REG - Polarean Imaging PLC - Clearance received for new MRI chest coil

Polarean ImagingAnnouncement

03/08/2023 07:00

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RNS Number : 1084I  Polarean Imaging PLC  03 August 2023

3 August 2023

Polarean Imaging Plc

("Polarean" or the "Company")

 

Polarean Receives Clearance for New MRI Chest Coil

Additional clearance for new MRI chest coil further supports the recently
announced collaboration with

Philips

 

Polarean Imaging Plc (AIM: POLX), a commercial-stage medical device leader in
advanced MRI scanning of the lungs, announces it has received 510(k) clearance
from the U.S. Food and Drug Administration (FDA) for the Company's specialised
MRI chest coil to now include Philips 3.0T MRI scanners for the visualisation
of the Xenon-129 (129Xe) nuclei.

 

The Polarean XENOVIEW™ 3.0T Chest Coil is a flexible, single channel,
transmit-receive RF coil tuned to image 129Xe nuclei while a patient is
positioned inside a multinuclei-capable MRI scanner. The XENOVIEW Chest Coil
is indicated to be used in conjunction with compatible 3.0T MRI scanners and
approved hyperpolarised 129Xe for oral inhalation for the evaluation of lung
ventilation in adults and paediatric patients, aged 12 years and older. The
addition of the new Philips configuration does not affect the intended use of
the device; the safety and effectiveness has been confirmed with testing.

 

Christopher von Jako, CEO of Polarean, said: "Polarean continues to develop
and launch new devices and accessories that empower sites to perform modern
respiratory imaging, enabling as many clinicians as possible to use our
technology for their patients. This FDA clearance also further supports our
recently announced collaboration with Philips, by expanding our product line
to be compatible with their advanced MRI systems."

Enquiries:

 

  Polarean Imaging plc                                         www.polarean.com / www.polarean-ir.com
  Christopher von Jako, 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

 

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.   The company also commercialises
systems (such as the HPX hyperpolarisation system), accessories (such as
Xe-specific chest coils and phantoms) and FDA-cleared post-processing software
(to support ventilation defect analysis), to support fully integrated modern
respiratory imaging operations.

 

 

PLC-RNS-2316

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