REG - Polarean Imaging PLC - Submission of new Phase III study protocol to FDA

Polarean ImagingAnnouncement

Tue 07:00

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RNS Number : 8813U  Polarean Imaging PLC  12 August 2025

Polarean Imaging Plc

("Polarean" or the "Company")

 

Submission of new Phase III study protocol to FDA for expanded indication of
XENOVIEW

Gas exchange protocol submitted for final feedback is key to finalising the
plan for this trial

Polarean Imaging plc (AIM: POLX), a commercial-stage medical imaging
technology leader in functional Magnetic Resonance Imaging ("MRI") of the
lungs, announces the submission of a new Phase III clinical trial protocol to
the U.S. Food and Drug Administration (FDA) to support an expanded indication
for XENOVIEW® (xenon Xe 129 hyperpolarised).  XENOVIEW® is the Company's
FDA-approved contrast agent for MRI of the lungs. The proposed expansion would
include quantitative gas-exchange imaging in addition to the currently
approved ventilation imaging indication.

 

As part of the submission, Polarean has formally requested written feedback
from the FDA under a Type C meeting to guide development and alignment on the
Phase III study design. The FDA review of the proposed clinical trial should
be completed by Q4 2025.

 

The new protocol aims to evaluate the safety and diagnostic performance of
XENOVIEW in assessing how effectively the lungs can transfer gas from the air
into the bloodstream (pulmonary function), as compared to the standard of care
test which is currently used. There is a substantial need to quantify and
visualise gas-exchange abnormalities across a range of chronic obstructive,
interstitial and pulmonary-vascular diseases. If approved, the expanded
indication would significantly broaden the clinical utility of XENOVIEW by
enabling clinicians to obtain a more comprehensive picture of lung function
through non-invasive imaging.

 

Christopher von Jako, Ph.D., Chief Executive Officer of Polarean said:
"Submission of this new protocol and our Type C meeting request marks a
critical milestone in Polarean's clinical development programme and mission to
transform pulmonary imaging.

 

"Embarking on a multi-center trial to add gas-exchange to the existing
ventilation indication is key to our growth strategy. If successful, this
expanded utility of XENOVIEW will have the potential to provide a
comprehensive, multi-compartment assessment of deep lung function, information
that is not currently with conventional imaging or pulmonary function tests,
all in a single breath hold."

 

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.

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

 

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 / Ben Good

 Walbrook PR             Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com
 Anna Dunphy / Paul McManus / Marcus Ulker       Mob: +44 (0)7876 741 001

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.

 

Please see full prescribing information at www.XENOVIEW.net

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