TIDMPOLX
RNS Number : 5415B
Polarean Imaging PLC
02 June 2023
Polarean Imaging Plc
("Polarean" or the "Company")
Collaboration with Philips to be featured at ISMRM 2023
Philips' MR 7700 MRI scanner to be combined with XENOVIEW (TM) ,
showcasing the capability to enhance pulmonary imaging by providing
regional maps of ventilation in patients' lungs
Polarean Imaging plc (AIM:POLX), the medical imaging company,
announces that it has entered into a collaboration with Philips, a
global leader in health technology, to advance the field of
hyperpolarised Xenon MRI. Philips will showcase its 3T MR 7700
system ("MR 7700"), featuring fully integrated multi-nuclei
imaging, including Polarean's XENOVIEW (xenon Xe 129
hyperpolarised) technology at the 2023 International Society for
Magnetic Resonance in Medicine Annual Meeting & Exhibition
("ISMRM"), held from 3-8 June, in Toronto, Canada.
This non-exclusive collaboration facilitates the sharing of
technical data and marketing materials to jointly advance the field
of Xenon MRI into the clinical realm. The collaboration delivers an
advanced solution for the evaluation of lung ventilation in
patients 12 years of age and older based on Xenon gas MR imaging,
providing clinicians with enhanced productivity and image quality
improvements. XENOVIEW has not been evaluated for use with lung
perfusion imaging.
Combining XENOVIEW with Philips MR 7700 multi-nuclei MRI scanner
may allow clinicians to view a patient's lungs in greater detail,
while also enabling them to accurately measure lung ventilation.
For patients with pulmonary disease, it has the potential to make
the difference between early diagnosis and intervention in serious
obstructive lung diseases. The first XENOVIEW clinical scan in
North America recently took place at Cincinnati Children's Hospital
Medical Center on a Philips MRI system using the 510(k) cleared
multi-nuclei imaging scanning module.
Polarean team members, including Richard Hullihen, CEO and Alex
Dusek, CCO will be onsite at ISMRM 2023 (booth #G23) to provide
information on the technology and also for networking.
Richard Hullihen, CEO of Polarean, said: " Having attained FDA
approval for the first and only hyperpolarized MR contrast agent
with the launch of XENOVIEW at the beginning of 2023, we are
excited to enter this agreement with Philips. Its strategic focus
on patient and workflow centric multi nuclei imaging in its 3T
system provides a uniquely capable platform for clinicians to
extend their assessment of lung ventilation. By deploying this
novel technology to visualize otherwise unobtainable clinical
information using MRI technology, MR imaging can now be expanded
into pulmonary medicine, providing a quantitative tool to help
clinicians and the patients they treat."
Ruud Zwerink, General Manager of Magnetic Resonance and Digital
X-Ray at Philips, said "With the MR 7700, we have seamlessly
integrated multi-nuclei MR imaging into everyday workflows, making
multi-nuclei studies of six different nuclei across all anatomies
as simple as dragging and dropping the selected protocol onto an
exam card. Our collaboration with Polarean to bring hyperpolarized
Xenon imaging into the equation is a major breakthrough in our
efforts to improve the diagnosis and management of respiratory
disease."
Enquiries:
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
PLC-RNS-2310
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END
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June 02, 2023 10:00 ET (14:00 GMT)
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