REG - Polarean Imaging PLC - New Xenon MRI System order received

Polarean ImagingAnnouncement

10/05/2024 07:00

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RNS Number : 8883N  Polarean Imaging PLC  10 May 2024

Polarean Imaging plc

("Polarean" or the "Company")

 

New Xenon MRI System order received

Top-tier academic hospital becomes the first de novo site in the southeast U.S

 

Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in
advanced Magnetic Resonance Imaging ("MRI") of lung function, announces that
it has received its second de novo order for a new Xenon MRI System from the
University of Alabama at Birmingham ("UAB") Hospital, a top-tier academic
hospital in the south-eastern region of the U.S. The 'de novo' designation
indicates that UAB Hospital is acquiring this innovative imaging technology
for the first time, without a prior research programme utilising the Polarean
Xenon MRI System. This milestone underscores the increasing adoption and
impact of Polarean's cutting-edge MRI solutions.

 

The Company expects to install the new system later this year and will
collaborate closely with the hospital team, as it does with its existing
clinical sites, to develop a strong Xenon MRI programme. This programme will
support clinical imaging, NIH-funded research, and pharmaceutical-sponsored
trials, aligning with Polarean's commitment to advancing medical research and
patient care.

 

Christopher R. von Jako, Ph.D., CEO of Polarean, said: "Expanding our user
base is one of the five key growth pillars we identified last year, and so I
am delighted to have received our second de novo system order from UAB
Hospital, a prestigious top-tier U.S. academic facility. Hospital acquisition
of new capital equipment can be a lengthy process, and so momentum continues
to build for our sales success. Contingent on the installation of this
polariser system, and the two additional previously announced system orders,
during 2024, the Company has completed sales and firm orders as of today that
would result in 2024 revenue of approximately $2.5M. We expect additional
orders to come in this year that will result in additional 2024 revenue. We
are very excited to see that our commercial growth strategy is yielding
tangible results."

 

Alex Dusek, Chief Commercial Officer of Polarean, said: "Feedback on the
Polarean technology from physicians continues to be overwhelmingly positive,
and we look forward to working closely with clinicians and scientists at UAB
hospital to help establish the approved use of XENOVIEW™ for the
visualisation of ventilation patients aged 12 and older. We are continuing to
have productive meetings with our other high-priority centres, as they work
through the necessary steps of the value assessment and procurement process.
These centres are becoming increasingly aware of our technology's clinical,
scientific, and economic value in lung ventilation, as well as research into
gas exchange and cardiopulmonary for future applications, where we recently
strengthened our patent portfolio."

 

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 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
                     (mailto: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
revolutionizing 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
(http://www.XENOVIEW.net)

PLC-RNS-2333

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