Duke spinout Polarean exceeds expectations with lung-imaging trial, seeks meeting with FDA
A successful Phase 3 trial of Polarean Imaging’s drug-device combination for lung imaging has the Research Triangle Park company poised to seek next-step advice from regulators with the Food and Drug Administration.
Polarean, a spinout of Duke University, is pursuing clinical use of a three-dimensional technology that has been limited to research labs so far. But the company says its clinical importance is in its ability to improve images of patients’ lung function and capacity using a whiff of a harmless gas called hyperpolarized 129Xenon during magnetic resonance imaging (MRI). The Polarean method then uses three-dimensional mapping to monitor respiratory function.
In conjunction with MRI, the inhaled hyperpolarized gas assesses lung function and capacity with Xenon scintigraphy. This technique provides a unique and sensitive way to monitor changes in lung structure and function.