Eman Namati, SpectraWAVE - AI-Enabled Intravascular Imaging | LSI USA '24

Eman Namati  0:04  
Thank you again for having me today I'm super excited to share the spatulate story and what our vision is for coronary artery disease management and specifically use of intravascular imaging to support stenting. So our vision is all around cardiovascular disease. And the mission that we have is to really combine and integrate the latest technology and optics and computational methods to improve the outcomes for patients with coronary artery disease. As many of you probably know, patients who exhibit and symptomatic of angina or chest pain typically are recommended for a diagnostic angiogram. And here the physicians, the interventional cardiologists, specifically, are looking for major blockages in the three major arteries that feed the muscle of the of the heart. This is a very standard standard procedure. There's about 12 million of these performed each year. And here, you know, if they identify a blockage, which is shown here in the in the illustration, the best outcomes come from not just using the angiography, or this extra vascular imaging, to evaluate how to optimize the planning and placement of the stent. But to use intravascular imaging, so take a device that can go inside the blood vessel, typically through the femoral or radial artery access and evaluate not just the inner lumen, which is what you see with angiography, but actually the native dimensions of the vessel prior to the disease. And in addition, as I'll show other morphologies, that are really important for to prep the vessel and and make sure that you have a very successful outcome to data for the use of intravascular imaging to improve the outcome of patients who are diagnosed and indicated for stenting is unequivocal. So very recently, actually, in the last couple of months, there was a meta analysis done, showing that over 22, randomized controlled trials have been done comparing outcomes, patient outcomes, heart outcomes, with angiography versus use of imaging versus angiography alone, and, you know, you have outcomes, like re stenting thrombosis down by 48%, but all the way to all cause mortality drops. When you use intravascular imaging to optimize stent placement, there's quite an unusual level of evidence and has really driven the field to grow. So over, you know, the last five to 10 years this, this field has seen significant growth, particularly in the US, and is now north of 20% of these PCI procedures, these percutaneous coronary procedures use intravascular imaging. This is growing not just because of the clinical evidence, but intravascular imaging is actually a very strategically important category for portfolio sales. So many of the large medical device companies have a intravascular imaging product that really anchors and, and creates a beachhead for them to sell their stents, balloons, guide cats, etc. And this is really supporting a $10 billion plus market worldwide. Now, this clinical evidence has has continued to drive up and level up societal guidelines, and we expect another level up to level one designation today to level two A. And when that happens, we believe that the market will grow at an even even faster rate. So where do we stand today in the legacy imaging products that that exist? Well, generally speaking, there are two kind of predominant factors for a physician. And ultimately, there's trade offs between these two. So one is image quality and image capability. And the other is workflow constraints. So you can see, you know, these are the three top market leading intravascular imaging products that are on the market. And in one case or the other, either the image quality is not as high or the workflow is is challenging. And this covers both acquisition of the data acquisition of the imaging set as well as interpretation. So there's a mix there that has to happen to come to get a good outcome. So where do we sit? So we've really developed and pushed a core optical technology called optical coherence tomography, beyond what we thought was actually achievable to and and we refer to this as deeper ICT, really a play on words there on the depth of penetration that we achieved, as well as the deep learning algorithms that underlying the the core technology. And we combine this with near infrared spectroscopy to provide very accurate evaluation of lipid. So in addition to the structural imaging, and really across the board, have addressed many of the key limitations that we believe have limited the adoption of these technologies in the in the clinical and the clinical space. So what does the product look like? So we have a piece of capital that you can see on the left side here. This is a custom device that we've that we've designed and built, we have a Single use, disposable device that goes through the coronary arteries, again, typically through the femoral or radial axis. And then, on top of this, we have a proprietary software platform. And because we really just designed this in the last few years, is truly using the latest, both hardware and software to enable almost real time AI analytics. And I'll show you in a moment what that what that looks like. But really, the core of the technology is around the imaging itself. And I'm going to show you a few back to back and competitive comparisons that really exemplify the leap that we've made in image quality. That is, of course very nice to look at, but actually very critical in this in this space. So our images is shown on the right here against a standard Octa product by a competitor. And some of the things features that you'll see is not only do we clearly see the plaque and the back wall of the park, which is really important in modifying vessels, prior to stenting, we clearly see the vessel boundary, which is important for determining the native lumen dimension vessel dimension. And then also we have this yellow arc which represents validated and quantified lipid content in this in this region in the in the vessel wall itself. Here's another example. This is a great example of our ability to identify the vessel boundary, which is referred to as the El or External Elastic lamina. Again, this is super important for stent sizing, because this is the native dimension before the disease that you see in the intima. Here. Here's some examples against iOS platforms. And this is you know, this is really actually against a platform that is truly, I would say more on the standard of standard of care. And what you see is with our technology, you can very clearly evaluate the calcium load and specifically the the thickness of the calcium which is which is super important, again, when you want to pre modify the vessel prior to stenting. And here's another example. Again, it's truly night and day difference in the image quality that we bring to market. But this is not where we stopped, because ultimately, it's all about how quickly can you get to the answer. And how quickly can the physician make its decisions. So this is the standard algorithm that's used with intravascular imaging MLD Max, and I'll show you with our platform, after we do a sub second, you know, less than one second pullback, scan to collect the data. Within a few seconds, all of the key analytics are presented to the physician. And what you're seeing down here is a physician scrolling back and forth, and placing flags exactly where they want to place the edges of the stent. And immediately what what what comes out of this is all of the dimensions that are needed to size the stent. So here they know they need a 38 millimeter stent with a proximal expansion at about 2.8 millimeters, and a distal at 2.8 as well. And what's really wonderful about this system is that once that information is acquired and and settled on, it shows you exactly where those flags are in the angiographic image, which is what's used to guide the stenting itself. And then similarly, once the stent is placed, they reimage the vessel to confirm that the stent was placed in an optimized way, confirm the location and confirm both that there's no dissection. So damage of the vessel wall itself good opposition of the stent to the to the lumen, as well as full expansion of the vessel to reference diameters. And again, if there is a region in this case, we automatically highlight if there's a lack of expansion, and we show that on the angiographic image so that they can go back and dilate to dilate the image. We've had incredible reception to this technology both from a clinical standpoint in our commercial so we are now an early commercial stage company. We recently deployed our first systems and a truly getting a very positive response to the to the product. As I said, we're now in our commercial stage. And we're taking a very you know, systematic approach here we're in a limited market release today, which we believe will will drive us towards a full market release later this year. We are in a series B fundraise for those who are interested in this space and would like to find out more please please reach out incredible you know growing market truly best in class platform. You know the commercialization has now kicked off with with fantastic response and just a fantastic team. Ultimately this is all about The team. I didn't show you any pictures here, but it is, you know, from the founders all the way through to the engineering staff just just an amazing group that that's developed this and soon we'll have a physiology add on to really complete our diagnostic workflow. So super excited about what's, what's the common again, please reach out if you have any questions or would like to participate. Thank you.