Polarean Imaging PLC (LON:POLX) has completed patient enrolment for a Phase III clinical trial of its MRI lung scan technology.
The medical imaging specialist said it had enrolled 80 patients, 48 of which are in a lung transplant pathway while the remaining 32 are for lung resection, a process where part of the lung tissue is removed.
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Polarean is aiming to show in the trials that its drug-device combination, which uses a type of Xenon gas in a magnetic resonance imaging (MRI) machine, is as good as current methods for diagnosing breathing problems.
The trials are now in the image and statistical analysis stage, a process that is expected to take around 10 weeks and will conclude with a readout of the trial.
The readout will then form the basis for a pre-new drug application (NDA) meeting with the US Food and Drug Administration (FDA), with a formal application to be lodged in the second quarter of next year.
Polarean added that it had appointed Alex Dusek as its vice-president of commercialisation with immediate effect, consistent with its target of achieving commercial sales following FDA approval.
"The Company is pleased to have successfully completed enrolment for its Clinical Trials and looks forward to the next stage of statistical analysis ahead of readout and the proposed submission of the NDA”, said Polarean chief executive, Richard Hullihen.
“We are also pleased to welcome Alex Dusek to our team, as he brings a wealth of direct pharmaceutical industry launch preparation and commercialisation experience to Polarean, as we ramp up our commercialisation planning", he added.
In early trading on Thursday, Polarean’s shares were 0.7% lower at 22.9p.