Zacks's Investor Forum. On behalf of OTC Markets and our co-host, Zacks Small Cap Research, we are very pleased you have joined us. The next presentation of the day is from EMVision Medical Devices. Please note you may submit questions for the presenter. You can also view a company's availability for a one-on-one meeting by clicking Book a Meeting. At this point, I'm very pleased to welcome Adam Millhouse, Head of Strategy and Corporate Development of EMVision Medical Devices, which trades on the OTC under the symbol EMVDF and on the ASX under the symbol EMV. Welcome, Adam.
Good afternoon, ladies and gentlemen. It's a pleasure to be here with you today to take you through our story. EMVision is a medical technology company seeking to reduce the burden of stroke and traumatic brain injury through the deployment of two novel brain scanning devices, the emu bedside brain scanner for in-hospital use, and the First Responder unit for the pre-hospital market, including road and air ambulances. Our first device, the emu, is pictured in the top right-hand of this slide, and below that is our First Responder unit, again, for road and air ambulances. These are genuine world-first products founded in Australia at the University of Queensland after more than a decade of research and development. EMVision was formed in 2017 to acquire this technology, and since then we have invested over AUD 60 million to advance and commercialize these efforts.
Our devices offer a differentiated solution in the market, targeting unmet clinical needs by providing a portable, non-ionizing, and rapid neurodiagnostic solution directly at the point of care. We are targeting large addressable markets, a multi-billion dollar opportunity in stroke, and a second planned indication in traumatic brain injury, which is an even larger market than stroke in terms of annual incidents. We have reported encouraging clinical data from a multi-site study in Australia with our emu device, which I'll take you through later in the presentation, and these results gave us the confidence to proceed with our pivotal trial for the emu, and here we are working with leading institutions such as the Mayo Clinic and Mount Sinai in New York.
We are fortunate to have the support of several industry partnerships and collaborations, and are led by an experienced board and management team who are well-aligned with shareholders. Management and insiders of EMVision own around 20% of the company. To introduce you to some of the leadership team, Scott Kirkland is the CEO and Co-Founder of EMVision. Scott brought into the company several members of the original University of Queensland research team, including Professor Stuart Crozier, our Chief Scientific Officer and Co-Inventor of the technology. Stuart is also responsible for intellectual property that can be found in around two-thirds of MRI machines globally. Forough Khandan, our Chief Technology Officer, joined us from Nanosonics, which is a billion-dollar Australian med tech success story, where she was previously Head of Program Management for their trophon2 device.
Dr. Christian Wight, our Head of Regulatory and Clinical Affairs, has worked on over a dozen successful FDA submissions over the course of his career. Turning to our board, we have a range of experience across major Australian healthcare companies, including Sonic Healthcare and Ramsay Health Care, two of the largest listed healthcare companies on our local exchange, both of which have substantial offshore operations. Why are we targeting stroke? Well, unfortunately, the statistics around stroke are quite alarming. It is already one of the leading causes of death and disability globally, and incidence is forecast to almost double by 2050. In stroke, mortality rates are high, disability rates for survivors are high, and these factors combined place enormous direct and indirect costs on our societies and health systems.
In the U.S., for example, there are over 800,000 strokes each year, with an estimated annual cost of over $50 billion, according to the American Heart Association. Now, the good news is there are very effective modern stroke treatments available, but they are time-sensitive and require differentiation of stroke type before they can be administered. Just to expand on that last point, there are two types of stroke, an ischemic stroke, which is a clot in the brain, and a hemorrhagic stroke, which is a bleed. The challenge is they present with very similar symptoms but have fundamentally different treatment pathways. You need to know which stroke subtype the patient has before they can receive treatment, and you need to know this as fast as possible.
One thing that is well established in stroke, the sooner the patient receives treatment, the greater their chances of surviving and ultimately achieving functional independence. Now, today, not enough patients are receiving access to these life-saving treatments, and in many cases, it is simply because they fall outside the treatment window. They are either not diagnosed in time or they don't reach a stroke-capable hospital fast enough. This is the challenge that EMVision is trying to help solve. To detect and classify a stroke, you need to know what is happening inside the brain. CT is the workhorse in stroke imaging, and it does a fantastic job when it's available. These devices can't be widely deployed at the point of care because of their size, their cost, and also operational complexities. Our devices have been designed to fill the gaps where traditional imaging is either unavailable or impractical.
For example, at the patient's bedside or in the back of every ambulance. This is our value proposition, a portable brain scanner that is non-ionizing, easy to use, and also cost-effective for healthcare systems. I want to emphasize on this slide that our devices are not designed to compete with or replace CT or MRI, but rather complement them to fill gaps in existing care pathways and help clinicians reduce time to treatment. We think of our solution as like an ECG for the brain, in that they can be performed quickly at the point of care to support urgent follow-on decision making. Where do our devices fit in the stroke care pathway? The greatest unmet clinical need is concentrated in three key areas, and this is where we can impact positive change and reduce time to treatment.
Firstly, in the pre-hospital environment, our First Responder device, this is a miniaturized version of the emu, this is ideally positioned to be a scalable solution in ambulances to inform earlier transfer and patient management decisions. For patients that present at the hospital, the emu can be used in the emergency department for a quick initial scan to accelerate patients through the triage process and receive the right treatment faster. The emu can also play a monitoring role in ICUs or stroke wards to keep a closer eye on patients at risk of secondary or post-operative strokes. Many patients in these settings are. They can be unconscious, difficult to move because they may be on life support, for example. It can be hard for clinicians to detect complications in these patients as they occur. Our emu device can be moved to the patient's bedside.
They can scan these patients on a regular basis to help clinicians keep a closer eye on patients and escalate potential complications faster. Ultimately, what we're looking to achieve across the care pathway is to provide clinicians with more information earlier so that they can treat patients faster. Because we know in stroke, time is everything. To provide some context on how our devices function, they contain proprietary hardware and software components. Our technology uses ultra-high frequency radio signals, which have a very safe profile and are not too dissimilar to the full body scanners that we walk through in airports. The hardware contains an antenna array in the headset, which sends these signals into the patient's head, and our AI algorithms make sense of the complex information to determine if a suspected stroke has occurred, and if so, which type of stroke and its approximate location.
We can generate these insights in minutes to support faster triage, treatment, and transfer decisions to help patients receive timely care and better outcomes. Importantly, our technology is protected by a comprehensive portfolio of patents, trademarks, and trade secrets. As I mentioned earlier, we conducted a 300-patient multi-site study in Australia with our emu device, which showed high levels of diagnostic accuracy for the detection and classification of hemorrhagic and ischemic strokes. For devices like ours to improve clinical decision-making, you generally need high sensitivity, which refers to true positive classifications, and high specificity, which is true negative classifications. If I can turn your attention to the table on the bottom left of this slide. In this study for hemorrhages, we reported a sensitivity of 92% and specificity of 85%. For ischemic strokes, we had 95% sensitivity and 80% specificity.
These results, although on a smaller sample, they compare very well with commonly used tools in stroke care, which you can see on the bottom right-hand panel of this slide, and they come in a unique form factor and value proposition. Now, what really excited clinicians about these results was the ability of our device to detect very small strokes. Historical attempts to develop more traditional neuroimaging-based mobile brain scanners have typically not been able to detect very small strokes in a smaller form factor. These results were very exciting for us, and they gave us the confidence to proceed with our pivotal validation trial for the emu, which is currently in progress. Over the course of our journey, we have been fortunate to have the support of several industry partners, and to call out a couple on this slide.
Keysight Technologies is a long-standing technology collaborator of ours. For those of you that don't know Keysight, this is a $50 billion U.S.-listed technology company that supplies a bespoke component in our devices. We've been working with Keysight for several years now, and they have also invested directly in our company and are currently our largest shareholder, owning around 9% of EMVision. We are also an industry partner of the Australian Stroke Alliance. This is a collaboration of 40 organizations, including some of the leading minds in stroke.
To date, the ASA has received over AUD 55 million from the Australian government to create a framework for improving stroke patient outcomes and reducing the inequalities we see in rural and regional Australia. The ASA is seeking another funding tranche from the government to roll out their program nationally, which will create the infrastructure, including trained workforces and telehealth connectivity, in which our scanners can plug in and be positioned to help patients across the country. We've also been fortunate to receive around AUD 27 million in non-dilutive grants to date, which have been a strong endorsement for what we are trying to achieve and the work we are doing, and also an invaluable source of funding over our journey. Turning to our addressable market, we have very large opportunities to pursue for both devices.
If we start with the emu, and if you consider the U.S. market alone, there are over 10,000 opportunities to deploy the emu into emergency departments, ICUs, and stroke wards across the country. If you break this down into the highest resource settings, there are approximately 1,500 primary and comprehensive stroke centers in the U.S., which tend to receive the highest volumes of stroke patients. Then on the other end of the spectrum, there are also around 1,500 critical access hospitals. These are smaller regional settings that may not have round-the-clock access to CT imaging. Collectively, these high-priority targets in the U.S. represent an addressable market for emu device sales alone of over $500 million. Turning to our First Responder, the opportunity is even larger. 60,000 road and air ambulances in the U.S. Our high priority targets include aeromedical ambulances.
This is a very expensive form of transport, which takes some time to mobilize. We want to arm the staff on board with as much information as possible to accelerate transfer and treatment decisions. We also wanna align ourselves with the leading tertiary institutions in the U.S., which often have their own EMS units, as well as the advanced life support ambulances, which tend to be the most equipped fleets to deal with medical emergencies like stroke. As I said, very large opportunities for us to go after in the U.S. alone. What does our revenue model look like? It's very simple, and it's designed to provide affordable products to the market at attractive margins back to EMVision. We intend to offer customers a traditional capital equipment plus consumables model, as well as a subscription arrangement for customers who prefer that structure.
For the emu, we are targeting a device cost of approximately $175,000, which would place it in line with a high-quality ultrasound device. In addition to that, we intend to charge a consumables fee of $25 per scan and servicing contracts equal to around 10% of the device cost per annum. For our First Responder, we expect to charge around $75,000 for the device, $50 per scan for consumables, and then similar servicing terms to that of the emu. Where are we in our commercialization journey? For the emu, we have completed the product development work and domestic clinical study, and we are now in the process of conducting a pivotal validation trial.
The regulatory strategy for the emu targets an FDA first submission under the De Novo pathway, followed shortly after by CE mark in Europe and TGA in Australia, both leveraging the work from our FDA submission. We have established a pilot manufacturing facility for the emu at our offices in Sydney, which can currently produce up to three emu devices per week. That's in-situ capacity of around AUD 40 million in emu device sales annually, just in our current footprint. For the First Responder, we are currently undertaking three separate studies in Australia across road, air, and mobile stroke unit ambulances as part of our product development workflow.
The regulatory pathway of the First Responder will leverage the prior work of the emu, and here we will be required to demonstrate that the device is as good or better than the emu as part of a 510(k) regulatory submission. In terms of the substantial equivalence, the as good or better, that is certainly our expectation. We are also in the process of establishing a pilot production line for the First Responder in Sydney with similar capacity to that of the emu. Expanding on our pivotal trial for the emu, obviously a significant event for our company. We commenced site activations in late March of 2025 and are now enrolling patients across eight hospitals. This includes hospitals in the U.S.
We have, UTHealth in Texas, the Mayo Clinic in Florida, as I said, Mount Sinai in New York, and UCLA in California, alongside our Australian trial sites at The Royal Melbourne Hospital and Liverpool Hospital in Sydney. These are all, world-class comprehensive stroke centers, leaders in stroke care and innovation, who treat high volumes of stroke patients every day. In terms of trial design, up to 10 patients were enrolled at each site as part of an extensive training and verification process. Our primary analysis then includes 300 suspected stroke patients, including 150 hemorrhages, with a primary endpoint of at least 80% sensitivity and 80% specificity for diagnostic accuracy.
We are targeting enrollment completion around the middle of this year. This data will form the basis of our submission for FDA De Novo clearance and market entry in the U.S. during 2027. In light of our clinical progress, we are now preparing to transition from pure R&D to commercial execution. How do we propose to enter market? Initially, we are preparing for a targeted direct launch into the stroke belt of the U.S., which is a cluster of states in the South that have consistently demonstrated higher stroke incidence and mortality rates than the rest of the country. This is a logical place for us to start, particularly given we have two of our pivotal trial sites located in this region.
As you can see on the right-hand panel of this slide, that there is a critical mass of high-priority targets for us to penetrate in the stroke belt for both the emu and the First Responder. Our reimbursement strategy is based on accessing temporary payment programs, which incentivize the uptake of new technologies, and then using these to bridge the time it takes to establish permanent reimbursement in the U.S. market. Longer term, there are three core pillars to our growth strategy. Firstly, once we are established in the U.S. stroke belt with reference sites and supporting patient benefit studies, we will look to scale nationally, either through the build-out of a direct sales force or potentially with the help of a strategic third party.
We will also expand internationally, including in Europe via the Northern European countries, as these typically have better-funded health systems and strong appetites for innovative technologies. In Australia, we plan to work with the Australian Stroke Alliance to drive domestic adoption, and we also see opportunities in other developed Asian countries for our devices in time. Finally, we see indication expansion into traumatic brain injury as a natural fit for our devices. This would not only increase the clinical utility of our products but also expose us to an even larger market than stroke in terms of annual incidents. In the near term, we will have a lot to talk to the market about over the next six-12 months. For the Emu, we of course have our pivotal trial running, which is really the major catalyst in the near term for our company.
We also have our first clinical benefit study commencing in regional South Australia, which will document the ability of a telehealth-enabled emu device to improve stroke care, stroke workflow metrics in remote Australian locations. That's really exciting for us. Turning to the First Responder, we are progressing through three studies that I mentioned earlier and working towards device finalization and substantial equivalence testing for regulatory clearance. We will also continue to ramp up our industry engagement and commercialization activities as we prepare for market entry. Finally on our cap table, we are well-funded to deliver on our clinical and regulatory programs following a capital raising conducted last year. We work very hard to control our costs and keep our cash burn low, and we remain focused on securing additional non-dilutive grant opportunities for future funding.
For my final slide, I will leave you with some clinical feedback on our devices and to summarize some of the key messages that I'd like to leave you with today. The ability to diagnose stroke quickly and at the scene of the patient has lagged behind the breakthroughs we've seen in recent decades for treating and reversing the effects of stroke. At EMVision, we are developing and commercializing a new category of portable brain scanners, which have the potential to transform the way stroke is diagnosed and accelerate access to these life-saving treatments. As a company, we are approaching a major inflection point in our journey with the completion of the pivotal trial for our first device, the Emu, results readout for that study, followed by FDA De Novo submission for clearance to enter the U.S. market.
I appreciate your attention today and please reach out directly. I believe I'm out of time, but please reach out directly if you have any questions. Thanks.