FDA clears Polarean's lung disease diagnostic Xenoview

US medtech company Polarean Imaging has secured FDA approval for Xenoview, a drug device combination used alongside magnetic resonance imaging (MRI) to measure how well the lungs are functioning.

The diagnostic consists of a new hyperpolarised contrast agent based on xenon 129 gas, with a chest coil device used to enhance the MRI signal within the lungs and image processing software in order to provide a visual representation of lung ventilation.

It has been approved for evaluation of lung ventilation in adults and paediatric patients aged 12 years and older and, according to Polarean, is the first and only inhaled MRI hyperpolarised contrast agent to reach the market. It provides an alternative to other lung ventilation assessment technologies that use potentially harmful ionising radiation, like computed tomograph (CT) scanning.

MRI has only recently emerged as an option for lung ventilation testing, aided by technological advances, as previously low proton density in lung tissue and pulmonary and cardiac motion made it hard to get an accurate assessment.

Xenoview involves a single 10- to 15-second breath hold during an MRI as the patient wears the chest coil device. The image of the inhaled hyperpolarised xenon 129 gas reveals how deeply air would enter into lung tissue whilst breathing, helping to diagnose and manage patients with serious lung conditions, including chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF).

London Stock Exchange-listed Polarean noted there are more than 30 million people in the US with chronic lung diseases, adding that there is a significant unmet need for non-invasive diagnostic technologies like Xenoview which provide regional maps of ventilation in the lungs.

The approval is the culmination of a lengthy effort by the North Carolina-based company to get the imaging technology over the regulatory line.

It's first marketing application was turned down in October 2021 with an FDA request for more technical and manufacturing information focusing on the xenon hyperpolariser system.

Polarean refiled in March 2022, and six months later the FDA requested additional information from the contract manufacturing organisation (CMO) responsible for manufacturing the xenon 129 gas blend used in Xenoview.

With approval now in hand, the company intends to focus its commercialisation efforts towards the top 1,000 or so US academic and teaching hospitals providing respiratory medicine services.

It estimates that the market equipment alone could be $500 million, backed up by ongoing sales of the contrast agent for diagnostic use, as well as for supporting pharma companies running trials of new therapies for respiratory diseases.