Polarean receives FDA approval for drug device combination product

28th Dec 2022 08:10

(Sharecast News) - Medical imaging technology group Polarean said on Wednesday that its drug device combination product has been granted approval by the US Food and Drug Administration.

Polarean stated the FDA had approved its XENOVIEW asset, prepared from the Xenon Xe 129 Gas Blend, for use with magnetic resonance imaging for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.

The AIM-listed group also announced that two 510(k) devices were cleared by the FDA that will further support a successful launch of the technology into the clinical marketplace - XENOVIEW VDP and XENOVIEW 3.0T Chest Coil.

Chief executive Richard Hullihen said: "FDA approval represents [an] achievement of a major milestone for Polarean's technology. This was only possible in close collaboration with multiple research clinicians and scientists globally, who we thank for their tireless and enthusiastic work.

"Approval of XENOVIEW represents a major step forward in modern respiratory imaging and we are proud to have pioneered this exciting new technology for clinical use. The commercial team at Polarean is prepared to rapidly launch XENOVIEW for clinical application."

As of 0820 GMT, Polarean shares had shot up 42.35% to 69.75p.

Reporting by Iain Gilbert at Sharecast.com