Thanks for joining us today with our pivotal study well underway for De Novo FDA, De Novo clearance. We feel now is an appropriate time to give our shareholders and the market more color on our go-to-market preparations, and we'll continue to provide updates on our go-to-market plans as we progress. Thank you for joining. This is really important as we transition from an R&D-focused entity to a company focused on commercialization. Looking back at that R&D, there's been over seven years of development at EMVision Medical Devices Ltd to add to a further decade of R&D at the University of Queensland. We, in fact, estimate over $50 million has been invested in the development of our technology to date. It is a genuine world first, and we have an expansive IP portfolio across hardware, software, and of course, it originally spun out of the University of Queensland.
You'll be aware we have two products: our EMU™ device, which is over my right-hand shoulder. It's a cart-based system designed for in-hospital use, undergoing a pivotal study at the moment for FDA De Novo clearance. Our First Responder scanner, which is our ultra-lightweight helmet, this unit here, is designed for road and air ambulance deployment via a backpack. The value proposition is very simple for our products: portable, fast, easy to use, rapid neurodiagnostic capabilities to open the door to earlier triage, transfer, or treatment decisions. Those decisions are key for the indications we're targeting, our first being acute stroke care and our second being traumatic brain injury. We've completed a successful multi-site pre-validation study called EMView in Australia, and that gave us confidence to progress to our pivotal study, which is currently recruiting. We have some fantastic relationships locally and abroad.
To name just a few, we're a key industry and commercial partner of the Australian Stroke Alliance, as well as a longstanding strategic collaboration with Keysight Technologies, who are also our number one shareholder, 8.7% of EMVision Medical Devices Ltd. In terms of our team, just to name a few people that you may or may not be familiar with, our Chief Scientific Officer and co-inventor, Professor Stuart Crozier, has previously developed IP that's used in the majority of MRI machines. Farouq Khandan, our CTO, is the former head of program management at Nat... was the former Head of Program Management at Natasonics, a very successful medical device company. The most recent addition to our board, Carmel Monahan, was the former CEO of RANSI Healthcare Australia.
Carmel ran a large group of hospitals, around 70 plus, and has a very deep understanding of the procurement process, how hospitals buy technology like ours. On the other hand, Pat, who joined the board a little bit before Carmel, spends about six months of the year on the ground in the U.S., driving sales for MedTech over there. We have both sides of that coin adequately covered on the board. Now, why are we starting in stroke? The incident rate is growing. You can see the stats here. One in four adults will have one in their lifetime. Unfortunately, many of those strokes result in some form of permanent disability. A byproduct of that is the health economic impact. The burden on society is astronomical. You can see here, it's pegged at around $890 billion as of 2021 and forecast to grow to $1.6 trillion by 2050.
Pretty sobering statistics here. Of course, there are effective treatments for stroke. There is something that can be done to change the trajectory of these numbers. They require, they're very time sensitive and they require that determination of stroke type. Again, there's ischemic strokes, blockages, 80% of cases or so, hemorrhages, around 20% of cases, or bleed. The first challenge is many patients that present with stroke symptoms are in fact not a stroke. They're what's commonly known as stroke mimics. This may be a patient with a migraine or they've had an epileptic fib, or in rare cases, they have had a brain tumor and they present with stroke symptoms. It could be around 40% of cases presenting to an ED. There's a challenge separating those patients. Then those that do have a stroke, the symptoms can appear very similar for both a bleed and a blockage.
There are certain signs that may indicate one over another. For example, that might be nausea, vomiting, or really high blood pressure, or loss of consciousness with a hemorrhage. These are clues. They're not definitive. As a result, any meaningful triage, transfer, or treatment decisions in terms of reliable, accurate decisions need to wait for neuroimaging today. There are lots of interventions that can be applied. For hemorrhagic stroke, there's early blood pressure management, which has been demonstrated to improve functional outcomes for patients. There's anticoagulation reversal. This is a reversal of blood thinners for patients on something such as warfarin, and again, that reduces mortality rates. Most patients don't receive these interventions very early. Only around one in three will receive these interventions in the first hour from the onset of the stroke, which is the most effective period.
On ischemic stroke, there's of course clot-busting drugs, thrombolysis to dissolve clots. There's thrombectomy to physically retrieve a clot. A small minority of patients actually receive these treatments, let alone within the first hour or two. Earlier treatment can result in better outcomes, less disability, and less burden on society and the healthcare system. How do we achieve this? CT does an excellent job when it's available. Because of its size, its cost, its complexity, they are not machines that can be widely deployed at the point of care to speed up these decision-making processes. Our value proposition is very simple. For the EMU™ device and the First Responder scanner: portable, light, easy to use, non-ionizing, safe. For the EMU™ device, nurses can run our scans. They run the majority of our scans in our clinical studies.
For the First Responder scanner, paramedics can run the scans, send the data through via telehealth to a neurologist to guide that decision-making. There has been a lot of fantastic work, both locally and abroad, with mobile stroke unit research. These are trucks with CTs in the back that effectively bring the emergency department to the patient. One study in the United States reported that when they compared patients getting treated in a mobile stroke unit to a standard ambulance, only 3% of patients in a standard ambulance get treated in the first hour, the golden hour. This is when the clot is softest, the best opportunity to intervene and have the most positive impact. Only 3% in the first hour with a standard ambulance, 33% with a mobile stroke unit. This leads to patients having higher chance of functional independence at 90 days. This is fantastic for patients.
Let me be very clear. The challenge is there are only 45 of these globally because of the cost. If you look at the top right of this slide here, the setup cost is around $1 million U.S. The annual running cost is another $1 million U.S. on top. What the healthcare community and what the stroke community has been crying out for is a scalable, cost-effective solution to meet this challenge. We really feel our First Responder scanner is perfectly situated to address this unmet need. What we want to do with that device by deploying it pre-hospital in the first instance is open the door to better informed triage and transfer decisions.
For example, do we take this patient to the nearest hospital, or perhaps do we need to bypass that hospital and take them to a comprehensive stroke center because they may need neurosurgery or they may be eligible for a thrombectomy? That decision-making can potentially save hours. We know in stroke, time is everything. It is critical to make better-informed transfer decisions. What we're seeking to achieve as well in the field is open the door to infield treatment decisions. In the first instance for hemorrhage, that may mean early blood pressure management. It may mean anticoagulation reversal. What we're shooting for as well is opening the door to infield thrombolysis and clot-busting drugs. When the patient arrives at the hospital, there are plenty of opportunities to improve efficiencies there.
At a large tertiary center, maybe a role for our device in the ED to bypass the CT in the ED and send that patient directly to the angio suite if they're suitable for intervention. The clinicians are telling us that that alone could potentially save 20, 25 minutes in terms of door-to-thrombectomy or door-to-puncture time. If the patient's at a smaller regional hospital that may not have advanced neuroimaging capabilities, will they need help? They need more information to make better-informed decisions around whether they keep that patient there or do they need to transfer them to another center and where. When it comes to in-ward, whether it's an ICU or a stroke ward, we know an ICU today, particularly for patients that are very unwell, and we understand in the U.S. the average neuro ICU has about 18 beds.
Those patients may get monitored every hour or every four hours. There is an opportunity there as part of their rounds for the nurses to run scans with our device to keep a closer eye on these patients, particularly those that are at risk of deterioration and complication. You can imagine it's very challenging to take some of these patients down to radiology, particularly if they're on something such as ECMO, heart and lung machines. We're very fortunate to have some strong clinical data behind us in our EMView study, which we completed last year at three comprehensive stroke centers in Australia. We had reported high accuracy for the determination of hemorrhage or not and ischemia or not. This study gave us confidence to proceed with our pivotal trial.
We also had a meeting with the FDA to align on the design of that pivotal trial to support FDA De Novo clearance. One of the most exciting elements from this study were some of these very small strokes that were detected in our test data. This is unseen test data. You can see here, up at the top left, there's a subarachnoid hemorrhage of 1.7 mL, and below that, there's a bleed in the thalamus of 0.7 mL. Our clinical collaborators were very excited when they first saw these because there has been a lot of effort to create a portable, lightweight diagnostic tool to solve this challenge. The issue is a lot of the tools they've seen in the past don't see these kinds of strokes. They can see a massive stroke, but they just miss these smaller targets. They're really limited exclusively to triage decision-making at best.
This type of sensitivity, again, we will confirm the limits of our detection in our pivotal study. This was incredibly encouraging. Certainly, there's some fantastic enthusiasm from our clinical collaborators. We do have some fantastic collaborations both on the technology front, so Keysight Technologies, longstanding product collaboration. They supply a bespoke component in our device. They are a global leader in test and measurement, a U.S.-headquartered company with a market capitalization of around $30 billion. They are also our largest shareholder, having invested $15 million at $2.05 in February of 2024. We have a fantastic relationship with Keysight. We're exhibiting together in MEDICAR in November, which is one of the largest medical device conferences in the world. The Australian Stroke Alliance is a group led by Professors Jeff Donen and Steve Davies, who are incredibly influential in improving outcomes in stroke globally through some of their trial work.
They brought together 40 organizations, including paramedics across the country, to transform pre-hospital stroke care and effectively create a blueprint that can be rolled out globally. They have already attracted $55 million in Commonwealth funding to support their program. They are now targeting a significant tranche to deploy their model of care nationally. That includes everything from the novel technology scanners, including we're a key commercial and technology partner there, to workforce education, cloud-based telemedicine, and particularly addressing some of the significant inequalities in stroke outcomes in rural and regional Australia. We're part of NVIDIA's Inception program. They provide co-marketing support as well as preferential pricing. When we get to grants, we've had a fantastic track record in non-dilutive grants since inception. It's about $27 million. We have a number of schemes and programs still running that were recently awarded.
The Industry Growth Program, a few months back, to support the development and commercialization of our First Responder scanner with $4 million remaining on that grant, $0.4 million remaining under our Australian Stroke Alliance program. Most recently, we were awarded a Commonwealth CRCP grant. This is to run a regional benefits study in regional South Australia, working with the Australian Stroke Alliance, Tyson and their telehealth solution, Zeus, and SA Health through the Rural Support Service. This is a different study from our pivotal study. It's not about diagnostic accuracy. It's about demonstrating the ability to save time in the stroke care workflow and outcomes. We will be targeting a series of hospitals in regional South Australia. It could be everywhere from Riverland to Whyalla, Huron potentially, and running over, expecting to start the study in the new year.
We'll have our device or devices deployed at these hospitals with telehealth, with a dedicated stroke nurse to generate that valuable data to show we can save time. We know that data is critical to support reimbursement initiatives and really to drive adoption of our product and to support marketing of our product. That study is funded under a CRCP grant. Now, when we look at the market itself, we know when we think about ICUs and stroke wards and emergency departments on the assumption of one device per each of those settings, it is a very large market. You know, 10,000 opportunities in the U.S. If we drill down further and think about our highest priority targets, at one end of the spectrum, it's comprehensive and primary stroke centers. These are the highest volume stroke hospitals. At the other end of the spectrum, it's critical access hospitals.
These are smaller regional hospitals, 25 beds or less. They still get stroke patients. They need to make timely decisions. Do they keep them? Do they transfer them? They don't necessarily have advanced 24/7 neuroimaging capabilities. Between those two categories, there's about 3,000 addressable opportunities. On our price point for our capital equipment, that's circa half a billion dollar capital equipment opportunity alone on those targets, plus consumables, plus service. When we get to the First Responder market, it's even bigger. There are 60,000 road and air ambulances in the U.S. If we drill down and focus on our higher priority targets, aeromedical is obviously a key category. The tyranny of distance, the cost of delivering that service. Unfortunately, due to the time it takes for dispatch, arrival, transferring a patient to a tertiary center, many of these patients are just completely outside the windows for stroke treatment.
If you can bring that diagnostic tool and treatment to those patients, there's a dramatic opportunity to improve outcomes there. With aeromedical, 1,500 to 1,800 opportunities in the U.S. Of course, we want to align with academic-affiliated EMS, at the top-tier institutions. Advanced life support ambulances are a key category as well. These, a bit like our local MACA ambulances, tend to have highly trained paramedics on board, defibrillators, ECG monitors. They are most likely to be sent out to a cardiac or neuro event, and they represent about a third of the market there. Our revenue model is very simple. We expect to offer the capital equipment range around $175,000 U.S. for the EMU™ device. We have a series of consumables underpinned by our coupling media, which performs a role similar to ultrasound gel. It is our proprietary formula.
We have contract manufacturer arrangements in place, both locally and abroad. We don't necessarily have to ship this liquid halfway across the world. We're targeting about $25 US per patient per scan, plus service contracts, which we expect to sell for around 10% of the annual capital equipment cost. Moving to the First Responder, we expect to price the device between $15,000 and $100,000 US. We have a series of consumables, again underpinned by the coupling media. They'll be priced at around $50 per patient per scan. We also have a series of accessories, spare battery packs, chargers, et cetera, and an app that the paramedic can download onto their phone or tablet. Of course, they always tell us, don't give me another tablet or device to worry about charging. I want something I can download on my existing tools. That's what we're doing.
Service contracts are at about 10% of the capital equipment per annum. Where we are at in our journey, I talked about the pre-validation trial, EMView, underway in our pivotal trial. It's progressing well. I'll get into more detail on that study shortly. From a regulatory perspective, we are targeting an FDA-first submission. Shortly after that FDA submission has gone in, leveraging the same data, we would expect to make a CE mark submission for CE marking for European clearance. When it comes to local, we would expect to leverage our FDA clearance for TGA, so TGA recognizing our FDA with minimal review. That is an expedited pathway back home. For our pre-hospital device, back in March, we took the First Responder out with the Royal Flying Doctor Service, ran a series of healthy volunteer scans. That was a successful exercise.
We are now shortly kicking off and expect, in fact, later this month to start a feasibility and usability study with the RFDS. They'll be enrolling around 30 patients, aeromedical retrieval patients. We also have a mobile stroke unit study, just workflow data collection. Our device will be in the back getting scans alongside the CT. That study is going to kick off likely next quarter. Likewise, with the standard road ambulance study in the John Hunter region, which is a workflow implementation study, usability study. Three pre-hospital studies, and they all feed into a body of clinical development and substantial equivalence testing to show that our First Responder is, from a safety and efficacy perspective, as good or better than the EMU. It's certainly our expectation that it will be at least as good.
There is a big opportunity, in fact, to even exceed the performance with the EMU™ Bedside Scanner, given the design we have generated with 28 antennas and some high-performance components in there as well. From a regulatory perspective, we are seeking to leverage the De Novo clearance for the EMU™ device to pursue a 510K pathway for the First Responder scanner. Again, leverage all the heavy lifting that's being done with the EMU™ Bedside Scanner to speed up and smooth the path to market for the First Responder scanner. In terms of our pivotal study, each site completes a small number of scans as part of their training verification. We have 300 suspected stroke patients for our primary analysis against our primary endpoint, which is the detection of hemorrhage or not, exceeding 80% sensitivity specificity. We have 150 confirmed hemorrhages and 150 suspected strokes.
All sites we work with are very high volume. A number of sites will see over 3,000 suspected strokes a year and over 300 confirmed hemorrhages. If you look at some of the names here, you know, Mayo Clinic, Mount Sinai, UCLA, UT Health, we're really working with some of the best names internationally in stroke care research and innovation. We're really fortunate to have those collaborations in place. A number of those were inbound collaborations as well. There were plenty of other additional sites that we just couldn't practically fit in the study, but have the opportunity to run future studies within the United States. We're on track to wrap up that study in the first half of next calendar year. That will then form the basis for a De Novo submission. In the background, our dossier is well advanced.
The performance data out of that study slots into that dossier. In parallel, we're running a continuous innovation study at three sites in Australia. This is effectively a data collection study that allows us to continue to feed training data into our algorithm. We have an AI model that makes sense of our signals. There's transmission, there's reflection, there's scatter. That model makes sense of those signals to make a determination, stroke type, stroke, stroke type. That performance increases as we provide more training data. We continue to collect training data to continue to further increase that performance and develop additional features. What's unique about this study is we'll be enrolling patients with traumatic brain injury for the first time as well. We're focused on that next indication. There's around 15 million strokes worldwide each year, and there's around 26 million patients that are medically treated for traumatic brain injury.
It's a big opportunity to expand the use case with our existing product line. Think of it as a bit of a software upgrade and a 510K to expand the indications in the future. When it comes to market launch, we're really focused on targeted, pragmatic, phased launch in the U.S. and really focusing on that expanded stroke belt. With Texas and Florida in there, it's about 13 states. Coincidentally, we have some great sites that we're working with there already: Mayo Clinic in Jacksonville, Florida, and UT Health, Memorial Hermann Texas Medical Center in Houston. This is a region within the U.S. where the incidence and mortality rate for stroke is much higher than the rest of the country.
If we drill down again at those high priority targets I mentioned earlier—high volume stroke sites, comprehensive primary stroke centers, as well as those smaller regional sites, critical access—there's around 800 opportunities there. It's quite a meaningful category and launch zone. With the First Responder, aeromedical, academic affiliated EMS, and advanced life support, there's a bit over 6,000 opportunities there. Both are very attractive launch areas. We expect to launch with a dedicated direct service model. It is a new technology that we are seeking to commercialize here. That means there is more education. We need to take the clinical community on the journey, and the best way to do that is with our own people. They will do the best job.
Once we understand how to sell the product most effectively, we can then look to scale, either building out our own direct sales force further or bringing on a distributor. We have that optionality. From our engagements with distributors, it is very clear they are very keen to get their hands on the technology because their own internal R&D programs are really focused on incremental improvements to existing product lines. This is not the type of product that's going to—I would be very surprised if this is a top product that popped out of one of the major groups. For us, it's direct launch targeted in that region, building credibility, building trust, and owning those relationships end to end. There's also, of course, some benefits of going direct in terms of unit economics and go from there.
We know from an incentive perspective, again, salespeople whose mortgage repayments count on selling your product are always going to do a superior job to someone who has a catalog of 20 other things to sell. That's just the reality. When it comes to reimbursement, we're looking at multiple programs that are designed to help foster the adoption of innovative technology. For the EMU™ Bedside Scanner, in the first instance, that's the New Technology Add-on Payment program. The criteria for that are new, cost, substantial clinical improvement. To give you an interesting case study of a company that has obtained NTAP in the stroke space, one called VizAI, it's a triage and notification tool. It's effectively a software upgrade. Think of it for a CT or a software solution for CT.
It analyzes the CT image, and if a suspected large vessel occlusion stroke is identified, it will send an automatic alert to the interventional neuroradiologist or the team. In their studies, they were able to demonstrate a saving of 15 minutes. Fifteen minutes doesn't sound like a lot, but again, time is everything in stroke. That product is now in, I understand, over 1,600 hospitals in the U.S. I think NTAP reimbursement is about $1,000 per patient per scan. That's the opportunity there under the EMU™ NTAP. There are some other longer-term opportunities around those disease-related group payment buckets being updated to incorporate the use of the product following the NTAP period. In terms of rural critical access, they get a unique reimbursement scheme designed to help minimize inequality in regional America. In terms of the First Responder scanner, there's a similar program called the New Technology Ambulatory Payment Classifier.
It has a more frequent review cycle than NTAP. NTAP, there's an annual submission. There are multiple for the New Technology Ambulatory. It does have a slightly shorter life than NTAP, though, and then it moves into the Ambulatory Payment Classifier for the longer-term piece there. When it comes to scaling the business, I talked about a dedicated and focused launch in the U.S. stroke belt region. When we want to scale, we have the optionality of either building out our sales force further or partnering with a third party to have a hybrid kind of direct distributor model. One thing that we know is the evolving landscape in the U.S., having KOLs or key opinion leaders, clinicians that are supportive, enthusiastic is critical, but also just as critical is convincing the economic purchasers, the procurement committees, and what's often called value analysis committees.
The best way to do that is to generate what's known as post-approval data. You're in market and you have studies that you can collaborate with a top-tier institution, run a study on a very specific use case that shows X, Y, Z benefit. That's the type of data, whether it's time savings or freeing up bed time, reduced length of stay in an ICU, freeing up or better utilization of clot retrieval services or neurosurgery, whatever that may be. That type of data goes a long way to, A, supporting reimbursement piece, as well as helping market and drive adoption of the product. It's exactly the type of data that we're seeking to generate through our CRCP grant in regional South Australia that I talked about locally. I would envisage we'd run similar studies in the U.S. as well to help.
It's essentially you're validating medical claims to make marketing claims. When it comes to international expansion and looking at Europe, we really want to enter that market by the Nordics and the DACH regions of Austria, Germany, et cetera. Those regions are typically the best well-funded healthcare systems in that region. They have a track record of adopting innovation. We have some fantastic relationships. In fact, we're going to be in both Norway and Germany in November, meeting with some leaders in stroke care. There's a great opportunity there locally. Again, I've talked about this fantastic relationship with the Australian Stroke Alliance, and they're working on that implementation. They've built an excellent program, and they're now looking to obtain the funding to roll that out nationally.
In terms of new indications, I touched a little bit on traumatic brain injury, potentially opens up an expanded market, including military opportunities, which we're looking at with a few of our U.S. collaborators, as well as potentially increasing the consumable revenue profile of the products. What underpins all this? In the first instance, it's really the compelling value proposition. I've spent a lot of time in the United States this year, as have a number of my colleagues, speaking with clinicians. The feedback we get is very clear. They haven't seen a similar staged device with a similar value proposition and a comparable form factor. We really do feel we are ahead of the pack in terms of what we're seeking to provide with our products. We're continuing to build out our clinical evidence, which is effectively our currency, to convince the community to adopt the product.
To do so, we have to work with the leaders in stroke care, which is what we're doing. Whether it's at the institutions and the research teams and the investigators involved in the sites, to our advisors, to our trial steering committee and other collaborators, we're working with some of the best names in the business and many that have had influence over guidelines, particularly American Heart Association stroke care guidelines in the United States. I've talked about our reimbursement strategy, targeting those programs designed to foster the adoption of innovative products like ours. We have an extensive podium strategy. We're participating at multiple conferences throughout the year. We have a presentation at a Mayo Clinic stroke conference in October. We have another one at the World Stroke Congress in Barcelona, again in October, that a clinical collaborator is giving.
Almost every month, there is an international stroke conference that we will be participating at, as well as ongoing exhibits. We have multiple papers in progress as well. We've established a pilot commercial production line for the EMU™ device locally. We can build under that configuration up to three EMU™ devices per week. We don't need to invest in a whole lot of CapEx to build and ship devices. We can do that today to grow it. It's more storage and warehousing. It's more production technicians. When it comes to the First Responder scanner, and again, this is activity supported through that industry growth program grant, we have recently taken on the adjacent premises at our Macquarie Park headquarters, and we are establishing a pilot production line for our First Responder scanner there. I've talked about our commercialization strategy.
Phased, pragmatic, leveraging our existing relationships, which really are best in class. By virtue of that body of clinical work, we have a significant number of catalysts over the next six to twelve months on the EMU™ Bedside Scanner pivotal trial, progress updates, moving into the first half next year, readout, updates along the continuous innovation study. We also expect to kick off our regional benefits study, the CRCP-supported study in the new year. On the mobile, on the First Responder scanner program, we have those three pre-hospital studies all on track to kick off this year: aeromedical, mobile stroke unit, road ambulance. That feeds into commercial production translation, all the clinical development, substantial equivalence testing, and of course, regulatory body engagement for both programs throughout. Ongoing value drivers, podium strategy, it's a good time to give the market more color in our go-to-market strategy.
We'll continue to provide those updates as it progresses. We also continue to pursue non-dilutive grants, both Commonwealth, state, international opportunities. I've talked about our production capabilities and growing those for the First Responder scanner. We're very proud of our track record in terms of conservative capital management. You can see our burn over the previous financial year is very modest. Net of non-dilutive funding, about $2 million a quarter. We've achieved a lot in that time, including building many devices, running multiple clinical studies. We have a team of about 40 staff now between Sydney and Brisbane. You can see here in terms of our historic funding, the overwhelming majority has been through non-dilutive grants, about $27 million. We've also paired that with our strategic investor in Brisbane. I hope this was helpful color around our go-to-market and our transition from R&D focus to commercialization focus.
I look forward to hopefully seeing a number of you at our AGM in November. Thank you.