XENOVIEW is a groundbreaking hyperpolarized MRI contrast agent that is the first and only of its kind to receive FDA approval for both adolescents and adults – a major milestone that presents a tremendous market opportunity.
Polarean Imaging plc (AIM: POLX), a medical imaging technology company, is thrilled to announce that the U.S. Food and Drug Administration has granted approval for its groundbreaking drug device combination product, XENOVIEW. XENOVIEW, a hyperpolarized contrast agent prepared from the Xenon Xe 129 Gas Blend, is indicated for use with magnetic resonance imaging (MRI) for the evaluation of lung ventilation in adults and pediatric patients aged 12 and above. This revolutionary product has the potential to revolutionize the way lung ventilation is evaluated and bring a much-needed breath of fresh air to medical imaging.
XENOVIEW revolutionizes pulmonary medicine by offering a safe, radiation-free alternative for visualizing lung ventilation. This revolutionary imaging procedure requires a single 10-15 second breath hold MRI, with the dose of XENOVIEW created through the Polarean HPX hyperpolarization system. Patients can now benefit from a more advanced imaging technique without worry of harmful radiation exposure.
More than 30 million Americans are affected by chronic lung diseases, and there is an urgent need for non-invasive diagnostic technology to help them manage their condition. XENOVIEW is a revolutionary technology that provides healthcare specialists with regional maps of ventilation in their patients’ lungs, enabling them to make informed decisions about their treatment. With this powerful tool, pulmonologists, surgeons, and other respiratory specialists can improve the lives of their patients.
Polarean is proud to have achieved a major milestone with the FDA approval of their pioneering technology, XENOVIEW. This has only been possible through the dedicated efforts of research clinicians and scientists around the world. The commercial team is now ready to launch XENOVIEW for clinical use, marking a significant advancement in modern respiratory imaging. According to Chief Executive Officer Richard Hullihen, “This is an exciting step forward and we are thrilled to have pioneered XENOVIEW for clinical use.”
Dr. Jason Woods, Director of Research in Pulmonary Medicine at Cincinnati Children’s Hospital Medical Center, is delighted that XENOVIEW is now available to adolescent and adult patients. This MRI technology provides the capability to evaluate regional lung ventilation with a safe profile, meeting a major unmet need for individuals seeking to better understand their lung disease.
Polarean is thrilled to announce that, in addition to the FDA approval of the XENOVIEW NDA, two 510(k) devices were also cleared by the regulatory body, setting the stage for a successful launch of the technology into the clinical arena. This exciting news marks a major milestone in the company’s journey and reinforces the potential of the XENOVIEW device.
XENOVIEW VDP is more than just image processing software – it is a powerful platform that provides clinicians with the tools to visualize and evaluate lung ventilation in adults and pediatric patients aged 12 and above. By combining a pulmonary hyperpolarized 129-Xe MR image and a proton chest MR image, XENOVIEW VDP can quantify the normalized xenon intensity of a ventilated space, allowing for the numerical classification of hyperpolarized 129-Xe ventilation MR images. In short, XENOVIEW VDP is a powerful tool that can help clinicians assess lung ventilation quickly and accurately.
The Polarean XENOVIEW 3.0T Chest Coil is a revolutionary tool that enables MRI scans of the lungs in adults and children aged 12 and above. This single-channel, transmit-receive RF coil is tuned to the 129Xe frequency, allowing users to inhale hyperpolarized Xe-129 gas and obtain an MR image of the regional distribution of the gas in the lungs. With this state-of-the-art technology, medical professionals can now assess lung ventilation with greater accuracy and precision than ever before – all while utilizing the power of a 3.0T MRI.
About XENOVIEW
Two groundbreaking clinical trials comparing XENOVIEW MRI to xenon Xe 133 scintigraphy in adult patients with pulmonary disorders have led to FDA approval of XENOVIEW. The trials, which were prospective, multi-center, randomized, open-label and cross-over, achieved their primary endpoints with a mean XENOVIEW dose of 99 mL Dose Equivalent (“DE”) of hyperpolarized xenon Xe 129, administered within 5 minutes of measurement. These results signify a major advance in the diagnosis and treatment of pulmonary disorders.
A study that compared XENOVIEW and xenon Xe 133 imaging in 31 patients with respiratory disorders such as pulmonary mass (44%) and COPD (35%) revealed that the mean difference in the predicted postoperative percentage of remaining lung ventilation between the two imaging methods was within a pre-specified equivalence interval. The observed estimate of 1.4% (95% confidence interval: -0.8%, 3.6%) showed that the two methods were nearly equivalent in predicting postoperative lung ventilation. These results could prove beneficial to those seeking respiratory surgery, in order to determine the most effective imaging method for their individual needs.
In a study comparing XENOVIEW and xenon Xe 133 imaging for the evaluation of possible lung transplant surgery in 49 patients, the results showed that the mean within-patient difference in the percentage of overall lung ventilation contributed by the right lung between XENOVIEW and xenon Xe 133 imaging was within a pre-specified equivalence interval with an observed estimate of 1.6%. These patients had a medical history of respiratory disorders, such as interstitial lung disease, idiopathic pulmonary fibrosis, COPD, and other pulmonary fibrotic disorders. The findings suggest that XENOVIEW and xenon Xe 133 imaging are both effective in evaluating patients with respiratory disorders prior to lung transplant surgery.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Administration of supplemental oxygen during XENOVIEW imaging can reduce image quality, so it’s important to take precautions. To avoid this, make sure to pause oxygen inhalation two breaths before beginning the imaging breath hold, and resume it immediately afterward. Taking these simple steps can ensure a high-quality XENOVIEW imaging experience.
Inhaling an anoxic gas like XENOVIEW could lead to transient hypoxemia in certain individuals. It is essential to be mindful of oxygen levels and any signs of hypoxemia, and treat them as needed. Don’t forget to keep an eye out for any changes in oxygen saturation and symptoms of hypoxemia to ensure your patient’s safety!
Adverse Reactions
XENOVIEW is not approved for use in pediatric patients younger than 12 years old, however, published literature in pediatric patients aged 6 to 18 has reported a variety of transient adverse reactions. These include blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, euphoria and more. In addition, adult patients taking XENOVIEW in efficacy trials experienced oropharyngeal pain, headache, and dizziness.