polarean Regulatory News (POLX)

1 February 2023

Polarean Imaging Plc  

("Polarean" or the "Company") 

 FDA grants New Chemical Entity designation for XENOVIEW

Polarean Imaging plc (AIM: POLX), the medical imaging technology company, announces that the U.S. Food and Drug Administration ("FDA") has granted New Chemical Entity ("NCE") designation for its drug product, XENOVIEW. XENOVIEW, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarised contrast agent indicated for use with magnetic resonance imaging ("MRI") for evaluation of lung ventilation in adults and paediatric patients aged 12 years and older. XENOVIEW has not been evaluated for use with lung perfusion imaging. It has designated a five year market exclusivity period.

XENOVIEW expands the opportunity for pulmonary medicine to utilise the first and only inhaled MRI hyperpolarised contrast agent for novel visualisation of lung ventilation without the risk of exposing patients to ionising radiation. The dose of XENOVIEW, created through the Polarean HPX hyperpolarisation system, is administered in a single 10-15 second breath-hold MRI procedure.

More than 30 million Americans suffer from a chronic lung disease and there is a significant unmet need for non-invasive diagnostic technology. XENOVIEW can provide pulmonologists, surgeons, and other respiratory specialists with regional maps of ventilation in their patients' lungs to assist them in managing their disease.  

Richard Hullihen, Chief Executive Officer of Polarean said: "FDA designation of New Chemical Entity represents an achievement of a major milestone for the Company's technology. As the first ever hyperpolarised noble gas inhaled oral contrast agent approved, this designation provides the important first mover protection envisioned under the Hatch Waxman legislation."

Enquiries: 

About Polarean (www.polarean.com)

The Company and its wholly owned subsidiary, Polarean, Inc. (together the "Group") are revenue-generating, medical imaging technology companies operating in the high-resolution medical imaging space. Polarean aspires to revolutionize pulmonary medicine by bringing the power and safety of MRI to the respiratory healthcare community in need of new solutions to evaluate lung function, diagnose disease, characterize disease progression, and monitor response to treatment. By researching, developing, and commercializing novel imaging solutions with a non-invasive and radiation-free functional imaging platform, Polarean's vision is to help address the global unmet medical needs of more than 500 million patients worldwide suffering with chronic respiratory disease. Polarean is a leader in the field of hyperpolarization science and has successfully developed the first and only hyperpolarized MRI contrast agent to be approved in the United States. On December 23, 2022, the FDA granted approval for Polarean's first drug device combination product, XENOVIEWTM (xenon Xe 129 hyperpolarized). 129Xe MRI is also currently being studied for visualization and quantification of gas exchange regionally in the smallest airways of the lungs, across the alveolar tissue membrane, and into the pulmonary bloodstream for future clinical indications.

XENOVIEWTM is a trademark of Polarean, Inc. POL-PR-2201