polarean Regulatory News (POLX)

Polarean Imaging Plc

("Polarean" or the "Company")

Promotion & Sales Representative Agreement

New commercial partnership to accelerate US market growth

Polarean Imaging plc (AIM: POLX), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ("MRI") of the lungs, announces that it has signed a Representative Agreement with Ascend Imaging LLC ("Ascend Imaging"), for the promotion and sale of Polarean products in specific US states.

Under the agreement, Ascend Imaging will act as a non-exclusive, independent manufacturer's representative in four US states, supporting the promotion and sale of the Company's Xenon MRI platform. Ascend will complement Polarean's existing commercial team by identifying new prospective customers, driving engagement, and supporting the negotiation and closure of sales opportunities.

Ascend Imaging specialises in radiology and radiation oncology solutions, including advanced imaging hardware and artificial intelligence (AI) technologies. Their team brings deep expertise and long-standing relationships with healthcare providers across their regions - making them a strong strategic fit for Polarean's targeted expansion in functional lung imaging.

Alan Huang, Ph.D., Vice President of Sales for Polarean, said: "We are pleased to welcome Ascend Imaging as a strategic sales partner. Their focus on radiology and radiation oncology, combined with a deep understanding of imaging workflows and strong customer relationships, aligns well with our commercial strategy. This partnership enhances our reach in key US regions while maintaining operational efficiency, and we expect it to support meaningful commercial momentum in the second half of 2025 and beyond."

Wesley Adams, President of Ascend Imaging, said: "We are excited to partner with Polarean to help bring their groundbreaking Xenon MRI technology to more healthcare providers. Our experience in radiology and AI solutions, combined with long-standing customer relationships, positions us well to support Polarean's mission of revolutionizing pulmonary medicine. We look forward to expanding access to this important imaging 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.

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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.