New Drug Application Resubmission update
20 April 2022
Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company, with an investigational drug‑device combination product using hyperpolarised 129Xenon 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.
|Polarean Imaging plc||www.polarean.com / www.polarean-ir.com|
|Richard Hullihen, Chief Executive Officer||Via Walbrook PR|
|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 [email protected]|
|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 (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 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.