First clinical scan using XENOVIEW conducted at Cincinnati Children’s Hospital Medical Center
May 11 2023 - 10:05AM
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 |
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,
XENOVIEWTM (Xenon Xe129 hyperpolarised). Xe129 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
Michelle Rash
Vice President
RLF Communications
336-823-5501
mrash@rlfcommunications.com
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