FDA expands Xenoview indication down to 6 years for MRI lung ventilation evaluation | Image credit: Contemporary Pediatrics

On June 2, 2025, the FDA approved a supplemental new drug application to expand the indication of xenon Xe 129 hyperpolarized (XENOVIEW; Polarean Imaging plc) for oral inhalation down to patients aged 6 years and older. As a result, this younger population, down from the previous indication of 12 years and older, can now use XENOVIEW with MRI for evaluation of lung ventilation. With the expanded approval, the number of eligible patients for XENOVIEW has increased by approximately 1 million, according to a press release from Polarean Imaging.¹

"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," said Christopher von Jako, PhD, CEO, Polarean, in a statement. "We look forward to launching a controlled US market release of the pediatric Dose Delivery Bags later this year, starting with Cincinnati Children’s."

The supplemental FDA approval also included the introduction of new XENOVIEW Dose Delivery Bag sizes which are designed for smaller lungs of the younger population now eligible for use of the oral inhalation. Additionally, corresponding updates to the HPX Polarization Measurement Station, to measure various bag sizes, has also been included in the approval.

“This approval is an exciting step for children with chronic lung diseases, such as cystic fibrosis, asthma, bronchopulmonary dysplasia, and inflammation following bone-marrow transplant," added Erik Hysinger, MD. Hysinger is a pediatric pulmonologist at Cincinnati Children's, which will receive the first of the pediatric Dose Delivery Bags. "For years, I’ve studied Xenon MRI in children ages 6 to 12, and expanding access to younger patients offers clinicians a powerful tool to characterize disease progression, monitor response to therapy, and guide interventions like airway dilation or tissue removal. This imaging platform enhances our ability to deliver more personalized, precise care for children with complex respiratory conditions," said Hysinger.

Functionality of XENOVIEW

According to Polarean, XENOVIEW illuminates distribution of gas in the lungs and allows clinicians to evaluate regional lung ventilation. It is prepared from the Xenon Xe 129 gas blend. A HPX Hyperpolarizer transforms Xenon Xe 129 Gas Blend into a hyperpolarized state by placing a non-radioactive isotope of the xenon source gas into a beam of polarized laser light in the presence of very small amounts of an alkali metal. The process leaves the xenon Xe 129 chemically unchanged, but with magnetically aligned nuclei.^1,2

The hyperpolarized xenon Xe 129 creates a unique MRI signal (resonance frequency) that can be detected to determine its distribution throughout the lungs. Compared to air that is typically within the lung, hyperpolarized xenon Xe 129 enhances the MRI signal by a factor of 100,000.

Safety and efficacy of XENOVIEW

In a pair of prospective, multicenter, randomized, open-label, crossover clinical studies, XENOVIEW MRI imaging was compared to xenon Xe 133 scintigraphy in adult patients with pulmonary disorders. Study 1 featured patients being evaluated for possible lung resection surgery (n = 32), while study 2 featured patients being evaluated for possible lung transplant surgery (n = 49). The primary analysis was pre-specified equivalence interval between XENOVIEW™ and xenon Xe 133 imaging.³

Each study demonstrated equivalence of XENOVIEW to xenon Xe 133 scintigraphy in assessment of regional lung ventilation. XENOVIEW was well tolerated, according to Polarean, with adverse reactions reported in 14% of patients, of whom 98% had received a single administration of XENOVIEW. Adverse reactions reported by more than 1 patient were: oropharyngeal pain (n = 4), headache (n = 2), and dizziness (n = 2).

Reference:

1. FDA expands XENOVIEW indication to include children from six years of age. Polarean Imaging. Press release. June 2, 2025. Accessed June 2, 2025. https://polarean.com/wp-content/uploads/2025/06/US-Press-Release-Version_-Pediatric-Label-Expansion_2025-06-02.pdf

2. What is XENOVIEW? Polarean. Accessed June 2, 2025. https://xenoview.net/about-xenoview/hyperpolarized-xe-129-gas/

3. XENOVIEW provides effective measurement of regional lung ventilation. Polarean. Accessed June 2, 2025. https://xenoview.net/about-xenoview/efficacy-and-safety/