US FDA approves Polarean Imaging’s drug device combination product, Xenoview

Polarean Imaging plc, the medical imaging technology company, announces that the US Food and Drug Administration (FDA) has granted approval for its drug device combination product, Xenoview.

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 paediatric patients aged 12 years and older. Xenoview has not been evaluated for use with lung perfusion imaging.

Xenoview expands the opportunity for pulmonary medicine to utilize the first and only inhaled MRI hyperpolarized contrast agent for novel visualization of lung ventilation without exposing patients to any ionizing radiation and its associated risks. The dose of Xenoview, created through the Polarean HPX hyperpolarization system, is administered in a single 10-15 second breath hold MRI procedure.

More than 30 million Americans suffer from a chronic lung disease and there is a significant unmet need for non-invasive diagnostic technology. Xenoview can provide pulmonologists, surgeons, and other respiratory specialists with regional maps of ventilation in their patients’ lungs to assist them in managing their disease.

Richard Hullihen, chief executive officer of Polarean said: “FDA approval represents achievement of a major milestone for Polarean’s technology. This was only possible in close collaboration with multiple research clinicians and scientists globally, who we thank for their tireless and enthusiastic work. Approval of Xenoview represents a major step forward in modern respiratory imaging and we are proud to have pioneered this exciting new technology for clinical use. The commercial team at Polarean is prepared to rapidly launch Xenoview for clinical application.”

Dr. Jason Woods, director of research in pulmonary medicine at the Cincinnati Children’s Medical Center added: “My colleagues and I in the Xenon MRI research community are thrilled that this technology is now available to reach both adolescent and adult patients. With the availability of Xenoview in the clinical setting, we will have the ability to evaluate regional lung ventilation, delivered with a benign safety profile, which has been a major unmet need for the patients that look to us to better understand their lung disease.”

Polarean also announces that, simultaneously with the approval of the Xenoview NDA, two 510(k) devices were cleared by the FDA that will further support a successful launch of the technology into the clinical marketplace:

Xenoview VDP is image processing software that analyzes a pulmonary hyperpolarized 129-Xe MR image and a proton chest MR image to provide visualization and evaluation of lung ventilation in adults and paediatric patients aged 12 years and older. This image analysis platform quantifies normalized xenon intensity of a ventilated space using a pulmonary hyperpolarized 129-Xe ventilation MR image and accompanying proton chest MR image. The software will be used by clinicians to assist in the interpretation and numerical classification of hyperpolarized 129-Xe ventilation MR images.

The Polarean Xenoview 3.0T Chest Coil is a flexible, single channel, transmit-receive (T/R) RF coil tuned to 129Xe frequency on a 3.0T MRI magnetic field of a compatible MRI scanner. The Polarean Xenoview 3.0T Chest Coil is indicated to be used in conjunction with compatible 3.0T MRI scanners and approved xenon Xe 129 hyperpolarized for oral inhalation for evaluation of lung ventilation in adults and paediatric patients aged 12 years and older. The Chest Coil is intended to be worn by a patient who inhales hyperpolarized 129Xe gas (Xenoview) to obtain an MR image of the regional distribution of hyperpolarized 129Xe in the lungs.

Clinical Trial Results: FDA approval of Xenoview was based on clinical trial results from two prospective, multi-center, randomized, open-label, cross-over clinical trials that compared Xenoview MRI to xenon Xe 133 scintigraphy in adult patients with pulmonary disorders. The mean Xenoview dose used in these trials was 99 mL Dose Equivalent (DE) of hyperpolarized xenon Xe 129 at the time of measurement within 5 minutes of administration. Both trials met their primary endpoints.

Study 1 compared Xenoview and xenon Xe 133 imaging in patients being evaluated for possible lung resection surgery. Patients had a medical history of respiratory disorders such as pulmonary mass (44%) and COPD (35%). Additional concomitant respiratory disorders were reported, including; cough (15%), sleep apnoea syndrome (12%), and asthma (12%). In the primary analysis of 31 patients, the mean within-patient difference in the predicted postoperative percentage of remaining lung ventilation between Xenoview and xenon Xe 133 imaging was within a pre-specified equivalence interval with an observed estimate of 1.4% (95% confidence interval: -0.8%, 3.6%).

Study 2 compared Xenoview and xenon Xe 133 imaging in patients being evaluated for possible lung transplant surgery. Patients had a medical history of respiratory disorders, including; interstitial lung disease (49%), idiopathic pulmonary fibrosis (29%), COPD (22%), and other pulmonary fibrotic disorders (14%). In the primary analysis of the 49 patients who completed both scans, 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% (95% confidence interval: -3.7%, 0.5%).

The company and its wholly owned subsidiary, Polarean, Inc. (together the Group) are revenue-generating, medical imaging technology companies operating in the high-resolution medical imaging space.