REG - Polarean Imaging PLC - First order for XENOVIEW gas blend received

Polarean ImagingAnnouncement

26/04/2023 07:00

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RNS Number : 4351X  Polarean Imaging PLC  26 April 2023

Polarean Imaging Plc

("Polarean" or the "Company")

 

First order for XENOVIEW(TM) gas blend received from Cincinnati Children's
Hospital Medical Center

Clinical cylinder sale marks key milestone and execution of commercial plan

 

Polarean Imaging plc (AIM: POLX), the medical imaging technology company,
announces that it has received its first order for a gas blend cylinder for
the production of XENOVIEW (xenon Xe 129 hyperpolarized) from Cincinnati
Children's Hospital Medical Center ("Cincinnati Children's"). XENOVIEW is the
only hyperpolarised 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.

 

The cylinder should provide adequate doses for over 100 patient scans.
Cincinnati Children's, which conducted much of the pioneering research in
adolescent children, expects to begin scanning of hospital clinic patients in
May.

 

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.

 

Richard Hullihen, CEO of Polarean, said: "Since receiving FDA approval at the
end of 2022, we have been working diligently to clear the path for commercial
distribution of our proprietary gas blend to sites that already have Xenon MRI
infrastructure. We are delighted to secure our first sale of a cylinder and
cartons of dose delivery bags for clinical use as we continue to execute our
commercial plan."

 

Enquiries:

 

 Polarean Imaging plc                                              www.polarean.com / www.polarean-ir.com
  Richard Hullihen, 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

 RLF Communications (US media enquiries)       mrash@rlfcommunications.com

 Michelle Rash                                 336-823-5501

 

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
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.

 

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)

POL-PR-2304

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