Polarean Imaging new drug application gets FDA acceptance

Medical imaging technology company Polarean Imaging updated the market on the status of its new drug application with the US Food and Drug Administration (FDA) on Wednesday.

The AIM-traded firm said it had received notification of acceptance of the application by the FDA.

It said the FDA had confirmed that the review would follow the standard review time frame, with a target Prescription Drug User Fee Act (PDUFA) action date of 5 October 2021.

The company said it was planning to make full use of that time for commercialisation and launch preparation.

“FDA acceptance for the filing of Polarean's NDA represents another important step forward for the company's platform,” said chief executive officer Richard Hullihen.

“If approved, Polarean's drug-device technology could provide a new diagnostic option for patients with pulmonary disease.”

Polarean also announced the planned retirement of its chief operating officer Ken West as an employee.

The board said it had approved West’s continued involvement with Polarean as a consultant to the company, with West to transition to being a non-executive director with immediate effect.

“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,” Richard Hullihen added.

At 1135 GMT, shares in Polarean Imaging were down 6.71% at 69.97p.