Polarean Imaging (POLX), the medical‑imaging technology company with a proprietary drug‑device combination product using hyperpolarised xenon-129 gas to enhance Magnetic Resonance Imaging (“MRI”) in pulmonary medicine, has provided an update regarding the US Food and Drug Administration, retirement of Ken West, COO and issue of options.

US Food And Drug Administration (“FDA”)

In October 2020, Polarean announced it had submitted of a New Drug Application (“NDA”) 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 Company has announced today that this NDA application has now been accepted by the FDA.

However, further to the application for NDA Priority Review announced in October, the FDA has informed Polarean that the NDA will have to follow the Standard Review process, which is approximately three months slower, with a target Prescription Drug User Fee Act (“PDUFA”) action date of 5 October 2021.

Nevertheless, the Company has committed to using the extra time productively, advancing ‘commercialisation and launch preparations’.

Richard Hullihen, Chief Executive Officer of Polarean said, "FDA acceptance for the filing of Polarean's NDA represents another important step forward for the Company's platform. If approved, Polarean's drug-device technology could provide a new diagnostic option for patients with pulmonary disease.”

Directorate Change

Polarean also confirmed the planned retirement of Mr Ken West, as Chief Operating Officer and full-time employee of the Company. However, the Board has approved Ken's continued involvement with Polarean as a Consultant and the transition to Non-Executive Director with immediate effect.

Richard added: “The Board would like to thank Ken for his expert and untiring contributions, particularly in managing the NDA submission and its successful acceptance by FDA for review. I look forward to Ken's continued support at both the Board level and in relation to special projects."

Grant and Exercise of Options

Polarean has granted options over a total of 900,000 ordinary shares of 0.00037p each in the Company to new employees, as per the terms of the Company's share option plan. The exercise price for the New Options is 73p per Ordinary Share, and they will vest over a four-year period.

The Company has also received notification to exercise options over 1,318,800 Ordinary Shares. The exercise price of the options was 15p and the Company will receive cash proceeds of £197,820 as a result of the options being exercised.

Following the grant of the New Options and the exercise of the options referred to above, there are 21,012,087 outstanding options and warrants over Polarean's Ordinary Shares, representing 12.9% of the Company's Ordinary Shares and total voting rights on a fully diluted basis.

 

Shares in POLX have performed exceptionally strongly over the past three months rising from 45p in October to opening at 75p following this announcement. However, disappointment around the delay incurred by the Standard Review timetable has seen the shares trend down 8.6% in early morning trading.