REG - Polarean Imaging PLC - U.S. Patent granted for Xenon MRI

Polarean ImagingAnnouncement

16/04/2024 07:00

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RNS Number : 6907K  Polarean Imaging PLC  16 April 2024

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                                        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
                     (mailto:polarean@walbrookpr.com)
 Anna Dunphy / Phillip Marriage          Mob: +44 (0)7876 741 001 / +44 (0)7867 984 082

 

 

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 (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.

 

PLC-RNS-2330

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