Polarean Imaging reports on phase III lung trials

2017 12 20 17 16 6396 Lung General 400

Polarean Imaging is touting the results of two phase III clinical trials for its drug-device combination that uses hyperpolarized xenon-129 (Xe-129) gas with MRI to visualize and quantify regional lung function.

When polarized with Polarean's system, Xe-129 enables functional, regional, and quantitative MR imaging of the lungs. Patients inhale Xe-129 as a gas during a 10-second breath-hold procedure. During clinical trials, ventilation in zones of interest was quantified and compared with images, similarly quantified, from a different imaging modality.

Both clinical trials met their primary end points within the prospectively defined equivalence margin (± 14.7%) when compared with a reference standard approved by the U.S. Food and Drug Administration (FDA), 133-xenon scintigraphy imaging.

Polarean plans to submit a new drug application (NDA) to the FDA in the third quarter of this year.

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