REG - Polarean Imaging PLC - FDA Approves XENOVIEW™ (Xe 129 hyperpolarized)

Polarean ImagingAnnouncement

28/12/2022 07:00

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RNS Number : 9761K  Polarean Imaging PLC  28 December 2022

28 December 2022

Polarean Imaging Plc

("Polarean" or the "Company")

 

 FDA Approves Polarean's XENOVIEW™ (xenon Xe 129 hyperpolarized)

for use with MRI for the evaluation of lung ventilation

 

●     XENOVIEW represents the first and only hyperpolarized MRI contrast
agent

●     FDA approved indication includes both adolescents and adults
representing a significant market opportunity

 

Polarean Imaging plc (AIM: POLX), the medical imaging technology company,
announces that the U.S. Food and Drug Administration ("FDA") has granted
approval for its drug device combination product, XENOVIEW. 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. XENOVIEW
has not been evaluated for use with lung perfusion imaging.

 

XENOVIEW expands the opportunity for pulmonary medicine to utilize the first
and only inhaled MRI hyperpolarized contrast agent for novel visualization of
lung ventilation without exposing 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.

 

More than 30 million Americans suffer from a chronic lung disease and there is
a significant unmet need for non-invasive diagnostic technology. XENOVIEW can
provide pulmonologists, surgeons, and other respiratory specialists with
regional maps of ventilation in their patients' lungs to assist them in
managing their disease.

 

Richard Hullihen, Chief Executive Officer of Polarean said: "FDA approval
represents achievement of a major milestone for Polarean's technology. This
was only possible in close collaboration with multiple research clinicians and
scientists globally, who we thank for their tireless and enthusiastic work.
Approval of XENOVIEW represents a major step forward in modern respiratory
imaging and we are proud to have pioneered this exciting new technology for
clinical use. The commercial team at Polarean is prepared to rapidly launch
XENOVIEW for clinical application."

 

Dr. Jason Woods, Director of Research in Pulmonary Medicine at the Cincinnati
Children's Medical Center added: "My colleagues and I in the Xenon MRI
research community are thrilled that this technology is now available to reach
both adolescent and adult patients. With the availability of XENOVIEW in the
clinical setting, we will have the ability to evaluate regional lung
ventilation, delivered with a benign safety profile, which has been a major
unmet need for the patients that look to us to better understand their lung
disease."

 

Polarean also announces that, simultaneously with the approval of the XENOVIEW
NDA, two 510(k) devices were cleared by the FDA that will further support a
successful launch of the technology into the clinical marketplace:

 

XENOVIEW VDP is image processing software that analyzes a pulmonary
hyperpolarized 129-Xe MR image and a proton chest MR image to provide
visualization and evaluation of lung ventilation in adults and pediatric
patients aged 12 years and older. This image analysis platform quantifies
normalized xenon intensity of a ventilated space using a pulmonary
hyperpolarized 129-Xe ventilation MR image and accompanying proton chest MR
image. The software will be used by clinicians to assist in the interpretation
and numerical classification of hyperpolarized 129-Xe ventilation MR images.

 

The Polarean XENOVIEW 3.0T Chest Coil is a flexible, single channel,
transmit-receive (T/R) RF coil tuned to 129Xe frequency on a 3.0T MRI magnetic
field of a compatible MRI scanner. The Polarean XENOVIEW 3.0T Chest Coil is
indicated to be used in conjunction with compatible 3.0T MRI scanners and
approved xenon Xe 129 hyperpolarized for oral inhalation for evaluation of
lung ventilation in adults and pediatric patients aged 12 years and older. The
Chest Coil is intended to be worn by a patient who inhales hyperpolarized
129Xe gas (XENOVIEW) to obtain an MR image of the regional distribution of
hyperpolarized 129Xe in the lungs.

 

About XENOVIEW

 

Clinical Trial Results: FDA approval of XENOVIEW was based on clinical trial
results from two prospective, multi-center, randomized, open-label, cross-over
clinical trials that compared XENOVIEW MRI to xenon Xe 133 scintigraphy in
adult patients with pulmonary disorders. The mean XENOVIEW dose used in these
trials was 99 mL Dose Equivalent ("DE") of hyperpolarized xenon Xe 129 at the
time of measurement within 5 minutes of administration. Both trials met their
primary endpoints.

 

Study 1 compared XENOVIEW and xenon Xe 133 imaging in patients being evaluated
for possible lung resection surgery. Patients had a medical history of
respiratory disorders such as pulmonary mass (44%) and COPD (35%). Additional
concomitant respiratory disorders were reported, including; cough (15%), sleep
apnea syndrome (12%), and asthma (12%). In the primary analysis of 31
patients, the mean within-patient difference in the predicted postoperative
percentage of remaining lung ventilation between XENOVIEW and xenon Xe 133
imaging was within a pre-specified equivalence interval with an observed
estimate of 1.4% (95% confidence interval: -0.8%, 3.6%).

 

Study 2 compared XENOVIEW and xenon Xe 133 imaging in patients being evaluated
for possible lung transplant surgery. Patients had a medical history of
respiratory disorders, including; interstitial lung disease (49%), idiopathic
pulmonary fibrosis (29%), COPD (22%), and other pulmonary fibrotic disorders
(14%). In the primary analysis of the 49 patients who completed both scans,
the mean within-patient difference in the percentage of overall lung
ventilation contributed by the right lung between XENOVIEW and xenon Xe 133
imaging was within a pre-specified equivalence interval with an observed
estimate of 1.6% (95% confidence interval: -3.7%, 0.5%).

 

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 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
(http://www.xenoview.net)

 

US Customer support

Polarean offers support for customers who need assistance with; placing an
order, reimbursement support, service request, and general inquiries. You may
reach the Customer Care Center at 1-844-XENOVIE(W) or (1-844-936-6843) or via
e-mail at info@polarean.com.

 

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014.

 

Enquiries:

 

  Polarean Imaging plc                                         www.polarean.com (http://www.polarean.com/) / www.polarean-ir.com
                                                               (http://www.polarean-ir.com/)
  Richard Hullihen, Chief Executive Officer                    Via Walbrook PR
  Kenneth West, Chairman

  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

 

 

About Polarean (www.polarean.com (http://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
function, 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. On December 23, 2022, the FDA
granted approval for Polarean's first drug device combination product,
XENOVIEW(TM) (xenon Xe 129 hyperpolarized). (129)Xe MRI is also currently
being studied for visualization and quantification of gas exchange regionally
in the smallest airways of the lungs, across the alveolar tissue membrane, and
into the pulmonary bloodstream for future clinical indications.

 

XENOVIEW(TM) is a trademark of Polarean, Inc.
 
POL-PR-2201

 

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