Sense Neuro Diagnostics | Geoffrey Klass, CEO

(Transcription)

Geoffrey Klass  0:00  

Morning, Jeff Klass and the CEO of Sense diagnostics. And here at cents, we've developed technology to detect, measure and monitor neurological disorder of the brain. And we do so in real time, and non invasively. And the first application of the technology we use is for stroke and traumatic brain injury patients. We have a great team, I won't go through everybody. But there's one bond that we all have, we've all lost somebody to either stroke or traumatic brain injury very close to us. So we're very passionate about what we do, and we know that we're going to do is going to be very successful. For those patients that would stroke and traumatic brain injury time is brain so they need to get immediate access to the right kind of care, in order to treat effectively what is going on. If they lose time, then they lose brain. And this has result in permanent disability and even death for these people. So our solution is non evasive triaging and monitoring of these patients in real time. Now, right now we're developing three different devices. And should it not be up there? Oh, I'm sorry, three different devices. The first one over here on the left New stat that's used in the neuro ICU to monitor patients. The one in the middle neuro Hawk will be used in the emergency room. And with EMS personnel. This is a triage device. This will determine if somebody is having a stroke, most importantly, by stroke subtype, and also we can detect bleeding from a traumatic brain injury. And then finally, we're under contract with the government to create a TBI detection and monitoring device for the military. current standard of care in the hospital of somebody's in the neuro ICU hospital personnel come in about every hour and check their condition. The problems here are if there is a declining condition, the outward signs leg. Also these patients can be unconscious, it can be intubated, it could have just been woken up, it's very difficult to tell exactly what's going on inside the brain, our device is going to monitor their condition on an ongoing basis. Each minute, we're going to take a scan, single scan takes two and a half seconds, and we get 360 data points to the brain will alarm if there's been an expansion greater than three ml. In the case of er, we all know how overcrowded they are these days, right? They're always overcrowded even more so now. This is a very effective triage tool in the in the emergency room. Also with EMS, they come upon a patient, they really don't know what's going on, they have a model, it's called scoop and scoop. They bring these patients right to the closest hospital for treatment. And this is not always the best decision. So with our device, they're going to be able to put that on the patient's head, they'll be able to triage them because we're going to tell them exactly if they're having a stroke and what kind of stroke it is. That's the most important decision. And also we'll be able to tell if they're having bleeding from a traumatic brain injury. And for the military, there is nothing so being able to have a device such as ours to be used in the field. When a warfighter has been injured, it's very critical to his survival. So how do we work in each of those different headsets, there's nine antenna, these nine antennas send and receive low power radio frequency one 500 out of a cell phone through the brain, normal brain tissue is going to give off a very specific signal stroke. ischemic tissue from a stroke is going to give off again a different signal because the brain tissue has now changed, pulling from blood from hemorrhage, that's gonna give off a third signal. Our algorithms then calculate the change in signal and from that we're able to determine what's going on inside the patient's brain. Now, as I said, 360 data points in two and a half seconds, we have seen bleeds as small as one ml very small size of the pink and ischemic tissue, excuse me as small as three ml. Our competition, most of them are just making a device to be used in ambulances. Our device is going to be used, as I said, ambulances in the ICU in the ER, anywhere where stroke or traumatic brain injury could present itself. That's where we're going to be with our product. We distinguish ourselves with our ability to determine what kind of stroke it is, or bleeding but also we we you know, we cover the entire brand, the whole cranial vault, and we are moving tolerance. And we do continuously monitor and we're very cost effective to the market. So it's very affordable. Where we stand right now for the hospital monitoring device that's in clinical trial right now, in the US, Canada and India. We hope to finish that trial up by around the second quarter of or I'm sorry, by the first quarter of next year and launch commercially in the third quarter of 23. For the emergency room device, we're going to kick off that clinical trial the first of July, and then we hope to be commercial with that By the fourth quarter of next year, so two products in 2023 gonna market, the military device we're in performance period number one $2.43 million contract, that leads us into period two, which is an 8.10 to $10 million contract that includes, again, a clinical trial that the FDA has to do well, we have to go through for FDA submission. In the end, we're the sole source contract or to the military for that device. Path to commercial success. So this is the US model, but we're going to open in Canada, India at the same time, and we already have our distribution model setting up in Europe. But in hospital, where are we in the monitoring device, that's where we go first. From there that leads us into the ER for selling that the ER is a good takeoff point to getting into the EMS market. What really excites us though, is eventually getting into the consumer market because this device needs to be in all organized sports, professional amateur college, you name it, but that's where it needs to be. also needs to be a nursing homes and emerging care facilities and Doctor facilities anywhere with stroke is going to present itself. So the consumer market is huge. And that's where we ultimately need to go. In the US, we're going to be selling this device on a razor razor blade model for the hospital monitoring device. It's a monitor, which will cost about $5,000. One time sale, the headset is disposable, that'll be about $5,000 per headset. In the EMS er device, the technology, the software will be resident as an app on their cell phone or on their tablet, the headset, which is very small and disposable will go for about $200 apiece. And that is a very good way to fit into that market. Canada, not a big commercial opportunity for us. But we are doing clinical research up there now. And for our new product development, radiofrequency engineering happens to be a big thing up in the Montreal area with people from McGill and the University of Montreal. India, stroke and traumatic brain injury are a big problem there. That's why we're doing majority of our half of our trial will be done in India. But also we already have manufacturing and distribution partners set up in that country. So as soon as we're approved, we're going to markup. Europe, we're already establishing our distribution market in the continent. We'll be filing for our CE mark in the second or third quarter. Military, as I said, sole source provider to the US Department of Defense. We've already had conversations with NATO. They're extremely interested in what we have, and we'll be meeting again with them in Brussels in September. So we started with a million and a half a non dilutive funding, primarily NSF, we did half a million or two and seed most important partner for us. And our seed round was Cleveland Clinic. So that's a good stamp of approval that we're on the right track. Right now we're in our series B, we're raising $17 million. And of that we've already got about seven and a half 8 million in, we're in due diligence with some others. But when we finalize that we have 5 million in reserve at the end of this year, that 5 million takes us to commercial in 2023. Primarily used for clinical trial work and product development. And our financial projections, we're launching two products in 2023. So the lift begins. And these numbers are only for sales in the US. So we do have Europe rest of world which will be additive to this. Exit strategy, we're talking to, you know, major imaging companies already EMS companies, medical devices, they're all very interested now. So we feel very comfortable that we're going to have that kind of exit. So why invest in us, I think, you know, we have very distinct advantages over our competition. We have a excellent leadership team. But it's a very important unmet medical need that we're trying to address. The other thing I want to point out just before I finish up here is that we will be accelerating our r&d in the oncology space that we move into all neurodegenerative and we have a sudden cardiac arrest application. So thank you for your time. Thank you for hearing about Sense Diagnostic. If you want to know more. I'll be in the breakout session after this.