Polarean's Xenon MRI approved by FDA for ages 6+, adding 1 million eligible patients

Polarean Imaging (POLX) Follow | POLX, a leader in advanced MRI lung imaging technology, said that the US FDA had approved its application to lower the minimum patent age for XENOVIEW from 12 to 6 years old. XENOVIEW is Polarean's proprietary Xenon MRI technology, which uses hyperpolarised Xenon Xe-129 to illuminate hidden lung diseases non-invasively.

XENOVIEW was already FDA-approved for adults and children aged 12 and older. The FDA's decision to lower the minimum age to 6 significantly broadens access to the technology to an additional c. 1 million paediatric patents in the US. The FDA approval also includes the introduction of new XENOVIEW 'Dose Delivery Bag' sizes, tailored for smaller lungs of younger patients.

Christopher von Jako, CEO of Polarean, commenting: "... 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."

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Polarean announces the long anticipated FDA approval of its Xenon MRI technology for pediatric patients aged 6 and older, lowering the previous age limit from 12 years. The extension opens POLX's addressable market to a critical segment where its technology can have a significant impact - children suffering from chronic lung conditions, such as cystic fibrosis, asthma, bronchopulmonary dysplasia, and post-bone marrow transplant inflammation.

Polarean's XENOVIEW promises to revolutionise medical imaging with the ability to illuminate hidden lung diseases non-invasively, enabling early intervention. The radiation-free method targets a significant unmet medical need of 42 million in the US suffering from chronic respiratory disease. The extension announced today to c. 1 million children aged 6-12 gives clinicians a powerful option to characterise disease progression, monitor response to therapy, and guide interventions.

The first to implement the new indication will be the world-renowned Cincinnati Children's Hospital Medical Center, an existing customer of Polarean's. POLX's Xenon MRI has seen rapid sales growth in recent quarters, poised to accelerate through its growing collaboration with Philips. Applications span the spectrum of respiratory conditions, including asthma, bronchopulmonary dysplasia, COPD, Covid-19, cystic fibrosis, pulmonary arterial hypertension, radiation-induced lung injury, and post-transplant lung monitoring.

Prior to today's announcement, Polarean and Philips had already partnered to bring advanced Xenon lung MRI to children aged 6 and older with chronic obstructive lung disease. As part of this collaboration, Polarean’s technology is now fully integrated into Philips' clinical workflow on 3.0T MRI systems, enabling a complete scan in under one minute with just two 10-second breath-holds, using the Polarean XENOVIEW 3T Chest Coil.

In FY24, POLX's revenue more than tripled to $3.1m across 22 active customers, beating guidance. Backed by a $12.6m fundraising round led by strategic partners, the company's current cash runway should extend at least until Q2 2026. With the comfortable cash balance, POLX is well-positioned for further growth. If takeup continues its current trajectory, by end of FY25 POLX's total installed clinical base should be 12-14 systems, with sites performing 5-6 scans per week and revenues of US$5-6m. Profitability would then be expected by FY27.

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