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(Alliance News) - Polarean Imaging PLC on Wednesday reported positive results from two trials of its magnetic resonance imaging drug-device combination product.
The medical imaging products developer said two phase III clinical trials of the company's drug-device combination, which uses hyperpolarized Xenon gas MRI to visualise and quantify regional lung function, met their primary endpoint.
Both trials met their primary endpoints, within the prospectively defined equivalence margin when compared to the FDA-approved reference standard, Xenon scintigraphy imaging, Polarean said.
Polarean plans to use the new data from the trials for a pre-new drug application meeting with the US Food & Drug Administration. The company plans to submit a new drug application for its drug-device combination to FDA in the third quarter of 2020.
Shares in Polarean closed at 31.62 pence each in London on Wednesday, up 0.4%.
By Tapan Panchal; tapanpanchal@alliancenews.com
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