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RNS Number : 3108B Polarean Imaging PLC 30 September 2022
Polarean Imaging Plc
("Polarean" or the "Company")
Update on New Drug Application
FDA grant of 90-day extension
Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company,
with an investigational drug‑device combination product using hyperpolarised
xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary
medicine, announces that, further to the announcement made on 22 September
2022
(https://www.londonstockexchange.com/news-article/POLX/update-on-new-drug-application/15639330)
, the U.S. Food and Drug Administration ("FDA") has granted a 90-day extension
to the review timeline of the New Drug Application ("NDA"), to 30 December
2022. The FDA will conduct periodic meetings during the extended review
period to ensure that any questions that arise during the remaining review can
be rapidly addressed to provide the best chance at a positive review decision
by the extended date.
Polarean's net cash balance remains strong, with $22.7m held as at 30 June
2022,which, based on strategic decisions, provides finance to the Company into
2024.
This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014.
Enquiries:
Polarean Imaging plc www.polarean.com (http://www.polarean.com) / www.polarean-ir.com
(http://www.polarean-ir.com)
Richard Hullihen, Chief Executive Officer Via Walbrook PR
Kenneth West, Chairman
Stifel Nicolaus Europe Limited (NOMAD and Sole Corporate Broker) +44 (0)20 7710 7600
Nicholas Moore / Samira Essebiyea / Kate Hanshaw (Healthcare Investment
Banking)
Nick Adams / Fred Walsh / Nick Harland (Corporate Broking)
Walbrook PR Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com
(mailto:polarean@walbrookpr.com)
Anna Dunphy /Phillip Marriage Mob: +44 (0)7876 741 001 / +44 (0) 7867 984 082
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
5 October 2021. On 30 March 2022, the Company filed the resubmission of its
NDA with the US FDA and received an indicative Goal Action Date of 30
September 2022. The Company has since been granted a 90-day extension to the
review timeline, to 30 December 2022.
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.
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