Polarean Imaging Plc (“Polarean” or the “Company”) NDA Submission
07 Octubre 2020 - 7:15AM
Business Wire
NDA submission for Polarean’s hyperpolarised
129Xenon gas drug-device diagnostic for lung imaging
Polarean Imaging plc (AIM: POLX), the medical‑imaging technology
company, with an investigational drug‑device combination product
for magnetic resonance imaging (MRI), announces its submission of a
New Drug Application (“NDA”) and request for priority review to the
US Food and Drug Administration (“FDA”) for hyperpolarised 129Xenon
gas used to evaluate pulmonary function and to visualise the lung
using MRI.
The submission of the NDA follows the Company’s successful
completion of two Phase III clinical trials (the “Clinical Trials”)
which demonstrated effective measurement of regional lung
ventilation. In the Clinical Trials, Polarean’s 129Xenon gas MRI
was used to measure regional pulmonary function in patients with a
wide variety of underlying lung diseases who were being evaluated
for possible lung resection or lung transplant surgery. As detailed
in the Company’s announcement of 29 January 2020, both Clinical
Trials met their primary endpoints, showing pre-defined equivalence
of hyperpolarised 129Xenon Gas MRI to an approved comparator,
133Xenon Scintigraphy, and displayed a benign safety profile.
129Xenon, when polarised in Polarean’s proprietary drug-device
system, permits functional, regional and quantitative imaging of
the lungs using MRI, without the risk of exposing patients to
ionising radiation. The polarised 129Xenon is administered as an
inhaled gas that is given to patients in a 10 second breath-hold
MRI procedure.
Commenting on the submission, Richard Hullihen, CEO of
Polarean, said: “The NDA submission of 129Xenon gas MRI as a
drug-device combination represents another key regulatory milestone
for our Company. I am delighted with the performance of Polarean’s
team, who have worked tirelessly to achieve this important goal,
and would also like to thank the institutions, clinicians and
patients who took part in the studies that have formed part of this
NDA.
“More than 30 million Americans suffer from a chronic lung
disease and we see a significant unmet need for non-invasive,
quantitative and cost-effective image-based diagnostic technology
without exposing patients to ionising radiation. We look forward to
working with the FDA to address this unmet need.”
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
About Polarean (www.polarean.com)
The Company and its wholly owned subsidiary, Polarean, Inc.
(together the "Group") are revenue-generating, medical drug-device
combination companies operating in the high-resolution medical
imaging market.
The Group develops equipment that enables existing MRI systems
to achieve an improved level of pulmonary function imaging and
specialises in the use of hyperpolarised Xenon gas (129Xe) as an
imaging agent to visualise ventilation.129Xe gas is currently being
studied for visualisation of gas exchange regionally in the
smallest airways of the lungs, the tissue barrier between the lung,
and the bloodstream and in the pulmonary vasculature. Xenon gas
exhibits solubility and signal properties that enable it to be
imaged within other tissues and organs.
The Group also develops and manufactures high performance MRI
radiofrequency (RF) coils which are a required component for
imaging 129Xe in the MRI system. The development of these coils by
the Group facilitates the adoption of the Xenon technology by
providing application-specific RF coils which optimize the imaging
of 129Xe in MRI equipment for use as a medical diagnostic as well
as a method of monitoring the efficacy of therapeutic
intervention.
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version on businesswire.com: https://www.businesswire.com/news/home/20201007005538/en/
Polarean Imaging plc www.polarean.com /
www.polarean-ir.com Richard Hullihen, Chief Executive Officer Via
Walbrook PR Jonathan Allis, Chairman SP Angel Corporate Finance
LLP Nomad and Broker Tel: +44 (0)20 3470 0470 David Hignell /
Soltan Tagiev (Corporate Finance) Vadim Alexandre / Rob Rees
(Corporate Broking) Walbrook PR Tel: +44 (0)20 7933 8780 or
polarean@walbrookpr.com Paul McManus / Anna Dunphy Mob: +44 (0)7980
541 893 / +44 (0)7876 741 001
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