FDA expands XENOVIEW® indication to include children from six years of age
MWN-AI** Summary
Polarean Imaging plc announced significant news today regarding its innovative product, XENOVIEW®, as the US Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (NDA) to expand its indication to include children aged six years and older. Previously, XENOVIEW was approved only for those aged 12 and above. This approval marks a notable shift, expanding the accessible patient demographic by approximately one million individuals and considerably broadening Polarean's total addressable market.
XENOVIEW is designed to work in conjunction with Magnetic Resonance Imaging (MRI) to evaluate lung ventilation, now catering to both adults and young pediatric patients. The recent FDA decision also allows for the launch of new Dose Delivery Bag sizes tailored for younger patients, complemented by updates to the HPX Polarization Measurement Station to accommodate these changes.
Dr. Christopher von Jako, CEO of Polarean, expressed the company's enthusiasm for this expansion, highlighting the potential for improved patient care in children with chronic respiratory conditions such as cystic fibrosis and asthma. The addition of XENOVIEW to pediatric medical care is expected to enhance clinical capabilities for monitoring respiratory disease progression and therapy responses.
Pediatric Pulmonologist, Dr. Erik Hysinger from Cincinnati Children’s, echoed the excitement surrounding the expanded access, explaining that this imaging technology provides clinicians vital tools for personalized care management in young patients with complex respiratory issues.
Polarean Imaging, established in 2012, is dedicated to advancing lung health and expanding its groundbreaking MRI technology, aiming to address the significant unmet medical needs of over 500 million patients worldwide suffering from chronic respiratory diseases. The company plans to initiate a controlled market release for the pediatric Dose Delivery Bags later this year, starting with Cincinnati Children’s Hospital.
MWN-AI** Analysis
Polarean Imaging plc has recently received FDA approval to expand the indication of its revolutionary imaging agent, XENOVIEW®, to include pediatric patients aged six years and older, marking a pivotal milestone for the company and the medical imaging field. This regulatory approval not only broadens access to the technology for approximately one million additional patients but also significantly expands Polarean’s total addressable market, which is critical for future revenue growth.
Investors should closely monitor the company's strategic moves following this approval, particularly the planned controlled market release of new Dose Delivery Bag sizes specifically designed for younger patients. The interest from key healthcare institutions, such as Cincinnati Children’s Hospital, suggests tangible demand for XENOVIEW in pediatric care for chronic respiratory conditions. As awareness of and demand for advanced imaging options grow, Polarean’s ability to market effectively to hospitals and clinics will be crucial.
Moreover, the expansion to include younger patients aligns well with broader trends in personalized medicine and the increasing focus on addressing chronic respiratory diseases in children. Investors should consider the implications of this approval within the larger context of the healthcare market, particularly as it relates to the advancement of non-invasive imaging technologies that are essential for accurate diagnosis and treatment.
From a stock performance perspective, while Polarean has had fluctuations typical in the biotech sector, the positive FDA news could lead to bullish market sentiment. It may be prudent to consider accumulating shares as the company prepares for its pediatric rollout and continues to establish its presence in a less saturated segment of the medical imaging market. In conclusion, maintaining a long-term view on Polarean is advisable, given its potential for substantial growth tied to this expanded indication.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
DURHAM, NC and LONDON, June 02, 2025 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX) (“Polarean” or the “Company”), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ("MRI") of the lungs, announces that the US Food and Drug Administration (“FDA”) has approved the Company’s Supplemental New Drug Application (“NDA”) to expand the indication of XENOVIEW®. This approval immediately lowers the minimum patient age from 12 to six years old, significantly broadening access to this technology and expanding Polarean’s total addressable market.
The approval means that XENOVIEW can now be used with MRI for evaluation of lung ventilation in adults and pediatric patients aged six years and older, representing an increase in the number of eligible patients by approximately one million. The FDA supplement approval also includes the introduction of new XENOVIEW Dose Delivery Bag sizes tailored for smaller lungs of younger patients and corresponding updates to the HPX Polarization Measurement Station to measure various bag sizes. This approval reinforces Polarean’s dedication to advancing functional lung imaging and increasing access to its technology, enabling enhanced care for a broader patient population.
Christopher von Jako, Ph.D., Chief Executive Officer of Polarean, said: "We are delighted that the FDA has approved our Supplemental NDA, allowing XENOVIEW to be used in younger pediatric patients, increasing the number of patients eligible to use our technology by approximately one million. 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 pediatric Dose Delivery Bags later this year, starting with Cincinnati Children’s.”
Erik Hysinger, MD, Pediatric Pulmonologist from Cincinnati Children’s, said: “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. 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.”
For more information, visit www.xenoview.net .
About Polarean
Polarean is a revenue-generating medical imaging technology company revolutionizing pulmonary medicine through direct visualization of lung function by introducing the power and safety of MRI to the respiratory healthcare community. This community is in desperate need of modern solutions to accurately assess lung function. The Company strives to optimize lung health and prevent avoidable loss by illuminating hidden disease, addressing the global unmet medical needs of more than 500 million patients worldwide suffering from chronic respiratory disease. Polarean is a leader in the field of hyperpolarization science and has successfully developed the first and only hyperpolarized Xenon MRI inhaled contrast agent, XENOVIEW ® , which is now FDA-approved in the United States. Polarean is dedicated to researching, developing, and commercializing innovative imaging solutions with its non-invasive and radiation-free pulmonary functional MRI platform. This comprehensive drug-device platform encompasses the proprietary Xenon gas blend, gas hyperpolarization system, as well as software and accessories, facilitating fully integrated modern respiratory imaging operations. Founded in 2012, with offices in Durham, NC, and London, United Kingdom, Polarean is committed to increasing global awareness of and broad access to its XENOVIEW MRI technology platform. For the latest news and information about Polarean, please visit www.polarean.com .
XENOVIEW IMPORTANT SAFETY INFORMATION
Indication
XENOVIEW™, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 years and older.
Limitations of Use
XENOVIEW has not been evaluated for use with lung perfusion imaging.
CONTRAINDICATIONS
None.
Warnings and Precautions
Risk of Decreased Image Quality from Supplemental Oxygen: Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold.
Risk of Transient Hypoxia: Inhalation of an anoxic gas such as XENOVIEW may cause transient hypoxemia in susceptible patients. Monitor all patients for oxygen desaturation and symptoms of hypoxemia and treat as clinically indicated.
Adverse Reactions
Adverse Reactions in Adult Patients: The adverse reactions (> one patient) in efficacy trials were oropharyngeal pain, headache, and dizziness. Adverse Reactions in Pediatric and Adolescent Patients: In published literature in pediatric patients aged 6 to 18, transient adverse reactions were reported: blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria. In at least one published study of pediatric patients aged 6 to 18 years, transient decrease in SpO2% and transient increase in heart rate was reported following hyperpolarized xenon Xe 129 administration.
Please see full prescribing information at www.xenoview.net .
Contact Information:
Polarean:
Chuck Osborne
Chief Financial Officer
+1 (919) 206-7900, ext. 117
cosborne@polarean.com
Polarean Investors:
Anna Dunphy / Phillip Marriage
+44 (0)20 7933 8780
polarean@wallbrookpr.com
Polarean Media Contact:
Alexis Opp
+1 (919) 206-7900, ext. 145
aopp@polarean.com
General inquiries: info@polarean.com
Follow Polarean on LinkedIn here
Polarean:Chuck OsborneChief Financial Officer+1 (919) 206-7900, ext. 117cosborne@polarean.comPolarean Investors:Anna Dunphy / Phillip Marriage+44 (0)20 7933 8780polarean@wallbrookpr.comPolarean Media Contact:Alexis Opp+1 (919) 206-7900, ext. 145aopp@polarean.comGeneral inquiries: info@polarean.com
FAQ**
How does the recent FDA approval for Polarean Imaging PLC PLLWF's XENOVIEW® technology impact patient access to lung imaging in Durham, NC compared to cities like London?
What potential market growth opportunities exist for Polarean Imaging PLC PLLWF in Durham, NC, following the expansion of their pediatric patient age indication to six years and older?
How might healthcare providers in London leverage Polarean Imaging PLC PLLWF’s advancements in MRI technology to improve patient outcomes for chronic respiratory diseases?
In what ways could the partnership with Cincinnati Children’s Hospital enhance Polarean Imaging PLC PLLWF's presence in the pediatric pulmonary care market, particularly in comparison to similar facilities in London?
**MWN-AI FAQ is based on asking OpenAI questions about Polarean Imaging PLC (OTC: PLLWF).
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