LONDON (ShareCast) - (Sharecast News) - Medical imaging technology company Polarean Imaging, which has a proprietary magnetic resonance imaging (MRI) drug-device combination, announced on Thursday that the enrolment for its phase 3 non-inferiority clinical trials was now complete for both the lung transplant pathway and the lung resection pathway.
The AIM-traded firm said the clinical trials enrolled a total of 80 patients, of which 48 were in lung transplant and 32 were in lung resection, respectively.

It said the aim of the trials was to demonstrate non-inferiority of its drug-device combination, which uses hyperpolarised 129-Xenon gas MRI, against an approved comparator for the diagnostic evaluation of pulmonary ventilation.

The readout process would now move to image and statistical analysis - a process which was currently expected to take around 10 weeks, and would conclude with the readout of the clinical trials.

On the current advice of Polarean's regulatory consultants, the completion of readout would form the basis for a pre-new drug application meeting with the FDA.

Following the meeting and incorporation of its conclusions into the NDA submission, the process would conclude with the company's NDA submission, currently estimated by the end of the second quarter of 2020.

Additionally, consistent with Polarean's target of achieving commercial sales upon receiving FDA approval, the company announced that Alex Dusek had joined the firm as vice-president of commercialisation - a non-board role - with immediate effect.

Prior to joining Polarean, Dusek had led multiple biopharmaceutical product launches in pulmonary disease, oncology cell therapy and HIV therapeutics, including at Bayer and United Therapeutics.

"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 chief executive officer 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."

At 1559 GMT, shares in Polarean Imaging were down 13% at 20.01p.

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