Polarean Imaging PLC FDA acceptance for filing of New Drug Application (5951J)
December 23 2020 - 1:00AM
UK Regulatory
TIDMPOLX
RNS Number : 5951J
Polarean Imaging PLC
23 December 2020
Polarean Imaging Plc
("Polarean" or the "Company")
FDA acceptance for the filing of New Drug Application
Corporate Update
Polarean Imaging plc (AIM: POLX), the medical--imaging
technology company, with a proprietary drug--device combination
product using hyperpolarised xenon-129 gas to enhance magnetic
resonance imaging (MRI) in pulmonary medicine, provides an update
regarding the status of its New Drug Application ("NDA") with the
US Food and Drug Administration ("FDA") and other corporate
developments.
Acceptance of NDA
The Directors are pleased to announce that Polarean has received
notification of acceptance of the Company's NDA by the FDA. The FDA
has confirmed that the review will follow the standard review time
frame with a target Prescription Drug User Fee Act (PDUFA) action
date of 5 October 2021. The Company plans to make full use of this
time with regards to commercialisation and launch preparation.
Director Update
Polarean also announces the planned retirement of Mr Ken West,
Chief Operating Officer, as an employee of the Company. The Board
has approved Ken's continued involvement with Polarean as a
Consultant to the Company and Ken will also transition to
Non-Executive Director from Executive Director with immediate
effect.
Richard Hullihen, Chief Executive Officer of Polarean said, "FDA
acceptance for the filing of Polarean's NDA represents another
important step forward for the Company's platform. If approved,
Polarean's drug-device technology could provide a new diagnostic
option for patients with pulmonary disease.
In addition, the Board would like to thank Ken for his expert
and untiring contributions, particularly in managing the NDA
submission and its successful acceptance by FDA for review. I look
forward to Ken's continued support at both the Board level and in
relation to special projects."
Grant of Options
Polarean announces that upon the recommendation of the Company's
remuneration committee, it has granted options over a total of
900,000 ordinary shares of 0.00037p each in the Company ("Ordinary
Shares") to new employees pursuant to the terms of the Company's
existing share option plan (the "New Options").
The exercise price for the New Options is 73 pence per Ordinary
Share and they will vest over a four-year period.
Exercise of Options
Finally, the Company has received notification from certain
option holders to exercise options over 1,318,800 Ordinary Shares.
The exercise price of the options was 15p and the Company will
receive cash proceeds of GBP197,820 as a result of the options
being exercised.
Application has been made for the 1,318,800 new Ordinary Shares
(the "New Ordinary Shares") to be admitted to trading on AIM
("Admission"), which is expected to occur at 8.00 a.m. on or around
30 December 2020. The New Ordinary Shares will rank pari passu with
the existing Ordinary Shares. The Company does not hold any
Ordinary Shares in treasury.
Following the grant of the New Options and the exercise of the
options referred to above, there are 21,012,087 outstanding options
and warrants over Polarean's Ordinary Shares, representing 12.9% of
the Company's Ordinary Shares and total voting rights on a fully
diluted basis.
Total Voting Rights
Following Admission, the total issued share capital of the
Company will consist of 163,212,935 Ordinary Shares. This number
may be used by shareholders as the denominator for the calculations
by which they will determine if they are required to notify their
interest, or a change to their interest in, the Company under the
FCA's Disclosure Guidance and Transparency Rules.
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
SP Angel Corporate Finance LLP Nomad Tel: +44 (0)20 3470 0470
and Broker
David Hignell / Adam Cowl (Corporate
Finance)
Vadim Alexandre / Rob Rees (Corporate
Broking)
Stifel Nicolaus Europe Limited (Joint Tel: +44 (0)20 7710 7600
Corporate Broker)
Nicholas Moore / Ben Maddison / Samira Essebiyea (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)7876 741 001
About Polarean (www.polarean.com)
The Company and its wholly owned subsidiary, Polarean, Inc.
(together the "Group") are revenue generating, medical drug-device
combination companies operating in the high resolution medical
imaging market.
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 and gas exchange regionally
in the smallest airways of the lungs, the tissue barrier between
the lung and the bloodstream and in the pulmonary vasculature.
Xenon gas exhibits solubility and signal properties that enable it
to be imaged within other tissues and organs.
The Group operates in an area of significant unmet medical need
and the Group's technology provides a novel diagnostic approach,
offering a non-invasive and radiation-free functional imaging
platform which is more accurate and less harmful to the patient
than current methods. The annual burden of pulmonary disease in the
US is estimated to be over US$150 billion.
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