Chapters Transcript Video Innovation Horizon Back to Symposium Alright, um, is my mic on? You guys hear me? OK, there we go, um, I, uh, hate to let you down. I've won 0 Emmys, um, but I'll try anyway, um, so I'm here to tell you a little bit about our, our innovation, a little bit about who we are in R&D, and, uh, what our pipeline looks like and what we're doing and hopefully get you excited to work with us as we listen to what you have to say over the next day or so. Um, starting out with, uh, we have a global team. It's a large team, over 250 engineers and associates around the world. We have people in Europe and Ireland and Germany and Switzerland and, and then in a few different locations in the United States, and we have a number of different skill sets across. Those folks, experts in Nanol technologies like uh our Denali filter, uh, the, the self-expanding stents, stent graphs, graphs, uh, dialysis catheters, you name it, we've just got all sorts of, uh, capabilities. Oh, and, and not to mention uh drug coatings as well. Uh, this is just a little snapshot of our pipeline and the, the way it works. We have a few different phases of getting a project started and, and, and into our what we call our new product development pipeline which I'll show a little later. Uh, but it all starts with ideas. People submit. People throughout the company submit different ideas. We go out, talk to you folks, watch your procedures, and try to come up with different ideas, and we have over 90 ideas in our overall pool. They go from our pool into our funnel where we have multiple stages that they progress through, and we have 20 active ideas right now, and this is kind of that risk reduction time where you're looking to say what makes sense? Is there a market for. Something is it time now? Maybe not now, maybe later we keep an eye on those things and it's just working through that portfolio and again getting out and getting early research from the market to see what makes sense. Another key part of that, as you see in the bottom, uh, left of the slide there, is that about 10 or so projects are archived each year. Uh, that's another important thing is saying no. Uh, it's difficult sometimes it's your baby sometimes, but, but knowing when it's the right time to move on from something and go to the next idea. Um, we have a lot of capabilities within the organization driving all of this, and the number I'll focus on the bottom right there is the, uh, 150 qualified, uh, IDRs is our invention disclosures, so we have a lot of people submitting a lot of ideas every year to get through and create this pipeline that we have, um. We at PI are focused on underdiagnosed chronic diseases. I'm not gonna dig into this a whole lot, but just to show you, we have oncology, which, uh, I know this is, uh, about PAD, end stage kidney disease, uh sorry, peripheral vascular disease. Um, we have PAD and venous disease that are all some of the things that we're looking at, so that entire funnel covers the, the scope of those areas. Um, in 2025, some of the things that we accomplished this year is, is we had two launches. They were both on our oncology platform, one being a drainage bag for our Peritex product line to give, uh, basically faster drainage and more flexibility to the patients. And we also launched a couple of new breast, uh, tissue markers in our ultracore, uh, uh, pipeline. Those are called cur uh sorry, curls and clover, and, uh, we just know those it offers a, a better, uh, uh, portfolio for those markers. We also initiated the Extract clinical study, which is a perspective multi-center single arm study to, uh, show to assess the clinical use of Rotorex in real world clinical application, and we're really excited about how that's going and seeing how those results go as we move for as we move forward. Now here's our pipeline and, and what you can see on the top row is our new product launch is getting to launch and on the bottom it's getting to our IDEs, getting to our, our studies, um, what, what I did throw one on there. The first one you'll see in Compass is an oncology related item, but I know there's some interventional radiologists in here, uh, so it's a, it's a multi-modality, uh, vacuum assisted biopsy device that we're really excited about, uh, launching in 2026 as well as that. We've got our Revelo, uh, product which is a self-expanding, uh, stent graft, and we're gonna launch it in the in the EU this year and then follow up with that EIAC launch in the US next year and with the SFA indication in 2028. Um, we also have another launch we're excited for in the middle of this year which is our Liberty tip stent graft which I'll talk a little about the study, uh, in, in just a moment there. Um, we have a number of other, uh, IDs and registries that we're moving toward. I'm moving toward. I mentioned the extraTRACT study, uh, the agility study, which is for our iliac and SFA indications for the self-expanding stent graft, and then we've got in the in the horizon in 2027. Uh, a couple of studies for our, our drug coated balloon platform which is called psionics both above the knee SFA and BTK, and then we have a couple of atherectomy programs coming up which I'll, I'll show a slide on later as well. Um, this is just a snapshot of what goes into some of these projects as we move along. As I said, we're really excited about the upcoming launch of the TIPS Liberty TIPS stent graft program. But in order to get to this, in order to get to the right type of product at the right time, this is just like combining multiple years into one slide of all the work that goes into this 650+ primary inputs through case observations, interviews, uh, quantitative and qualitative surveys, probably with some of you in, in the room, uh, to identify some really unique user needs and, and come up with a device that we think is gonna make a real impact in the market. Uh, this is just an example. We do that we have a, a version of this for every product that we go through. This is about getting out to the customers, getting out to you, hearing from you, and that's why we're so pleased to have, uh, this summit like this, and, and I'm super excited in, sorry, I shouldn't pat that. I'm super excited in an R&D to be part of this and, and participating and, and getting this, uh, and be able to take this back to my engineers. All right, so our liberty tip stent graft, we have, uh, completed our enrollment and our follow up of the Arch clinical study, and some of the things that we're going after here is a wider anatomical range size, uh, in order to also reduce the incidence of hepatic encephalopathy and a, a real key differentiator is our easy to use delivery system which we're super excited about and think it's gonna make a big impact in the market. We have our agility clinical study, which is a broad clinical study that covers both an iliac and an SFA indication, and, uh, what we're looking for here for differentiation is to show, uh, reduced edge stenosis compared to current devices. We have a lower profile delivery system and an easier to use delivery system. Again, things we're super excited about that we've, uh, seen our user needs from, from speaking with you all. Um, in the pipeline, uh, one of our, I mentioned the two atherectomy devices. One of them is called, uh, you're probably aware of Rotorex, and this is Rotorex SV. The SV stands for small vessel, and the idea is a lower profile Rotorex to get to below the knee lesions. Um, it's, uh, what we, what we're looking for here is lower profile and for mixed morphology. So in those, uh, below the knee lesions where you have a little bit of calcium, you have some, uh, some, some, uh, thrombus formation. Uh, the Rotorex can get in and, and, uh, remove the thrombus and remove some of that like you would normally have with our larger rotorex. With the addition on this one, it's a little hard to see, but in the image you can kind of, kind of see the sparkly stuff on, on, on the tip there. We've got a diamond coated tip on the rotorex to help navigate through those calcified sections of a mixed morphology lesion. Uh, we have a proposed clinical study design, so this is not final, but it's proposed right now for a single arm versus a performance goal, uh, that we're gonna work with the FDA on in the future. And then I'm gonna jump to our other uh atherectomy device which is Optimus. This is a an orbital atherectomy device and what we're shooting for here and hoping to prove is that we have increased and more efficient luminal gain. We don't have any capital equipment with this device and we're looking for improved safety, less particulate, more even, uh, um, uh, removal of the plaque, and again a proposed clinical study design below that we will work through with FDA. Um, next up is our psionics program. As I mentioned before, this is our drug coated balloon. This is a errolimus, uh, balloon, uh, and something I'm gonna point out here is our balloon design. There's a few other devices you may have heard of, uh, uh, that are in trials and working through and trying to get Cerrolimus out there for the SFA, and where we stand out is our, our, our coding technology. We're looking for a 3 phase approach to the release of the drug here. So all of the devices that you've probably heard of have what we call a burst release. So it's just when you first inflate the balloon, it puts that serolimus into the tissue and gets a burst release. Some of the technologies you may have heard of have small, uh, uh, bio. Uh, degradable beads, uh, bioabsorbable beads, and they'll give you what we call a short term sustained release. Ours has a combination of both small beads and large beads, as you can see in the image. We have 10 micron and 35 micron beads. The idea there is you get the burst of the initial balloon inflation. You get some of the short term couple week duration with our 10 micron beads and then you get that longer term 60 to 90 day duration of of the drug getting into the tissue with our larger beads. This is unique. This is what stands out. This is what's gonna make our technology really compete and you can see in the in the bottom left there are proposed clinical study design there which is a RCT versus Paclitaxel. Um, and last but not least is our ionic drug coded program for DCB for BTK. This is similar design across the board, just smaller size balloons, obviously, um, and we're super excited about this and that longer term durability of the coating. And the other thing we're really excited about, we've got a lot of innovation that I've just gone through today, but one thing that we try to innovate on as well is our study designs. And so this one, what you'll see is it's a Bayesian design, and one of the nice attributes about that is it allows for interim looks, which means if you have a good enough result along the way, you can end that, uh, clinical study early. Potentially and save a lot of time and get to market a little faster so it's just another way we're trying to be innovative and work through our our portfolio here. So, uh, this is what I had to present today on our innovation pipeline and if you see me around tonight, tomorrow, I'd love to talk to you about whatever I'm super interested in what you have to say or answer any questions about any of these products as we move forward. Thank you. Published Created by
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