Corporate News

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 received an order for a new Xenon MRI System from the National Institutes of Health (“NIH”) Clinical Center in Bethesda, Maryland, USA. This is the world’s largest hospital dedicated exclusively to clinical research, and this is the first system to be purchased directly from Polarean by the NIH.

Since opening in 1953, the NIH Clinical Center has been recognised for serving as a model research hospital, providing innovative therapy and high-quality patient care, treating rare and severe diseases, and producing outstanding clinician-scientists whose collective work has set a standard of excellence in biomedical research.

Christopher von Jako, Ph.D, CEO of Polarean, said: “The NIH Clinical Center is the nation’s largest hospital devoted entirely to clinical research. It is a key resource for trials on rare diseases, experimental therapies, and cutting-edge medical research. The advantages of owning a clinical Xenon MRI system will allow for high performance polarization of Xenon for studies of innovative MRI techniques to better characterise lung disease.

“We are delighted to be working alongside Dr. Campbell-Washburn, a true pioneer in the lung imaging field, and her team, to conduct in-depth research on the most serious of respiratory conditions and find new ways to improve the lives of patients everywhere.”

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.

Enquiries:

  Mob: +44 (0)7876741001 / +44 (0) 7980541893 / +44 (0)7867984 082

Polarean Imaging plc			www.polarean.com / www.polarean-ir.com
Christopher von Jako, Ph.D., Chief Executive Officer    Charles Osborne, Chief Financial Officer				Via Walbrook PR
Stifel (NOMAD and Sole Corporate Broker)					+44 (0)20 7710 7600
Nicholas Moore / Fred Walsh / Brough Ransom / Ben Good
Walbrook PR	Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com
Anna Dunphy / Paul McManus / Marcus Ulker

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.

 

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