REG - Polarean Imaging PLC - CMS grants reimbursement code for XENOVIEW

Polarean ImagingAnnouncement

29/08/2023 07:00

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RNS Number : 5425K  Polarean Imaging PLC  29 August 2023

Polarean Imaging Plc

("Polarean" or the "Company")

 

CMS grants reimbursement code for the Polarean XENOVIEW™ MRI Technology

Code effective from 1 October 2023

 

Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in
advanced MRI scanning of the lungs, announces that the US Centers for Medicare
& Medicaid Services ("CMS") has established a new reimbursement code for
the Polarean XENOVIEW™ (xenon Xe 129, hyperpolarised) technology, effective
from 1 October 2023.

 

The code (C9791) 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". This was announced as part
of the release of the October 2023 Healthcare Common Procedure Coding System
(HCPCS) code set. The payment level associated with the XENOVIEW™ MRI code
is yet to be announced and is expected to be received in the coming weeks.

 

Christopher von Jako, Ph.D., Polarean's Chief Executive Officer said: "We have
been working diligently with CMS, our clinicians and hospital-based billing
stakeholders over the past several months and view this as an important step
towards enhancing accessibility to this innovative technology.  We look
forward to learning the payment details tied to the new code, in the coming
weeks, as we continue to increase access to XENOVIEW™ MRI for patients
suffering from ventilation-associated lung diseases."

 

Enquiries:

 

 Polarean Imaging Plc                                        www.polarean.com / www.polarean-ir.com
 Christopher von Jako, PhD, 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 (http://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
ventilation, diagnose disease, characterise 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 hyperpolarisation science and
has successfully developed the first and only hyperpolarized 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) hyperpolarized). Xe(129) 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.

 

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-2319

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