TIDMPOLX
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 Via Walbrook PR
Officer
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
PLC-RNS-2315
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