Matthieu De Beule Presents FEops at LSI USA '23

Transcription

Matthieu De Beule  0:05  

Good afternoon as almost pronounced correctly, I'm Matthieu De Beule from Belgium. I'm one of the co-founders of FEops for additional scale up, and we're focusing on. So my vision is that AI will play a key role in providing physicians insights that they don't have today based on the imaging that they do have today. And we're well on track to pioneer this type of technology in the structural heartspace, which is related to heart valves and the left atrial appendage. And we also see a large opportunity in the in the coronary artery disease space for this type of technology. If we look at some milestones that we have achieved for the last couple of years, there are many, but the most important ones are that we are a thing, the only company out there and strictly heartspace that has the regulatory cleared technology, both in Europe under the MDR, as in the United States, where we went through the De Novo process because there was just no predicate device available on the US markets. Next to that we have conducted a clinical trial, a randomized control trial 200 patients randomized one to one that really shows the power of this type of technology for this patient cohorts. And we're also now rolling it out to commercially as we speak. We will be raising at 10 million this year for two reasons. One is to commercialize our structural heart business, but also to start developing technology for new indications. Now we have a team of about 40 people currently all located in Ghent, Belgium. And we are, let's say, well guided by some industry veterans in our board of directors, you might recognize some of the faces at the bottom of this slide. So amongst others, we have Rob Michaels on our board, who has been the CEO of CoreValve, and the CEO of CordiaQ. Both companies were acquired by Medtronic and Abbot and other leading devices in this space. We've also paid on our boards. He has leadership positions that Abbot he was CEO of Biosensors. And next to that, we have now a new chairman, which is you and Thompson who is the current president and CEO of Zeiss, and has been developing the digital heart strategy or digital health strategy for for example, j&j and Samsung. Now, what do we do so we take medical images. So if you go and have an intervention, typically medical images are taken for transcatheter based interventions, we take these images, and we can transform this image into a digital twin of the patients that allows you to preoperatively assess different treatment scenarios. And I will come back to that later. Now. We've applied that technology in different disease states who have validated technology on the left atrial appendage sites on the track that go to the aortic valve site on the microfossils tricuspid. site and pulmonary valve sites. And we're also now moving into the coronary space. Now looking from a development perspective, we are furthest along the path in the LA space, because that's where we recently published a study in jack on the results of the clinical trial. And I will come back to that later on. But we have similar clinical data available in Tavi and Mitro. And we are now also, as I said, exploring new developments on the coronary site. Now zooming in a little bit more in detail, to give you a picture of what we actually do currently, as set if a patient is treated for structural heart intervention, the gold standard treatment is minimally invasive therapy, meaning that the physician needs to rely on medical imaging to make very important decisions such as what is the implant size that I will select and where I put the device. So if you look to the picture on the left on top, this is the current gold standard medical images of the patients, sometimes you do 3d reconstruction in an overlay of an indifferent device on that anatomy. And then you have to figure out in your mind on how that device will be formed, how the patient anatomy will be formed to assess whether the device will sit properly and do its function. Now what we have developed is predictive technology that allows you to take the same images and predict preoperatively how the device will be formed, as mentioned on the bottom. And this has a significant impact. For example, on efficiency, what we have been able to show in our clinical study is that on average, people use 1.2 to 1.4 devices per patient for this intervention based on classic planning. With our technology, we have been able to reduce it to 1.03, which is the lowest number ever published to date. Now, if you look to another disease states, which is aortic valve disease, there, there's also again, a minimally invasive approach which is called Tavi in Europe or whatever, in United States. And there are also complications occurring such as leakage if the device loads ceiling well against Native anatomy, or risk of conduction abnormalities. We have built predictors for that. So now preoperatively, we can assess the risk of these complications. And we have also clinical evidence showing that for example, for complex patients, and that means we're able to reduce this complication rates significantly. Another area of interest is mitral valve replacement. This is again a market that will evolve significantly in the years ahead of us with where, for example, screening of patients very challenging because for the mitral valve, which is located in the center of your heart, it's very important to screen that patient over the whole cardiac cycle to really see whether there's a good fit throughout the whole cardiac cycle. And there, the screening process is very time consuming as we speak, and not always that accurate. So what we developed, there is again, a fast screening approach with a very accurate risk of a seven for example of LVT obstruction. And on the coronary sites, this is also an emerging market where it's clear that CT imaging or CCTA scans will be the gold standard imaging modality of the future. But it's pretty time consuming to assess, for example, complex lesions, so also their AI and automation will find that space. Now zooming in a little bit on the clinical data that we gathered, so this is it's defined as a landmark trial, its first trial ever for this type of predictive technology, instructional heartspace, where we have done a study where we collected 200 patients randomized one to one so 100, with classic planning based on just messing on the anatomy and doing an overlay of an anti foam device, compared to our technology, Philips Heartcatch, where we predict how a device interacts with that particular patient. What we've learned there was was pretty interesting, so they did 10 sites in Europe and union and Canada. And what we for example saw is that you're able to reduce the procedure time significantly, we were able to reduce the contrast usage, we were able to have 100% procedural success. But next to that also the number of patients where they went in with one device landed it in one position got out again, that success rate doubled in our arm. In addition to that, we also saw about the ceiling of these devices, which of course the purpose of that device. And we've also seen a significant risk and reduction for an apple BRT. So this is both a significant impact both on efficiency and on outcome based on this digital twin approach. Now we are working closely together with our leading hospitals worldwide, boats, or three some in the United States, in Europe and in China. And they're also working together actively with all leading manufacturers in the space. Now, if you look to that markets, it's very big markets. Structural heart market is expected to grow, patient numbers will double in the coming three to four years. And same thing on the coronary side and increase in number of CCDA scans is expected significantly. So it's a pretty large total addressable markets. Now looking at competition, of course, we're not the only ones in this interesting space. I think in the structural heartspace, I think it's fair to say that we are pioneering we have been developing this platform for the last eight years, have done 1000s of analysis on patients coming from all over the world and have now both regulatory cleared product both in Europe and United States and have the clinical data to back it up on the coronary site. They are where we will also lead let's say, develop some differentiating technology so that we can also go against for example, clearly cultural, etc. Now, if you're doing a financing history, we've raised 10 million to date we plan to double it with our Series C. So we have the full support over existing investor syndicate which will open to one maximum two new investors to join us in this venture. And we expect to close this round normally by by summer somewhere. I thank you for your attention if you have any questions happy to address these after talking