REG - Polarean Imaging PLC - FY24 trading update

Polarean ImagingAnnouncement

27/02/2025 07:00

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RNS Number : 6081Y  Polarean Imaging PLC  27 February 2025

 

Polarean Imaging Plc

("Polarean" or the "Company")

 

FY24 Trading Update

 

Polarean Imaging plc (AIM: POLX), a commercial-stage medical imaging
technology leader in advanced Magnetic Resonance Imaging ("MRI") of lung
function, provides a full year unaudited trading update for the year ended 31
December 2024 ("FY24") and a commercial update.

 

The Company expects to report FY24 unaudited revenue of between US$3.0 million
and $3.1 million (audited 2023: $891k), exceeding the upper end of revenue
guidance of US$2.5 million to US$3.0 million.

 

As of the date hereof, the Company has 22 Xenon MRI platform customers, seven
sites of which have either received or pending clinical hyperpolariser
systems. This represents an increase of four customers with installed or
pending clinical hyperpolariser systems compared to the prior year,
demonstrating continued progress in the commercialisation of the Company's
platform.

 

Proprietary Xenon gas blend cylinders and other consumables sales increased
more than 50% from FY23 to FY24, highlighting the growing number of Xenon MRI
scans occurring.

 

During the second half of the year, a key focus for the Company was recruiting
top-tier sales talent, with Dr. Alan Huang joining as VP of Sales in Q3 FY24.
The sales team is currently comprised of six people providing coverage across
the U.S. and allowing for an enhanced sales pipeline, as evidenced by the
aforementioned year-on-year increase in sales.

 

Post-period end, the Company has continued to make commercial traction
demonstrated by the recently announced distribution agreement with a Taiwanese
company, Sumtage, to distribute Polarean's products in Taiwan. This agreement
is the first distribution agreement signed by the Company and the first step
in commercialising its products outside of the U.S., pending regulatory
clearance.

 

The Company's unaudited cash and cash equivalents balance as of 31 December
2024 was US$12.1 million, a cash runway that extends through Q1 FY26.

 

Christopher von Jako, Ph.D., CEO of Polarean, said: "The financing we
completed in June 2024 was key for Polarean in the early phase of our
commercialisation strategy, allowing us to attract some top sales and medical
talent and execute on further key aspects of our five-pillar commercial
strategy.

 

"With our enhanced team and clear strategy, we were able to exceed our revenue
target for FY24 beyond the upper end of our increased guidance, more than
tripling our revenues from 2023. Our pipeline is now building nicely,
including further expected de novo sales.

 

"Alongside the strategic progress the Company has made, including our recent
entry into the APAC region evidenced by the recently announced Taiwanese
partnership, Polarean is well positioned for 2025 and to demonstrate further
commercial progress in advancing our Xenon MRI platform."

 

As previously announced, the Company will hold a Virtual Investor Day on
Wednesday, 12 March 2025 at 2:00pm GMT. To register for the webinar, please
use this link: Zoom Webinar - Register
(https://us06web.zoom.us/webinar/register/WN_Gr8nQPj4TImTFoUzOvzEIw) . The
Company will provide additional updates as appropriate.

 

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 / Nick Harland / Ben Good

 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

 

Polarean is a revenue-generating medical imaging technology company
revolutionising pulmonary medicine through direct visualisation 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 optimise 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 hyperpolarisation science and has successfully developed the first and only
hyperpolarised 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 hyperpolarisation 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 (http://www.polarean.com/) .

 

XENOVIEW IMPORTANT SAFETY INFORMATION

 

Indication

XENOVIEW®, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarised
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 hyperpolarised 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

 

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