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

Polarean ImagingAnnouncement

31/07/2024 07:00

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RNS Number : 5460Y  Polarean Imaging PLC  31 July 2024

31 July
2024

 

Polarean Imaging plc

("Polarean" or the "Company")

 

New Xenon MRI System trade-in agreement entered with the University of Kansas
Medical Center

 

Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in
advanced Magnetic Resonance Imaging ("MRI") of lung function, announces it has
entered into a trade-in agreement to exchange the University of Kansas Medical
Center's ("KUMC") existing research hyperpolariser for a new clinical-grade
Xenon MRI hyperpolariser system to be provided by Polarean.

 

KUMC is a top-tier academic centre that has pioneered Xenon MRI research
across multiple therapeutic areas. The new hyperpolariser will advance the
already strong programme that includes clinical research in asthma, cystic
fibrosis, long COVID, pulmonary hypertension, interstitial lung disease, and
scleroderma. KUMC researcher Dr. Peter Niedbalski recently received a grant to
lead a multi-centre study initiative to use Xenon MRI to identify structural
determinants of low lung function and respiratory symptoms in young adults.

 

The new equipment is being purchased as part of a device trade-in in which
KUMC will trade in an earlier research hyperpolariser for the latest
FDA-approved system, suitable for clinical scans. Polarean expects to install
the new system later this year and will work closely with KUMC to advance
clinical imaging, NIH-funded research, and pharmaceutical-sponsored trials.

 

World-renowned pulmonologist Mario Castro, M.D., MPH, at KUMC, said: "My team
and I have been using Xenon MRI for research purposes for nearly eight years
now. We believe that it offers unique insights into disease characterization
and monitoring response to treatment. I look forward to receiving the upgraded
Polarean hyperpolariser, continuing our research, and planning clinical scans
in the future."

 

Christopher von Jako, Ph.D, CEO of Polarean, said: "The team at KUMC has been
a valued champion of our pulmonary functional Xenon MRI platform technology
for a number of years, pioneering its use across multiple disease areas with
their research-grade hyperpolariser. We are delighted to see KUMC upgrading
its hyperpolariser as part of its broader expansion of pulmonary imaging
capabilities. This underscores the growing importance that top-tier
institutions are placing on Xenon MRI technology."

 

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 Adams / 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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