Fantastic. Thanks, Matt. It's a pleasure to be here. I can see from your attendee list there's a few familiar faces. I'm pleased to share a bit of an update on our story as well as an introduction for those for which it is new. You can see I'm calling in from our headquarters in Macquarie Park. Hopefully you can see our products behind me. Our emu device, and I have our 1st Responder with me as well. Just our backpack version here, which you can see on the screen. Really at its heart, we're seeking to transform stroke and traumatic brain care, acute brain injury care.
We have an in-hospital and pre-hospital category of portable brain scanners, which is a new modality using radio frequency signals, which we've spent now the better part of eight years developing after spinning it out of the University of Queensland. We've invested over AUD 60 million. It is a genuine world first. We have a large and growing patent family across hardware and software in various stages of prosecution, including a number that have been granted in U.S., Europe, and Asia. It is a genuine world-first or a zero to one product. There are no other products delivering a similar clinical utility from a similar form factor. There are efforts to make CTs and MRIs and other modalities smaller or smarter, but we're not seeing comparable levels of size and clinical utility.
We are a truly differentiated solution, and our objective is ultimately to speed up time to triage, transfer or treatment decisions, which are all time critical in both stroke and traumatic brain injury. We're starting in stroke. It is well, it's the second leading cause globally of both mortality and disability. There's around 15 million strokes that occur worldwide each year. When it comes to traumatic brain injury, our second planned indication, there's around 26 million cases of traumatic brain injury that are medically treated each year. We have some encouraging clinical data under our belts from our homegrown studies across three Comprehensive Stroke Centers in Sydney, Melbourne and Brisbane, and we have an international pivotal clinical trial recruiting across a number of academic centers in the U.S. and in Australia.
We've also got a team that has done this before, developed novel IP, validated new technology, medical technology, gone through the FDA process successfully and into global commercialization and growth from there. In terms of that team, our newest addition is Karl Pechmann, our CFO, who is very experienced in terms of med tech commercialization in both U.S., Europe and at home. Our CTO is Forough Khandan. She's the former head of program management at Nanosonics. Head of corporate development and strategy, Adam Millhouse, former fund manager and banker from Macquarie. Professor Stuart Crozier is one of the co-inventors of our technology. Most MRIs use IP that Stuart developed in a previous life. Robert, our head of design, incredibly experienced, also happened to work on the first trophon product at Nanosonics.
Christian Wight, our Head of Regulatory and Clinical Operations, has multiple successful FDA clearances under his belt. Got a great board, particularly for a company of our size, and the latest addition to our board is Carmel Monaghan. Carmel was previously CEO of Ramsay Health Care Australia, and she retired from that position not that long ago. She is also on the board of Regis Healthcare, a large aged care player. Carmel has a deep understanding of the hospital procurement process and in particular, what is required to overcome barriers to adoption for novel technology. Why are we starting in stroke? I mentioned the stats. Unfortunately, I imagine many people on this call will know someone, a friend or family member that have had a stroke.
You know, one in four people globally will have one in their lifetime. Many of these result in some form of permanent disability. As a result of that disability, which can mean long stints in rehab, assisted care, permanent assisted care, situations where survivors may require help getting changed, eating their meals, getting around. The burden both on society and in terms of health economic burden is dramatic. Even within the hospital system, the near and medium-term burden is quite large, particularly when patients are very unwell, have poor outcomes, and spend significant periods of time in ICU, for example. That, that's the burden. Now, of course, the good news is the evolution of treatments and interventions for stroke over the last two decades has been transformational.
The two types, the blockage, the ischemic clots can be treated with thrombolytics, clot-busting drugs. They can be treated with clot retrieval. It's, think of it as a guide wire that goes up through the groin, past the heart, into the brain to remove clots out of the brain, restore that blood flow. It's an incredibly effective procedure. It's a very specialized procedure, and like the drugs that are used to treat clots, it's incredibly time sensitive. The earlier patients receive these treatments, unequivocally the better their outcomes. That is proven through a number of large randomized clinical trials. Time is everything in stroke. The other type of stroke, which is rarer, intracerebral hemorrhages, is responsible for a high mortality component of strokes. In those situations, clinicians are seeking to lower patients' blood pressure.
If a patient is on blood thinners, they want to provide anticoagulants to reverse those blood thinners. There is also various surgeries that can be formed to try and evacuate the bleed. There's minimally invasive surgeries. Again, these solutions are not provided or widely available everywhere. They are very specialized and only provided at certain hospitals. You can see there, time is brain. The overriding principle is, it's a big problem. We, the healthcare community, can do something about it. It's incredibly time sensitive. When it comes to making triage, transfer, or treatment decisions, they need to be made as efficiently and accurately as possible to ensure the right patient gets the right level of care. Today, it's really CT that's helping drive this decision making, which does an excellent job whenever it's available.
I think there's a lot of assumptions that CT is just everywhere, and in fact, most hospitals do have CTs. That's the reality. That doesn't always mean that when a patient arrives in an ED, they're immediately in the CT. In some sites, they are, but that is certainly not the widespread case. Some sites don't have 24/7 coverage for CTs. There's also efforts to make CTs smaller and take them out into the field because, again, we know if we can diagnose and treat earlier, the outcomes are superior. How do we get that decision making out into the field? There are efforts to make CTs small enough to put into customized ambulances, known as mobile stroke units, which are fantastic for patients, but there's very few of them around 'cause of their cost.
The cost to equip and the cost to run, particularly when you think about a customized truck with a CT in the back, with a specialist technician to run, et cetera, et cetera, et cetera. Our value proposition is really all around equitable access, portable, lightweight, easy to use, cost-effective, and non-ionizing. What that means is we're not using or sending X-rays. We send radio frequency signals that are not too dissimilar from what your mobile phone would use to transmit voice and data. We don't require all this infrastructure to protect users and operators from the signals being sent. They're inherently safe. As a result, the devices, whether it's the emu in hospital, could be operated by nurses, physicians, or the First Responder device could be operated by paramedics, any healthcare professional with the appropriate training.
When we get to the use cases, again, we know hospitals are very well-oiled machines, and many are able to deliver incredibly sophisticated acute stroke care. Nevertheless, there are significant areas of friction and delays that occur even in the largest systems. In the U.S., there's a Joint Commission that establishes the criteria that the top tier hospitals have to meet to be designated as a Comprehensive Stroke Center. One of that criteria is achieving a door to puncture time, from door arrival to commencing those surgeries for clot retrieval of 90 minutes. That sounds like a long time from arriving at the hospital. That's the benchmark that's required to obtain, among with other criteria, the top echelon of stroke care in the status in the U.S.
There are areas of opportunity to expedite stroke care. When it comes to emergency departments, there are multiple scenarios. One scenario, and the most obvious one that we've talked about is the settings where there may not be either immediate access to a CT, maybe it's a very small rural hospital, or it's a smaller site that does have CT, but they don't have a radiographer on available on site 24/7, and they might need to call someone in. In those settings, there can be meaningful delays to getting that diagnosis. There's a role there. If they don't have a 24/7 radiographer, it is very unlikely that they also have the facilities to perform the more complex stroke interventions. They usually have to transfer these patients. They want to make expedited transfer decisions.
Where are we sending them, getting to the right center? In larger hospitals that do have CTs, multiple CTs, MRs, in those settings, there are scenarios where there is a lot of pressure on the existing imaging tools, whether it's CT or MRI. There could be a multi-vehicle trauma, gunshot, a whole lot of different patient cohorts that may require immediate entry into the CT. They're rarer situations, but they are situations that they do have to deal with. There are other scenarios where they have patients that are likely mimics, as in they present with stroke symptoms. They are, in fact, not a stroke. It may be a migraine or, in rare cases, a tumor or an epileptic event.
They want to be comfortable to rule out that they are not an acute stroke that requires urgent acceleration of stroke care. Finally, at the biggest comprehensive centers that perform high volumes of thrombectomy, so clot retrieval, the number of clinicians, they are very interested in what's known as a direct to angio model. We talked about that door to thrombectomy time of around 90 minutes. A direct to angio model is a model whereby the patient receives a scan at the front door with our device and can skip the CT in the emergency department and go directly to the angio room for that intervention, potentially saving 20, 30 minutes or more in that process and improving the utilization of that angio suite. That's the emergency department.
When it comes to in-field pre-hospital setting, unfortunately, the world of stroke care is really 20-30 years behind the world of cardiac care. Today when patients are assessed in the field with a suspected heart attack, there's an ECG, there's an in-field test that can give the paramedics, give clinicians a high degree of confidence around what they are dealing with, and in advance, they can notify the cardiologist, they can get the cath lab ready, and they're straight there ready to go. We don't have that in stroke. These patients, they are assessed with stroke scales, they have varying degrees of symptoms, and they're really undifferentiated. They may be a stroke, they may not.
They need to get to the CT, and often what happens is they may be taken to the nearest hospital, have a CT, and then found they need to get transferred somewhere else for treatment. Conversely, they get sent to a major center and it turns out, well, it was a mimic or something else, they don't need that high level of care and they've clogged up the system. In the very first instance, making better, more informed decisions and more timely decisions around where do these patients need to go is crucial for EMS services. Where we're heading, and one of our, ultimate objectives of our technology is to open the door to in-field treatments. There are a whole variety of treatments that can be applied in the field that can be highly effective.
For patients with confirmed hemorrhage, that can include blood pressure management, so lowering their blood pressure, demonstrated to reduce the growth of those bleeds, minimize disability, improve outcomes, reversing blood thinners, so anticoagulation, reversal of someone's on warfarin or a similar drug. The holy grail where we're heading towards is opening the door to in-field thrombolysis, so clot-busting drugs, for those patients. We've talked about ED, we've talked about pre-hospital. Once those patients are admitted to hospital and they're recovering, there is a chance of complications following those strokes. Bleeds can get bigger. A clot can become a bleed. It's known as a hemorrhagic transformation.
Patients may be in for routine orthopedic surgery or cardio surgery, and they might have AF, and they have a stroke after their surgery, and they might be under the effects of anesthesia, and it's very hard to detect those post-operative strokes. There's a role in the wards to detect fresh strokes after an event, as well as is the condition getting worse, is it staying the same? Because today, to take a patient out of ICU, they may be intubated on ventilator, it's very challenging. The nurse will have to go with that patient, and that means they're off the floor for 1-2 hours, and suddenly the ICU is short-staffed. It's a whole ordeal to take them down, not without its risks.
The ability to keep a closer eye on patients at the bedside is also a very attractive application of our technology. How does it work? We have a series of antennas that surround the head. They send an RF signal between 0.5 and 2 gigahertz into the brain. Those signals will transmit, reflect, and scatter. One antenna will transmit and the rest listen. What we're looking for is a contrast in the dielectric properties of tissue. That's effectively what we measure, the conductivity and the permittivity. Those values are different for a healthy brain versus a brain with a bleed, versus a brain with a clot, versus a brain with a clot that's one hour old, versus 12 hours old, versus 24 hours old.
We use that contrast and have an AI model that makes sense of that contrast and the signals to determine, does this patient represent a patient with a likely bleed in the brain or a likely blockage in the brain? We've been designing our product with clinicians, with end users from day dot to ensure that we're building something useful that meets their requirements. I discussed the IP portfolio that's growing. In addition to both stroke and TBI diagnosis, we own a portfolio that's applicable to other parts of the body in due course.
A little bit about the successful multi-site study that we've completed in Australia, some time back now, known as EMView, and that ran across Royal Melbourne, Liverpool, and Princess Alexandra Hospitals, all Comprehensive Stroke Centers, and we used a lot of that data to train those AI models, but we also had a meaningful portion left aside to do blind testing of those models. For both hemorrhage detection and ischemia detection, we were incredibly pleased by the levels of accuracy that we were able to achieve in those. Now, it is a smaller sample, and hence why a pivotal trial is required to generate the data necessary for the FDA.
Nevertheless, it was very encouraging to allow us to move to that next step, and we have a number of papers that are currently under peer review for this study at high impact journals. In terms of collaborations, we're very fortunate to have a long-standing collaboration with a U.S. technology company called Keysight. Now, they are the global leader in test and measurement. Their market cap is close to $50 billion. They have established a very successful business in a whole host of categories, from 5G networks to data centers, automotive, semiconductor. They are actively growing their healthcare category. What's unique about our relationship is Keysight and EMVision have worked together for several years to generate bespoke components for our products that allow us to emit and measure our signals.
They're called VNAs that we've co-developed with Keysight. They live in our scanners. Our addressable market, when we talk about 60,000 road and air ambulances in the U.S., effectively becomes Keysight's addressable market as well for that particular product. They're also an equity investor of ours. In fact, they are the single largest shareholder of EMVision. They've invested $17 million, and they own about 9% of EMVision. That's a fantastic relationship with the leader in that space. We also have a great relationship with a group known as the Australian Stroke Alliance. This is a consortium led by Professors Geoffrey Donnan and Stephen Davis, who have been pioneers in stroke care. I talked about many of those advancements and innovations in stroke treatment and interventions over the last 2 decades plus.
Steve and Geoff have played pivotal roles in many of those advancements in getting them through validation and ultimately into the healthcare system. That group is really seeking to provide a level of pre-hospital stroke care that today is only available through a multi-million dollar mobile stroke unit truck, but could be available wherever patients are via any standard ambulance and via any aeromedical service, including Royal Flying Doctor Service, who we're currently running a study with. We're really pleased to be a long-term commercial and industry partner, and they've received significant funding through the federal government, north of AUD 55 million. Today, we've been receiving about AUD 8 million of that as a non-dilutive grant to support our program. We're also a member of NVIDIA's Inception program, which gives us preferential access to high-performance computing.
Talking about why this technology makes sense now, the ability to run simulations, to train large models, test those models, all requires high-performance computing, which a decade ago, it just take too long. It just wasn't practical. We are using NVIDIA's technology in a rather unique way. We have AI in our product, but we are not trained on CTs or MRIs or ultrasounds like most common AI solutions. We are trained on the signals that we get from our unique hardware. No one else can go out and buy 1,000 EMVision scans. It's proprietary. Then we have our own AI models that we train on that data to make sense of those signals to arrive at a diagnosis at the point of care.
We've been very fortunate with support across a number of grant programs in the past and currently. We have an Industry Growth Program with AUD 4 million remaining to draw down on its non-dilutive funding, supporting the commercialization and development validation of our First Responder device. We also secured a Cooperative Research Centres Projects grant, or CRC-P, for the emu product to run a benefit study in regional South Australia to show beyond diagnostic accuracy when we implement this model of care. Our device integrated with telehealth, and we're partnering with Tytan and their Zeus product for this. How can we demonstrate in these lower resource settings, many of which do not have an on-site neurologist, how can we demonstrate meaningful time savings to that diagnosis, to treatment, to intervention, to those transfer decisions?
That study is designed to generate tangible data for us that we can leverage for initiatives such as reimbursement, as well as obviously marketing the product and driving adoption. In terms of that market opportunity, I talked about EDs, neuro ICUs, stroke wards. Across the U.S., we estimate about 10,000 opportunities there. If we think about the category of stroke care hospitals, the highest tier that provide 24/7 advanced neuroimaging interventions such as thrombectomy and neurosurgery. They are Comprehensive Stroke Centers. There's about 200-300 of those in the U.S. The next level down, which are also high volume centers, but do not provide thrombectomies, is Primary Stroke Centers, and there's about 1,400 of those in the U.S. They are particularly motivated to improve their door-in, door-out transfer time.
When they get a patient that may require that intervention, that specialist surgery, they want to make more efficient decisions and in getting them in and getting them out and transferring them.
Theoretically, if they had our scanner at the front door and were able to do a very quick five-minute scan by a nurse, part of the triage in ED, if they had information with a high degree of confidence that there is indeed a suspected stroke, it's hemorrhage or ischemic, they can then make a determination, well, maybe we need the ambulance to stay that's just dropped this patient off because otherwise they're gonna go through this whole CT process and 30, 40 minutes later, they're gonna be calling up saying, "Hey, we need to get an ambulance over here to transfer this patient to hospital XYZ." Just little things like that. Workflow improvements and efficiencies can generate meaningful time savings even at centers that have a CT.
Then when we get to road and air ambulance, it is of course the biggest both commercial opportunity and transformative opportunity to improve outcomes for patients. Because the reality is, the closer we can bring our device to patients in the field and bring down that time to diagnosis, the greater impact we can have on reducing time to treatment and ultimately outcomes for patients. In some of our studies at the moment, patients are literally getting scanned in their living room. We've had scans completed on couches, on futons, literally in their living room, not on a stretcher, in an ambulance, in their home. That really does come back to this holy grail for neurologists.
Imagine if we can treat these patients at the scene within 30 minutes of their stroke taking place because they know the outcomes for those patients are far superior, far less disability, and therefore less burden on their healthcare system. Our high priority targets within the pre-hospital market are really aeromedical. You can imagine these services are dealing with the tyranny of distance, and whether that's, you know, hundreds of kilometers or thousands of kilometers, really remote locations, long transfer times to dealing with harsh conditions like they do in the Nordics, ice on chopper blades, mountains, a whole lot of different issues.
They really wanna make the correct transfer decisions in those settings, make sure they're going to the right environment, and because many of those patients are outside the traditional treatment windows, they're really looking for a solution that will allow them to open the door to in-field treatment as well. The other high priority categories for us are academic EMS fleets. A number of the sites we work with, whether it's Mayo Clinic in Florida or UTHealth Houston, have their own EMS or ambulance fleet. It's a natural progression for us to move from the in-hospital setting at some of these sites into their pre-hospital environment. Finally, advanced life support ambulances.
These are the highest tier of ambulances in the U.S. that have all the equipment that you would expect, ECGs, monitors, defibrillators, et cetera. They make up about a third of that market. In terms of the revenue model, it's pretty simple for both devices, capital equipment, consumables and service. We are targeting industry high margins, which I'm sure many of you would be familiar what they look like for capital equipment and consumables. There is an opportunity once we expand beyond stroke care and into TBI to meaningfully increase that consumable revenue profile. I imagine just got a few minutes left, I'll just go quickly through where to from here. We have for the emu, a pivotal trial running at eight hospital sites.
It's recruiting well, it's ramping up. We've implemented a bunch of initiatives over the last several months, including extra network sites within some of these groups, such as Mount Sinai and Memorial Hermann in Houston, expanding hours of coverage, so after-hours recruitment as well. We expect a standalone release in the next month or so, with a trial progress update for our pivotal. That study, once we wrap up our recruitment, do the readout, that will form the basis of our FDA De Novo submission. We can then leverage that FDA approval back to Australia for TGA, and following the FDA submission, we would use a very similar data pack for our CE marking to enter Europe.
Our market entry pathway for the First Responder, we have an advanced prototype that is undergoing multiple feasibility, usability studies that are recruiting at the moment. We are in the background translating that advanced prototype to commercial production equivalent hardware, which we can take into data collection to train and test our AI models. Alongside that, we'll be engaging with the FDA on our substantial equivalence plan. This is to demonstrate that that device is as good or better than the EMU. From a simulation perspective, all the work we're doing at the moment, we are setting the device up to be superior to the EMU in every facet. We then plan to use the FDA 510(k) pathway. We short on time, Matt? How are we going?
Yeah. I'll jump in. We've literally got one minute and someone's been very patient with one question, so I'll give you that before we go. It was just with regards to the appointment of Carmel to the board. They've asked, can you just mention what insights around navigating hospital procurement Carmel has brought?
Yeah, sure. Carmel, and Carmel did a lot of work before she joined the board, as you would expect, someone of that level of expertise and reputation. That included talking to a lot of clinicians who she knew through her professional life. I think one of the key learnings is you need a clinical champion at these sites, whether it's a senior neurologist, interventional neurologist, ED physician, critical care. There are lots of different clinicians that have motivation to have one of these devices. But you also need compelling business case, economic data to provide a value analysis committee or a procurement committee that's looking at the hard numbers. Fortunately for stroke and the way reimbursement works in the U.S. is DRG or disease-related group payments, there is a strong motivation to reduce length of stay.
If you can improve that time to treatment and you know, as a result, there are less complications, there are better outcomes, that rather than spending three weeks in ICU, they're spending two weeks or one week or whatever that number is, you can save the hospital a significant amount of money. Obviously reimbursement as well, which we're planning to pursue through the New Technology Add-on Payment is another big factor. Yeah, lots of views on procurement, but also incredibly well connected locally and internationally as well.
Very good.
So
If there's any further questions, obviously feel free to get in touch with us at NWR or Scott. Thanks, Scott, for your presentation today.
Pleasure. I didn't realize I'd talk so long then.
No, no problem.
Thanks for joining in, everyone.
The last presenter for today is up now, which is Phillip on one of our private companies. Hope you can join us for that.