Holger Friedrich, Aqua Heart - Single Shot Ablation Solution for AFiB | LSI USA '24

Holger Friedrich  0:03  
My name is Holger Fridrich. I'm the CEO of aqua heart, and we develop a pulmonary vein ablation system for the treatment of, for the first time, treatment of atrial fibrillation. Our system is powered by steam, and we call that SBA, and we are raising currently in a rounds to perform our first new trial of a total of $15 million Let me see. Let me introduce to you what steam powered ablation is. Our workflow is pretty pretty standard for the for the pulmonary vein isolation. So we go through the groin in the venous system. Then we go transeptile. We have developed our own deflectable transeptile sheath. And then we deploy a double balloon system over the wire into one Ostium of the pump of any pulmonary vein. The the outer balloon, as we call it, is a compliant balloon that is blown up with CO two and and with that, we basically occlude this pulmonary vein. Once we are happy with the placement, we then start the production of steam into an inner balloon. And the inner balloon is, as you can see, a little bit smaller than the outer balloon. And where both balloons touch, there is a heat transfer into the tissue. And since steam is a very effective agent to and very high energy agent, this this heat transfer into the tissue is a very fast process, and we can isolate a pulmonary vein in under 10 seconds, which which will drive the procedural times down to a level that that is currently very hard to achieve, if not Not, not achievable. Now, if you look at the US and global markets for atrial fibrillation treatments, then it is very interesting to look at the at the age distribution of the people, because atrial fibrillation, as you might know, is definitely a disease of the elderly population. You there's an assumption that up to 15% of the people above 65 will develop atrial fibrillation. That makes 1 billion people in the world being over 65 and that makes about one 50 million potential patients for the for for the atrial fibrillation ablation. Now the reality is that currently, we are only treating about 1 million patients globally with ablation, and already are spending $8 billion on these on these people. The mismatch between the number of patients and the number of ablations is important, especially under the light of what we call first line therapy. There has been a growing evidence of growing body of evidence of the idea that whenever you are diagnosed with atrial fibrillation, you should get a an ablation therapy by the means of pulmonary veins isolation, and that has proven to to show a survival benefit for patients. So this different from the old days where atrial fibrillation was a domain of of drug treatment. I think nowadays it is pretty clear that the first first of first diagnosis should lead to this intervention, to the pulmonary vein isolation. But and so knowing knowing this, you might ask, why is everyone with atrial fibrillation not treated with a pulmonary vein isolation in the first place? Already? Now there are, according to our talks to physicians and key opinion leaders, of course, there are quite a few challenges with the technology available. First of all, it is cost. I mentioned already. It's an $8 billion market, but its cost is not only cost is not only the price of devices and and doctors, it's also the cost of of the lengthy procedures we have, RF procedures, which is a predominant technology to do. Two ablations currently, which which can take up to three hours. Some people say can even take longer. You need 3d mapping, typically, which requires another engineer in the room. So overall, you you have a very expensive setup to do these, to do these treatments. On top of that, these cases are complex. The doctors need a lot of experience. Very often, these electrophysiologists need to be trained for for eight or 10 years before they really can do these complex procedures with with with a long learning, learning curve, of course, and so that limits the availability of treatment places, and of course, there are also side effects. And I'm we are very aware of the fact that we came into a time where everybody, also here on stage is is hyping a technology called PFA, pulse fueled ablation. We are not pulse fueled ablation. We are. We are a good old heat powered ablation, energy and we know our we know our potential risks very well, because that therapy has or heat treatment of ablation has been around for for certainly, 30 plus years, and despite the fact that everybody said PFA is completely harmless and doesn't do anything now, new reports talk about hemolysis, kidney failure, coronary spasms and reduced long term atrial function. These are all problems you don't want to have if you just are treated for foreign atrial fibrillation. The steam powered ablation, however, has several advantages. We preserve the tissue function, maintenance. We maintain the atrial function. We have no blood cell damage. The procedure is scalable, and that is especially important for emerging markets. We have a low hurdle to perform just an over the wire balloon placement. And this can be even done by interventional cardiologists. We believe that our procedural times will be under 30 minutes from skin to skin, and the fully automatic delivery of the energy and the gas exchange through our generator makes it very easy to perform the therapy is also extremely effective. We see extremely nice ablation zones and very clean ablation limits. So So we believe that long term, we could be more effective than other than other therapies. The company itself has raised so far $7 million we have 58 global patent assets. We have done successful in vivo in vitro testings. And 24 is a very important year for us. We are doing our chronic animal study, followed by design freeze, and we hope that we can do the first in human tests already this year, the investment opportunity is, as I said, 15 million. We have just introduced a bridge to that 15 million to give us a little bit more time to price the round. And this bridge is now open for investment opportunity. And that brings us from the concept to reality. As you can see, our our final generator is ready. The products are ready. And this is our catheter system. This also ready. As I said, we have a

deflectable cheese. And also the catheter itself is is deflectable. So looking at the setup of our company, we are very lean in terms of the direct employees. We're using contract manufacturing and contract engineering houses in the US. Our chairman is Eric Fein, certainly one of the most experienced gentlemen in this industry, having been the Group President for St Jude Medical during the abbots merger. We are also using Professor Venkat Tola canali from from Minneapolis as a clinical advisor, and he's doing our clinical our clinical cases. And at the same time, we have a very seasoned Scientific Advisory Board spearheaded by Professor Vivek Reddy and Professor Peter neu, who are both leading our scientific developments. Now, again, the timeline for this year is pretty strict, and I think in the next 12 months we will see the first in human studies. Followed by approvals, approval studies, in in Europe, and then after, after that, in, in the US. Thank you very much for your interest, little bit over the time, but good to be here. Thank you very much. Applause.