REG - Polarean Imaging PLC - First clinical scan using XENOVIEW in Cincinnati

Polarean ImagingAnnouncement

11/05/2023 14:45

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RNS Number : 1498Z  Polarean Imaging PLC  11 May 2023

Polarean Imaging Plc

("Polarean" or the "Company")

 

First clinical scan using XENOVIEW(TM) conducted at Cincinnati Children's
Hospital Medical Center

Scan marks a key milestone for imaging of lung ventilation

 

Polarean Imaging plc (AIM:POLX), the medical imaging company, announces that
the first clinical scan utilising its XENOVIEW (xenon Xe 129 hyperpolarized)
technology in the United States has taken place at 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 pediatric patients aged 12 years
and older.

 

The first patient to receive a clinical scan using XENOVIEW is a 19-year-old
male with cystic fibrosis. Cincinnati Children's has several other patients it
believes are medically indicated for the lung imaging XENOVIEW provides and
anticipates performing scans to monitor patients on a more regular basis.

 

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 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: "The first clinical scan in the
United States is a significant milestone for Polarean and the XENOVIEW
technology. This scan ushers in a new era of lung imaging, opening the door to
the greater potential of MRI technology in pulmonary medicine.  We are in
discussions with numerous other medical centers about the adoption of this
novel technology and expect this ability to view lung ventilation more fully
will be available at additional hospitals in the coming months."

 

Dr. Jason Woods, Director of Research in Pulmonary Medicine at Cincinnati
Children's, added: "I am thrilled to be extending XENOVIEW from research to
the clinical setting so that we can serve more patients in need at our
hospital. Being able to use this technology for the evaluation of ventilation
in the clinic, including on patients as young as 12 years old, increases the
population of people that could benefit from this revolutionary imaging
technology."

Inquiries:

 

 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 (mailto:mrash@rlfcommunications.com)
 Michelle Rash                               001 336-823-5501

 

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)

 

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