REG - Polarean Imaging PLC - FDA submission to expand minimum age for XENOVIEW™

Polarean ImagingAnnouncement

01/08/2024 07:00

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RNS Number : 7522Y  Polarean Imaging PLC  01 August 2024

Polarean Imaging Plc

("Polarean" or the "Company")

 

FDA submission to expand minimum age for XENOVIEW™

 

Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in
advanced Magnetic Resonance Imaging ("MRI") of lung function, announces that
it has submitted a New Drug Application ("NDA") supplement to the US Food and
Drug Administration ("FDA"), to allow the administration of XENOVIEW™ to
paediatric patients aged six years and older. This supplement includes updates
to the HPX Polarisation Measurement Station and new XENOVIEW™ Dose Delivery
Bag sizes.

 

Currently 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 paediatric
patients aged 12 years and older.

 

Christopher von Jako, Ph.D, Chief Executive Officer of Polarean, said: "I am
pleased to have submitted our NDA supplement to the FDA to expand the minimum
age of XENOVIEW™ to paediatric patients six years and older. If granted,
this will allow our technology to help even more children with chronic lung
conditions and their clinicians, allowing for better management of their
disease. I look forward to further updating the market in due course."

 

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 Nicolaus Europe Limited (NOMAD and Sole Corporate Broker)                                                      +44 (0)20 7710 7600
 Nicholas Moore / Samira Essebiyea / Kate Hanshaw (Healthcare Investment
 Banking)
 Nick Harland (Corporate Broking)

 Walbrook PR       Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com
 Anna Dunphy / Phillip Marriage      Mob: +44 (0)7876 741 001 / +44 (0)7867 984 082

 

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 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

 

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