REG - Polarean Imaging PLC - Company Update

Polarean ImagingAnnouncement

07/12/2023 07:00

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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™ 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
(https://www.muhealth.org/our-stories/completing-puzzle-mu-researchers-pioneer-new-diagnostic-tool-respiratory-diseases)
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 (http://www.polarean-ir.com)
 Christopher von Jako, Ph.D, 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.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™) 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 (http://www.polarean.com) .

 

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-2325

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