Randy AuCoin Presents Exact Imaging at LSI USA '23

Transcription

Randy AuCoin  0:05  

Thanks, everyone that was impressive by Karen to be able to go through and do that with without the slides. That's very impressive. So well done Karen. So I'm Randy Aucoin, President CEO of Exact Imaging, we're a Toronto based company. So the Canadian content is here. We're a commercial stage, clinically focused medtech company. We're a rapidly growing now on our commercial adoption for prostate cancer diagnosis, but also for merging with new emerging technologies on the treatment side, so guiding the treatment as well. We have a worldwide alliance with a company called EDap TMS in from a sales and marketing standpoint. And so this is a technology that came out of the University of Toronto at Sunnybrook Hospital, and very innovative disruptive technology. And there's a I'll show some clinical evidence, very strong evidence on the supporting the value proposition. So an experienced team won't go into this to this a lot, but just an experienced management team, that have been in medtech and have done lots of things in medtech in terms of growing value, taking something from very early stage and moving it through to successful commercialization and usually eventually exit. And it's supported by a strong board and some leading clinical advisors. So let's talk a little bit about the clinical problem. When it comes to prostate cancer, there's a lot of it. So in depending on the country, one in seven, or one and eight men get it, it's the second leading cause because there's so much prostate cancer is the second leading leading cause of cancer death when it comes to men. And the challenges if you just use conventional ultrasound and transrectal ultrasound, you will end up having to do a blind biopsy when it comes time if you have suspicion of prostate cancer, you'll have to do a blind biopsy. And as the diagram shows here, the samples were collected from where the cancer wasn't. And that would result in a misdiagnosis, in this case, a false negative. And if that was serious prostate cancer, it would move on and could metastasize Of course, and ended up killing the man. Now, multi parametric MRI has come along in recent years and has improved this greatly the challenges as you can imagine, now, if you have to do on a multi parametric MRI, and then come back for the biopsy procedure, doing a fusion procedure, that that adds a lot of extra costs and a lot of extra time. So we have a technology called Micro Ultrasound is probably a lot of micro gonna be used at this conference, not because it's a small ultrasound, but because it sees very small things. And it has much higher runs at a much higher frequency 29 megahertz instead of the normal, it's let's say nine megahertz for a conventional ultrasound. And that gives incredible detail 300% improvement in the resolution, it allowed us to develop a risk based protocol to be able to characterize what's happening inside the prostate and the suspicious areas. And it's a commercially approved and now selling. So it's in United States, Canada, Europe, Brazil, about to be approved in Japan. So lots of lots of good things happening this way. The technology is really innovative from a standpoint of its on the transducer construction, how you make the probe, as well as the signal path. And it's it really is rocket science on how this is made. And that's what the patent portfolio of over 100 patents is surrounding. So it's very innovative technology very different that can then the conventional ultrasound, this image here or this set of images. On on the left is the conventional ultrasound. On the right is the multi parametric MRI and this is all and centers our images and this is the same prostate This is a the same prostate a man getting Image three ways. We were the only one able to pick up there was no target on MRI. Nothing of course in the conventional ultrasound, but we were able to sit there urologist was able to use our scoring system and say there's a Primus four, which we'll talk about that is very that that is something that we have to take a biopsy of they did and it turned out to be an aggressive cancer that they needed to catch. And so that's the difference that technology can make. This here is when we show this to urologist or radiologists they say, wow, like we've never seen this type of detail. This is these are biopsy tracks from a biopsy performed two years ago on a man and so they you can't see this with MRI. You can't see this with anything else other than our technology. And they just say Wow, that's incredible the resolution you have. This is the scoring system with that resolution, we can now develop a scoring system called Primus, where in columns one and two that's most likely to be benign, not cancer, and in three, four and five, particularly four and five that's most likely to be clinically significant prostate cancer and the urologist or radiologists use this to direct their biopsies accordingly. This can be done either trans rectally or transparently. It doesn't doesn't matter, one probe they just changed the disposable and they can Do the approach trans directly or transparently. So that's great. And this here is the way we do fusion. So if if a urologist or radiologist has access to high quality, well interpreted MRI and they want to do a process called Fusion, if they use our fusion, they can actually see what's on the MRI, which we do picture and picture. And then they can say, oh, there it is, on the micro ultrasound, let me make sure the needle passes through it, and I get a great biopsy. So confirm what's on the MRI with the micro ultrasound. And that's very innovative approach. We have a mastery program this has been the key to us having excellent publications is we've been able to replicate everyone being able to go and repeat, repeat what's happening in the clinical evidence with our Mastery program, take them all the way from beginner to expert level. And that's been excellent. Or I mentioned our worldwide partnership with eat up TMS, they make a high intensity focused ultrasound machine that's really good at treating prostate cancer. And we believe we're the best in the world at finding early stage prostate cancer that needs treatment. So that synergy has been fantastic. And they have infrastructure in over 60 countries, which we're leveraging. So some facts and figures, we have over 50 peer reviewed publications now, over 80,000 Men imaged and biopsied at 180 clinics or hospitals around the world, we're in three sets of guidelines, the NCCN guidelines, EA use guidelines, European guidelines and the French guidelines. And so the clinical evidence would show that if you have access to high quality, well interpreted MRI, and you would like to do a fusion process, that when you combine it with a micro ultrasound, you will get higher levels of detection than if you combine it with conventional ultrasound. And so so that we have a number of studies now showing that and we're proving it out on a large scale. Now. Also, if you have if you have something called a pyre adds three on MRI, this is a problem because it says well, we don't know what's happening. We're not sure what that means. And so you can use micro ultrasound, our technology to further risk stratify and come up with whether that's should indeed be biopsied or can be ignored. But in alert and lots of places in the world, I'm from Canada, we have a pretty good waiting list for MRI, for anything that's non emergent. And so if you don't have access to high quality, well interpreted eye, well interpreted MRI, this might be in South America or some other countries, or even throughout Europe in some countries. Good news is the micro ultrasound has been shown to be just as effective as that fusion process without needing the MRI. So our technology exact view, micro ultrasound on its own, can do the same job as if you had a full blown fusion process. We've done this in four studies now. And you know, in this one here, for example, over 1000 patients at 11 institutions, and and we were as good or better than the MRI on all levels. We have a an optimum trial coming up a first randomized controlled trial 17 institutions internationally, three arms in that trial, very exciting. And that will prove out and allow us to go into the guidelines worldwide and mainstream. So in summary, the urology community has really embraced this exact view platform because it's very novel. The sales are it's accelerating, we let in 2022, we generate over 10 million in revenue. And we're on track to generate over 20 million this year as a comparison, q1 last year 22. We did six units, and we've done 15 units in 2023. So we feel good about that. We're launching aggressively in new markets around the world. The clinical evidence, there's a new study coming out every week, which is very positive. And with our training program, it's been very positive. And the optimum trial now is running to generate that RCT level evidence level one a evidence to get into the guidelines worldwide. And thanks very much for your time. Thanks