CMS grants reimbursement code for the Polarean XENOVIEW™ MRI Technology
29 August 2023 - 2:10PM
Polarean (AIM: POLX), a commercial-stage medical device leader
in advanced MRI scanning of the lungs, announces that the Centers
for Medicare & Medicaid Services (CMS) has established a new
reimbursement code for the Polarean XENOVIEW™ (xenon Xe 129,
hyperpolarized) technology, effective October 1, 2023.
The code (C9791) enables healthcare providers a path to bill for
“magnetic resonance imaging with inhaled hyperpolarized 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.
“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,” said Christopher von Jako, Ph.D.,
CEO of Polarean. “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.”
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 ventilation, 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 Dec. 23, 2022, the FDA granted
approval for Polarean’ s first drug device combination product,
XENOVIEW™ (Xenon Xe129 hyperpolarized). Xe129 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.
Contacts:
Polarean:Chuck OsborneChief Financial Officer+1
(919) 206-7900, ext. 117cosborne@polarean.com
Investors:Anna Dunphy / Phillip Marriage+44
(0)20 7933 8780polarean@wallbrookpr.com
Media Contact:Michelle Caissie+1 (919) 206-7900,
ext. 136mcaissie@polarean.com
XENOVIEW IMPORTANT SAFETY INFORMATION
IndicationXENOVIEW™, 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 UseXENOVIEW has
not been evaluated for use with lung perfusion imaging.
CONTRAINDICATIONSNone.
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
POL-PR-2310
Polarean:
Chuck Osborne
Chief Financial Officer
+1 (919) 206-7900, ext. 117
cosborne@polarean.com
Investors:
Anna Dunphy / Phillip Marriage
+44 (0)20 7933 8780
polarean@wallbrookpr.com
Media Contact:
Michelle Caissie
+1 (919) 206-7900, ext. 136
mcaissie@polarean.com
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