LONDON (ShareCast) - (Sharecast News) - Polarean Imaging announced on Monday that it has received approval from the US Food and Drug Administration to expand the use of its lung imaging agent Xenoview to include children aged six and older, opening access to an additional one million potential patients.
Previously approved for use in patients aged 12 and above, Polarean said Xenoview is used in conjunction with MRI to assess lung ventilation.

The AIM-traded firm said the newly-approved supplemental new drug application also included smaller dose delivery bags specifically designed for paediatric use and updates to Polarean's HPX polarisation measurement station to accommodate these new formats.

It described that expansion as a significant milestone in its strategy to broaden adoption of its non-invasive lung imaging technology and enhance diagnostic capabilities in functional respiratory imaging across both adult and paediatric populations.

"We are delighted that the FDA has approved our supplemental NDA, allowing Xenoview to be used in younger paediatric patients, increasing the number of patients eligible to use our technology by approximately one million," said chief executive officer Christopher von Jako.

"This expanded indication further enhances our technology's clinical utility, offering clinicians an advanced tool to assess the lungs in children with chronic respiratory conditions, and strengthens its return on investment for hospitals.

"We look forward to launching a controlled US market release of the paediatric dose delivery bags later this year, starting with Cincinnati Children's."

At 1135 BST, shares in Polarean Imaging were up 6.65% at 1.36p.

Reporting by Josh White for Sharecast.com.

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