DURHAM, NC and LONDON September 8, 2023 (GLOBE NEWSWIRE) – Polarean (AIM: POLX), a commercial-stage medical device leader in advanced magnetic resonance imaging (MRI) of the lungs, announced today it has partnered with VIDA Diagnostics (VIDA), a clinical imaging intelligence company providing medical imaging software solutions which manage the complexities of digital biomarkers.  The companies are partnering to develop solutions that further enable the Polarean xenon 129 MRI platform to accelerate clinical and research use.

DURHAM, NC and LONDON August 29, 2023 (GlobeNewswire) – Polarean (AIM: POLX), a commercial-stage medical device leader in advanced MRI scanning of the lungs, announces that the Centers for Medicare & Medicaid Services (CMS) has established a new reimbursement code for the Polarean XENOVIEW™ (xenon Xe 129, hyperpolarized) technology, effective October 1, 2023.

Polarean (AIM: POLX) (the “Company”), a commercial-stage medical device leader in advanced MRI scanning of the lungs, announces it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s specialized MRI chest coil to now include Philips 3.0T MRI scanners for the visualization of the Xenon-129 (129Xe) nuclei.

Polarean Imaging plc (AIM: POLX), the medical imaging company, announces that the Company’s Board of Directors has appointed Christopher von Jako, Ph.D. (“Dr. von Jako”) as Chief Executive Officer and director of the Company, effective immediately. Dr. von Jako succeeds Richard Hullihen, who will be retiring and will be stepping down as a Director of the Company, effective immediately. Mr. Hullihen will assist the Company in a transitional position for the next six months.

Polarean Imaging plc (AIM:POLX), the medical imaging company, announces that it has entered into a collaboration with Philips, a global leader in health technology, to advance the field of hyperpolarized Xenon MRI. Philips will showcase its 3T MR 7700 system (“MR 7700”), featuring fully integrated multi-nuclei imaging, including Polarean’s XENOVIEW (xenon Xe 129 hyperpolarized) technology at the 2023 International Society for Magnetic Resonance in Medicine Annual Meeting & Exhibition (“ISMRM”), held from 3-8 June, in Toronto, Canada.

Polarean Imaging plc’s (AIM:POLX), the medical imaging company, announces that the first clinical scan utilizing its XENOVIEW (xenon Xe 129 hyperpolarized) technology in the United States occurred today at Cincinnati Children’s Hospital Medical Center (“Cincinnati Children’s”). XENOVIEW is the only hyperpolarized contrast agent approved by the U.S. Food and Drug Administration for use with magnetic resonance imaging (MRI) for the evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.

Polarean Imaging plc (AIM: POLX), the medical imaging technology company, has been selected as one of the featured companies as a poster presenter at the American Thoracic Society’s(“ATS”) 2023 Respiratory Innovation Summit (“RIS”), taking place 19-20 May in Washington D.C.

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.