told investors on Monday that enrolment for its Phase III Clinical Trials passed 80% (39 of 48 patients) in the lung transplant pathway.
It also said that enrolment passed 50% (16 of 32 patients) in the lung resection pathway.
Polarean is an AIM listed medical-imaging technology company with a proprietary drug-device combination product that helps visualise pulmonary function in the MRI market.
The Company’s Phase III Clinical Trial aims to demonstrate non-inferiority of its drug-device combination, which uses hyperpolarised 129-Xenon gas MRI, for the evaluation of pulmonary ventilation.
Polarean also told investors that it plans to add a third trial site at the University of Cincinnati ("UC"), which is already one of the Company's key clinical collaborators.
The company said the third trial site was added to ensure no more than 65% patients were enrolled in a single site, to improve the rate of enrolment for the lung resection pathway, and to align the pathway completion dates.
The third trial site at will be activated in June 2019.
Richard Hullihen, CEO of Polarean, said: "We are satisfied with the progress of our Clinical Trials to date. We are pleased to be adding an additional trial site at UC to improve the enrolment process for the lung resection pathway, thereby extending our collaboration with UC.”
He added: “I look forward to providing shareholders with further updates as the Clinical Trials progress towards completion"
Company directors said they were confident Polarean is on track to meet its timetable for the submission of a New Drug Application with the US Food and Drug Administration.
If approved, commercial launch is expected to occur during during the second half of 2020.
Follow News & Updates from Polarean here:
Tlou's Managing Director, Mr Tony Gilby said “The Company will now progress with additional work on the ground to deliver a Gas-to-Power solution that can bring significant benefits to the country and to our shareholders. I look forward to updating the market as we continue to develop the project."
Tone Goh, Executive Chairman of GST, commented: "The Company is delighted to have signed this LOI with SIAM. SIAM are one of Thailand's leading business groups and we look forward to working with them to progress this planned data centre project.”
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