Polarean Gains FDA Approval for Lung Imaging Agent

Polarean Imaging, a Durham-based medical imaging technology company, has received regulatory clearance for a drug and device combination product that helps doctors visualize lung function in patients with chronic lung disease.

The U.S. Food and Drug Administration granted approval for Xenoview, a contrast agent used with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. Lung ventilation is the flow of air into and out of the lungs during inhalation and exhalation.

“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,” said Richard Hullihen, chief executive officer of Polarean. “The commercial team at Polarean is prepared to rapidly launch Xenoview for clinical application.”

Xenoview, prepared from a xenon gas blend denoted as 129-Xe, is the first and only inhaled MRI hyperpolarized contrast agent to be approved in the United States for novel visualization of lung ventilation without exposing patients to any ionizing radiation and its associated risks, according to Polarean. Xenoview is administered in a single 10- to 15-second breath-hold MRI procedure.  

Xenoview is intended to provide pulmonologists, surgeons and other respiratory specialists with regional maps of ventilation in their patients’ lungs to assist them in managing their disease.   

“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,” said Jason Woods, Ph.D., director of research in pulmonary medicine at Cincinnati Children’s Hospital Medical Center. “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.” 

More than 30 million Americans suffer from a chronic lung disease, and there is a significant unmet need for non-invasive diagnostic technology. The annual economic burden of pulmonary disease in the United States is estimated to be over $150 billion.

Enhancing MRI scans

The principle behind the Xenoview technology involves transforming the inert gas xenon into a hyperpolarized state using laser light. This process leaves the gas chemically unchanged, while its nuclei are magnetically aligned.

The hyperpolarized gas is inhaled by a patient to fill the space in the lungs normally occupied by air. The gas enhances the MRI signal, making lung function and regional ventilation visible in an MRI scan.

FDA approval of Xenoview was based on the results of two clinical trials, one involving adult patients with pulmonary disorders and one involving patients being evaluated for possible lung resection surgery.

Xenoview has not been evaluated for use with lung perfusion imaging, which shows how blood is flowing in the lungs, the company noted.

Related devices also approved

Polarean also announced that, along with the approval of Xenoview, two medical devices were also cleared by the FDA that will further support a successful launch of the Xenoview technology into the clinical marketplace.

One of them is Xenoview VDP, image-processing software that helps clinicians with the interpretation and numerical classification of Xenoview ventilation MRI scans.

The other approved device is the Xenoview 3.0T Chest Coil, a flexible, single channel, transmit-receive radio frequency coil for use with compatible MRI scanners in the evaluation of lung ventilation. The Chest Coil is intended to be worn by a patient who inhales Xenoview during an MRI scan. 

Early support from NCBiotech

Polarean’s vision is to help the more than 500 million patients worldwide who suffer from chronic respiratory disease by developing non-invasive and radiation-free novel imaging solutions.

The company was spun out of Duke University in 2016 after securing all of GE Healthcare’s assets in the field of hyperpolarized gas MRI, including the exclusive rights to about 30 patent families.

In 2017 Polarean received a $250,000 Small Business Research Loan from the North Carolina Biotechnology Center to support automation of Xenoview to improve the device's safety, workflow and medical economics.

Polarean is now a public company. Its shares are traded over the counter on the OTC Markets under the symbol PLLWF.