REG - Polarean Imaging PLC - Request for temporary suspension to be lifted

Polarean ImagingAnnouncement

14/03/2023 07:15

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RNS Number : 8778S  Polarean Imaging PLC  14 March 2023

14 March 2023

Polarean Imaging Plc

("Polarean" or the "Company")

 

Request for temporary suspension from trading on AIM to be lifted

 

Following a press release by the US Federal Reserve and the US Federal Deposit
Insurance Corporation ("FDIC") stating that the FDIC transferred all deposits
and substantially all assets of the former Silicon Valley Bank to a newly
created, full-service FDIC-operated 'bridge bank' in an action designed to
protect all depositors of Silicon Valley Bank, the Company has verified its
account balances and its ability to access its funds, and confirms it has full
access to its previously outlined resources. Operating activities of the
Company have proceeded unaffected throughout the course of this event.

As a result, the Company has requested that the temporary suspension of the
Company's ordinary shares on AIM is now lifted.

 

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the
European Union (Withdrawal) Act 2018.

 

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

 

 

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
revolutionize pulmonary medicine by bringing the power and safety of MRI to
the respiratory healthcare community in need of new solutions to evaluate lung
function, diagnose disease, characterize disease progression, and monitor
response to treatment. By researching, developing, and commercializing 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 hyperpolarization science and
has successfully developed the first and only hyperpolarized MRI contrast
agent to be approved in the United States. On December 23, 2022, the FDA
granted approval for Polarean's first drug device combination product,
XENOVIEW(TM) (xenon Xe 129 hyperpolarized). (129)Xe MRI is also currently
being studied for visualization 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.

 

 

About Xenoview

 

Indication

Xenoview, prepared from the xenon Xe 129 Gas Blend, is a hyperpolarised
contrast agent for use with magnetic imaging (MRI) for evaluation of lung
ventilation in adults and paediatric patients aged 12 years and older.

 

Limitations of Use

Xenoview has not been evaluated for use with lung perfusion imaging.

Important Safety Information

 

Contraindications

None.

 

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 saturation 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 Patients:  In published literature in
paediatric patients aged 6 to 18 years, the following transient adverse
reactions were reported:  blood oxygen desaturation, heart rate elevation,
numbness, tingling, dizziness, and euphoria.   In at least one published
study of paediatric patients aged 6 to 18 years, transient decrease in SpO2%
and transient increase in heart rate were reported following hyperpolarised
xenon Xe 129 administration.  XENOVIEW is not approved for use in paediatric
patients less than 12 years of age.

 

See full U.S. Prescribing Information at www.xenoview.net

 

XENOVIEW has received marketing approval in the United States and not in other
countries.

 

XENOVIEW(TM) is a trademark of Polarean, Inc.
 

 

 

 
PLC-RNS-2304

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