Geoffery Klass 0:00
I'm Jeff Klass. I'm CEO of sense diagnostics. And at sense, we've developed technology to detect, measure and monitor neurological disorder of the brain. And what we have is very much a platform technology, but the first application of that technology is for stroke and traumatic brain injury patients, for stroke and traumatic brain injury patients, Time matters. Time is brain is is often heard. But unfortunately, everything is very subjective these days, for triaging a patient in the field in an emergency room and to monitor them when they're in the narrow ICU. So with our device, we're able to determine what is going on, whereas right now, in an ambulance, they come upon a stroke patient or traumatic brain injury patient, that patient gets picked up and delivered to the closest Regional Hospital. Now, that hospital could be very unprepared to handle the kind of problem the patient's having. So if they're having a hemorrhagetic stroke or if they have a large vessel blockage, these people need to be at a comprehensive stroke center. And unfortunately, if that's found out at the regional it takes about five hours by the time they're cared for at the Regional Hospital, then transferred to the Comprehensive Stroke Center, where they can get the kind of treatments that they need. So we have headsets with antenna that send low power radio frequency through the brain. It's 1/500 of a cell phone, so very low power. But as those signals transfer through the brain, normal brain tissue gives off one signal. Ischemic tissue, where there is no blood, gives off another, and then a hemorrhage, obviously pulling blood, gives off a third signal, our algorithms then calculate the difference in the signals, and from that, we're able to determine what is going on within that patient's brain. And a single scan, we get 1800 data points of the entire cranial vault, all the way down through the deep structures, down into the brainstem, and we're able to give an answer from setup of the device to an answer to what is going on, is less than five minutes. And our technology is developing quickly, and we expect to have that down in two minutes in very short order. Here, yeah, the market opportunity for us is really it's expensive, when we look at the United States, for a triage device to handle this that we're developing, the market is about $2 billion and that is just for the ambulance and the ER market. As we look at it, we're also developing a military device. That military device, that market is probably about 200 million. And then to do ICU monitoring, that's a third area. ICU monitoring is about 200 million, but there's much greater markets outside of that. There's a tremendous need for our device in nursing homes, where falls are the biggest problem that they have, and in urgent care facilities, people don't go to an emergency room anymore. They go to urgent care facilities. And Urgent Care Facilities most often do not have any form of device whatsoever to assess that patient. They'll send them to the closest hospital for further treatment. So we measure the all other markets as much greater than 2 billion, and that's in the United States. So we've been doing our clinical trials in India, and they've just finished up, you know, as part of the current trial, and we'll be submitting to the India regulatory authorities. At the same time, we submit to the FDA, and we also have distribution and manufacturing partners in India ready to go. So we're very excited about that. In Canada, we've been doing our clinical trials there as well, and that's also where our core lab is. So we're at the University of Calgary, we're at McGill and the Montreal Neurological Institute St Michael's in Toronto. TBI is actually a pandemic in that country, so they're very anxious to get something like this. Have just finished up our pivotal trial, and we will be filing with the FDA so we're close to commercial we'll start our commercial activities in the first quarter of next year. Right now we're just going through the FDA for stroke indication and for bleed no bleed indication. But what we want to be able to add to that is a size and location readout on the device as well. Not so critical that we have that in the first iteration, because the feedback we get is look, just now telling us what's going on is enough. So it's a global problem. We have a global solution, and we're just really ready to hit the market and get going. You.
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