Antony Odell Presents Echopoint Medical at LSI Europe '23

Transcription

Antony Odell  0:05  
Thanks very much. I'm probably anyone's least likely idea of the Caped Crusader. But we are on a crusade at Echopoint Medical. And the crusade is about the fact that women get a very raw deal in heart diagnosis. Echo point medical is aware. And the numbers support us that there is a condition called Inoca. Everyone's aware that you might have a big Archer in your heart blocked and that's a very well established stents, all that kerfuffle. But there are numerous patients who circle through the hospital system where they can't find any blockage in your maze of vessels. And what we're talking about there is microvascular disease, and typically, four times as many women as men present with in Inoca and comorbidities as men. So women can cycle through the system, not be diagnosed. And we have numerous stories of women who have come to us as we've gone through our journey, who have been poorly served by the hospital system. So our vision is iKor. iKor is a single solid state sensor incorporates into a standard micro catheter device that basically goes into this into the cath lab workflow seamlessly. The first thing that happens you go into the cath lab is you get a wire put down, you can use your favorite wire, interventional cardiologist, the micro catheter goes over it, you press one button, you get pressure, temperature flow. And that's the beginning of proper microvascular disease diagnosis. So the training needed for the interventionist is minimal or non existent, you get an instant result, and you get actionable data. The device you can see here is on that that microcatheter there the size of a human hair, it's based off standard telecommunications, Opto electronics, and that's where our IP lies. So the fiber electronic fiber optic technology is based around a laser heated parcel of blood, we heat momentarily, you measure the time of flight between that pulse and the sensor at the other end, pressure, temperature flow one button. So what do you get? Well, I'm not going to go through this, there's a lot of information on this slide. But essentially, the take home from this slide is that the heavy lifting has been done by the big guys, flow has been very well characterized as a clinically necessary parameter. The European Society of Cardiology mandated a couple of years ago, that you need a flow diagnosis to really understand the basis of certain types of patient type, patient cardiac patients, the American Society followed on shortly afterwards. So there are metrics CFR FFR that exist that when you have certain ratios of those or limitations of those, you know which treatment pathways you're going to go, that might mean medication, that might mean a stent, that might mean another treatment. We've done a first inhuman trial. We started this in January of this year. This is the team that delivered our first couple of patients. At the front there is Sally Arroway. She's our development engineer. So she's been working on the system. And the rest of the team is the bots team in London, where we did the first couple of patients. We've done 10 patients, it's a limited 10 patient clinical proof of concept study. We did our last patient a couple of weeks ago. So we've now closed that out for recruitment purposes. But just to emphasize, this is a class three device here in Europe. So we had to do pretty much a full C dossier submission for this. So it's not a light exercise. And one of the take homes from our first in human study. Well, we completed the recruitment. We did submit an abstract to TCT we found out last week that we've had that accepted so we'll be presenting this, this clinical data at TCT in San Francisco in 2023. In a few weeks time, we confirm the ease of use this is one really important point for us. I spent the first half of my career working with companies like j&j, Versanius, Stryker, and we had lots of money, we had lots of Salesforce muscle we had all the all the gadgets you could possibly want to make things a success. The thing that's very hard to do, even when you're a big company is changed clinical practice. So this had to fit seamlessly into what people were doing today. We didn't want to change process, procedure or feel. And that's another important point. In most patients, we observed the visible change in temperature that comes from the laser pulse. So we confirm that the operating principle works in a human being and we showed some other effects where noise Master signal, but we know the answers to that we knew that going in. But what we do want to do and is important part of the quality process is you learn from the experiments you undertake, particularly clinical studies. So, the team that's delivered this, myself as CEO, He's based in Eindhoven. He's got 20 plus years experience in Phillips, and Malcolm and Adrian. Now Malcolm is a clinician, a very important component to me when I was looking at this, this technology, whether to join the team. It had a really good strong clinical focus from the get go. I see too many companies where you've got great ideas, great technology, and you're kind of searching for something to do with it. This had a clear purpose to begin with. I invested Albion Park walk, UCLB where the technology came from University College London, we developed a team of around 10 people, some of those not full time equivalents. But consultants. And we focused on an interventional procedure, the catheter based physiology. The market opportunity for this is big and can be bigger, around 1 million cardiac cath lab procedures performed in the US annually. Press pressure wires are becoming an increasingly common part of those procedures. It's growing around 60% CAGR at the moment, we believe when you add flow to that you're going to grow that market. So we believe there's a strong opportunity to grow that opportunity to round in excess of 2 billion user suspects in the marketplace, I won't go through them at the moment, we haven't had the time to go through an exhaustive competition slide. But just to say, I am talking about our platform technology here, we can do multiple things with our sensor. And there's an imaging component to it as well. If you want to find out more about that. I'm happy to talk about it in a separate venue. But at the moment, we're focusing on coronary physiology, the competition? Well, very briefly, we've got Philips, they've taken their product off the market. It was very complicated to use. They're redesigning it, we believe Abbott are working with Cora Ventus, a Swedish company, which is a very complex flow based solution. But they've invested quite a bit of time and effort in developing that. We provide something that's simple that Joe Average interventional cardiologists can use. Our regulatory route for the US is a 510K, we've determined the code and equivalence that we need to do, we're going to undertake a q sub process to confirm those predicates. So we are headed into a commercial focus on the US. We've engaged with three major strategics in the space already I met with two of them this week, which has been great. We're engaging, strongly biased in terms of us location, clinical advisory group, that input input to the FDA process is important for that to CAG. But also we're engaged with to US hospitals with access post market clinical sites. The other thing that's driving adoption here is a significant change in reimbursement in the US. Now you actually have a level two endovascular procedure, which significantly incentivizes cath labs to use this this type of flow metric. And we believe that's giving us a strong tailwind see adoption in the US when we get approval. A route to market is a fairly classic thing we've got some optimization to do on the device following the trial, the usual testing for the FDA, and then a 510K submission. We're looking to raise 4 million, most of that's covered by Insider money at the moment, I'd love to have another million, preferably coming from the outside to support our journey towards US approval. Our board will be augmented by Chuck Carnian, who's an ex Boston Scientific executive based in Boston, again, looking at a very US centric approach as we move through our Series A cash. So just to re emphasize, we have a platform with sensors to make interventional therapy decisions. We've completed our seed phase, we're ready for final product development. And we want to get the cash and the engine to drive us into commercialization. Thank you