polarean Regulatory News (POLX)

Polarean Imaging Plc

("Polarean" or the "Company")

Ascend Imaging agreement expansion

Extended 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 expanded its Representative Agreement with Ascend Imaging LLC ("Ascend Imaging") which will enable extending coverage into additional US states.

Under the expanded agreement, Ascend Imaging will continue to act as a non-exclusive, independent manufacturer's representative, supporting the promotion and sale of the Company's Xenon MRI platform. The expansion will increase the footprint to 19 US states, up from four states in the original agreement. Ascend Imaging will continue to 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.

Christopher von Jako, Ph.D., Chief Executive Officer for Polarean, said: "Our collaboration with Ascend Imaging has already proven highly productive, and we see clear value in their ability to connect us with the right decision-makers at leading institutions. By expanding this partnership into additional states, we can further strengthen our commercial reach and accelerate adoption of Xenon MRI, advancing our mission to transform pulmonary medicine and ultimately improving outcomes for patients across the country."

Wesley Adams, President of Ascend Imaging, said: "Xenon MRI is gaining momentum as institutions recognise the value of regional functional lung imaging. With hospitals increasingly seeking innovative solutions that are supported by reimbursement, we are excited to expand our partnership with Polarean and help bring this important technology to more patients and providers."

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.