polarean Regulatory News (POLX)

Polarean Imaging Plc

("Polarean" or the "Company")

Order received for upgraded hyperpolariser

Cincinnati Children's Hospital Medical Center upgrades their existing research system to provide additional flexibility for research and clinical scanning

Polarean Imaging Plc (AIM: POLX), a commercial-stage medical device leader in advanced Magnetic Resonance Imaging ("MRI") of lung function, announces that it has received an order for a new polariser to replace the research polariser at Cincinnati Children's Hospital Medical Center ("Cincinnati Children's"). Cincinnati Children's is ranked as the number one children's hospital for 2023/2024 in the United States by U.S. News & World Report.

Cincinnati Children's previously purchased the first clinical polariser and continues to demonstrate a commitment to the future of Xenon MRI for challenging lung diseases. Cincinnati Children's performs hospital clinical imaging on both children and adults (from their neighbouring partner institution, UC Medical Centre). Led by Dr. Jason Woods, the hospital runs a robust research programme focused on the Xenon MRI platform technology. The new polariser will enable Cincinnati Children's to leverage the benefits of cutting-edge technology and providing flexibility to expand XENOVIEW™ capabilities for their research and clinical patients.

Christopher R. von Jako, Ph.D., CEO of Polarean, said: "I commend the ongoing work of the entire team at Cincinnati Children's, both in research and clinical care. They consistently recognise the benefits that pulmonary functional Xenon MRI technology offers to children with chronic lung disease and have extended access to this technology to the adjacent adult hospital. We look forward to working closely with their team to ensure a swift implementation of the new system."

Dr. Jason Woods, Director of Research in Pulmonary Medicine at Cincinnati Children's said: "We are excited to enhance our research capabilities with Polarean's latest technology. This upgrade will allow us to further explore the applications of Xenon MRI in paediatric pulmonary care and expand our current clinical offerings for the benefit of our patients."

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About Polarean

Polarean is a revenue-generating medical imaging technology company revolutionizing 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

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