Polarean Imaging
Plc
("Polarean" or the "Company")
2024 Polarean Strategy
Update
Polarean Imaging plc (AIM: POLX),
a commercial-stage medical device leader in
advanced magnetic resonance imaging ("MRI") of the lungs, provides
an update on the Company's plans for 2024.
Company
Update
·
The Company continues to make substantial progress
toward the implementation of the five-pillar growth strategy
outlined in its half-year report.
o Drive
utilisation: When new medical
devices are introduced, hospital physicians need to be educated on
their benefits in order to drive utilisation. The Polarean
commercial team has been regularly visiting the Company's initial
two clinical sites, Cincinnati Children's Hospital Medical Center
and the University of Missouri Health Care, educating
pulmonologists and radiologists on the benefits of the XENOVIEW™
technology. The number of scans at these sites has been steadily
increasing.
o Grow user base:
Hospital acquisition of capital equipment is a
notoriously lengthy process, with an average time from introduction
to sales closing of between 18 to 24 months. The Company has been
actively navigating obstacles to transition multiple research sites
to clinical status, alongside engagement of new sites to introduce
the Polarean pulmonary functional MRI technology as a solution to
their unmet diagnostic needs. Both existing customers and potential
clients are becoming increasingly aware of the technology's value
in lung ventilation diagnostics as well as its significant future
growth opportunities in gas exchange and cardiopulmonary
applications.
o Broaden reimbursement
coverage: In adopting new diagnostic
technologies, US-based hospitals look carefully at the return on
investment, driven by the reimbursement rates of private and
government insurers. Following the Centers for Medicare &
Medicaid Services issuance of the reimbursement code for XENOVIEW
scans and the associated reimbursement rate of between $1,201 and
$1,300 in October 2023, hospitals are steadily recognising the
economic benefits of integrating the XENOVIEW technology into the
clinical care pathway for patients with lung disease. Medicare (the
U.S. government-funded health insurance for people aged 65 and
older) coverage is important in the elderly population suffering
from chronic lung diseases that XENOVIEW is tailored to address.
Polarean has further confirmed evidence that the initial clinical
sites have attained reimbursement by both private insurers and
Medicaid (the U.S. government-funded programme providing health
coverage to low-income individuals and families). The Company is
working to broaden reimbursement coverage with additional private
U.S. health insurers to strengthen the value proposition for the
adoption of XENOVIEW.
o Expand total addressable
market: In its initial regulatory
approval, the FDA outlined specific
requirements to expand the approved patient age range for XENOVIEW
from twelve to six years old, marking a significant milestone in
the product's accessibility to younger patients.
The Company has made notable progress in meeting
these FDA requirements. Additionally, the Company is incorporating
insights gathered from the October 2023 FDA meeting to support a
development plan for the approval of new indications to include gas
exchange and cardiopulmonary applications. With XENOVIEW's safety demonstrated in
the prior Phase 3 clinical trials combined with over a
decade of research and publications on gas exchange and
cardiopulmonary applications, the Company is confident that a
forthcoming clinical trial required to expand the indications for
XENOVIEW has been considerably de-risked.
o Further develop
partnerships: The Company's existing
strategic partners Philips (a leading MRI company), VIDA (a leading
clinical lung imaging intelligence company), and NUKEM Isotopes (a
leading medical stable isotope supplier), remain involved and
instrumental in helping advance the XENOVIEW technology.
Additionally, Polarean has been actively engaging multiple
pharmaceutical ("Pharma") and medical technology ("MedTech")
companies to increase awareness and adoption of the Polarean
technology. Currently, clinicaltrials.gov lists numerous clinical
trials underway that utilize Xenon MRI technology to evaluate the
effectiveness of existing and new pharmaceutical treatments.
In January 2024, the Company participated in the annual Xenon-129
MRI Clinical Trials Consortium Meeting. This meeting also
brought together other representatives from the Pharma and MedTech
sectors, like GE HealthCare, Genentech, Philips, and Siemens, to
share insights and advancements of Xenon MRI.
·
The Company remains committed to fortifying its
intellectual property portfolio to further consolidate its position
as a market leader. Alongside existing patents predating 2023, the
Company has recently secured two new patents, one in the US and the
other in Japan. This development ensures the extension of
Polarean's patent protection from 2032 and beyond, bolstering its
competitive advantage. Moreover, the Company currently has over 15+
patent applications pending, underlining its dedication to
innovation and future growth.
·
In August 2023, the Company implemented strict
cost control measures. These measures resulted in a cash balance of
$6.1m on 31 December 2023 (unaudited), extending the cash runway
into October 2024 (previously June 2024).
·
For the Company to continue to make commercial and
strategic progress, additional financing will be required as set
forth below.
Commercial and Strategy
Update
Financing
Plan
·
To achieve the commercial targets below, the
Company will need access to additional capital.
·
The Company is exploring the appropriate financing
options, with an anticipated launch in Q2-2024
o Assuming a minimum financing of $10m, NUKEM Isotopes intends
to commit $2.5m and Bracco intends to commit $2.0m to a prospective
fundraise in the future
o The
Company has obtained advanced assurance from His Majesty's Revenue
& Customs (HMRC) to confirm £2.5m ($3.1m) of Enterprise Investment
Scheme availability
·
A minimum of $10m in financing would allow the
Company to:
o Expand and develop the sales team to achieve meaningful
commercial traction
o Finalise the FDA plan for the anticipated gas exchange
trial
o Further develop strategic relationships
o Fund
the Company into Q1-2026
·
The Company is still in discussions with NUKEM
Isotopes and Bracco about the terms and conditions of this
potential financing opportunity. There can be no certainty that a
financing will take place this year nor as to the terms and
conditions of any such financing. A further announcement will be
made in due course.
·
Any financing agreement with NUKEM Isotopes would
constitute a related party transaction.
·
Future financing and/or strategic relationships
are needed to fund the future FDA clinical trial and grow the
Company to profitability
o Profitability projected for late 2027, post-gas exchange FDA
approval
o Total of $30m to $35m, inclusive of money raised in the
anticipated 2024 financing, from investment and strategic deals
needed to fund the Company to profitability, investment focused
on:
§ Resources
to enhance and accelerate commercialisation efforts
§ Product
development, including the FDA Phase III clinical trial to drive
the commercialisation of the gas exchange label expansion and
continuous improvement of the system
Commercial
Plan
·
Given the progress on the five-pillar growth
strategy outlined above, the Company is poised to achieve the
following commercial targets:
o End
of 2024
§ Total
installed clinical base of five to seven systems
§ Sites
performing three to four scans per week, which potentially enables
sites to earn a positive return on investment on the Polarean
technology
§ Revenue of
$2m to $3m, as compared to less than $1m (unaudited) in
2023
o End
of 2025
§ Total
installed clinical base of 12 to 14 systems
§ Sites
performing five to six scans per week
§ Revenue of
$5m to $6m
o 2026
through 2028
§ Profitable
at $25m to $30m revenue (post-gas exchange FDA approval)
§ 2028
projected revenue of $35m to $40m
§ Total
installed clinical base of 60 to 70 systems at end of
2028
§ Sites
performing over 10 scans per week in 2028
Christopher von Jako, Ph.D., CEO of Polarean,
said: "We have made important
headway in 2023, and we anticipate this positive momentum to
continue into 2024 and beyond. Clinicians and healthcare providers
in the U.S. are increasingly recognising the
potential of our
technology in aiding disease characterisation, providing visual and
quantitative assessments of response to therapy, and guiding
interventions for various challenging lung
diseases. We are confident in our
abilities to execute this plan, and additional financing
will enable us to meet our milestones
effectively.
"I extend my gratitude to our
strategic investors, loyal customers, and the outstanding Polarean
team for their unwavering support. Together, we look forward to a
positive 2024."
Daniel Plumpe, Managing Director of NUKEM
Isotopes,said: "We are very excited to see
such a positive update from Polarean. Our faith in the Polarean
team is evident as we recently increased our investment to over
10%, making us the largest shareholder in the Company. We have a
long-standing relationship with Polarean as a provider of their
xenon-129 gas, a critical component of the Company's pulmonary
functional MRI product, and we look forward to seeing continued
progress as they look to increase their number of
sites."
Fulvio Renoldi Bracco, Bracco Imaging CEO said:
"As a
significant shareholder in Polarean, it is encouraging to see the
work that has been done to date, and the focus the Company has had
and continues to have on delivering value. We remain a strong
supporter of the business and truly believe in the technology and
the value it brings to patients."
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
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
|
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About Polarean
Polarean is a revenue-generating
medical imaging technology company revolutionizing pulmonary
medicine through direct visualization of lung function by
introducing the power and safety of MRI to the respiratory
healthcare community. This community is in desperate need of modern
solutions to accurately assess lung function. The Company strives
to optimize lung health and prevent avoidable loss by illuminating
hidden disease, addressing 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
hyperpolarization science and has successfully developed the first
and only hyperpolarized Xenon MRI inhaled contrast agent,
XENOVIEW™, which is now FDA-approved in the United States. Polarean
is dedicated to researching, developing, and commercialising
innovative imaging solutions with its non-invasive and
radiation-free pulmonary functional MRI platform. This
comprehensive drug-device platform encompasses the proprietary
Xenon gas blend, gas hyperpolarization system, as well as software
and accessories, facilitating 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™, 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-2328