Predistroke · Portable solution for prehospital diagnosis of stroke in the ultra-acute phase

This project will change the clinical landscape for the early and differential diagnosis of stroke – moving the diagnosis to the primary ambulance intervention site with the use of Strokefinder – an innovative medical diagnostic device based on microwave technology. Today, stroke is responsible for 405,000 deaths (9%) in men and 583,000 (13%) deaths in women each year. The projections indicate that between 2015 and 2035, overall there will be a 34% increase in total number of stroke events in the EU. Most strokes (87%) are ischaemic (caused by thrombosis or embolisms) and the rest (13%) are haemorrhagic (caused mainly by rupture of blood vessel or aneurysm). The complications of ischaemic strokes may be limited by early thrombolytic therapy (treatment to dissolve blood clots). However, while 20-30% of patients arriving at specialised stroke centres may receive thrombolytic therapy, only 3-4% of the patient population are given such treatment, mainly due to long lead times in transport to and from the diagnostic instruments (CT-scans). A haemorrhagic stroke (bleeding) excludes thrombolysis therapy until a proper diagnosis is performed. Medfield Diagnostics has developed a portable, more affordable and easy-to- use diagnostic device for this clinical dilemma. The device utilizes changes in the electromagnetic properties of the brain as a biomarker to exclude haemorrhagic stroke. After having provided proof-of- principle in smaller clinical trials and developed a robust prototype, the objective of the proposed project is to develop a business plan that will guide a large-scale prospective clinical trial to validate the device and optimize the go-to-market strategy. The goal is to make early stroke diagnostic and more effective personalized treatment accessible to a much wider population of patients across the EU.