Clearance received for new MRI chest coil

Polarean Imaging PLC

03 August 2023

 

3 August 2023

Polarean Imaging Plc

("Polarean" or the "Company") 

Polarean Receives Clearance for New MRI Chest Coil

Additional clearance for new MRI chest coil further supports the recently announced collaboration with
Philips

Polarean Imaging Plc (AIM: POLX), 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 specialised MRI chest coil to now include Philips 3.0T MRI scanners for the visualisation of the Xenon-129 (129Xe) nuclei.

The Polarean XENOVIEW™ 3.0T Chest Coil is a flexible, single channel, transmit-receive RF coil tuned to image 129Xe nuclei while a patient is positioned inside a multinuclei-capable MRI scanner. The XENOVIEW Chest Coil is indicated to be used in conjunction with compatible 3.0T MRI scanners and approved hyperpolarised 129Xe for oral inhalation for the evaluation of lung ventilation in adults and paediatric patients, aged 12 years and older. The addition of the new Philips configuration does not affect the intended use of the device; the safety and effectiveness has been confirmed with testing.

Christopher von Jako, CEO of Polarean, said: "Polarean continues to develop and launch new devices and accessories that empower sites to perform modern respiratory imaging, enabling as many clinicians as possible to use our technology for their patients. This FDA clearance also further supports our recently announced collaboration with Philips, by expanding our product line to be compatible with their advanced MRI systems."

Enquiries: 

Polarean Imaging plc			www.polarean.com / www.polarean-ir.com
Christopher von Jako, Chief Executive Officer			Via Walbrook PR
Kenneth West, Chairman
Stifel Nicolaus Europe Limited (NOMAD and Sole Corporate Broker)				[phone]
Nicholas Moore / Samira Essebiyea / Kate Hanshaw (Healthcare Investment Banking)
Nick Adams / Nick Harland (Corporate Broking)
Walbrook PR	Tel: [phone] or [e-mail]
Anna Dunphy / Phillip Marriage		Mob: [phone]

About Polarean (www.polarean.com)

The Company and its wholly owned subsidiary, Polarean, Inc. (together the "Group") are revenue-generating, medical imaging technology companies operating in the high-resolution medical imaging space. Polarean aspires to revolutionise pulmonary medicine by bringing the power and safety of MRI to the respiratory healthcare community in need of new solutions to evaluate lung ventilation, diagnose disease, characterise disease progression, and monitor response to treatment. By researching, developing, and commercialising novel imaging solutions with a non-invasive and radiation-free functional imaging platform. Polarean's vision is to help address the global unmet medical needs of more than 500 million patients worldwide suffering with chronic respiratory disease. Polarean is a leader in the field of hyperpolarisation science and has successfully developed the first and only hyperpolarised MRI contrast agent to be approved in the United States.   The company also commercialises systems (such as the HPX hyperpolarisation system), accessories (such as Xe-specific chest coils and phantoms) and FDA-cleared post-processing software (to support ventilation defect analysis), to support fully integrated modern respiratory imaging operations.

PLC-RNS-2316

 

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