Holger Friedrich Presents Aqua Heart at LSI Europe '23

Transcription

Holger Friedrich  0:01  
Hello, everybody. I'm very happy to be here and to present to you my company, Aqua Heart, we are developing a novel system for the treatment of atrial fibrillation with pulmonary vein ablation. We're doing this on the basis of the money that we have raised so far $7 million, and we are introducing A Round raise of $15 million. That is launching in q4 for the completion of the first in human study in 2024. My name is Holger Friedrich. I'm the CEO of the company. The problem of atrial fibrillation affects 100 million people in the world. And it is the number one cause of stroke and the despite spending $8 billion already annually. On the treatment of atrial fibrillation, only 1 million people receive ablation therapy. And there has been a paradigm shift in the last couple of years. The accepted first line therapy for pulmonary vein. Accepted first line therapy for atrial fibrillation treatment is pulmonary vein isolation, and nothing else and aqua hearts. Technology offers exactly an easy to use safe, effective and very efficient solution for this goal, and we believe that with our distinct ablation lines, we can be even more successful than other ablation modalities. We are really in this sense, single purpose company we are just the screwdriver to fix screws. We are the company that fixes pulmonary veins in atrial fibrillation cases. Our solution is a steam based double balloon system. So so we are a single shot ablation system, we can during the ablation monitor the pulmonary vein signals. So we have a real time pulmonary vein signal monitoring and steam as an entity of energy creation is extremely high and has an extremely high energy content. And so that enables us to do this complete ablation in under 10 seconds. That is what we call first line therapy made easy circumferential transmural in under 10 seconds. If you look at the market opportunity. As I mentioned earlier, we have currently a market of about $8 billion in ablation therapy, about one quarter of this $8 billion is what what we call single shot ablation the rest is other catheter designs. But remember that a nearly all ablations have to start with a PV isolation. So we believe with our solution, we can a grab a very significant part of this quarter, and b we can probably even grow that quarter and see we hopefully can grow the bubble overall. We have done several animal series of course, and we have repetitively seen some very favorable results. You can see here that the laser does not work as you can see that the laser doesn't work but but you see this very distinct ablation lines with only very minimal border zones. This is really compared to other energy applications very special and leads us to the to the belief that we can be more successful in the long term outcome of these ablation procedures. I would like to draw your attention to these white lines on the ECG on the on the right hand side. This is our real time ECG monitoring of pulmonary vein signals. So when I click here, this button the ablation is starting in the lab. And you can see that in this particular case, it's particular case the signals disappear within I think six seconds in this case. So so this, this is what our tool can do in a single application, complete ablation of the of the pulmonary vein, we have not seen any any safety concerns. And we believe that the customer of course has to be enabled to operate on more patients. We have to enable more cardiologists to do these procedures. That's why we are proposing a very simple solution. We have an over the wire deployable balloon catheter we haven't generator that is fully automated and that has that has, that gives the operator of a very easy access to the therapy, that's really a true one button operation for the operator. Because of our, because of our real time PV single monitoring, we do not need 3d mapping systems, which are additional costs for the lab and additional time consuming for the procedures done. We believe that with all all taken all together, that we can cut down the procedural times for an ablation to about 30 minutes. Now, what have we accomplished so far, I want to point out that we have a very broad and robust IP protection. Globally, we have in all the relevant geographies, currently about 58 assets that they are concerning the general idea of tissue ablation with steam, but also special technical technological details of our catheter and generator system. We have the prototypes completed we are in the in the final refinement stage and running the chronic animal study towards the end of this year, and and we're then in the stage where we can prepare our first in human study. If you look at the history of ablation, then of course, radiofrequency ablation was the first introduction to that completely novel therapy in the 80s. It's it's still the mostly used energy source. However, there are some shortcomings especially it takes a lot of skill it takes a lot of time in procedural times of two to three hours are not rare. cryo ablation in the early 2000s brought the next step towards single shot ablation. However, cryo also has limitations for the timing that it takes to ablate but also some safety concerns. In the last few years. PFA has been extremely hyped. And we believe that PFA has solved many problems that our F was carrying. So we would say that PFA is probably the better RF, but the best of all worlds is our single shot, ultra short, high safety profile, easy to use. Steam tool and the real time signal monitoring can guide the ablation. So we are the simplest fastest and the safest pulmonary vein ablation tool available. Let me just briefly introduce my colleagues from the board. Eric Fein, the former group president for St. Jude is the chairman of the board. Professor Sharma has invented the technology. And I'm very happy to have my friend Andrea beefy here in the audience, our board member very successful entrepreneur and businessman from Italy. And our team is very lean. We are relying on contracts, engineering, contract manufacturing houses and we have in house engineering and financial competence to manage that. Our scientific advisory boards is spearheaded by Professor Vivek Reddy from New York and Professor Peter Nigel from Prague, very, very accomplished and world renowned scientists in this area. I think probably the best that that you can find. In summary, ladies and gentlemen, I would like to say that we have a very strong IP covered proprietary ablation technology. We have a very experienced team. We have the potential to combine the benefits of speed safety, effectiveness of PFA and the advantage of a true single shot procedure with real time PV single monitoring. And currently we are financed through our chronic animal study. We'll looking to raise 15 million for the completion of our first in human study in a series a thank you very much