Polarean Reports the NDA Submission of Hyperpolarised 129Xenon Gas Drug-Device Diagnostic to the US FDA for Lung Imaging

Shots:  

• The company reports NDA submission and request for PR to the US FDA for hyperpolarised ¹²⁹Xenon gas used to evaluate the pulmonary function and to visualize the lung using MRI. The NDA submission follows the completion of two P-III studies, demonstrating the effective measurement of regional lung ventilation
• Both the studies met their 1EPs showing pre-defined equivalence of hyperpolarised 129Xenon MRI vs 133Xenon Scintigraphy and displayed a benign safety profile
• ¹²⁹Xenon gas MRI was used to measure regional pulmonary function in patients with lung diseases who were being evaluated for possible lung resection/ transplant surgery and is administered as an inhaled gas that is given to patients in a 10sec breath-hold MRI procedure

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