POLX Polarean Imaging Plc

Polarean Imaging plc

("Polarean" or the "Company")

Taiwanese distributor agreement with Sumtage

First distribution agreement, expanding Polarean's international reach

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 a distribution agreement with Sumtage Enterprise Company Limited ("Sumtage") for the distribution of Polarean's Xenon MRI platform in Taiwan.

This agreement represents the Company's first distribution deal, expanding Polarean's international reach and paving the way for Polarean's innovative Xenon MRI platform to be sold and used in Taiwan. Polarean will work collaboratively with Sumtage to achieve the necessary regulatory clearances necessary for commercial launch in Taiwan.

Sumtage is a medical distributor with 30 years of experience in introducing the latest and most advanced medical equipment from overseas into the Taiwanese market, and offers customers additional maintenance and clinical support service post-sale. Sumtage has a comprehensive portfolio of medical imaging and diagnostic technologies, catering to the diverse needs of healthcare professionals.

Christopher von Jako, Ph.D., CEO of Polarean, said: "Sumtage are highly experienced in selling cutting-edge medical technology in Taiwan, making them the ideal partner to help us expand access to our innovative Xenon MRI platform into this market. While our own sales team remains focused on expanding the number of user sites within the United States, I am pleased to see our first commercial entry into the Asia-Pacific region via a high-quality distributor, where we believe our platform can provide great benefit to pulmonary patients and their physicians. We will work with Sumtage to achieve regulatory approval for our platform in Taiwan ahead of commercial launch, and look forward to further updating the market in due course."

Hui-Lin Su, General Manager of Sumtage, said: 'We are excited to work with Polarean to bring this groundbreaking Xenon MRI technology to Taiwan to help address lung diseases such as lung cancer, COPD, and asthma. The Polarean Xenon MRI platform enables advanced lung function assessments, allowing physicians to identify affected regions at earlier stages and facilitate timely treatment. We have already seen strong interest from leading academic medical centers, highlighting the significant potential of this technology to improve lung health in Taiwan."

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 hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 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