Trent Reutiman Presents Mercator MedSystems at LSI USA '24

Trent Reutiman  0:03  
Imagine delivering a targeted therapeutic drug or biologic deep inside the body to a local or regional disease, and being able to do that with pinpoint accuracy and precise dosing, and and then being able to visually diagnose that that therapeutic went only to its intended target, such as microinfusion core technology by Mercator. We are a C corporation in the Bay Area where ISO certified for manufacturing in the clean room, have about 12 employees. It's a hybrid between full time and part time. We have a broad and deep IP portfolio. We have two peer reviewed study publications. We have an awarded grant for BTK peripheral artery disease, and we have an awardable DVT score awaiting permanent budget passed by Congress. The device have regulatory approval, and we have our own reimbursement code for microinfusion, and we have a public Chinese company partner that has distribution rights to mainland China, if you look at the evolution of vascular care, you know, on the left here, you'll see all the tools that you're familiar with, and they've been presented at these meetings, angioplasty, stents, atherectomy, some newer ones, lithotripsy, thrombectomy, And then on the right, clearly, we've met unmet needs through local drug delivery in some of these applications. Think of drug eluting stent in the coronary and even Paclitaxel balloons and above the knee peripheral arterial disease. Even with all that, there are challenges and unmet needs in below the knee disease with the DCB and ds. And then on the venous side there, there's a different disease state, which is inflammation. And so there's an opportunity to bring drug delivery to the venous venous intervention. Here you can see a video up in the left of the device. It's a really efficient device. We don't have to surface coat drug onto the product. It has a 510, K and a CE mark. It's a 34 gage needle, which is as small as you can make a needle, and it's very controllable. No drug is put through the balloon. You don't deliver any drug until you get the micro needle exactly where you want it. And so there's really no off target mess. Comes in a range of sizes. It's a non compliant balloon. So really in just four sizes, you can go all the way from two millimeters up to 18 millimeters. And some of those are more for arterial applications. Obviously the bigger devices for the venous application. And, you know, they don't intersect each other, so projects on this side are independent of one another. So if we look at our BTK program and and the addressable market here in peripheral artery disease below the knee, in those complicated cases, 70% of those patients will go on to restenosis at one year. And while drug coated balloons have been successful above the knee, they've proven fairly unsuccessful below the knee. And so if you look at that, there's over 350,000 interventions already taking place in this in this anatomy, and that leads to a greater than $1 billion total addressable market that's already transacting that we can be adjunctive to here in the US I talked about the backdrop for BTK. There's a number of DCB studies that have failed, nobody's made it to FDA approval. And I think the important part here is no sirolimus DCB study has produced any randomized or controlled data yet, and if Paclitaxel balloons weren't able to get the job done there, it's hard to imagine that align this balloon will be able to do it. There is some recent data on the resorbable scaffold that's interesting, but that's also only showing improvement in very short lesions. So if you look at the results from a randomized study phase two that we did on the left, you can see the end point. It's freedom from clinically relevant target lesion failure, another moniker for patency below the knee. And this is a double blinded randomized study. So we had a control group that got saline through the device, and then a treatment group that got a sirolimus analog. And here you can see in the protocol group, we had about a 20% Percent improvement over intervention by itself, with no drug delivery. And then in the tougher group, if you take out the task, a lesions, the short lesions, and really get to the more complex disease, the drug showcased even better. This work is all published. You can find it online, and we really believe that this can be the first approved local drug therapy for BTK interventions, shifting then to DVT and a real a new opportunity, and one that's unique to us. I'm going to talk a little bit about anti inflammation treatment. That's the local steroid treatment, and it's only possible by microinfusion. You can't get enough steroid coated onto a balloon or a stent. So I think you all know about DVT. It's getting a lot of attention. Thrombectomy has revived the space. Stents have recently been improved. This is blood clot forms in one or more of the deep veins. Current treatments are limited to opening the vein. So you know, anticoagulative therapy, lytics, thrombectomy and stents. But despite that, a large number, too many of these patients, are progressing on to post thrombotic syndrome, despite an intervention, and PTS is severe and even life threatening. It has a great barometer for severity, the volatile score. It's a multi factorial score, and you either end up with mild, moderate or severe. And patients are designated as such as I said, it's debilitating to many patients, and once a patient has PTS, it's really hard to intervene on them and get them back. So we're really trying to be proactive and prescriptive here. So

I'm going to lay out that whole market all at one time. Right now, in FEM pop, there is no standalone intervention. There hasn't been anything that's warranted catheter based intervention in the FEM pop segment, which is actually one of the biggest segments, a lot of the work is being done in ilio FEM it's thrombectomy, it's stenting. It's growing fast. You know, we're converting there to more and more cases. You know, market caps are supporting a long term growth in intervention here. And then, of course, isolated tibial FEM is anticoagulative, and there is some isolated iliac and common femoral disease well handled by thrombectomy and stenting. It does very well there, but it is the smallest part of the market. So with over a million patients here, and our opportunity to bring a new green space FEM pop intervention and then prove better results in more comprehensive or more extensive Helio FEM disease, there's a big market there for us, a $2.5 billion total addressable market. Here's the results that we have today, and I'm going to focus you here this. We're focused on a six month PTS rate. You can see the two catheter therapy studies from attract and cabin PTS rates reported at somewhere between 25 and 30% roughly. And then you know about a 10% moderate to severe outcome in PTS there as well. Inari has recently put data out on their clout registry, 24.4% so a very modest improvement despite the seemingly better or more utilized device. And then we treated 20 patients. Followed them out to six months. We had one patient with mild pts. So, you know, just a really attractive outcome. None of the patients progressed on to have moderate or severe. We're very excited. The signal's very strong. It's not like, you know, two thirds of the patients are driving the signal here. This is very consistent. 19 patients all headed in the same direction. One progressed on to PTS, mild PTS, but by the end of one year, was back to non pts. So this is a busy slide, but I'll try to break it down quickly. So in DVT, we have a study in acute DVT, which I just showed you the data from the first 20 patients on. We're also enrolling a chronic arm of that dexterity study. And I guess the gist of it is by the end of 2025 we'll have randomized data about another 100 patients, 60 acute, 40 DVT, and we'll have the first randomized data in drug delivery, in venous interventions. The capital raise on that is $15 million and then at the same time, if. You look out to early 2027 we can deliver that all the way to FDA approval, and we can even layer over the BTK study at the same time. We would love the synergy of conducting both of those studies on the same overhead, so to speak. And so $30 million to get DVT all the way to the market. 40 million to get DVT and sirolimus BTK drug delivery all the way there. So really, this is a proven, next generation local drug delivery platform. There is a precedence for local drug delivery solving mechanical revascularization shortfalls. We're the only company in BTK restenosis with positive randomized RCT results. BTK microinfusion is the only technology that can shift reimbursement to the drug and off the device. There's no incremental reimbursement for a drug coated balloon right now. So we have first mover therapeutic advantage with a large Tam and a large, serviceable and obtainable, obtainable market in DVT. And there is a large DRG in DVT, as as many of you may know, but there is an additional opportunity here for a breakthrough and ntap and ultimately a CPT code. Thanks so much applause.