REG - Polarean Imaging PLC - New Drug Application Resubmission update

Polarean ImagingAnnouncement

20/04/2022 07:00

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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 Officer                Via Walbrook PR
 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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