Korean distributor agreement with DK Healthcare

Polarean Imaging plc

("Polarean" or the "Company")

Korean distributor agreement with DK Healthcare in South Korea

Expanding commercial reach and advancing lung imaging innovation in Asia-Pacific

Polarean Imaging plc (AIM: POLX), a commercial-stage medical imaging technology leader in advanced Magnetic Resonance Imaging ("MRI") of lung function, announces it has signed an exclusive distribution agreement with DK Healthcare Co., Ltd. ("DK Healthcare") for the distribution of Polarean's Xenon MRI platform in South Korea.

This agreement represents Polarean's second international distribution partnership, strengthening the Company's commercial presence across the Asia-Pacific region. Through this partnership, Polarean is strategically positioning its innovative Xenon MRI platform for entry into one of the world's most advanced medical imaging markets. The Company will collaborate with DK Healthcare to obtain the necessary regulatory clearances ahead of commercial launch in South Korea.

DK was founded in 1986 and is headquartered in Seoul. They are a leading provider of diagnostic radiology systems and imaging technologies in Korea, and DK Healthcare is one of the affiliates of DK. Through long-standing partnerships with global medical device manufacturers, DK Healthcare has built a reputation for delivering cutting-edge imaging solutions, along with comprehensive technical, clinical, and maintenance support.

Christopher von Jako, Ph.D., CEO of Polarean, said: "We are delighted to partner with DK Healthcare, one of South Korea's most respected medical imaging distributors, to expand access to our Xenon MRI platform. South Korea's strong emphasis on early detection and precision medicine makes it an ideal growth market, and this agreement accelerates our dual-track strategy to grow internationally through high-quality regional partners while our U.S. team continues to drive adoption domestically."

Joonhyuk Lee, CEO of DK Healthcare, said: "We are excited to introduce Polarean's Xenon MRI technology to Korea's leading hospitals and imaging centers. This platform offers clinicians a new dimension in lung function assessment by enabling visualisation of ventilation and gas-exchange that was previously impossible with conventional imaging. We believe Xenon MRI will play a vital role in transforming respiratory care in South Korea through enhancing early detection and outcomes for patients with lung cancer, COPD and beyond."

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.