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Founder-led medical technology company EMVision (ASX: EMV) has today unveiled its proof of concept device for a backpack-sized brain scanner to be used by first responders, which if successfully commercialised would allow paramedics to scan and send images to experts from the site of a suspected stroke.
With more than 100 strokes estimated to occur in Australia every day, the technology has the potential to drastically improve the speed of diagnosis and treatment, particularly in settings where traditional imaging modalities like CT (computed tomography) and MRI (magnetic resonance imaging) are not readily available.
"An abiding certainty in stroke is that the fastest possible diagnosis and treatment will result in better outcomes, such as less disability, for patients," says Scott Kirkland, CEO and co-founder of the Brisbane-founded, Sydney-based company.
"There is a huge unmet clinical need for a portable, cost-effective, and easy-to-deploy device that can distinguish whether a suspected ischaemic or haemorrhagic stroke has occurred.
"We are excited by the opportunity to help revolutionise prehospital stroke care and make a substantial positive impact on one of the major causes of global disability."
The First Responder device leverages the underlying innovation from EMVision’s emu brain scanner, which is a trolley-mounted device targeted for use in intensive care units, stroke and neurology wards, and rural emergency departments.
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The technology works by placing a simple cap on the patient's head for quick scans and timely stroke and stroke subtype assessment, coupling afe, ultra-high frequency radio signals with powerful artificial intelligence to produce rapid insights at the patient’s bedside.
This First Responder unit is a second-generation device with a lighter and miniaturised design, with expanded antenna coverage designed to offer full brain coverage in a single scan.
It will now be the subject of a series of studies and developments to ensure its usability, reliability, and functionality to support the regulatory approval pathway. Both devices can be operated at the point-of-care by any healthcare professional with minimal training.
"We are looking forward to the validation of the sensitivity and specificity for detection of blood in hyperacute stroke patients using the EMVision device, against CT scanning, the current gold standard in stroke management," says Australian Stroke Alliance co-chair, Professor Stephen Davis.
"The weight of the device — about 10 kilograms — compares extremely favourably to a conventional mobile CT scanner of at least 500 kilograms.
Stroke Foundation CEO Dr Lisa Murphy says this is an exciting step forward in reducing the gap that exists between regional and metropolitan stroke care.
"Every Australian patient deserves access to fast treatment and quality stroke care, regardless of their postcode," Murphy says.
"Access to fast diagnosis and treatment of stroke can be the difference between life or death and recovering well or living with severe disability, so technology like this is critical in improving outcomes for survivors of stroke."
Professor Geoffrey Donnan, co-chair of the Australian Stroke Alliance, emphasises the importance of the identification of blood as a prerequisite for therapeutic decision-making in acute stroke management.
"Early results are encouraging and the lightweight nature of the EMVision device is likely to make it useful in the prehospital stroke environment," says Donnan.
The emu and the first responder device are not available for sale nor evaluated by the FDA or other global regulators. The devices may only be used by authorised sites in controlled clinical investigations. Market entry for the emu device is planned for next year, with the first responder device to follow.
EMV shares have risen 3 per cent to $2.055 at the time of writing, with the company's market capitalisation now at more than $372 million.
Earlier this year the med-tech company received a $15.28 million investment from Keysight Technologies Inc (NYSE:KEYS), a global leader in radiofrequency testing and measurement technology that is also a longstanding collaborator with EMVision.
When the investment was announced, it gave the California-headquartered group an 8.73 per cent stake, making it the largest single shareholder ahead of Kirkland, who in the last annual report had a 4.96 per cent share.
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