REG - Polarean Imaging PLC - New Drug Application Resubmission

Polarean ImagingAnnouncement

31/03/2022 07:00

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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
(https://www.polarean-ir.com/content/news/corporate-news/061021) . 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 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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