TIDMPOLX
RNS Number : 7860L
Polarean Imaging PLC
08 September 2023
Polarean Imaging Plc
("Polarean" or the "Company")
Partnership with VIDA to streamline adoption of advanced MRI of
the lungs
Two best-in-class lung imaging companies combine expertise for
the deployment of xenon 129 MRI platform
Polarean Imaging plc (AIM: POLX), a commercial-stage medical
device leader in advanced magnetic resonance imaging ("MRI") of the
lungs, announces that it has partnered with VIDA Diagnostics
("VIDA"), a clinical imaging intelligence company providing medical
imaging software solutions which manage the complexities of digital
biomarkers. The companies are partnering to further enable the
Polarean xenon 129 MRI platform to accelerate clinical and research
use.
VIDA has empowered more than 1,000 clinical and research sites
globally with its imaging management platform, a cloud-native
AI-enabled solution that drives standardisation and efficiencies in
clinical trial imaging operations. The platform includes a unique
orchestration engine used to integrate and optimise multimodality
clinical algorithms and enable new high-quality imaging biomarkers
to be more accessible to researchers, and clinical trials, as well
as adopted into the clinical care workflows.
The collaboration between Polarean and VIDA is intended to
support the integration of xenon 129 MRI workflow into the clinical
continuum of care to establish a clinical trial network for
pharma-sponsored drug and device development using standardised
xenon 129 MR image acquisition and data-sharing methods, and to
create automated image processing workflows and algorithms. These
new products and services will be utilised to expand access to
xenon 129 MRI as a lung imaging service and to investigate new
indications and biomarkers in broader populations with unmet
medical needs. Additionally, through this collaboration, each
company will foster new research collaborations and amplify the
opportunities it can bring to its lung imaging customers.
Christopher von Jako, Ph.D., CEO of Polarean, said: "Polarean
continues to cultivate partnerships with entities that enhance our
core capabilities. We are excited to form this partnership with
VIDA, a world-renowned organisation in the field of lung imaging
software platform solutions and biomarker development, to
capitalise on their complementary expertise. Furthermore, this
partnership perfectly aligns with our objective of extending the
reach of XENOVIEW MRI, to provide tools to physicians that treat
patients suffering from chronic lung disease."
Susan Wood, Ph.D., CEO of VIDA, said: "VIDA and Polarean are
natural partners. Both companies share a goal of empowering
providers with advanced medical imaging solutions to enhance
clinical decisions and accelerate bringing new therapies to
patients. We are excited at the prospect of expanding our imaging
platform portfolio through our collaboration with Polarean, thereby
introducing pioneering MRI-based lung imaging biomarkers."
Polarean recently launched the first and only inhaled MRI
hyperpolarised contrast agent, XENOVIEW(TM) (xenon Xe 129,
hyperpolarised), for novel visualisation of lung ventilation. Since
the technology is based on MRI, it does not expose patients to any
ionising radiation and its associated risks. The dose of XENOVIEW,
created through the Polarean HPX hyperpolarisation system, is
administered in a single 10-15 second breath-hold MRI procedure.
XENOVIEW is indicated for use with MRI for evaluation of lung
ventilation in adults and paediatric patients aged 12 years and
older. XENOVIEW has not been evaluated for use with lung perfusion
imaging.
Enquiries:
Polarean Imaging plc www.polarean.com / www.polarean-ir.com
Christopher von Jako, Ph.D, Chief Via Walbrook PR
Executive Officer
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
VIDA Tel: +001 (612) 432 0513
Marcel Nienhuis marcel@vidalung.ai
About Polarean ( www.polarean.com)
The Company and its wholly owned subsidiary, Polarean, Inc.
(together the "Group") are revenue-generating, medical imaging
technology companies operating in the high-resolution medical
imaging space. Polarean aspires to revolutionise pulmonary medicine
by bringing the power and safety of MRI to the respiratory
healthcare community in need of new solutions to evaluate lung
ventilation, diagnose disease, characterise disease progression,
and monitor response to treatment. By researching, developing, and
commercialising novel imaging solutions with a non-invasive and
radiation-free functional imaging platform. Polarean's vision is to
help address the global unmet medical needs of more than 500
million patients worldwide suffering with chronic respiratory
disease. Polarean is a leader in the field of hyperpolarisation
science and has successfully developed the first and only
hyperpolarised MRI contrast agent to be approved in the United
States. The company also commercialises systems (such as the HPX
hyperpolarisation system), accessories (such as Xe-specific chest
coils and phantoms) and FDA-cleared post-processing software (to
support ventilation defect analysis), to support fully integrated
modern respiratory imaging operations.
About VIDA Diagnostics, Inc.
VIDA is a clinical imaging intelligence company that is
accelerating the development of life-saving therapies to patients
through an AI-powered digital biomarker solution. With proprietary
imaging biomarkers for precise quantitative endpoints and a trial
imaging management solution, VIDA's solution is helping biopharma
sponsors save millions in drug development costs. VIDA's software
is FDA cleared, CE-marked, Health Canada licensed, TGA registered,
and PMDA certified for clinical use in the U.S., European Economic
Area, Canada, Australia, and Japan. Learn more at
https://vidalung.ai . Follow @vidalung on Twitter and LinkedIn.
XENOVIEW IMPORTANT SAFETY INFORMATION
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 Paediatric and Adolescent
Patients: In published literature in paediatric 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 paediatric
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 paediatric patients less than 12 years of
age.
Please see full prescribing information at www.xenoview.net
PLC-RNS-2322
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END
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September 08, 2023 02:00 ET (06:00 GMT)
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