Polarean Imaging PLC Completion of patient enrolment & PDMR appointment (5570S)
07 Noviembre 2019 - 1:00AM
UK Regulatory
TIDMPOLX
RNS Number : 5570S
Polarean Imaging PLC
07 November 2019
7 November 2019
Polarean Imaging Plc
("Polarean" or the "Company")
Completion of patient enrolment for Clinical Trials and PDMR
Appointment
Polarean Imaging plc (AIM: POLX), the medical-imaging technology
company, with a proprietary magnetic resonance imaging (MRI)
drug-device combination, announces that the enrolment for its Phase
III non-inferiority clinical trials (the "Clinical Trials") is now
complete for both the lung transplant pathway and the lung
resection pathway. The Clinical Trials enrolled a total of 80
patients of which 48 were in the lung transplant and 32 were in
lung resection, respectively.
The aim of the Clinical Trials is to demonstrate non-inferiority
of the Company's drug-device combination, which uses hyperpolarised
129-Xenon gas MRI, against an approved comparator for the
diagnostic evaluation of pulmonary ventilation.
The readout process will now move to image and statistical
analysis. This process is currently expected to take approximately
10 weeks and will conclude with the readout of the Clinical
Trials.
On the current advice of Polarean's regulatory consultants, the
completion of readout will form the basis for a Pre-New Drug
Application ("NDA") Meeting with the FDA. Following the Pre-NDA
Meeting and incorporation of its conclusions into the NDA
submission, the process will conclude with the Company's NDA
submission, currently estimated by the end of Q2 2020.
PDMR Appointment
Consistent with Polarean's target of achieving commercial sales
upon receiving FDA approval, the Company also announces that Mr.
Alex Dusek has joined as Vice-President of Commercialisation
(non-Board role) with immediate effect. Prior to joining Polarean,
Mr. Dusek has led multiple biopharmaceutical product launches in
pulmonary disease, oncology cell therapy and HIV therapeutics,
including at Bayer and United Therapeutics. Mr. Dusek earned a B.A.
in Linguistics from the College of William and Mary, pre-medical
programme at Columbia University, and received his M.B.A. from the
University of North Carolina, Kenan-Flagler Business School.
Richard Hullihen, CEO of Polarean, said: "The Company is pleased
to have successfully completed enrolment for its Clinical Trials
and looks forward to the next stage of statistical analysis ahead
of readout and the proposed submission of the NDA. We are also
pleased to welcome Alex Dusek to our team, as he brings a wealth of
direct pharmaceutical industry launch preparation and
commercialisation experience to Polarean, as we ramp up our
commercialisation planning."
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
Richard Morgan, Chairman
SP Angel Corporate Finance LLP Tel: +44 (0)20 3470 0470
David Hignell, Soltan Tagiev (Corporate
Finance)
Vadim Alexandre / Rob Rees (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, 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.
The Group also develops and manufactures high performance MRI
radiofrequency (RF) coils which are a required component for
imaging (129) Xe in the MRI system. The development of these coils
by the Group facilitates the adoption of the Xenon technology by
providing application-specific RF coils which optimise the imaging
of (129) Xe in MRI equipment for use as a medical diagnostic as
well as a method of monitoring the efficacy of therapeutic
intervention.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
MSCBFBLTMBJMBBL
(END) Dow Jones Newswires
November 07, 2019 02:00 ET (07:00 GMT)
Polarean Imaging (LSE:POLX)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024
Polarean Imaging (LSE:POLX)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024