REG - Polarean Imaging PLC - Update on New Drug Application

Polarean ImagingAnnouncement

22/09/2022 07:16

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RNS Number : 2803A  Polarean Imaging PLC  22 September 2022

Polarean Imaging Plc

("Polarean" or the "Company")

 

Update on New Drug Application

FDA request for additional information from Polarean's contract drug
manufacturer

 

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 the U.S. Food and Drug Administration ("FDA") has
requested additional information from Polarean's xenon-129 gas blend drug
manufacturing partner. This request is related to the recent cGMP (Current
Good Manufacturing Practice) pre-approval inspection at the partner's
production facility. The FDA has suggested that the required information would
constitute a major amendment to the New Drug Application ("NDA") that, if
timely submitted, would allow for the FDA to grant a 90-day extension to the
review timeline. The FDA has proposed frequent meetings to occur during the
extended review period to ensure that any questions that arise during the
review can be rapidly addressed to provide the best chance at a positive
review decision by the extended date.

 

The Company has received assurances from its drug manufacturing partner that
they will address the concerns. Polarean will provide an additional update on
the status of its NDA in due course.

 

Polarean's net cash balance is $22.7m as of 30 June 2022 which, based on
strategic decisions, could finance 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 / William Palmer-Brown (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 has received a PDUFA date of Sept 30, 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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