polarean Regulatory News (POLX)

Polarean Imaging Plc

("Polarean" or the "Company")

XENOVIEW® 3T coil passes Philips compatibility testing

Polarean's FDA cleared coil achieves important milestone, expanding clinical reach

Polarean Imaging plc (AIM: POLX), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ("MRI") of the lungs, announces that its FDA-cleared XENOVIEW® 3T Chest Coil has successfully completed compatibility testing conducted by Philips (Philips Medical Systems Nederland B.V.) and is now confirmed for use with Philips' latest 3T MRI platforms.

Following extensive validation by Philips, the XENOVIEW® 3T Chest Coil is now confirmed for integration with Philips MRI systems starting in early 2026, including 3.0T platforms such as the MR 7700 and Ingenia Elition X, along with their associated upgrade pathways. Building on Philips' introduction of Xenon MRI compatibility in 2022 with the MR 7700, the addition of the Polarean XENOVIEW 3T Chest Coil expands access to advanced pulmonary imaging and supports a new era of functional lung assessment. This confirmation, building on the coil's FDA clearance in 2024, positions the technology for rapid clinical adoption and revenue generation. The XENOVIEW 3T Chest Coil enables healthcare providers to seamlessly adopt advanced functional lung ventilation imaging, supporting broader clinical adoption and advancing the Company's commitment to innovation in pulmonary imaging.

This milestone marks a major advance in scaling Polarean's Xenon MRI technology across a major global installed base and enables clinical and research sites using Philips MRI systems to incorporate non-invasive, quantitative assessments of lung function as part of routine care and research. Following this, Polarean is well positioned to accelerate adoption, expand market penetration and enhance significant commercial and clinical value worldwide.

Christopher von Jako, Ph.D., Chief Executive Officer of Polarean commented: "This milestone marks another important advancement in our vision to optimise lung health and prevent avoidable loss by illuminating hidden disease. Compatibility with Philips' state-of-the-art MRI platforms greatly broadens the accessibility of Xenon MRI and will help more hospitals and imaging centres adopt this powerful technology. Equally significant, our FDA-cleared coil's seamless integration with Philips systems positions us to drive adoption by reducing workflow complexity for clinicians, accelerating market penetration and unlocking growth opportunities."

Gwenael Herigault, Global MR Clinical Leader at Philips commented: "The compatibility of Polarean's FDA-cleared XENOVIEW® 3T Chest Coil with Philips' 3T MRI systems reinforces our shared goal of expanding the capabilities of MRI to deliver deeper clinical insights. Together, we're enabling clinicians to access advanced lung imaging tools that help improve diagnostic confidence and patient care."

The compatibility statement confirms that the FDA-cleared XENOVIEW 3T Chest Coil can be used with Philips MR 7700, Ingenia Elition X, and compatible software upgrade configurations from 2026 onwards. This development significantly expands the potential reach of Polarean's technology and supports its goal of making functional lung MRI more widely available to clinicians and patients worldwide.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018.

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About Polarean

Polarean is a revenue-generating medical imaging technology company revolutionising pulmonary medicine through direct visualisation 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 optimise 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 hyperpolarisation science and has successfully developed the first and only hyperpolarised Xenon MRI inhaled contrast agent, XENOVIEW®, which is now FDA-approved in the United States. Polarean is dedicated to researching, developing, and commercialising 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 hyperpolarisation 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 www.polarean.com.

XENOVIEW® IMPORTANT SAFETY INFORMATION 

Indication

XENOVIEW, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarised contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 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.

Adverse Reactions

Adverse Reactions in Adult Patients: The adverse reactions (> one patient) in efficacy trials were oropharyngeal pain, headache, and dizziness. Adverse Reactions in Pediatric and Adolescent Patients: In published literature in pediatric patients aged 6 to 18, transient adverse reactions were reported: blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria. In at least one published study of pediatric patients aged 6 to 18 years, transient decrease in SpO2% and transient increase in heart rate was reported following hyperpolarized xenon Xe 129 administration. XENOVIEW is not approved for use in pediatric patients less than 12 years of age.

Please see full prescribing information at www.xenoview.net.