REG - Polarean Imaging PLC - Clinical imaging with XENOVIEW in Missouri

Polarean ImagingAnnouncement

31/07/2023 07:00

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RNS Number : 6207H  Polarean Imaging PLC  31 July 2023

 

31 July 2023

Polarean Imaging Plc

("Polarean" or the "Company")

 

University of Missouri Health Care to begin clinical imaging with XENOVIEW(TM)

Conversion is a key milestone in execution of commercial plan

 

Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in
advanced MRI scanning of the lungs, announces it has upgraded the University
of Missouri Health Care ("MU Health Care") Department of Radiology's polariser
system to a clinical configuration, and has delivered a gas blend cylinder for
the production of XENOVIEW (xenon Xe 129 hyperpolarised).

 

XENOVIEW is the first and only inhaled contrast agent approved by the U.S.
Food and Drug Administration for use with magnetic resonance imaging (MRI) for
the evaluation of lung ventilation in adults and paediatric patients aged 12
years and older. XENOVIEW has not been evaluated for use with lung perfusion
imaging.

 

MU Health Care's Department of Radiology, which launched a research programme
in pulmonary imaging in 2018 and has used Polarean's hyperpolarised xenon
technology since, expects to begin scanning of hospital clinic patients
imminently.

 

XENOVIEW expands the opportunity to visualise lung ventilation without
exposing patients to ionising radiation and its associated risks. The dose of
XENOVIEW, created through the Polarean HPX hyperpolarisation system, is
administered in a single 10 to 15 second breath-hold MRI procedure.  More
than 37 million Americans suffer from a chronic lung disease and there is a
significant unmet need for non-invasive diagnostic technology. XENOVIEW can
provide pulmonologists, surgeons, and other respiratory specialists with
regional maps of ventilation in their patients' lungs to assist them in
managing their disease.

 

Dr. Richard J. Barohn, Executive Vice Chancellor for Health Affairs and the
Hugh E. and Sarah D. Stephenson Dean of the University of Missouri School of
Medicine, said: "Xenon MRI is a unique technology that has the potential to
aid in early diagnosis of a variety of challenging lung diseases, leading to
earlier treatment in patients with asthma, cystic fibrosis, COPD and
bronchopulmonary dysplasia."

 

Talissa Altes, MD, professor and chair of radiology at MU Health Care said:
"Xenon MRI has been a passion of mine for over 15 years. I am extremely
pleased to see this unique technology move from research into clinical use for
a wide variety of patients. In addition to improving diagnoses and clinical
management of lung diseases, we look forward to contributing to future
advancements through our ongoing research using the XENOVIEW technology."

 

Christopher von Jako, CEO of Polarean, said: "I am delighted that MU Health
Care has upgraded its polariser system for clinical use, and will imminently
begin clinical scanning for pulmonary patients. This represents further
execution of our strategic plan to convert existing XENOVIEW research sites,
whilst in parallel looking to secure new installations."

 

Enquiries:

  Polarean Imaging plc                                         www.polarean.com / www.polarean-ir.com
  Christopher von Jako, Chief Executive Officer                Via Walbrook PR
  Kenneth West, Chairman

  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 (www.polarean.com)

 

The Company and its wholly owned subsidiary, Polarean, Inc. (together the
"Group") are revenue-generating, medical imaging technology companies
operating in the high-resolution medical imaging space. Polarean aspires to
revolutionise pulmonary medicine by bringing the power and safety of MRI to
the respiratory healthcare community in need of new solutions to evaluate lung
ventilation, diagnose disease, characterise disease progression, and monitor
response to treatment. By researching, developing, and commercialising novel
imaging solutions with a non-invasive and radiation-free functional imaging
platform. Polarean's vision is to help address the global unmet medical needs
of more than 500 million patients worldwide suffering with chronic respiratory
disease. Polarean is a leader in the field of hyperpolarisation science and
has successfully developed the first and only hyperpolarised MRI contrast
agent to be approved in the United States. On Dec. 23, 2022, the FDA granted
approval for Polarean's first drug device combination product, XENOVIEW(TM)
(Xenon Xe(129) hyperpolarised). Xe(129) MRI is also currently being studied in
the US, Canada, and Europe for visualisation and quantification of gas
exchange regionally in the smallest airways of the lungs, across the alveolar
tissue membrane, and into the pulmonary bloodstream for future clinical
indications. It has not yet been submitted to the Medicines and Healthcare
products Regulatory Agency in the UK for use outside of the research setting.

 

XENOVIEW IMPORTANT SAFETY INFORMATION

 

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-2315

 

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