Mark Rosser, Serac Imaging Systems - Breakthrough Molecular Imaging Technology | LSI Europe '22

Transcription

Mark Rosser  0:09  

Okay, good afternoon, everyone, Mark Rosser the CEO for Serac Imaging Systems. And our mission is to bring real time in life, molecular imaging to the patient bedside. So molecular imaging today is done in the nuclear medicine department. This is the Nuclear Medicine Department. And in the nuclear medicine department, the patient is injected with trace levels of a drug that's been radio labeled. And you're then able to follow the distribution of that radio pharmaceutical as it accumulates in different areas of the body, and form images of the distribution with a gamma or SPECT camera, like you see here. So we looked at cameras like these, and we turned to technology developed for X ray astronomy in the space industry. And we made a gamma camera like this. This is Serac cam. And it's my pleasure for the next few minutes to tell you a little bit more about that. So, first, a little bit more about molecular imaging and nuclear medicine. It is a very well established imaging modality. It's been around since the 50s 60s. And over 40 million procedures now performed annually in various indications, oncology, cardiology, neurology, of course, but many others thyroid function, renal function, liver function, et cetera, and some 10,000 Nuclear Medicine facilities globally, it's a very well established, well understood market. It's a functional imaging technique. So it tells you what's happening in the body, you literally see each molecule of a drug as its distributed, you can each photon that's emitted. And that allows you to form an image and generate insights into what's happening inside the body in real time. In current practice, however, there are some constraints. So there are a number of patients and patient groups who would benefit from access to this technology. And visiting a nuclear medicine department is difficult, sometimes even impossible. The cameras are big, as you see here, they require a dedicated room, each camera sits in its own dedicated room. And they're expensive, so a million dollars or more for a new system. And the industry trend actually is towards cameras that are increasingly complex, answering more and more sophisticated clinical questions. And that's really good. But these are overcomplicated for some of the more routine established and reimburse procedures that form actually the highest volume of nuclear medicine procedures. So we saw an opportunity then for a gamma camera that is smaller, lighter, portable, affordable, easy to use something much more streamlined than anything on the market today. And that led us to our product, Sera cam. And as you can see, this is orders of magnitude smaller. So if you're in Imperial, it's around nine inches long, it weighs about 11 pounds, you can literally hold it in one hand. A conventional camera, remember will fill a room, you can hold this in one hand. So this changes the picture. Now we have a gamma camera for molecular imaging, that is truly mobile, you can take this to the patient, wherever they are. It's a configurable installation. So it's shown here on a wheelbase, it can be floor mounted, it can be wall mounted, even desktop mounted. If it's on a wheelbase, it's easily moved around the hospital by a single operator fits through doorways goes in elevators, you can really take it anywhere. Operating Room is key. ICU COVID has taught all of us how difficult it is to move patients from the ICU, and how to treat them. Now you can take the camera to the patient. We focused a lot on making this really streamlined, really easy to use. So if you're at the point of care, it's very simple very fast, it's easily set up. So the whole camera head has a single power over Ethernet connection plugs into the back. So all the data streaming, all the camera controls all the power supply from one Ethernet connection. It's so simple to use. It also gives an opportunity to streamline workflows within the Nuclear Medicine Department. So this can take care of a lot of the more routine reimbursed procedures already performed at high volume. And because we started with technology from a different industry, with small in mind from the beginning, we've been able to build in some truly unique features that really improve the clinical utility for some important applications. And then what I'll focus on here is the hybrid gamma optical imaging What do I mean by that? So this is an image of a thyroid gland taken with a conventional camera. So the image of the thyroid gland, remember, it's functional imaging, not structural. So an ultrasound a CT and MRI might show an anatomically normal thyroid. But if you look closely here, what you can see in the right hand lobe is the patient's left hand side is lower uptake. So a deficiency of function in the thyroid, even though it may be anatomically normal. These hybrid images of the same patient on the same day, and you can see the optical image on the left, the camera image in the middle, and the hybrid image on the right side. So these are truly co aligned images, no parallax by design. So independent where the camera sits the distance from the patient, the angle of imaging, you have truly co aligned images, you see the same deficiency and uptake in the right hand lobe patients left as you look at it, especially in the bottom image. With Sera cam, it's much smaller, we can get much closer to the thyroid. So you get this real zoom in zoom out capability. And the fused image truco truly co aligned on the right side. Now imagine a patient with cancer. What happens in current practice is they'll go to the Nuclear Medicine Department, they'll have their injection, they'll have an image formed, the nuclear medicine physician will localize the lesion, where you need surgery. And they'll physically draw on the patient with a marker pen, the location of the lesion, patient then leaves the Nuclear Medicine Department and goes up to the operating room. And the physician is guided by an image in one hand, and a marker pen on the skin on the patient in front of them. Now, in real time, in surgery, the surgeon could see their own hands in the image as they operate. So where does that leave us in terms of value. So nuclear medicine, well established modality, as I said, but very different type of product to anything that's on the market today. Hybrid gamma optical imaging unique to Sera cam, no other gamma camera has that. And we've done some really good market research as recently as May this year, so it's very up to date. And the data we get from that tells us that in nuclear medicine only, we should expect sales from revenues from sales of systems and service combined well over $100 million a year. There's a lot more data on that available. But what I would draw your attention to is some upside potential which we have not included in those those those revenue projections. Life Sciences and veterinary nuclear medicines already used in those areas. And that's a very easy adjacency, for us. Those revenues are not included in those those forecasts. We see adjacent customer groups, we already talked about surgery, for example, but physician office, the ICU, pediatric ward, and so on. And really big pie here. We don't suit everything in this but in industrial nuclear applications. Now you can imagine a camera that can see radiation, and accurately overlay that and an optical image could have huge value in things like waste management, and nuclear decommissioning. So where are we today? We're pretty much through product development, we're about to enter our formal design verification testing, always one or two things come out of that. But essentially, that's done, we've done a lot of pre compliance testing. So we understand where we are with that. In parallel, we're going to do some more user trials. We're working with some key opinion at the sites at the moment to generate some more clinical data for adoption. And that will lead us up to our 510 K application with the FDA. It's type one device in the US. And we're looking for series A funding for product launch. So what does that give us series A funding up to $7 million, we got a good model on this that allows us to build our current commercial team take care of all the demand creation activities in preparation for launch, and afterwards, we enhance our supply chain capability, and capacity. And that gives us also all the working capital we need to get through us launch CE marking and European launch if Europe ever settles down, and ultimately to profitability. So our hope is that this series A investment round should be the one and only Institutional Equity round we need. We hope this will get us to profitability. Thanks for attention. My name again. Mark Rosser. Very happy to talk afterwards to anyone that has questions. Thank you