Polarean Imaging PLC (AIM:POLX, OTC:PLLWF) has hailed as a ‘major milestone’ the granting of new chemical entity (NCE) status by the US Food & Drug Administration (FDA) for a gas it created for use in MRI scans.
XENOVIEW, created from the Xenon Xe 129 Gas Blend, is a hyperpolarised contrast agent used to evaluate lung ventilation in adults and children aged 12 and older.
It is the first-ever hyperpolarised noble gas inhaled oral contrast agent approved and has been granted a five-year market exclusivity period.
The NCE designation protects the company's technology and offers first mover advantage as per the Hatch-Waxman legislation.
In a statement, Polarean chief executive Richard Hullihen said: "The FDA designation of new chemical entity represents a major milestone for the company's technology.
“XENOVIEW is expected to address the significant unmet need for non-invasive diagnostic technology in pulmonary medicine.
“Over 30 million Americans suffer from chronic lung disease and XENOVIEW has the potential to provide pulmonologists, surgeons, and respiratory specialists with regional maps of ventilation in their patients' lungs, helping them manage the disease effectively.”