Polarean Imaging PLC CMS grants reimbursement code for XENOVIEW (5425K)
29 August 2023 - 8:00AM
UK Regulatory
TIDMPOLX
RNS Number : 5425K
Polarean Imaging PLC
29 August 2023
Polarean Imaging Plc
("Polarean" or the "Company")
CMS grants reimbursement code for the Polarean XENOVIEW (TM) 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(TM)
(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(TM) 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 (TM) 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 Via Walbrook PR
Executive Officer
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 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(TM) (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(TM), 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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