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Recent Polarean News and Press Releases

First clinical scan using XENOVIEW™ conducted at Cincinnati Children’s Hospital Medical Center

May 11, 2023

Scan marks a key milestone for imaging of lung ventilation

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.

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Polarean to be a featured company at 2023 ATS Respiratory Innovation Summit

May 3, 2023

Polarean also exhibiting at 2023 American Thoracic Society annual meeting, providing a great opportunity to showcase XENOVIEW technology to other pulmonary care innovators and providers

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.

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Company Update

February 16, 2023

Company to focus on commercial sales of XENOVIEWᵀᴹ (xenon Xe 129 hyperpolarized), the first and only FDA approved hyperpolarized MRI contrast agent, and pursue corporate partnering opportunities to drive shareholder value

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.

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FDA Grants New Chemical Entity designation for XENOVIEW™ (xenon Xe 129 hyperpolarized)

February 14, 2023

New Chemical Entity designation from FDA provides a five-year market exclusivity period.

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.

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FDA Approves Polarean’s XENOVIEW™ (xenon Xe 129 hyperpolarized)

December 28, 2022

XENOVIEW represents the first and only hyperpolarized MRI contrast agent.
FDA approved indication includes both adolescents and adults representing a significant market opportunity.

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.

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Update on New Drug Application

September 22, 2022

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 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.

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NDA Resubmission

March 31, 2022

NDA submission for Polarean’s hyperpolarised 129Xenon gas drug-device combination product

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”).

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New System Order

February 22, 2022

Unit order for a Xenon Polariser system from McMaster University in Ontario, Canada.

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).

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Complete Response Letter Received from FDA

October 6, 2021

Requirement to address approvability issues identified by FDA ahead of NDA resubmission.

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.

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Polarean Announces NDA Submission of 129Xenon Gas MRI

October 7, 2020

NDA submission for Polarean's hyperpolarized 129Xenon gas drug-device diagnostic for lung imaging.

Polarean Imaging plc (AIM: POLX), the medicalimaging technology company, with an investigational drugdevice 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.

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Positive Results Announced from Pivotal Phase III Clinical Trials

January 29, 2020

Both trials met their primary endpoint, showing pre-defined equivalence of hyperpolarized 129Xenon Gas MRI to an approved comparator, 133Xenon Scintigraphy.

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.

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