REG - Polarean Imaging PLC - National Institutes of Health system order

Polarean ImagingAnnouncement

25/09/2025 12:15

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RNS Number : 8562A  Polarean Imaging PLC  25 September 2025

25 September
2025

 

Polarean Imaging plc

("Polarean" or the "Company")

 

National Institutes of Health orders Polarean's HPX Hyperpolarisation system

 

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:

 

 Polarean Imaging plc                                                  www.polarean.com
                                                                       (https://walbrookpr.sharepoint.com/sites/Polarean-WalbrookPR/Shared%20Documents/RNS%20announcements/www.polarean.com)
                                                                       / www.polarean-ir.com
                                                                       (https://walbrookpr.sharepoint.com/sites/Polarean-WalbrookPR/Shared%20Documents/RNS%20announcements/www.polarean-ir.com)
                                                                         
 Christopher von Jako, Ph.D., Chief Executive Officer                                                   Via Walbrook PR  

 Charles Osborne, Chief Financial Officer                                                                 
                                                                                                                                          
 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             Mob: +44 (0)7876741001 / +44 (0) 7980541893 / +44 (0)7867984 082

 

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 (http://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
(http://www.xenoview.net) .

 

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