Jacques Essinger, Polares Medical - Treating Mitral Valve Regurgitation | LSI USA '24

Jacques Essinger  0:04  
Good afternoon. My name is Jacques Essinger. I'm the CEO of Polares Medical and we're about to launch our Series C financing 20 million financing round to accelerate our clinical development. Polaris has been born out of success story, in fact, is a spinoff of Smitty Smith. This was a Swiss tavern Company, which was acquired by Boston Scientific in 217. I was the CEO of symmetries and impound the closing of a transaction with Boston Scientific, we spun off a module assets that we had previously acquired. And this is why headquarters based in Switzerland, where I'm currently living and our operation Baku operation based in Palo Alto, where I'm here on a very regular basis, headed by Alex cargo Han, a serial entrepreneur with a very serious successful track record. All together were 14 people mentioned we are in the module space the need is substantial according to net tech strategist is the greatest unmet need in Structural Heart Disease expected to be reaching progressively the tablet sized market market is currently dominated by edge to edge repair like the mitral clip of, of Albert, the Pascal from Edwards. However, these edge to edge can only treat correctly 70% And they leave a 30% of so called complex patient. This would have normally been the field for total mitral valve replacement. However, the so called tnvr do have pretty big challenge with a very high exclusion rate due to anatomical constraint. And this is that gap that we're feeling was what we call the Hemi valve, or Hemi valve, as the name says, it's a half valve. So we're basically replacing just the posterior leaflet, I'm pleased to introduce the first active force your leaflet replacement. This approach will be able to treat most of the Sokol complex patients without having the limitation of the tmvr. In addition, unique feature is really a fast and easy procedure. Our last case was less than 40 minutes catheter in catheter out fully retrievable after testing absolutely unique in the field of Mitro practicable outcome, unlike the edge to edge and finally preserve the options for future treatments such as tmvr. We have been pioneering the field of Hemi valve we had our first Eman was the first generation in 2019. It was a passive device built ating patient clinical experience establish the concept of tablished the safety had some efficacy, but with some limitation. And that led us after a number of iterations to bring our second generation which is an active design with a membrane out of pericardium that effectively mimic what the posterior leaflet is doing eight patients to date and counting and truly impressive results that I'll share with you. So, our system comes in different sizes, three anterior posterior sizes to medial lateral sizes, the delivery catheter 24, French similar size as the mitral clip system, coming with five anchors one primary to four secondaries for anchoring, and on this short video I'll highlight is in the lab, beating heart model how we deliver the most important and the only point is for the physician to place the primary anchor. From there, it's all preset together to bring down the guide rails. When the galleries are down, we bring the driver with the anchor, we engage the secondary anchors, one by one and when they are all three engage, and that's the beauty of the system. We can then check the regularization we can check the gradient. If it's good, we continue if it's not good, we remove with no consequence for the patient. So if it's a green light, we go we then further engage the secondary anchors one by one and then retrieve the driver and then we end up with a brand new cooptation surface for the anterior leaflet mentioned before first generation clinical experience of 18 cases. It was really a learning we have been pioneering this field nobody has done it before and what do we have learned? Nobody could tell us about it before. So we have learned a lot of things had quite some good results with the smaller devices. By the end, we move to the larger one. We've been hitting a wall. And we had several cases to retrieve the device with no adverse event, further confirming the safety of the procedure. What is your problem we had what we call now the MR versus gradient paradigm, with a passive device very challenging to be able to improve the gradient, sorry, improve the MR without creating a gradient. So what did we do? We took our initial design added a membrane, which we call the ACE, which stands for the adaptive cohabitation element. This is the device can see on black the frame in red, the ace in green, the anterior leaflet, and here you can see it in action. This is a recent case in the red, you can see all that color going up. This is the Mr. And this is the result after the case Mr has disappeared. And this was achieved with no change in the gradient. So very promising early results, the Mr. We're getting now in terms of results comparable to what you would get with a mitral clip. And this comes without increase in the graded or clinical strategy will be to focus initially on the complex patients going for 20 to 2425, building up our 40 patients clinical experience to be ready for going then to the pilot study, which we expect to be about 100 patients in these complex and it's still too early to speak about the RTC clinical pivotal trial competition. Well as growing as the Emmy valve is gaining traction. There was a recent presentation by Scott Lynn, at the CRT meeting, he was supposed to ask to give an update on the overall field of Hemi valve. And he came up with two main concepts, the Polaris one and the other one is the one from the foundry called halfmoon with a partnership with Medtronic, so from a competition standpoint, we're very good neighbor. What is great is that we have a very robust IP portfolio dated back to 2011. And we clearly have only priority dates that three date potential competitors that we are aware of. So with that mentioned before, we're going to raise our series See, we had two previous rounds 18 and 40 million respectively, very strong syndicate to Shang and they were longitude willing partners early bird at IDEO. And that Series C 20 million should bring us at a very clear value inflection point, which is what we call us. Id readiness for that 40 patients is our target and heavy completed the full ID preclinical validation with a closing sometime in November. Thank you