TIDMPOLX

RNS Number : 2996B

Polarean Imaging PLC

07 October 2020

Polarean Imaging Plc

("Polarean" or the "Company")

NDA Submission

NDA submission for Polarean's hyperpolarised (129) Xenon gas drug-device diagnostic for lung imaging

Polarean Imaging plc (AIM: POLX), the medical--imaging technology company, with an investigational drug--device combination product for magnetic resonance imaging (MRI), announces its submission of a New Drug Application ("NDA") and request for priority review to the US Food and Drug Administration ("FDA") for hyperpolarised (129) Xenon gas used to evaluate pulmonary function and to visualise the lung using MRI.

The submission of the NDA follows the Company's successful completion of two Phase III clinical trials (the "Clinical Trials") which demonstrated effective measurement of regional lung ventilation. In the Clinical Trials, Polarean's (129) Xenon gas MRI was used to measure regional pulmonary function in patients with a wide variety of underlying lung diseases who were being evaluated for possible lung resection or lung transplant surgery. As detailed in the Company's announcement of 29 January 2020, both Clinical Trials met their primary endpoints, showing pre-defined equivalence of hyperpolarised (129) Xenon Gas MRI to an approved comparator, (133) Xenon Scintigraphy, and displayed a benign safety profile.

(129) Xenon, when polarised in Polarean's proprietary drug-device system, permits functional, regional and quantitative imaging of the lungs using MRI, without the risk of exposing patients to ionising radiation. The polarised (129) Xenon is administered as an inhaled gas that is given to patients in a 10 second breath-hold MRI procedure.

Commenting on the submission, Richard Hullihen, CEO of Polarean, said: "The NDA submission of (129) Xenon gas MRI as a drug-device combination represents another key regulatory milestone for our Company. I am delighted with the performance of Polarean's team, who have worked tirelessly to achieve this important goal, and would also like to thank the institutions, clinicians and patients who took part in the studies that have formed part of this NDA.

"More than 30 million Americans suffer from a chronic lung disease and we see a significant unmet need for non-invasive, quantitative and cost-effective image-based diagnostic technology without exposing patients to ionising radiation. W e look forward to working with the FDA to address this unmet need."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

Contacts:

 
 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 / 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)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.(129) Xe gas is currently being studied for visualisation of 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 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 optimize 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.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.

END

MSCFLFVTIILRIII

(END) Dow Jones Newswires

October 07, 2020 02:00 ET (06:00 GMT)

Polarean Imaging (LSE:POLX)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024 Haga Click aquí para más Gráficas Polarean Imaging.
Polarean Imaging (LSE:POLX)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024 Haga Click aquí para más Gráficas Polarean Imaging.