Video Transcription
Eliane Schutte 00:02
Steve, good morning, and thank you very much. We're switching gears a bit from regenerative bone to regenerative cardiovascular implants, and I'm going to tell you the story about Xeltis, and we're determined to transform lives and transform the treatment of some devastating diseases, and we do this by developing transformative vessel implants, vessel implants that enable the creation of natural, living, longer-lasting vessels. And why is this now so important? This is important because we believe materials today are at their limits of what they can reach, and the conduit that Xeltis is developing will represent superior outcomes versus the classical materials. We're focusing on three different indications today, and we have our first approval insight focusing on hemodialysis access patients that are facing end-stage kidney disease. And the ambition is really after we have been successful in reaching all the approvals to change and revolutionize the vascular space, and we can. We can? We can solve all disease and bypass diseased vessels in the future, in the body, what we today have. We have some strong clinical data proving that we have higher patency rates. We can keep these vessels open for a far longer time, and also show an absence of infections. Current materials have reached their limits, as I mentioned, and this is just true for many indications. And one of the indications that is really important, where we see all these detrimental effects, is in vascular access. 4 million patients are facing end-stage kidney disease failure, which means their kidneys stop functioning. 80% of those 4 million will crash into dialysis, and crashing into dialysis means you need to be connected to a dialysis machine two to three times a week. Half a million of these patients every year will face an implantation of an access point in their arm or in the legs. But unfortunately, 20% of them already at six months face occlusions due to thrombosis, stenosis, calcification, and infections. So a clear indication where something needs to change. But there are also other indications, like coronary artery bypass grafting, where simply no solution exists. From an implant perspective, the only solution that exists is harvesting veins from the legs because simply materials, biomaterials, today are at their limit of what they can do in terms of very challenging indications. Amelia procedures are done every year, harvesting veins from the leg. Imagine you can just take something out of the pack that will do something similar as veins. We believe a material change in vascular is necessary, and Xeltis is the breakthrough in the last 60 years in the vascular space. What we do with our regenerative bio-absorbable polymer that gets replaced by tissue as it gets implanted. So a very elegant solution. We're utilizing the body's own bioreactor to restore; we do not necessarily need sophisticated biotech techniques outside of the body to create what the body can do given the right environment for the cells to host and nest and build up tissue by the self-healing nature of this technology. We keep these vessels open. These vessels last longer and reduce complication rates tremendously, as well as infections. We already have more than 140 patients treated with our technology. More than 20 patients have reached five years follow-up time, and we have seven trials ongoing, of which two are pivotal trials. The technology has novelty in two areas. One is the uniqueness of the polymer. The polymer is a unique composition that nobody else is utilizing, backed by Nobel Prize awarded science. And the beauty of this technology is that we've been able to tune the degradation rate, the resorption rate, versus tissue build-up in a healthy constructive manner. And this has been a decade of work of science, but we found a sweet spot of what is necessary to repair vessels, but also the way how we manufacture implants out of this unique polymer. We're using an electrospinning technique, which provides the nice environment for cells to nest, to home, to repopulate, but also break down in a pro-healing way. Break down this material. The LEAD program is the cold access, the arterial venous conduit for dialysis patients. And it's a vast market, as we see it, growing unfortunately, by the prevalence of diabetic disease and cardiovascular diseases. And this program is in the pre-commercial phase. It means we're on our way to see CE marking; our pivotal trial is about to close its enrollment this month, and we have our IDE approval for a pivotal trial in the US, and we're starting our pre-commercial activities as we speak. But next in line will be the coronary artery bypass grafting, a significant, large market, a vast market, because simply no solutions exist, and we're one of the first companies that showed that we can keep with this, our biomaterial vessels open for a long time, and then if we can change this, we can actually replace all types of diseased vessels in the body, continuing with the peripheral space. So what problem are we solving? Bringing a superior regenerative vessel for hemodialysis will solve the problem of the non-maturation of fistulas because as soon as you need to crash, as the patients are crashing into dialysis, we are able to bring this graft into immediate cannulation. Patients can be on dialysis machines immediately, but we're also bringing superior patency rates, and we see a lack of infection better than any type of solution. So this program is honestly the next in kind and will become the standard of care in the future. We're leveraging surgical techniques, and this product is also very cost-effective, showing already, with our first-in-human trial, that we're saving around 20,000 US dollars in the first year alone by avoiding interventions and also avoiding any type of complications due to infections. And this is what it looks like. People that think this is another polymeric product are wrong. Look what you see in here. You see something that becomes a vessel like already at the moment it touches the blood. And compare it against an ePTFE plastic tube that remains solid; at the moment you poke holes in it, the holes will remain. Our product will become a soft, pliable, compliant vessel over time. Our data shows superior outcomes. What you can already see and what we can share now in a non-confidential manner is our 20 patients, first-in-human trial, where we've shown that all these patients can remain on dialysis for more than a year. Compare that to the existing alternatives for patients; we're already outperforming what's out there today. But also look at our infection rate. It's 0%, and I can tell you, with today already doing more than 12,000 cannulations, we have consistently shown the absence of any type of infection. It shows that with our pro-healing immune response, this very material will create. We're fighting these bacteria. Bacteria will not adhere to these materials, and we're solving that problem. Now we've had, we are at now 150 patients today, and we're seeing high patency rates and the lack of infections consistently in the pivotal trial. So this will become the clear winner. We know that already the CABG is next in line. And you see here with our first 12 patients, 12 months patient data, that this small graft, which is constantly moving around the heart with every heartbeat, remains open. This is our timeline, the flagship and evaluation mostly driven today because we're in the pre-commercial phase for access, but it can be significantly larger as we progress in our clinical programs for the remaining indications. The pivotal trials ongoing; we need 140 patients one year follow-up will get us to win a PMA approval in the US. At the same time, we're filing for CE marking next year and starting with our commercial rollout. What we're today looking for is extending a runway from the beginning of 2026 to two more years to make sure and guarantee our FDA approvals, our CE marking, and also the rollout in Europe. And that is what we're currently after to target the vast markets in this space. And then we're... Remember that this
Eliane Schutte 10:00
is a versatile platform, a platform that has the ability to replace any type of diseased and/or bypass any diseased vessels over time, with CABG being the next in line. Thank you very much for your attention. Applause.
