Polarean Imaging PLC New Drug Application Resubmission update (6673I)
April 20 2022 - 2:10AM
UK Regulatory
TIDMPOLX
RNS Number : 6673I
Polarean Imaging PLC
20 April 2022
Polarean Imaging Plc
("Polarean" or the "Company")
New Drug Application Resubmission update
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 further to the RNS issued on 31 March 2022, the Company can
confirm that the US Food and Drug Administration ("FDA") has
accepted the resubmission of its New Drug Application (NDA) as a
complete response, and has established a user fee goal date of 30
September 2022, designating it Type 2.
Richard Hullihen CEO of Polarean CEO said: " We are happy that
the FDA has accepted our resubmission and look forward to resuming
the review process with them in the expanded context of our
response."
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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END
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