REG - Polarean Imaging PLC - Taiwanese distributor agreement with Sumtage

Polarean ImagingAnnouncement

03/02/2025 07:15

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RNS Number : 5550V  Polarean Imaging PLC  03 February 2025

 

Polarean Imaging plc

("Polarean" or the "Company")

 

Taiwanese distributor agreement with Sumtage

First distribution agreement, expanding Polarean's international reach

 

Polarean Imaging plc (AIM: POLX), a commercial-stage medical imaging
technology leader in advanced Magnetic Resonance Imaging ("MRI") of lung
function, announces it has signed a distribution agreement with Sumtage
Enterprise Company Limited ("Sumtage") for the distribution of Polarean's
Xenon MRI platform in Taiwan.

 

This agreement represents the Company's first distribution deal, expanding
Polarean's international reach and paving the way for Polarean's innovative
Xenon MRI platform to be sold and used in Taiwan. Polarean will work
collaboratively with Sumtage to achieve the necessary regulatory clearances
necessary for commercial launch in Taiwan.

 

Sumtage is a medical distributor with 30 years of experience in introducing
the latest and most advanced medical equipment from overseas into the
Taiwanese market, and offers customers additional maintenance and clinical
support service post-sale. Sumtage has a comprehensive portfolio of medical
imaging and diagnostic technologies, catering to the diverse needs of
healthcare professionals.

 

Christopher von Jako, Ph.D., CEO of Polarean, said: "Sumtage are highly
experienced in selling cutting-edge medical technology in Taiwan, making them
the ideal partner to help us expand access to our innovative Xenon MRI
platform into this market. While our own sales team remains focused on
expanding the number of user sites within the United States, I am pleased to
see our first commercial entry into the Asia-Pacific region via a high-quality
distributor, where we believe our platform can provide great benefit to
pulmonary patients and their physicians. We will work with Sumtage to achieve
regulatory approval for our platform in Taiwan ahead of commercial launch, and
look forward to further updating the market in due course."

 

Hui-Lin Su, General Manager of Sumtage, said: 'We are excited to work with
Polarean to bring this groundbreaking Xenon MRI technology to Taiwan to help
address lung diseases such as lung cancer, COPD, and asthma. The Polarean
Xenon MRI platform enables advanced lung function assessments, allowing
physicians to identify affected regions at earlier stages and facilitate
timely treatment. We have already seen strong interest from leading academic
medical centers, highlighting the significant potential of this technology to
improve lung health in Taiwan."

 

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 (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 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

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