Company’s second-generation device further miniaturises its portable brain scanner technology to tackle the global burden of stroke

EMVision (ASX: EMV), an Australian medical device company focused on the development and commercialisation of innovative portable brain scanning technology, has today unveiled its First Responder Proof of Concept device, designed for deployment via road and air ambulances.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240723068628/en/

EMVision's First Responder device aims to fundamentally transform stroke and traumatic brain injury outcomes for all patients, regardless of their location, by delivering sophisticated neurodiagnostic technology directly to the point of care (Photo: Business Wire)

The backpack-sized scanner weighs less than 25 lbs and will enable paramedics to scan and send images to stroke experts from the site of a suspected stroke. Globally, one in four people over age 25 will have a stroke in their lifetime and EMVision’s technology has the potential to drastically improve the speed of diagnosis and treatment, particularly in settings where traditional imaging modalities like CT and MRI 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. 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 revolutionize prehospital stroke care and make a substantial positive impact on one of the major causes of global disability,” said Scott Kirkland, Co-Founder and CEO at EMVision.

The First Responder device leverages the underlying innovation from EMVision’s emu™ brain scanner. The emu™ is a trolley-mounted device, targeted for use in intensive care units, stroke and neurology wards, and rural emergency departments, involving a simple cap placed on the patient's head for quick scans and timely stroke and stroke subtype assessment. It couples safe, 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 miniaturized 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.

Professor Geoffrey Donnan, co-Chair of the Australian Stroke Alliance, emphasized 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 are likely to make it useful in the prehospital stroke environment.”

Professor Stephen Davis, co-Chair of the Australian Stroke Alliance, said “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. The weight of the device — less than 25 lbs — compares extremely favorably to a conventional mobile CT scanner of at least 1,100 lbs.”

Dr Lisa Murphy, CEO of the Stroke Foundation, said “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. 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.”

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 authorized sites in controlled clinical investigations. Market entry for the emu™ device is planned for next year, with the first responder device to follow.

Full details of the announcement can be found at emvision.com.au/investors

About EMVision

EMVision Medical Devices Limited (ASX: EMV) is an innovative Australian medical device company developing a novel approach to looking inside the human body. Our product pipeline includes portable, non-invasive, affordable and safe neuroimaging devices. Our vision is to help transform and improve the timely diagnosis and treatment of stroke and other time-sensitive medical emergencies at the point of care. EMVision has offices in Sydney and Brisbane www.emvisionmedical.com

For further information, media or investor enquiries, please contact:

Dejan Toracki Head of Investor Relations +61 409 340 641 dtoracki@emvision.com.au

Sling & Stone Media and Communications emvision@slingstone.com +61 2 8073 5390

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