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

October 8, 2020 Auto Bot MedTech, regulatory, reports, Us FDA 0

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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