Polarean Imaging PLC First clinical scan using XENOVIEW in Cincinnati (1498Z)
11 May 2023 - 11:42PM
UK Regulatory
TIDMPOLX
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 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
RLF Communications (US media mrash@rlfcommunications.com
enquiries)
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
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