polarean Regulatory News (POLX)

Polarean Imaging Plc

("Polarean" or the "Company")

First Polarean Xenon Hyperpolariser to be installed in Asia

Collaboration with Philips and Sumtage to bring Xenon MRI technology to Taiwan

Polarean Imaging plc (AIM: POLX), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ("MRI") of the lungs, announces that the National Taiwan University Hospital ("NTUH") has entered into an agreement for a Xenon MRI research system in Taiwan through Polarean's strategic partner, Philips (Philips Medical Systems Nederland B.V.).

NTUH is widely recognised as Taiwan's leading academic medical centre, with a strong track record in clinical research and advanced patient care. The order will be supported by Polarean's newly appointed Taiwanese distributor, Sumtage Enterprise Company Limited ("Sumtage"), who will assist in the installation and training at NTUH, and work collaboratively with Polarean on the steps required to secure regulatory approval and reimbursement in Taiwan.

This milestone represents Polarean's first entry into Asia and an important step in building the foundations for future adoption of Xenon MRI in the region.

Christopher von Jako, Ph.D., CEO of Polarean, said: "This first Xenon MRI system in Taiwan, supported by Philips and Sumtage, marks an important milestone in our international strategy. The National Taiwan University Hospital is the country's premier academic medical centre, and this order highlights the recognition of Xenon MRI's potential in lung health. Together with Sumtage, we will focus on ensuring successful installation and training at NTUH while also advancing the regulatory and reimbursement pathways needed for broader adoption in Taiwan."

Hui-Lin Su, General Manager of Sumtage, said: "We are excited to partner with Polarean to bring this groundbreaking Xenon MRI technology to Taiwan. Our goal is to support hospitals like NTUH with not only the technology itself, but also the training and long-term support required for success. We look forward to working with Polarean to secure regulatory approval and reimbursement so that physicians and patients across Taiwan can benefit from this innovation."

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.

For more information, visit www.xenoview.net.

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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.

Please see full prescribing information at www.XENOVIEW.net