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Polarean Imaging scores phase III success

Published: 02:10 29 Jan 2020 EST

Polarean Imaging PLC -

Polarean Imaging PLC (LON:POLX) said two phase III clinical trials have “validated the belief” that its technology allows doctors and surgeons to visualise aspects of lung function that have gone undetected using traditional magnetic resonances imaging (MRI) techniques.

And it does so in a way that was both safe and allowed for quantitative analysis of the area of the lung being examined, it added.

Polarean has developed a drug-device combination that uses hyperpolarised 129-Xenon gas and MRI.

By inhaling and holding a small amount of the gas for just a few seconds, the patient is able to create a much stronger MRI signal, providing doctors with multiple images of lung structure and function.

Both phase III trials met their primary endpoint, which means they succeeded in showing that Polarean’s technology was at least equivalent to an approved comparator called 133 Xenon Scintigraphy.

The data revealed that the company’s approach provided an effective measure of regional lung ventilation.

The studies were performed in two distinct patient groupings - those where part of the lung had been resected (removed), and those that had received a transplant.

Polarean said it expects to submit a new drug application (NDA) for its drug/device in the third-quarter after what’s called a pre-NDA meeting with the US Food & Drug Administration.

“Given the limitations of existing methods to diagnose and monitor lung disease, we see a significant unmet need for non-invasive, quantitative and cost-effective image-based diagnosis technology without exposing patients to ionizing radiation,” said Polarean chief executive Richard Hullihen.

“We believe that our technology has the potential to overcome these limitations and we look forward to using data from the Clinical Trials to support our New Drug Application," he added.

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on 01/17/2024