Medical device company EMVision (ASX: EMV) has reported “excellent” results from a study gauging the effectiveness of its cutting-edge neurodiagnostic technology for the identification of stroke and stroke types.

The multi-site study – known as EMView – involved the testing of diagnostic algorithms on unseen data from 307 participants across the Liverpool, Royal Melbourne, and Princess Alexandra hospitals in Australia, including 277 suspected stroke patients.

Each of the participants was successfully scanned with the company’s portable brain scanner named ‘emu’, providing the data to power the group’s neurodiagnostic artificial intelligence (AI) algorithms.

According to EMVision, the study delivered high performance outcomes with respect to identifying haemorrhages, or in other words bleeding in or around the brain resulting from the rupture of a blood vessel, as well as blood clots known as ischemia.

More specifically, the company’s technology correctly diagnosed 92 per cent of patients with a haemorrhage and 85 per cent of those without the condition.

Similarly, results from the study revealed an 85 per cent success rate in diagnosing patients with ischemia and 78 per cent accuracy in identifying those without it.

Management noted that these results shine a light on the exceptional sensing capabilities of the group’s technology, including successful detection and classification of very small haemorrhages. It added that the AI-based diagnostic models demonstrated steadily improved performance as additional clinical training data was provided.

EMVision now plans to move forward with a validation trial to conclusively demonstrate the diagnostic performance of the group’s portable brain scanner, as it seeks to secure regulatory clearance from the US Food and Drug Administration (FDA). 

A tick of approval from the FDA could pave the way for commercialisation of the product.

The validation trial is anticipated to last between six and twelve months at a cost of about $4 million, with the company expecting to fund the trial with existing cash reserves. It has already locked in site visits at prospective US locations for the trial. 

EMVision chief executive officer, Scott Kirkland, said:

“There is a huge unmet need for stroke and stroke type diagnosis at the point-of-care. We can fill that need. We are very proud of these results which highlight our technology’s unique neurodiagnostic capabilities. We remain focused on progressing and executing our clinical validation and commercialisation strategy as we look to revolutionise stroke diagnosis and make a substantial positive impact on one of the major causes of global disability.”

Strokes represent one of the leading causes of death and disability around the globe. 

According to EMVision, about 25 per cent of adults over the age of 25 are projected to suffer from a stroke during their lifetime. Notably, more than 12 million people worldwide are forecast to have their first stroke this year alone, with 6.5 million people expected to die from the condition as a result.

Based on data from the World Stroke Organization, the global economic impact of strokes currently represents 0.66 per cent of global GDP, with the total cost of the disease estimated to surpass US$1 trillion by the end of the decade.