Planning and initiating regulatory approval for a new RF coil designed for polarised xenon MRI of the human lungs, this being introduced to give improved diagnosis and treatment planning of respiratory disease.

Respiratory diseases create a massive UK healthcare burden with 1 in 7 people having lung disease, costing the NHS > £6 billion PA, they are the UK s 4th-highest killer and are the most neglected disease in terms of advanced diagnostics and effective treatments. Clinical diagnostics largely rely on blunt respiratory function breathing tests and CT imaging of lung structural change (with its radiation burden). COVID-19 has highlighted their inadequacy and exacerbated a desperate need for safe means of monitoring the lungs in the longer-term. The lungs currently cannot be adequately imaged by commercially available 1H MRI systems provided by any of the main MRI vendors. The technology and applications of inhaled hyperpolarized xenon-gases to allow highly sensitive MRI of the lungs has been shown at a research level to demonstrate very effective diagnosis and treatment planning in a wide range of respirator diseases. It is now being transition to the clinical applications and all new technologies need to pass the request regulations for each territory. In order to produce polarised xenon MR images, existing scanners require two additions A xenon polariser. This is being developed and commercialised by the University of Sheffield but is not part of this grant application An RF coil optimised to detect xenon MR signal from the lungs. This is being developed by PulseTeq in collaboration with the University of Sheffield. The concept design has been completed successfully and has been followed with an operational prototype. This has demonstrated first class results and on this basis, the company has decided to complete the remaining steps required to launch the device as a commercial product. This grant addresses the question: what steps are required for the new RF coil developed by PulseTeq for xenon MR imaging to meet all the necessary regulations and how to ensure that they are implemented successfully, economically and efficiently. The grant will review the regulation, create a detailed plan and prepare the first device necessary for initial regulatory tests and for assessment in a patient and public initiate study at the University of Sheffield.