Gulam Khan, Centerline Biomedical - Non-X-Ray Based 3D Surgical Navigation Technology | LSI USA '24

Gulam Khan  0:03  
My name is Gulam    Khan, the CEO of center biomedical. Today I want to talk to you about our product called the I ops, which stands for inter operative positioning system. Well, the best way for me to explain why we develop this product is to give you an example of how image guided procedures are being conducted in operating rooms. This procedure is when a vascular surgeon is using fluoroscopic navigation to treat a patient suffering from vascular disease. Now, the ultimate goal of this procedure is to place a stent graft before that happens, and I'm going to really simplify a lot, the team is going to have to do a series of navigation tasks that basically involve moving guide wires and catheters, through the vascular system into position in the aorta, and into some of the vessels that branch off of the aorta. The problem with everything I just said is the image that we're looking at it, you can't see the vessels, you can't see the soft tissue. So as it was true 130 years ago, and it is still true. Now, the use of X ray type of imaging to see things doesn't help you see soft tissue doesn't help you see, in this case, the vascular structure. As a result, these cases are longer than they should be. cases that are longer there than they should be are not good for patients are not good for the team that standing in the room delivering the care. It's not good for the hospitals, because operating rooms are very, very expensive to run, the permanent cost is pretty extraordinary. Okay, I want to talk a bit about the people in the room every time fluoroscopic navigation is activated, everybody in that room is being exposed to radiation. These are some recent publications in which the authors explored how this exposure is impacting doctors who are doing these cases and some of the other caregivers want to talk about the about the study on the bottom here. Not too long ago, I was an audience member of a watching a presentation that a vascular surgeon gave where he was summarizing the harmful effects of radiation exposure on on surgeons who are doing these cases. After his presentation, there's a panel discussion with some of the thought leading endovascular surgeons in the world, we're discussing this exact issue. After a pause that was a lot longer than mine that I just gave you one of the surgeons said, Are we crazy? Why are we doing this to ourselves? There was another long pause and there wasn't really good answer. The answer eventually was because this is the way we have to do it. And it's important. Well, I think that we can do better than that. And we have to do better than that, because it's asking a lot for these surgeons to dedicate their lives, to develop the skills to save other people, while also putting their own health at risk. So here's our system, at least an example of many of the things that we can do. This is a preoperative CT scan, and we have merged a map that we've created of the aorta onto it, the key takeaway is you can actually now see the aorta, right, not just the bones. And this is the part of the anatomy that's going to be treated. In this case, you can see some of the vessels that branch off of the aorta, and you can see some of the calcium deposits that have developed. And in this example, we magnify the image a bit. But again, this is the vessel map that we've created. And we like to tell people that our system is kind of like the GPS system that you have in your car, a map is created. And then you can watch our catheters, and our guide wires that are built specifically with our system navigate through the anatomy. Key point here is as this tracking is happening of the devices, radiation is not being used, radiation does not power our system. And it's not how we track. So real quickly there the white piece that went up as a tip of the of the guide wire that works with our system. And the blue piece is the catheter that is also specifically designed to work with our IOPS portfolio. So summary and there's another look at some ways that our images can be manipulated 3d visualization with real time multicolor tracking of guidelines and catheters. Our objective is to improve procedure time to help reduce costs and also have a more effective procedure for the patients and for the staff. And we think it's important to mitigate the radiation to mitigate the radiation exposure that's happening to everybody in the room, particularly to surgeons who are experiencing a career long exposure. I don't want to show you what the system looks like. We basically have three components to our system. One is a cart that can be wheeled into the operating room into different operating rooms. In fact, we have a tracking system that is a combination of of equipment, including the guide wires and catheters that I showed you. And we also have a pretty advanced software element to our product that you can't see here very much other than it's on the on the monitor. An important point though, our system is agnostic to the other investments in imaging that a hospital has made so we can work with all the other major imaging equipment that's been installed at at quite an expense. So we're agnostic to what else is happening. We are We're currently cleared by the FDA for use in the descending aorta. And we have a robust IP portfolio protecting our technology. So stepping a bit away from the technical aspects of it, I want to talk about some clinical data that's being generated with the use of our system. This was a big milestone for us. This was a multicenter study conducted by the Cleveland Clinic and the University of North Carolina 30 patients. And this was presented at two critical vascular conferences in 2023. At the end of the study, the conclusion was for the for the task in which it was used, there was a 100% success rate. And I am so was proven to be safe and effective for those tasks. This is a, this is a before and after case, example. So in this case, it's one patient. And I love this single patient examples because they really do feel so meaningful when you can understand the story. But in this case, the patient came in with some pretty challenging anatomy, the first attempt to treat her was done without the use of IOPs, it was used with standard fluoroscopic guidance. After two and a half hours, the case had to be abandoned, because the amount of radiation or to use exceeded the allowable amount. The patient came back to the center same surgeon involved this time i ops was involved in a case. And that same difficult anatomy was accessed within 45 seconds, resulting in a successful treatment, which is really a great outcome. Another example I want to give, these are two different cases. And the first but these patients presented with pretty similar clinical challenges and ultimately, similar objectives for what the case was needed to accomplish. In the first case, I ops was not used. And in the second case, I ops was used. So again, two different patients, but pretty similar tasks that needed to be accomplished the statistics between these two and comparing the I ops case versus the case where I have so it's not used, it's pretty powerful 67%, less X ray time 75% less exposed radiation, total or time reduction of two hours, and 90% less contrast media used. And I haven't talked a lot about the use of contrast media and fluoroscopic imaging, but we're dealing with sick patients, and the introduction of toxic media is not the best thing for them. And I also want to reinforce the point of two hours or less operating time. The statistics vary on that. But the per minute charge, again is pretty high. So there's some math that adds up quickly. So here's the market opportunity, we elevate up to a 30,000 foot level. We're currently cleared, and we're currently commercialized in the United States for use in the descending aorta. So we're targeting vascular surgeons. We've also done some some advanced prototype working both hardware and software to explore the application of our system in the structural heartspace as well as to treat peripheral vascular disease. Further on the future, we think our technology has the potential to be applied to neurovascular procedures, as well as in ERC procedures in the GI endoscopy area. We have three revenue streams for our portfolio, the capital equipment is sold on its on its own. We also have consumable items that are one time use that are used per procedure. And then for our software and service, we offer agreements that present an annuity opportunity for the company. We add all that up into this opportunities, the large opportunity segments we have and it's it's a pretty big opportunity. Okay, so I've addressed some of the milestones that we've achieved, we have our first clearance, we had our first multicenter clinical study presented, we've commercialized in our market 2023 and 2024 of their real heavy product development years for us, as we get to the end of 2024, we're really excited to be releasing several second generation products, including a smaller catheter that works with our system, because all the disposable accessories do need to work with our system that but that smaller catheter we feel is going to open up even more cases for for use in our system in our current indication. Along the way, however, we've had multiple releases of our software platform, so we're going to be releasing our fifth generation of our IOP software. Why that's important is every release we do we make the system easy to use. And we also make the system more valuable with more information we're providing to guide these procedures.

So if I look at where we are now, and then where we're heading to Prague, the film, it's gonna be a big part of what we do. It's it's this virtuous cycle of users coming back to you and saying, here's how I'm using it. And I would like to have this and I would like to have that so I could use it for something else. We welcome that and we're always going to be working on on new new ways to apply our technology. We really want to look at the opportunity to expand and markets outside of our current indication. We're going to get more clinical data to support the value of our system. And we're going to be increasing our commercial investment. We've been in a limited market launch in our current indication market and That's gonna involve adding more salespeople to our company as we release our second generation products. And also more infield clinical support, as as we train customers on how to use our system. So with that, nothing happens without a great team, we're really excited on the top row is our team, we have almost 100 years of medical device experience there. And we're also very grateful to have scientific advisors from the different specialties that we've targeted, helping guide us as we consider different options and different technical opportunities. So to summarize, we're currently not raising a fund. However, as we get to the end of 2024, and we released our second generation product, we are going to kick off our Series C fundraising round, very happy to talk to anybody right now wants to learn more about it, understand what our strategy is there and what we're going to be doing with those funds. And also happy to talk to any companies regarding potential for strategic partnerships. I'm going to close on this. I was recently talking very recently talking to a surgeon who was looking at our system and we were explaining how it was using it a chance to play with it. And I asked him why he was interested and what his thoughts were. And he said, Hey, at the end of the day, if we see better, we treat better. That's a big part of summarizing our mission. I would add to that, if we could also make it safe so the surgeons aren't exposing themselves to harmful radiation, then that's that really is our mission combined. Thank you very much.