TIDMPOLX
RNS Number : 9405V
Polarean Imaging PLC
07 December 2023
Polarean Imaging Plc
("Polarean" or the "Company")
Company Update
Polarean Imaging plc (AIM: POLX), a commercial-stage medical
device leader in advanced magnetic resonance imaging ("MRI") of the
lungs, announces that it has received its first de novo order for a
new XENOVIEW(TM) polariser, and provides a comprehensive update
against the five growth initiatives set out at its interim
results.
First de novo order and system sales to high priority
institutions
The Company has received its first de novo polariser order from
a top-tier U.S. academic medical centre located in the northeast.
Polarean continues to have positive meetings and is in active
negotiations with additional top-tier academic medical centres.
Though there is never certainty as to the timing or outcome from
such negotiations, nor as to the speed of utilisation, management
is optimistic that these negotiations will lead to the XENOVIEW MRI
technology being more widely available in medical centres
throughout the United States.
Driving utilisation at newly established clinical sites
Both the University of Cincinnati Children's Hospital Medical
Center and the University of Missouri Health Care ("MU Health
Care") continue their efforts to increase clinical utilisation of
their polariser systems in patients with chronic lung disease. Both
centres have undertaken multiple clinical scans and Polarean
continues to work closely with these sites to ensure increased and
consistent utilisation. As with any new technology introduction,
radiology departments move carefully through the initial clinical
scans to ensure that the entire process comprising ordering,
scheduling, acquisition, image processing/reporting and billing
runs efficiently and integrates smoothly into their clinical
pathways, before promoting systemwide availability.
MU Health Care recently published an article and video detailing
its first clinical scan, to increase awareness of the XENOVIEW MRI
technology for its patient population.
In addition, Polarean is working closely with several medical
centres and their clinicians who are anticipated to be coming
online in 2024 to ensure a smooth integration of XENOVIEW MRI into
their infrastructure including their clinical and reimbursement
operations as they embark on establishing a successful novel
advanced imaging programme.
Establishing reimbursement coverage and payment
The new reimbursement APC-code (C9791) issued by the US Centers
for Medicare & Medicaid Services ("CMS") in August 2023 for the
XENOVIEW MRI technology corresponds to a payment range of between
US$1,201 to US$1,300.
The new code, along with additional existing codes for the
XENOVIEW MRI process, enables the hospitals to request a total
reimbursement of approximately $2,500, representing a significantly
improved economic incentive for the hospital. All seven United
States Medicare Administrative Contractors (MACs), who are
responsible for processing Medicare claims, are covering the code
as of 1 October 2023 based on medical necessity.
Building on the new code from CMS, work is beginning at
Polarean's clinical sites to further expand the reimbursement for
private U.S. health insurers to enable further utilisation of
XENOVIEW.
Developing key industry partnerships
The Company's collaboration with Philips continues to progress.
Polarean held a training session on the Company's technology in
October 2023 for the Philips US MRI sales force. Philips continues
to work with Polarean to introduce XENOVIEW MRI to its customer
base.
Polarean has signed contracts to sponsor a new clinical trial in
patients with COPD (chronic obstructive pulmonary disease) in
collaboration with a leading nebuliser device manufacturer. The
pilot study will explore the use of XENOVIEW MRI as the primary
outcome measure in the evaluation of different aerosol drug
delivery technologies of albuterol, a bronchodilator. Investigators
at the University of Virginia Health will be assessing differences
in lung ventilation, including quantification of hyperpolarised
xenon distribution pre- and post-bronchodilation, utilising the
proprietary Polarean XENOVIEW VDP software. The pilot study will
initially comprise of six patients; if this generates the expected
results, it could lead to a larger trial that would be similarly
cost-shared between Polarean and the industry partner. Patient
enrolment is expected to begin in early 2024.
The Company recently attended the Radiological Society of North
America ("RSNA") Annual Meeting in Chicago, IL, from 26-30
November, where management held several key meetings with both
existing and potential customers, suppliers, and strategic
partners. Several presentations were made at the RSNA Annual
Meeting on the use of Xenon MRI. Dr Cody Thornburg from MU Health
Care presented their early experience in using the XENOVIEW MRI
technology; the presentation included the discussion of their first
clinical case where a patient was admitted into the hospital with
exacerbation due to cystic fibrosis. XENOVIEW MRI uncovered
surprising ventilation defects that were not detected in the
patient's chest radiographs, which prompted a specific change in
management for the patient.
Expansion of current FDA labelling
The Company continues to make excellent progress on its
post-marketing requirement plan to seek US FDA approval to expand
the minimum current age of XENOVIEW MRI in children from twelve
down to six years old.
The Company had a productive discussion with the FDA in its
formal Type B meeting held in October, which provided additional
guidance on the path to expand the XENOVIEW indication to include
regional visualisation and quantitative assessment of gas exchange
and microvascular haemodynamics for both pulmonary and
cardio-pulmonary diseases. Management plans for the clinical trial
to begin in late-2024, with approval possible by the beginning of
2027.
Financing
The Company's current cash runway is expected to last into
Q3-2024. Management is continuing to evaluate all options for
further financing and will update the market further when
appropriate to do so.
Christopher von Jako, Ph.D., CEO of Polarean, said: "We are
delighted to have received our first de novo polariser order from a
top-tier academic medical centre, and we look forward to working
closely with them to establish the use of XENOVIEW for their
patients living with lung disease. As previously stated,
establishing orders for new imaging technologies often takes time,
even when clinicians are highly motivated to adopt the technology.
We continue to have positive meetings with other high priority
centres as they work through their budget cycle and value analysis
processes, as well our already converted centres and those we
expect to convert in 2024, to encourage increased utilisation of
the technology in clinic.
"We have made strong progress in all other areas of the growth
initiatives established at the interim results, and I believe that
we are setting the correct foundations to enable the XENOVIEW
technology to be a commercial success. While we are assessing
various financing options, I am confident that we will be able to
finance the Company for the medium term, and would like to extend
my thanks to our strategic investors for their continued strong
support."
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 U.S. subsidiary, Polarean, Inc.
are revenue-generating, medical imaging technology companies. The
Company aspires to revolutionise pulmonary medicine by bringing the
power and safety of MRI to the respiratory healthcare community
which is desperately in need of new modern solutions to evaluate
lung function. Polarean is dedicated to researching, developing,
and commercialising these novel imaging solutions with their
non-invasive and radiation-free functional MRI platform. The
Company strives to address the global unmet medical needs of more
than 500 million patients worldwide suffering from chronic
respiratory disease. Polarean is a leader in the field of
hyperpolarisation science and has successfully developed the first
and only hyperpolarised Xenon MRI contrast agent (XENOVIEW(TM)) to
be FDA-approved in the United States. The Company also
commercialises the systems, software, and accessories to support
fully integrated modern respiratory imaging operations. Founded in
2012, with offices in Durham, NC, and London, United Kingdom,
Polarean is committed to increasing global awareness of and broad
access to its XENOVIEW MRI technology platform. For the latest news
and information about Polarean, please visit www.polarean.com .
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-2325
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(END) Dow Jones Newswires
December 07, 2023 02:00 ET (07:00 GMT)
Polarean Imaging (LSE:POLX)
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Polarean Imaging (LSE:POLX)
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