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Polarean Imaging (POLX ) has filed for a resubmission of its New Drug Application with the US Food and Drug Administration for the company’s 129 Xenon drug-device combination product.
The filing of the NDA for this combination product, which using hyperpolarised 129 Xenon gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, follows the receipt of a complete response letter that the company received from the US FDA back in October 2021.
At the time, the Group noted that the issues associated with the delay were mostly technical or manufacturing-related in nature and centred around the Xenon hyperpolariser system.
The medical‑imaging technology company said that following a detailed discussion in the Type A meeting with the FDA, these issues have now been addressed in the resubmission.
Shares in Polarean Imaging were trading 20.19% higher at 62.5p following the news.
It is currently expected that the US FDA review period will take six months. In the meantime, the company said it is making full use of this time with regards to commercialisation and launch preparation and will further update the market once material information is received.
Commenting, Richard Hullihen, CEO of Polarean, said: “We have resubmitted the NDA for our 129 Xenon drug-device combination product, following extensive discussions with the FDA regarding the issues that were raised in the CRL. The entire Polarean team has worked diligently to ensure that all the points raised in the CRL were comprehensively addressed”.
Polarean Imaging operates in an area of significant unmet medical need. The annual economic burden of pulmonary disease in the US is estimated to be over US $150 billion.
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