REG - Polarean Imaging PLC - Expansion of Xenon MRI imaging platform

Polarean ImagingAnnouncement

10/03/2025 07:00

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RNS Number : 9086Z  Polarean Imaging PLC  10 March 2025

 

Polarean Imaging plc

("Polarean" or the "Company")

 

Expansion of Xenon MRI imaging platform for pharma-sponsored research

A leading global pharmaceutical collaborator has selected Polarean's Xenon MRI
clinical trial support services for a multicenter study

 

Polarean Imaging plc (AIM: POLX), a commercial-stage medical imaging
technology leader in advanced Magnetic Resonance Imaging ("MRI") of lung
function, announces the successful expansion of a new imaging service model to
enable the use of Xenon MRI in pharma-sponsored research, alongside its
partner VIDA Diagnostics ("VIDA"). This coincides with its selection by a
leading global pharmaceutical ("pharma") partner to utilise the new Xenon MRI
clinical trial support services platform as part of a sub-study within a
worldwide multicenter study trial testing an investigational lung therapy.

 

As the interest in using Xenon MRI as a sensitive marker of pulmonary
treatment effects has grown, there remains an unmet need for a Xenon MRI
imaging platform to streamline pulmonary drug development. This unmet need
includes harmonised image acquisition and processing and ensuring high-quality
image controls for pharma trials to run with potentially fewer patients and/or
at a faster pace to accelerate new drug time-to-market. Polarean's partnership
with VIDA
(https://www.londonstockexchange.com/news-article/POLX/partnership-with-vida/16115817)
, a leader in lung imaging intelligence, has enabled the establishment of an
imaging services platform and catalysed Polarean's capability to expand this
new business vertical, underlined by its selection in the multicenter clinical
trial.

 

The double-blind, randomised, placebo-controlled study is designed to evaluate
the safety, tolerability, pharmacokinetics, and efficacy of the
investigational therapy. The Xenon MRI sub-study will provide valuable
additional insights into ventilation, membrane conductance, and red blood cell
transfer in the lungs. The trial is expected to initiate in the fourth quarter
of 2025 at selected sites in the U.S. and Canada that have a Xenon MRI system.
Enrolled patients will undergo scans at baseline and at the study's conclusion
to evaluate drug-induced changes on various components of alveolar
gas-exchange. Together, Polarean and VIDA will provide site qualification and
training, image harmonisation, and Xenon MRI biomarker analysis for the
sub-study as part of this pharma partnership.

 

This new revenue-generating service model builds upon initial experience last
year with an industry partner who selected Xenon MRI ventilation defect
percentage (VDP) as the primary endpoint in testing different inhaled
drug-delivery devices at a single site. Xenon MRI offers a non-invasive,
radiation-free imaging approach that enables direct visualisation of lung
function through a single breath hold of the inhaled hyperpolarized gas.
Compared to traditional pulmonary function tests such as spirometry, Xenon MRI
provides a more sensitive and repeatable assessment of lung function, making
it an invaluable tool for reducing sample size and/or achieving greater power
to detect subtle treatment-induced changes in the evaluation of new
therapeutic interventions.

 

Christopher von Jako, Ph.D., CEO of Polarean, said: "We previously identified
pharma-sponsored trials as a new business vertical for us, and participation
in this multi-center clinical trial underscores the growing recognition of
Xenon MRI as a powerful tool in advancing the understanding and treatment of
lung diseases. Our ongoing collaboration with VIDA has enabled us to launch
our imaging services platform, enhancing the value proposition of Xenon MRI
for pharma partners and accelerating the expansion of this vertical. By
delivering precise and reproducible lung function measurements, our platform
can help drive innovation in respiratory medicine and support the development
of novel therapies that improve patient outcomes."

 

Alex Dusek, Chief Business Officer of Polarean, said: "Beyond sales of our
Xenon MRI system and proprietary gas blend, pharma-sponsored trials using our
unique imaging platform represent a key area of strategic growth for Polarean.
Being selected for these services by a renowned pharmaceutical company is a
key milestone for us. With VIDA as a partner, we have accelerated our ability
to establish Xenon MRI as an advanced imaging modality that provides
attractive biomarkers for pharmaceutical research. Providing a robust imaging
service platform for drug development trials also enhances the value
proposition for academic sites to build Xenon MRI programmes and be part of a
growing network of expert centres able to provide Xenon MRI and recruit
subjects for pulmonary drug trials."

 

As previously announced, the Company will hold a Virtual Investor Day on
Wednesday, 12 March 2025 at 2:00pm GMT. To register for the webinar, please
use this link: Zoom Webinar - Register
(https://us06web.zoom.us/webinar/register/WN_Gr8nQPj4TImTFoUzOvzEIw) .

 

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 / www.polarean-ir.com (http://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 / 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/) .

 

About VIDA

VIDA Diagnostics, Inc. (VIDA) is a clinical imaging intelligence company that
is accelerating the approval and adoption of life-saving therapies to patients
through an AI-powered digital biomarker solution. Learn more at
https://vidalung.ai (https://vidalung.ai) . Follow @vidalung on X and
LinkedIn.

 

 

 

 

 

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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