Video Transcription
Hamman de Vaal 00:03
Hi, I'm going to present our technology RE beat. It's a groundbreaking yet simple way to assist failing hearts. So when we look at the number of patients worldwide that are suffering from advanced heart failure and that would actually profit from mechanical circulatory support, there's more than 800,000 patients in both the EU and Europe, and as you can see by the pie chart, there's only a small sliver that can be served with current solutions. The red one is transplantation. The blue one is blood pumps, or LVADs, as they're also called, left ventricular assist devices. So the three main therapeutic problems that one faces is that there's simply a lack of organs, an organ donor shortage, traffic accidents are less prominent, etc. So that is a real problem for these patient groups. The second one is that current blood pump technologies, the left ventricular assist devices, or the total artificial hearts, lead to strokes and bleedings. The majority of those complications are related to the contact with blood. And the other problem is that the LVAD technologies, which are by far the most prominent of these technical solutions, only give left heart support, and 30% of these LVAD patients develop right heart failure. So what's our solution to this? We've developed a product called RE beat, and what that is, basically, is we would take a CT scan of the failing heart, and from the CT scan, we can then choose a best fitting, standardized implant from our range of implants. You can take this implant and insert it through a small cut, a mini left thoracotomy, or even a sternotomy, if you so choose. The surgeon can just make a small cut in the pericardium and insert it around the heart without any stitching. It fits really well. It's over the ventricles, and the implant itself has ECG sensors integrated with which we can interpret the ECGs in real time to squeeze the heart in synchrony with the heart's natural beat. And so this power is its pneumatic power. The implant is connected to an external controller via a drive line, a similar setup to what you have for an LVAD. And there's also a clinician tablet, which the clinician can monitor data with or adjust settings. So what is our competitive differentiation? The main thing is we avoid blood contact feedback. We often hear from surgeons, "Oh, another blood pump," that is basically what makes the landscape out. We can support one or both sides of the heart. It's a pulsatile support, not continuous flow, like the standard of care. Currently, we can be implanted minimally invasive, and through these advantages, we project to reduce costs and improve patient quality of life, and for that matter, we believe we present less invasive, less complication-ridden treatment, and can take, for that matter, a larger market share. What do our results look like? What you see here is just a loop from an animal experiment. We did 30 and 60-day survival experiments. You can see chronically, this device works for similar concepts. They haven't been able to manage this recently or ever. We have accelerated recovery times, confirmation of hemodynamic enhancement, excellent long-term ECGs, and long-term demonstration of safety. In terms of clinical results, we have initiated our first in-human clinical study. It's a short-term feasibility non-benefit study, the RE beat device implanted prior to LVAD implantation. We just put it in, switch it on, switch it off. To our measurements, it's just as a de-risking step for the chronic study that we are aiming for. The study is laid out to 15 patients in three centers, and the objective is just to show initial safety and short-term performance. As I said, we have seven patients going, and I think this is quite a nice video to see. Sorry for the blood, but you're at a med tech conference. It's literally we have a little plastic sleeve that we put around the implant, and the surgeon can just slip it in. Compare that to an LVAD, which requires a heart-lung machine. There are some off-pump procedures, but that's more cowboy style, and we can just slip it around the heart, on the beating heart, and close the chest, and that's obviously also tunnel the drive line for the chronic application. But this significantly improves and shortens operating time; it's much less invasive. And so what are the outcomes so far? We have no related severe adverse events, including MACE, no new ECG abnormalities, and no undesired tissue-device interactions. What performance and feasibility concerns? We can implant around the heart in less than five minutes. We have reliable and immediate detection of the ECG signals. We can show improvement of the hemodynamics. And so what we're working on now is just doing some technical refinements. This is the first in-human study, and we aim to complete the study by the end of this year, so that we can enter the long-term study at the end of 2026, beginning of 2026, when we submit there. And so we were founded by Professor Stephen Wildhirt. He is a cardiac surgeon with more than 20 years of experience. And we have engineering operations, regulatory, and commercial experience on the management team. That's the first row of people, and then our clinical advisory board. We have key opinion leaders from Hanover in Germany, Newcastle in the UK, and Copenhagen in Denmark. And it's just a great momentum that we've been able to realize in this sense. So it's traction we have been able to achieve. We've generated first clinical evidence. We've established a good key opinion leader network. We have an expanding IP portfolio in the US, Europe, and China, 15 granted patents, 11 pending. We've developed our own in-house clean room production so that we have all the competencies needed for that. So far, we've raised 37 million. That's 31 million in equity and 6 million in grants, and we've been invested by two family offices in the semi-strategic. Our go-to-market strategy is with the current funding we've landed here, and we are raising now an additional 20 million, a new investment that will unlock a further 50 million from the EIC fund, where EIC accelerator recipients, and this 35 million in total should take us through the pivotal trial and allow for market entry and first commercialization. When you look at our business model, we will be able to reimburse in Europe, at least in Germany and the UK, on existing DRG codes. We also have a small production cost, which would mean higher margins. And the attractive part of this is because we shorten hospital stays, because it's less invasive, we'll also be attractive for payers. Just briefly to say, if you look at a modest number of systems sold, of what this market is comprised of, it already leads to attractive revenues. So there's a lot to do. And even in small numbers, we can reach much success. So what are we looking for? As I said, we're looking for 20 million in new investment. An additional 15 million will come from the EIC, and we'll use these funds to fund our pivotal clinical trial and enter the market. Thank you very much for your attention. You're more than welcome to reach out to me, and now you.
