REG - Polarean Imaging PLC - Collaboration with Philips at ISMRM 2023

Polarean ImagingAnnouncement

02/06/2023 15:00

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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™, 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 (https://xenoview.net/)
(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 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™
(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)

 

PLC-RNS-2310

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