Polarean Imaging PLC New Drug Application Resubmission (6811G)
March 31 2022 - 2:01AM
UK Regulatory
TIDMPOLX
RNS Number : 6811G
Polarean Imaging PLC
31 March 2022
Polarean Imaging Plc
("Polarean" or the "Company")
New Drug Application Resubmission
NDA submission for Polarean's hyperpolarised (129) Xenon gas
drug-device combination product
Polarean Imaging plc (AIM: POLX), the medical--imaging
technology company, with an investigational drug--device
combination product using hyperpolarised (129) Xenon gas to enhance
magnetic resonance imaging (MRI) in pulmonary medicine, announces
that the Company has filed the resubmission of its New Drug
Application ("NDA") with the US Food and Drug Administration
("FDA").
The filing follows the Company's receipt of a Complete Response
Letter ("CRL") from the FDA on 6 October 2021 . Following detailed
discussion in the Type A meeting with the FDA, these issues have
now been addressed by Polarean in the resubmission.
It is currently expected that the FDA review period will take
six months. The Company is making full use of this time with
regards to commercialisation and launch preparation and will
further update the market once material information is
received.
Richard Hullihen, CEO of Polarean, said: "We have resubmitted
the NDA for our (129) Xenon drug-device combination product,
following extensive discussions with the FDA regarding the issues
that were raised in the CRL. The entire Polarean team has worked
diligently to ensure that all the points raised in the CRL were
comprehensively addressed".
"We look forward to completing the FDA review and approval
processes necessary to bring our unique technology to market
addressing the significant unmet need for our non-invasive,
quantitative and cost-effective functional lung imaging."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
Enquiries:
Polarean Imaging plc www.polarean.com / www.polarean-ir.com
Richard Hullihen, Chief Executive Via Walbrook PR
Officer
Jonathan Allis, Chairman
Stifel Nicolaus Europe Limited (NOMAD and
Sole Corporate Broker) +44 (0)20 7710 7600
Nicholas Moore / Samira Essebiyea / William Palmer-Brown
(Healthcare Investment Banking)
Nick Adams / Fred Walsh (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)7879
741 001
About Polarean (www.polarean.com)
The Company and its wholly owned subsidiary, Polarean, Inc.
(together the "Group") are revenue-generating, investigational
drug-device combination companies operating in the high-resolution
medical imaging research space.
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 ((129) Xe) as an
imaging agent to visualise ventilation. (129) Xe gas is currently
being studied for visualisation of gas exchange regionally in the
smallest airways of the lungs, across the alveolar tissue membrane,
and into the pulmonary bloodstream.
In October 2020, the Group submitted a New Drug Application
("NDA") to the FDA for hyperpolarised (129) Xe used to evaluate
pulmonary function and to visualise the lung using MRI. The Group
received a complete response letter on 6 October 2021.
The Group operates in an area of significant unmet medical need
and the Group's technology provides a novel investigational
diagnostic approach, offering a non-invasive and radiation-free
functional imaging platform. The annual economic burden of
pulmonary disease in the US is estimated to be over US $150
billion.
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