Jean-Luc Boulnois Presents FineHeart at LSI USA ‘23

Transcription

FineHeart  0:05  

Good morning. I'm Jean-Luc Boulnois, the Executive Chairman of FineHeart. And I'd like to introduce you to the ICOMS flow maker device which is fully implantable in the left ventricle. We have a very senior senior team, the founder, Alan Pascal is the CEO and co founder, together with Stefan Gasteig, a interventional cardiologist, a cardiac surgeon, and also an electrophysiologist and the inventor of the ICOMS. And I, myself have 30 years as an executive in international early stage companies in the world, we have also a whole team executing our plan. What is the problem of heart failure, it's actually a dreadful disease. It's the second cause of death in the g7 countries, mortality is 50% at five years, and it has more hospitalization than all cardiac, excuse me all, cancer combined in the US and Europe. The economic costs is astronomical, it exceeds $200 billion per year, there are 330,000 new cases per year, of which only 5000 Get a heart transplant 7000 Get a left ventricular assist device, and about 120,000 get what's called CRT, which is the treatment of a electric disease of the heart. Now you're left with about 200,000 untreated patients who have a mechanical disease or hemodynamic nature, and that is the target of FineHeart. from a human point of view, extremely degrading cost or quality of life, impaired social life, usually a lot of rehospitalization at a cost of $200,000 per year per patient. Now, what is the ICOMS flow maker, it's a unique intraventricular device, which is powered wirelessly through the skin with no external drive line. It has a positile oil pump, which is the result of 10 years of research. And the most important feature is that it is synchronized to the heart, the natural heartbeat of the heart, and as a result can provide real time monitoring and adjustment for cardiologists. This is based on 50 successful preclinical trials that we have done in Europe lately. As you can see on this chart on the right hand side is the turbine inside the left ventricle, which is activated during systole. to inject volume out of the left ventricle and is stable during diastole. On the left panel, you can see what it is actually does during systole. The red curve at the lowest minimum is that of a very severe heart failure patient with about 2.8 liters per minute of cardiac output. And we provide an extra flow with a natural physiologic orientation towards the aorta, and bring that to about five to six liters per minute, which is that of any normal patient in this room today. So the key thing is that it is adapted and to every severe heart failure patient. And the result, the reason that it is the case it is synchronized to the heartbeat of the patient. So it responds to the cardiac demand of the patient at anytime during the day, whether they are sleeping, whether they are walking, et cetera, et is pulse otile. So it respects the natural physiology of the heart. And as a result, it provides an increased cardiac output, an increased float to the vasculature. This is our clinical pipeline. There's three key dates here. 2023 first inhuman, which we intend to do in a few months from now. Second key date is 2026, where we seek EU approval with a CE marking and then 2029 We go for a PMA approval in the US. So this is supported by four clinical trials. The first one is a five to 10 patient for safety. This is the first in human. The next one is a early feasibility study in the US on 10 patients very sick NYHA class four, with a six month follow up to demonstrate safety and efficacy and start the first step of our activity in the United States. Then we have a particular trial in Europe, about 30 to 50 patients and a destination therapy strategy with a 12 month follow up to demonstrate the safety and efficacy of the device and obtain CE marking and then we replicate the same study with a larger population base a longer follow up in the US for the PMA approval. In 2029, importantly, we supported the first inhuman trial from our series B, which we raised in 2022. And it goes all the way to 2023. And we are currently starting today to raise our Series C $65 million, with a hope of the first revenue as a result of the EU approval of CE marking. So essentially, we're going to start with so called Inter Max, three to five, three to four, excuse me patients on a bridge to transplant therapy and expand the indication to a destination therapy over the time as a result of the approval in the United States, which we seek for 2029. And from there on, we will do the same thing in the US, we think we should have revenue in 2029. And as a result, we can expand to more geographic areas, as well as more cardiac centers and specialized transplant areas. Hospitals, we have a very solid bat cap table. On the right side, you can see that the founders and management still control about 21% We created a special vehicle, essentially around cardiologists, cardiac surgeon, and patient families with cardiac disease, which we call F h founders, which controls about 30% of the capital. So it's in private hands, then we have our institutional investors such as Broadview, Verve Capital, M Capital Erdi, that control about 33% of the of the of the equity. And finally, we have brought to industrial investors one is a specialist of implantable devices, Dalian and together with laowai to prepare for the expansion of the company on an industrial basis. Importantly, we recently obtained a very substantial 17 million euro grant a $70 million grant for our future Series C, which will anchor the the financing which we are starting to see today. And then we have of course, the support of BPIance and a number of other well known banks. So, what are the priorities? First of all, of course, we've submitted our dossier for the first in human trials, we will conduct that in Prague, starting in September 2023. we ramp up our manufacturing, and we are starting today, the financing round of this series C. So the key takeaways, this is actually when you think of it a game changer, there are no to the best of our knowledge. There are no devices that actually are active inside the ventricle, and that physiologically respect the natural contraction of the heart in order to improve the situation of a patient with severe heart failure. It's disruptive, very well protected. We have about 70 patents around this technology. It's all frozen, ready for implantation into the first patient. We have a clear road to commercialization, really realistic resources. The market is very wide about $20 billion target market. We think we can commercialize in less than four years. We have a very motivated team and we are raising the Series C as of today $65 million. And here is the team ready to make this heart beat. Thank you very much