- Polarean Imaging said completion of a key clinical trial had been extended to the third quarter of 2019 after it added third trial site.

The trials were aiming to demonstrate non-inferiority of the company's drug-device combination against an approved comparator for the evaluation of pulmonary ventilation.

Enrolment had now passed 85.4% in the lung transplant pathway and 62.5% the lung resection pathway.

To improve the rate of enrolment for the lung resection pathway, the company had added a third trial site at the University of Cincinnati, adding to existing sites at Duke University and at the University of Virginia.

Polarean Imaging said it remained confident that it was on track to meet its current timetable for the regulatory submission of a new drug application to the FDA.

If approved by the FDA, commercial launch was expected to occur during the second half of 2020.

'We are pleased to confirm that Polarean will be activating the additional trial site at UC this month, to help ensure a timely completion of the enrolment process for the lung resection pathway,' chief executive Richard Hullihen said.

'Enrolment for the lung transplant pathway is now nearing completion and I look forward to providing shareholders with further updates regarding our clinical trials as soon as practicable.'

At 9:26am: [LON:POLX] Polarean Imaging Plc Ord Gbp0.00037 share price was 0p at 16p

Story provided by