• EMVision is transitioning from R&D stage to commercialisation with its portable brain scanners to diagnose stroke
• First 60 minutes after a stroke is known as ‘the golden hour’ and is particularly critical for positive outcomes
• Pivotal trial for US FDA approval of emu bedside device due to start later in March as is an aeromedical trial with a First Responder device.

Special Report: For neuro-diagnostics medical devices company EMVision, 2025 is shaping up to be what co-founder, CEO and managing director Scott Kirkland describes as a “rubber hits the road kind of year”.

Following a positive meeting with the US Food and Drug Administration (FDA), EMVision Medical Devices (ASX:EMV) is preparing for a pivotal validation trial to support marketing approval for emu, its portable brain scanner.

EMVision was cofounded in 2017 by Kirkland who acquired the technology from UniQuest, the University of Queensland’s commercialisation arm, making its ASX debut in December 2018.

“After acquiring the original IP, we brought across a number of the co-inventors and have since built out a highly experienced in-house product development team,” he said.

“We estimate that in excess of $50 million has been spent on the development of our world first technology to date. We have about 40 staff between Sydney and Brisbane.

“Our headquarters are in Macquarie Park in Sydney, where we’ve developed a pilot production line.”

Focused on early detection of stroke

EMVision is focused primarily on the early detection of stroke with its second planned indication traumatic brain injury (TBI).

According to the World Health Organization, 15 million people annually worldwide suffer a stroke, with five million dying and another five million left permanently disabled.

“Globally one in four adults will have a stroke in their lifetime and that figure can be higher in certain countries,” Kirkland said.

There are two types of strokes. Ischemic strokes are caused by a blockage of an artery and are the more common type of stroke.

Haemorrhagic strokes are caused by bleeding and are less common.

The distinction isn’t just theoretical. Giving anti-clotting drugs to a haemorrhagic stroke patient – the standard treatment for more common ischemic strokes – can be fatal, causing them to bleed out.

‘Time is brain’ in stroke treatment

When it comes to treating stroke speed is crucial, as the first 60 minutes after a stroke – known as ‘the golden hour’ – can heavily influence outcomes.

Yet, emergency responders are often powerless until the stroke type, or even whether it’s a stroke, is confirmed.

“Treatment within the first three hours of onset and ideally within the first ‘golden hour’ dramatically improves chances of recovery with minimal or in some cases no disability,” Kirkland said.

And this is where a core component of EMVision’s value lies. The company’s emu and First Responder scanners can be used in hospitals, ambulances, or on-site at emergencies to deliver neurodiagnostic scans that not only detects stroke, but most importantly determines the type.

Named after the flightless native Australian bird, emu refers to electromagnetic unit and is the most advanced of the company’s two products.

“Much like our product, emus have great vision, and they’re very fast” he said.

Kirkland said EMVision was also focused on improving bedside monitoring with the emu device for patients at risk of further deterioration and complications or perioperative strokes.

“Our second-generation product, the First Responder, is a circa 10kg scanner that can be carried in a backpack and operated by trained paramedics with expert guidance via telehealth.”

“Time is brain when it comes to stroke care” Kirkland said.

Not a replacement for CT or MRI

Kirkland emphasised the company’s technology was not designed to replace a CT or MRI, which do a great job when they are available, but rather to fill the gap in all the areas where they are not readily available.

“A CT is the more common workhorse in stroke as [it’s] faster than MRI, more readily accessible and great in determining if a stroke has been caused by a bleed or, with contrast, a blockage, but they are very large, expensive and you need a radiographer for operation,” he said.

“They are not devices that can be widely deployed at the bedside or in resource constrained settings such as rural or regional locations”

“In terms of pre-hospital, there are around 40 trucks worldwide with a CT in the back called mobile stroke units, which deliver fantastic results for patients, but cost many millions and are not scalable.”

Weighing around 10kg, Kirkland said the aim of EMVision’s First Responder backpack scanner is for paramedics to be able to carry it and scan a patient immediately, with expert clinical guidance via telehealth, to help with materially faster triage, transfer or treatment decisions.

“After stroke type differentiation, studies have shown that for patients with a haemorrhage, lowering blood pressure can meaningfully improve outcomes, whilst those with ischemic stroke can often benefit from clot-busting drugs or specialised surgery to remove a clot known as a thrombectomy.”

Strong investor support

A leader in the field of test and measurement, NYSE-listed Keysight Technologies, which has a market cap of ~US$27 billion, has thrown its support behind EMVision.

Keysight has been a supplier and collaborator of EMVision for several years and has undertaken custom technology development for the MedTech innovator.

“They made a $15.3 million investment, at $2.05, in February 2024 and became a substantial shareholder with an 8.7% holding,” Kirkland said.

‘A rubber hits the road kind of year’

Kirkland said the company was now transitioning from R&D to commercialisation.

After last year releasing positive results of its pre-validation trial, Kirkland is confident heading into EMVision’s pivotal trial, due to start later this month, to support FDA De Novo clearance.

“With De Novo you have more work over a 510(k) pathway as you must prove safety and efficacy from ground principles, but once approved you really set the benchmark for anyone trying to come afterwards,” Kirkland said.

“emu will follow the De Novo route but that then becomes the predicate device for our backpack First Responder version so it follows a 510(k), which is a quicker path to market.”

The pivotal trial will be undertaken at luminary sites, four in the US and two sites in Australia.

The trial will include up to 300 suspected stroke patients with an estimated recruitment of six to twelve months.

“The expectation is to be in market pending FDA clearance during CY26.”

The company is also kicking off a usability and workflow implementation study for its First Responder device with the Royal Flying Doctor Service in South Australia this month.

“It’s a rubber hits the road kind of year,” Kirkland noted.

This article was developed in collaboration with EMVision, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.