POLX Polarean Imaging Plc

31 July 2024                                                                                                                                                       

Polarean Imaging plc

("Polarean" or the "Company")

New Xenon MRI System trade-in agreement entered with the University of Kansas Medical Center

Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in advanced Magnetic Resonance Imaging ("MRI") of lung function, announces it has entered into a trade-in agreement to exchange the University of Kansas Medical Center's ("KUMC") existing research hyperpolariser for a new clinical-grade Xenon MRI hyperpolariser system to be provided by Polarean.

KUMC is a top-tier academic centre that has pioneered Xenon MRI research across multiple therapeutic areas. The new hyperpolariser will advance the already strong programme that includes clinical research in asthma, cystic fibrosis, long COVID, pulmonary hypertension, interstitial lung disease, and scleroderma. KUMC researcher Dr. Peter Niedbalski recently received a grant to lead a multi-centre study initiative to use Xenon MRI to identify structural determinants of low lung function and respiratory symptoms in young adults.

The new equipment is being purchased as part of a device trade-in in which KUMC will trade in an earlier research hyperpolariser for the latest FDA-approved system, suitable for clinical scans. Polarean expects to install the new system later this year and will work closely with KUMC to advance clinical imaging, NIH-funded research, and pharmaceutical-sponsored trials.

World-renowned pulmonologist Mario Castro, M.D., MPH, at KUMC, said: "My team and I have been using Xenon MRI for research purposes for nearly eight years now. We believe that it offers unique insights into disease characterization and monitoring response to treatment. I look forward to receiving the upgraded Polarean hyperpolariser, continuing our research, and planning clinical scans in the future."

Christopher von Jako, Ph.D, CEO of Polarean, said: "The team at KUMC has been a valued champion of our pulmonary functional Xenon MRI platform technology for a number of years, pioneering its use across multiple disease areas with their research-grade hyperpolariser. We are delighted to see KUMC upgrading its hyperpolariser as part of its broader expansion of pulmonary imaging capabilities. This underscores the growing importance that top-tier institutions are placing on Xenon MRI technology."

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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