Polarean Imaging
Plc
("Polarean" or the "Company")
U.S. Patent granted for
dynamic cardiopulmonary blood flow imaging with Xenon
MRI
New patent expands the
utility of hyperpolarised Xenon MRI in the diagnosis and monitoring
of diseases of the pulmonary vasculature
Polarean Imaging Plc (AIM: POLX), a
commercial-stage medical device leader in advanced Magnetic
Resonance Imaging ("MRI") of lung function, announces the issuance
of U.S. Patent 11,944,424, covering the use of Xenon MRI for
cardiopulmonary blood flow imaging. The
Company met with the FDA in October 2023 regarding the gas exchange
indication, including cardiopulmonary blood flow imaging, and is
continuing to work towards completing its plans for a clinical
trial to expand the label for XENOVIEW™,
the Company's hyperpolarised Xenon MRI contrast agent.
The newly granted patent marks a
significant milestone, expanding the utility of hyperpolarised
Xenon MRI in the diagnosis and monitoring of diseases of the
pulmonary vasculature. With this patent, the Polarean Xenon MRI
platform is poised to revolutionise the imaging of pulmonary blood
flows and pressures.
Pulmonary vascular disease ("PVD")
poses a significant global health challenge, affecting the
intricate network of blood vessels within lung tissue and
connecting the lung to the heart. There is currently no
straightforward method for directly measuring blood flow and
pressure in the lungs, with the conventional approach requiring the
insertion of an invasive catheter through either the arm or leg
into the right side of the heart.
No other techniques currently exist
to visualise blood flows and pressures in the very small vessels
surrounding the lung air sacs. This region represents a "silent
zone" to most modalities and is precisely where the crucial
exchange of oxygen and carbon dioxide occurs. The absence of
effective non-invasive tools for assessing pulmonary vascular
function remains a persistent barrier to early diagnosis and
monitoring of PVD.
XENOVIEW is inhaled by the patient
which then dissolves into lung tissue and enters the pulmonary
microvasculature. This allows for dynamic measurement of its
distribution. This ability to reveal regional microvascular blood
flow impairment can be used to noninvasively detect pre- and
post-capillary pulmonary hypertension.
Christopher R. von Jako, Ph.D., CEO of Polarean,
said: "This new patent represents an important advancement for our
intellectual property portfolio, strengthening our market position
and marking a pivotal step toward achieving our vision of
optimising lung health and minimising preventable loss. Through our
innovative, non-invasive, radiation-free pulmonary functional
imaging platform, we aim to illuminate hidden diseases, including
those within the pulmonary vasculature. This breakthrough has the
potential to empower early intervention and significantly improve
patient outcomes."
Bastiaan Driehuys, Ph.D., Chief Scientific Officer of
Polarean, said: "This exciting new
technology introduces a fundamentally new contrast mechanism for
Xenon MRI that opens the door to non-invasive characterisation of
haemodynamics that are altered in patients with pulmonary
hypertension. In our research, we have seen this core new
capability pave the way to better diagnosis and monitoring of these
patients and comprehensive assessment of
dyspnea."
Enquiries:
Polarean Imaging plc
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www.polarean.com / www.polarean-ir.com
|
Christopher von Jako, Ph.D, Chief
Executive Officer
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Via Walbrook
PR
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Charles Osborne, Chief Financial
Officer
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Stifel Nicolaus Europe Limited (NOMAD and Sole Corporate
Broker)
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+44 (0)20
7710 7600
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Nicholas Moore / Samira Essebiyea /
Kate Hanshaw (Healthcare Investment Banking)
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Nick Adams / Nick Harland (Corporate
Broking)
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Walbrook PR
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Tel: +44
(0)20 7933 8780 or polarean@walbrookpr.com
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Anna Dunphy / Phillip
Marriage
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Mob: +44
(0)7876 741 001 / +44 (0)7867 984 082
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About Pulmonary Hypertension
Pulmonary hypertension (PH) is a
serious condition that is characterised by abnormally high blood
pressure in the lungs, impacting at least 1% of the global
population and commonly manifesting as dyspnea (shortness of
breath). While left-sided heart and lung diseases are primary
contributors to PH, distinct subgroups such as Group 1 (Pulmonary
Arterial Hypertension) and Group 3 (Pulmonary Hypertension due to
lung diseases and/or hypoxia) require focused attention due to
their unique pathophysiological mechanisms involving the pulmonary
vasculature. Without proactive management and timely intervention,
PH can progress to heart failure and result in
mortality.
About Polarean
Polarean is a revenue-generating
medical imaging technology company revolutionizing 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.
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.
PLC-RNS-2330