company Overview - Polarean Imaging is a commercial-stage medical imaging technology company focused on functional MRI of the lungs, aiming to improve pulmonary medicine through advanced imaging solutions [4] - The company has developed the first and only hyperpolarized Xenon MRI inhaled contrast agent, XENOVIEW, which is now FDA-approved for use in the United States [4] - Polarean's technology addresses the unmet medical needs of over 500 million patients worldwide suffering from chronic respiratory diseases [4] Product Details - XENOVIEW is indicated for use with MRI to evaluate lung ventilation in adults and pediatric patients aged 6 years and older [6] - The FDA approval includes new XENOVIEW Dose Delivery Bag sizes tailored for younger patients, enhancing the technology's clinical utility [2][3] Clinical Impact - The expanded indication allows clinicians to better assess lung conditions in children with chronic respiratory issues, such as cystic fibrosis and asthma, thereby improving personalized care [3][2] - The company plans to launch a controlled market release of the pediatric Dose Delivery Bags later in the year, starting with Cincinnati Children's Hospital [3]
Xenon MRI Featured Prominently at ATS 2025 Across Broad Clinical Spectrum
Globenewswire· 2025-05-15 12:49
Core Insights - Polarean Imaging plc is gaining recognition for its innovative Xenon MRI platform, which is being highlighted at major respiratory medicine conferences, indicating its growing importance in clinical imaging and drug development [2][3][5] Group 1: Company Overview - Polarean Imaging is a commercial-stage medical imaging technology company focused on functional MRI of the lungs, aiming to improve lung health and address unmet medical needs for over 500 million patients with chronic respiratory diseases [10] - The company has developed the first and only hyperpolarized Xenon MRI inhaled contrast agent, XENOVIEW™, which is FDA-approved for evaluating lung ventilation in adults and pediatric patients aged 12 years and older [11][10] Group 2: Conference Participation - Polarean will be featured at the American Thoracic Society's 2025 Respiratory Innovation Summit and the ATS 2025 International Conference, showcasing its commitment to engaging with leaders in pulmonary medicine [1][5] - At the ATS 2025 International Conference, Xenon MRI will be presented in over 30 posters and presentations from more than 10 leading clinical sites, demonstrating its sustained momentum and expanding role in clinical care and trials [3][6] Group 3: Research and Development - The presentations at the conferences will cover a wide range of respiratory conditions, including asthma, COPD, COVID-19, and pulmonary arterial hypertension, highlighting the versatility of Xenon MRI [4][6] - The company emphasizes the importance of building partnerships and strengthening collaborations with clinicians, researchers, and patient advocates to advance the field of functional lung imaging [5][6]