REG - Polarean Imaging PLC - FDA expands XENOVIEW indication

Polarean ImagingAnnouncement

02/06/2025 07:00

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RNS Number : 8945K  Polarean Imaging PLC  02 June 2025

Polarean Imaging Plc

("Polarean" or the "Company")

 

FDA expands XENOVIEW® indication to include children from six years of age

Increases number of eligible patients by approximately one million

Polarean Imaging plc (AIM: POLX), a commercial-stage medical imaging
technology leader in functional Magnetic Resonance Imaging ("MRI") of the
lungs, announces that the US Food and Drug Administration ("FDA") has approved
the Company's Supplemental New Drug Application ("NDA") to expand the
indication of XENOVIEW®. This approval immediately lowers the minimum patient
age from 12 to six years old, significantly broadening access to this
technology and expanding Polarean's total addressable market.

 

The approval means that XENOVIEW can now be used with MRI for evaluation of
lung ventilation in adults and paediatric patients aged six years and older,
representing an increase in the number of eligible patients by approximately
one million. The FDA supplement approval also includes the introduction of new
XENOVIEW Dose Delivery Bag sizes tailored for smaller lungs of younger
patients and corresponding updates to the HPX Polarisation Measurement Station
to measure various bag sizes. This approval reinforces Polarean's dedication
to advancing functional lung imaging and increasing access to its technology,
enabling enhanced care for a broader patient population.

 

Christopher von Jako, Ph.D., Chief Executive Officer of Polarean, said: "We
are delighted that the FDA has approved our Supplemental NDA, allowing
XENOVIEW to be used in younger paediatric patients, increasing the number of
patients eligible to use our technology by approximately one million. This
expanded indication further enhances our technology's clinical utility,
offering clinicians an advanced tool to assess the lungs in children with
chronic respiratory conditions, and strengthens its return on investment for
hospitals. We look forward to launching a controlled US market release of the
paediatric Dose Delivery Bags later this year, starting with Cincinnati
Children's."

 

Eric Hysinger, MD, Paediatric Pulmonologist from Cincinnati Children's, said:
"This approval is an exciting step for children with chronic lung diseases,
such as cystic fibrosis, asthma, bronchopulmonary dysplasia, and inflammation
following bone-marrow transplant. For years, I've studied Xenon MRI in
children ages 6 to 12, and expanding access to younger patients offers
clinicians a powerful tool to characterise disease progression, monitor
response to therapy, and guide interventions like airway dilation or tissue
removal. This imaging platform enhances our ability to deliver more
personalised, precise care for children with complex respiratory conditions."

 

For more information, visit www.xenoview.net (http://www.xenoview.net) .

 

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 / Nick Harland / 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 (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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