Polarean (AIM: POLX), a commercial-stage medical device leader in
advanced magnetic resonance imaging (MRI) of the lungs, announced
today 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 develop solutions that
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 standardization and efficiencies in
clinical trial imaging operations. The platform includes a unique
orchestration engine used to integrate and optimize 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 intends to support
the integration of xenon 129 MRI workflow into the clinical
continuum of care, to establishing a clinical trial network for
pharma-sponsored drug and device development using standardized
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 utilized 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.
“Polarean continues to cultivate partnerships with entities that
enhance our core capabilities. We are excited to form this
partnership with VIDA, a world-renowned organization in the field
of lung imaging software platform solutions and biomarker
development, to capitalize on their complementary expertise,” said
Christopher von Jako, Ph.D., CEO of Polarean. “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.”
“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,” said Susan Wood, Ph.D., CEO of VIDA. “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
hyperpolarized contrast agent, XENOVIEW (xenon Xe 129,
hyperpolarized), for visualization of lung ventilation. Since
the technology is based on MRI, it does not expose patients to any
ionizing radiation and its associated risks. The dose of
XENOVIEW, created through the Polarean HPX hyperpolarization
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 pediatric patients
aged 12 years and older. XENOVIEW has not been evaluated for use
with lung perfusion imaging. XENOVIEW IMPORTANT SAFETY
INFORMATION
IndicationXENOVIEW™, 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 UseXENOVIEW has
not been evaluated for use with lung perfusion imaging.
CONTRAINDICATIONSNone.
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.
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
revolutionize 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,
characterize disease progression, and monitor response to
treatment. By researching, developing, and commercializing 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 hyperpolarization science and has successfully
developed the first and only hyperpolarized MRI contrast agent to
be approved in the United States. The company also
commercializes systems (such as the HPX hyperpolarization 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.
Contacts:
Polarean:Chuck OsborneChief Financial Officer+1
(919) 206-7900, ext. 117cosborne@polarean.com
Polarean Investors:Anna Dunphy / Phillip
Marriage+44 (0)20 7933 8780polarean@wallbrookpr.com
Polarean Media Contact:Michelle Caissie+1 (919)
206-7900, ext. mcaissie@polarean.com
VIDA:Marcel Nienhuis+1 (612)
432-0513marcel@vidalung.ai
POL-PR-2311
Contacts:
Polarean:
Chuck Osborne
Chief Financial Officer
+1 (919) 206-7900, ext. 117
cosborne@polarean.com
Investors:
Anna Dunphy / Phillip Marriage
+44 (0)20 7933 8780
polarean@wallbrookpr.com
Media Contact:
Michelle Caissie
+1 (919) 206-7900, ext. 136
mcaissie@polarean.com
VIDA:
Marcel Nienhuis
+1 (612) 432-0513
marcel@vidalung.ai
Polarean Imaging (LSE:POLX)
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