Polarean Imaging plc (AIM: POLX), the medical imaging technology company, announces that following the approval by the U.S. Food and Drug Administration (“FDA”)  for its drug device combination product, XENOVIEW, it intends to pursue a dual strategy of using its current cash resources to maximize commercial sales of XENOVIEW, while also pursuing collaborations with pharmaceutical companies, magnetic resonance imaging (“MRI”) companies, Contract Research Organizations (“CRO”) and other strategic partners to fund the future commercial applications of the Company’s technology.

Polarean Inc, (AIM: POLX), the medical imaging technology company, announces that the U.S. Food and Drug Administration (“FDA”) has granted New Chemical Entity (“NCE”) designation for its drug product, XENOVIEW, prepared from the Xenon Xe 129 Gas Blend. XENOVIEW is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (“MRI”) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. XENOVIEW has not been evaluated for use with lung perfusion imaging. It has designated a five-year market exclusivity period.

Polarean Imaging plc (AIM: POLX), the medical imaging technology company, announces that the U.S. 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 pediatric patients aged 12 years and older. XENOVIEW has not been evaluated for use with lung perfusion imaging.

Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with an investigational drug-device combination product using hyperpolarised xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces that the U.S. Food and Drug Administration (“FDA”) has requested additional information from Polarean’s xenon-129 gas blend drug manufacturing partner.

Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with an investigational drug-device combination product using hyperpolarised 129Xenon gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces that the Company has filed the resubmission of its New Drug Application (“NDA”) with the US Food and Drug Administration (“FDA”).

Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with an investigational drug-device combination product using hyperpolarised xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces the Company has received an additional research unit order for a Xenon Polariser system from McMaster University in Ontario, Canada. The newest unit (version 9820) will supplement the University’s existing hyperpolarisation 129Xe MRI research programme which is currently using a prior Polarean model (version 9800).

Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with an investigational drug-device combination product using hyperpolarized xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces that the Company has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) for the New Drug Application (“NDA”) for their drug-device combination product.

Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company, with an investigational drug‑device combination product for magnetic resonance imaging (MRI), announces its submission of a New Drug Application (“NDA”) and request for priority review to the US Food and Drug Administration (“FDA”) for hyperpolarized ¹²⁹Xenon gas used to evaluate pulmonary function and to visualize the lung using MRI.

Polarean Imaging plc (AIM: POLX), a clinical-stage medical imaging technology company developing a proprietary magnetic resonance imaging (MRI) drug-device combination, today announced positive top-line results from two pivotal Phase III clinical trials of the company’s drug-device combination, which uses hyperpolarized ¹²⁹Xenon gas MRI to visualize and quantify regional lung function. 

The drug, ¹²⁹Xenon, when polarized in Polarean’s proprietary system, permits functional, regional and quantitative imaging of the lungs using MRI, without the use of ionizing radiation. ¹²⁹Xenon is administered as an inhaled gas that is given to patients in a 10-second breath-hold procedure. For patients who participated in the clinical trials, the ventilation in zones of interest was quantified and compared to images, similarly quantified, derived from a different imaging modality.