REG - Polarean Imaging PLC - Reimbursement code price range for XENOVIEW

Polarean ImagingAnnouncement

05/09/2023 12:00

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RNS Number : 4488L  Polarean Imaging PLC  05 September 2023

Polarean Imaging Plc

("Polarean" or the "Company")

 

Reimbursement code price range for the Polarean XENOVIEW™ MRI Technology

Payment range between $1,201 to $1,300, in-line with expectations

 

Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in
advanced magnetic resonance imaging ("MRI") of the lungs, announces that
following the RNS on 29 August 2023, the reimbursement code for the Polarean
XENOVIEW™ (xenon Xe 129, hyperpolarised) technology has been assigned to a
new technology Ambulatory Payment Classification code (APC 1551) which
corresponds to a payment range of between $1,201 to $1,300 as part of the
2023 Medicare Hospital Outpatient Prospective Payment System final rule.

 

The codes enables healthcare providers a path to bill for "magnetic resonance
imaging with inhaled hyperpolarised xenon-129 contrast agent, chest, including
preparation and administration of agent".

 

For further information on the details of the reimbursement code established
by the US Centers for Medicare & Medicaid Services ("CMS"), please see the
link to the latest RNS here
(https://www.polarean-ir.com/content/news/archive/2023/290823) .

 

Christopher von Jako, Ph.D., Chief Executive Officer of Polarean said: "We've
been working hard with CMS and welcome this news today from which aligns with
our original expectation on pricing reimbursement, and whilst the new code
does not guarantee coverage or payment, its effectiveness marks a key
commercialisation milestone for the Company."

 

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 (http://www.polarean-ir.com)
 Christopher von Jako, Ph.D, Chief Executive Officer         Via Walbrook PR
 Charles Osborne, Chief Financial Officer

 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.

 

XENOVIEW IMPORTANT SAFETY INFORMATION

 

Indication

XENOVIEW™, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized
contrast agent indicated for use with magnetic resonance imaging (MRI) for
evaluation of lung ventilation in adults and pediatric patients aged 12 years
and older.

 

Limitations of Use

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

 

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 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-2320

 

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