Corporate News

Update on New Drug Application

30 September 2022

FDA grant of 90-day extension

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, further to the announcement made on 22 September 2022, the U.S. Food and Drug Administration ("FDA") has granted a 90-day extension to the review timeline of the New Drug Application ("NDA"), to 30 December 2022. The FDA will conduct periodic meetings during the extended review period to ensure that any questions that arise during the remaining review can be rapidly addressed to provide the best chance at a positive review decision by the extended date.

Polarean's net cash balance remains strong, with $22.7m held as at 30 June 2022, which, based on strategic decisions, provides finance to 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 / 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 / Kate Hanshaw (Healthcare Investment Banking)


Nick Adams / Fred Walsh / Nick Harland (Corporate Broking)



Walbrook PR

Tel: +44 (0)20 7933 8780 or [email protected]brookpr.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 (129Xe) as an imaging agent to visualise ventilation. 129Xe 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 129Xe 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 received an indicative Goal Action Date of 30 September 2022. The Company has since been granted a 90-day extension to the review timeline, to 30 December 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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