Polarean Imaging PLC (AIM:POLX, OTC:PLLWF) shares leapt higher on Wednesday after the company revealed that the US medical regulator had given the green light for its XENOVIEW drug-device combination product.
The US Food and Drug Administration (FDA) granted approval for XENOVIEW to be used in the evaluation of lung ventilation in adults and children aged 12 and older, the company said, with its scanning software and chest coil devices also given clearance to support a successful launch of the technology into the clinical marketplace.
Using a Xenon Xe 129 gas blend, XENOVIEW is designed to improve the results of MRI lung scans.
The AIM-listed company said the product is now 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
It has not been evaluated by the FDA for use with lung perfusion imaging, the company noted.
The FDA also cleared the XENOVIEW VDP image processing software, which analyses the pulmonary hyperpolarized 129-Xe MR images and proton chest MR images to provide visualization and evaluation of lung ventilation to be used by clinicians to assist in interpretation and numerical classification of the images.
The Polarean XENOVIEW 3.0T Chest Coil is indicated to be used in conjunction with compatible MRI scanners and to be worn by a patient who inhales the hyperpolarized gas to obtain an MR image of the regional distribution of hyperpolarized 129Xe in the lungs.
In a statement, Polarean chief executive Richard Hullihen said the FDA approval was "a major milestone" and 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 shares rose 32.5% to 64.9p in early trading on Wednesday.