polarean Regulatory News (POLX)

31 July 2023

Polarean Imaging Plc

("Polarean" or the "Company") 

University of Missouri Health Care to begin clinical imaging with XENOVIEWTM

Conversion is a key milestone in execution of commercial plan

Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in advanced MRI scanning of the lungs, announces it has upgraded the University of Missouri Health Care ("MU Health Care") Department of Radiology's polariser system to a clinical configuration, and has delivered a gas blend cylinder for the production of XENOVIEW (xenon Xe 129 hyperpolarised).

XENOVIEW is the first and only inhaled contrast agent approved by the U.S. Food and Drug Administration for use with magnetic resonance imaging (MRI) for the evaluation of lung ventilation in adults and paediatric patients aged 12 years and older. XENOVIEW has not been evaluated for use with lung perfusion imaging.

MU Health Care's Department of Radiology, which launched a research programme in pulmonary imaging in 2018 and has used Polarean's hyperpolarised xenon technology since, expects to begin scanning of hospital clinic patients imminently.

XENOVIEW expands the opportunity to visualise lung ventilation without exposing patients to ionising radiation and its associated risks. The dose of XENOVIEW, created through the Polarean HPX hyperpolarisation system, is administered in a single 10 to 15 second breath-hold MRI procedure. More than 37 million Americans suffer from a chronic lung disease and there is a significant unmet need for non-invasive diagnostic technology. XENOVIEW can provide pulmonologists, surgeons, and other respiratory specialists with regional maps of ventilation in their patients' lungs to assist them in managing their disease.

Dr. Richard J. Barohn, Executive Vice Chancellor for Health Affairs and the Hugh E. and Sarah D. Stephenson Dean of the University of Missouri School of Medicine, said: "Xenon MRI is a unique technology that has the potential to aid in early diagnosis of a variety of challenging lung diseases, leading to earlier treatment in patients with asthma, cystic fibrosis, COPD and bronchopulmonary dysplasia." 

Talissa Altes, MD, professor and chair of radiology at MU Health Care said: "Xenon MRI has been a passion of mine for over 15 years. I am extremely pleased to see this unique technology move from research into clinical use for a wide variety of patients. In addition to improving diagnoses and clinical management of lung diseases, we look forward to contributing to future advancements through our ongoing research using the XENOVIEW technology."

Christopher von Jako, CEO of Polarean, said: "I am delighted that MU Health Care has upgraded its polariser system for clinical use, and will imminently begin clinical scanning for pulmonary patients. This represents further execution of our strategic plan to convert existing XENOVIEW research sites, whilst in parallel looking to secure new installations."

Enquiries: 

About Polarean (www.polarean.com)

The Company and its wholly owned subsidiary, Polarean, Inc. (together the "Group") are revenue-generating, medical imaging technology companies operating in the high-resolution medical imaging space. Polarean aspires to revolutionise pulmonary medicine by bringing the power and safety of MRI to the respiratory healthcare community in need of new solutions to evaluate lung ventilation, diagnose disease, characterise disease progression, and monitor response to treatment. By researching, developing, and commercialising novel imaging solutions with a non-invasive and radiation-free functional imaging platform. Polarean's vision is to help address the global unmet medical needs of more than 500 million patients worldwide suffering with chronic respiratory disease. Polarean is a leader in the field of hyperpolarisation science and has successfully developed the first and only hyperpolarised MRI contrast agent to be approved in the United States. On Dec. 23, 2022, the FDA granted approval for Polarean's first drug device combination product, XENOVIEWTM (Xenon Xe129 hyperpolarised). Xe129 MRI is also currently being studied in the US, Canada, and Europe for visualisation and quantification of gas exchange regionally in the smallest airways of the lungs, across the alveolar tissue membrane, and into the pulmonary bloodstream for future clinical indications. It has not yet been submitted to the Medicines and Healthcare products Regulatory Agency in the UK for use outside of the research setting.

XENOVIEW IMPORTANT SAFETY INFORMATION

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

PLC-RNS-2315