Polarean Imaging PLC Reimbursement code price range for XENOVIEW (4488L)
September 05 2023 - 6:51AM
UK Regulatory
TIDMPOLX
RNS Number : 4488L
Polarean Imaging PLC
05 September 2023
Polarean Imaging Plc
("Polarean" or the "Company")
Reimbursement code price range for the Polarean XENOVIEW(TM) 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(TM) (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 .
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
Christopher von Jako, Ph.D, 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 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(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-2320
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCSSUFSIEDSELU
(END) Dow Jones Newswires
September 05, 2023 06:51 ET (10:51 GMT)
Polarean Imaging (LSE:POLX)
Historical Stock Chart
From Apr 2024 to May 2024
Polarean Imaging (LSE:POLX)
Historical Stock Chart
From May 2023 to May 2024