REG - Polarean Imaging PLC - Partnership with VIDA

Polarean ImagingAnnouncement

08/09/2023 07:00

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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 (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
 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 (mailto: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
(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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