Mehran Khorsandi Presents Advanced Bifurcation Systems at LSI USA ‘23

Transcription

Mehran Khorsandi  0:05  

So I'm an interventional cardiologist based at Cedars Sinai with about 30 years of experience in practice, I specialize in complex coronary disease  and particularly bifurcations, which tend to be high risk than the vessels are large, we have an innovative technology which makes a procedure which is very difficult now and in large vessels often leads to coronary artery bypass surgery, we turned that into a very simple procedure, which can be done by everybody at the smaller hospitals as well. So our company is based in Livermore, we developed a platform delivery technology to treat coronary bifurcation lesions, a coronary disease that's currently treated currently treated by experts and larger hospitals with not reliable percutaneous outcomes necessarily into a very simple procedure. And we also address about a third of coronary bypass surgery in that is a comment from one of my colleagues who's experienced in the field, we make a very complex procedure into a fairly simple procedure with an elegant system. We have a highly differentiated technology, which affects about a fifth of all coronary angioplasty. As it turns out, the disease happens to be at the branch points in all angioplasty is what we do. And if it's a large vessel, we don't take chances because of on reproducible outcomes, and we sent him to bypass surgery. We have a platform technology which addresses all coronary bifurcation scenarios, and you will see how that is important. Because different techniques and different approaches are done. It's a very large addressable global market of about 1.6 million procedures annually. We make a procedure which is tedious, long and difficult by experts into a very simple procedure, which is much faster, we also make it much more effective, with a lower risk as well as lower costs with lower use of resources, both percutaneously. And obviously, if the patient doesn't need bypass surgery will be a lot less expensive. We've completed our research and development, we have a fully speced product. We've done extensive bench and animal testing, as well as first inhuman, which I will show you. We have manufacturing facilities in Livermore in Northern California, where we assemble the final product. This is the essence of what we do. On the left panel is a table from Journal of American College of Cardiology, which shows the quote unquote simplified approach to treatment of bifurcations. The operator first has to decide what technique they're going to use based on the anatomy they see. And as they take each step, they have to go through different branch points, according to what they see. And each procedure, each technique that is mentioned on the left panel in and of itself, is not necessarily in the skill set of every interventional cardiologist and they're complex. We turn that algorithm to a very simple algorithm on the right side, where one device addresses all bifurcation disease in a simple and effective device. And if you need an additional stent, you put the initial stent the way we do now with any non bifurcation lesion. As you see, our system on the left takes only four steps with guaranteed side branch access, which is very important on the left lower panel, or alignment towards the side branch is automatic, which is not possible now it's random. At the end, we have a symmetrically deployed stent, which is not deformed, which is not the case now and be automatically aligned based on our delivery system. And the procedural risk is much lower because of the guaranteed side branch axis and the fact that that the stent at the end is deployed symmetrically fully opposed to the wall. Here's an animation which is supposed to run automatically, which is not I don't know if it can. Okay, there we go. We have a dual catheter system where the stent which you see in blue is mounted on both catheters. As we advanced the system on the wire, and we go to the center divider and Karina we pull the side branch balloon back and we aligned the two radiographically obvious markers at the corona. Here's what we do, which is different, we deploy the side branch balloon first. In that process, the stent is oriented towards the side branch the vulnerable area, which is the opening of the side branch the Ostium is covered by a stent, which is not possible reproducibly now, we then inflate the main branch balloon after that we kiss and at the end, a stent is deployed symmetrically with orientation on the side branch which is not possible at all. Starting this tend to get deformed when we put them at the side branch now, and right now we don't have guaranteed access, we have to read cross into the stent into the side branch. So this technology is very well protected, we have an extensive IP portfolio. It addresses as I mentioned, every bifurcation scenario, regardless of the angles of where the plaque is located, and the sizes of the vessels. It's been a very large market. And as you may imagine, people have tried over the years to address it. The main shortcoming that everybody has had is that the procedures are very complex and tedious. And none of the technologies that have come to the market have simplified the procedure. People have devised very elegant stents, but the orientation of the stent at the bifurcation has been the key which has been missed. And at the end, the procedure was not making not only not simpler was also not reproducible and effective. In all patients in the US, Triton got FDA approval a couple of years ago. Unfortunately, they're not in the market anymore. The main reason is that they were assigned ranch only stents, they had to be used with a with an additional stent. And at the end, the procedure was similar to a culotte technique, which is a very complex procedure to do, all the other players in the market have had CE mark. But even in the European Union, they're not used again because the procedure at the end is not made any simpler than it is now and that is where the unmet need is, we have to have a simple solution which is reproducible and available to everybody. So as I mentioned, we have a very large addressable market is about 1.6 million procedures which are done at bifurcations. The larger ones go to bypass surgery, it turns out if you look at databases for bypass surgery, about a third of all bypass surgery is now done for large bifurcations such as lift main bifurcation, and the rest of them are done percutaneously our market is all of those. These are the results of our first in man, which were very compelling. We had 100% success rate in the patients we did and because of intravascular ultrasound, which is very detailed, you could see the stent is deployed, see metrically opposed to the wall the way it should be, we have very our major adverse clinical events in the 30. Day was zero, we had 12 month and geographic and clinical follow up in the first nine patients we did, which was done internationally by multiple operators, and very low restenosis. We were highly encouraged, and we've taken the next steps made the device a lot smaller. And we're now putting you through the FDA. We've had very compelling and very positive comments from the FDA as we move forward, we'll get to it. Here's a couple of examples of what we've done. That's a proximal narrowing in very important vessel in the heart that led pre and post. This next panel shows what my colleagues would refer to as a Widowmaker. If that artery closes, it frequently leads to sudden death. And you see again, the pre and post this was done in India by a colleague of mine, and this is a procedure which took about 10 minutes for that lesion to do, which is impossible with what we do at the time. So we are gearing up with our fully developed products to go through the US pivotal trial. As I said, we've had extensive discussions with the FDA which has been very positive. We think we will be embarking on our pivotal trial towards the end of the year. And we will be completing it sometime next year expecting conditional premarket approval in 2025. We have a highly experienced team, we have a small board which is experienced with clinical aspects of what we're developing as well as the technical aspects in manufacturing as well as a very experienced team in managed with management skills. We do have institutional investors in our Series A, which happens to be Abiomed as well as Cedar Sinai. We have luminaries and key opinion leaders which continue to be very excited, wanting to see the device come to the market. And here you see some of the comments. I'm not going to go through them. So we're very excited as we develop a relatively simple technology addressing a very complex disease. We raising 20 $30 million as we gear up to go through our pivotal trial. As I mentioned, we're expecting premarket approval in Sometime in 2025. Here is an overview and a summary of what we've done so far as we went through our Series A which be completed in 2021. We have a large addressable market with a broad patent portfolio which protects us and we are ready for mass production at our facilities in Northern California with very positive comments from the FDA. Thank you very much.