TIDMPOLX

RNS Number : 6673I

Polarean Imaging PLC

20 April 2022

Polarean Imaging Plc

("Polarean" or the "Company")

New Drug Application Resubmission update

Polarean Imaging plc (AIM: POLX), the medical--imaging technology company, with an investigational drug--device combination product using hyperpolarised (129) Xenon gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces that further to the RNS issued on 31 March 2022, the Company can confirm that the US Food and Drug Administration ("FDA") has accepted the resubmission of its New Drug Application (NDA) as a complete response, and has established a user fee goal date of 30 September 2022, designating it Type 2.

Richard Hullihen CEO of Polarean CEO said: " We are happy that the FDA has accepted our resubmission and look forward to resuming the review process with them in the expanded context of our response."

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 
 
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 (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, 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 6 October 2021.

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. The annual economic burden of pulmonary disease in the US is estimated to be over US $150 billion.

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

MSCILMPTMTIBBLT

(END) Dow Jones Newswires

April 20, 2022 02:10 ET (06:10 GMT)

Polarean Imaging (LSE:POLX)
Historical Stock Chart
From Aug 2024 to Sep 2024 Click Here for more Polarean Imaging Charts.
Polarean Imaging (LSE:POLX)
Historical Stock Chart
From Sep 2023 to Sep 2024 Click Here for more Polarean Imaging Charts.