REG - Polarean Imaging PLC - Xenon MRI System trade-in agreement

Polarean ImagingAnnouncement

19/07/2024 10:45

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RNS Number : 0197X  Polarean Imaging PLC  19 July 2024

19 July
2024

 

Polarean Imaging plc

("Polarean" or the "Company")

 

Xenon MRI System trade-in agreement entered with the University of Virginia
Health Hospital

 

Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in
advanced Magnetic Resonance Imaging ("MRI") of lung function, announces that
it has entered into a trade-in agreement to exchange the University of
Virginia Health System's ("UVA Health") existing two research hyperpolarisers
for two new clinical-grade hyperpolariser systems to be provided by Polarean.

 

UVA Health is an integrated health system with a world-class academic medical
center that includes a Level 1 Trauma Centre, an NCI-designated Comprehensive
Cancer Center, and UVA Health Children's, the number one pediatric hospital in
Virginia. UVA Health's Hyperpolarized Gas MR Imaging Center faculty pioneered
the application of Xenon MRI for a variety of lung diseases, including asthma,
cystic fibrosis, and bronchopulmonary dysplasia.

 

Replacing these research hyperpolarisers is the first step to UVA Health
advancing its leadership position in the Mid-Atlantic as a centre of
excellence for NIH grants, industry-sponsored trials, and clinical patient
referrals for this novel imaging modality. Polarean expects to install the new
systems later this year and will collaborate closely with UVA Health to ensure
a successful implementation that enhances the Xenon MRI research program and
establishes the foundation for clinical Xenon MRI capabilities.

 

Christopher von Jako, Ph.D, CEO of Polarean, said: "We are delighted to see
UVA Health upgrade both of their hyperpolariser systems to clinical grade.
This milestone underscores the increasing adoption of Polarean's technology
and the continued progress in our strategy to convert previously research-only
centres to clinical-grade, in addition to establishing de novo sites. We look
forward to working with the team at UVA Health to ensure that their
implementation of our Xenon MRI technology is successful as it continues to
advance research and move into clinical use."

 

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
 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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