Trent Reutiman Presents Mercator MedSystems at LSI USA '23

Transcription

Trent Reutiman  0:00  

Good morning, everyone. Let me start here by giving you a brief background on Mercator. We're headquartered in the Bay Area. We're a C corporation. We manufacture in our own company on cleanroom. Got 14 employees, it's a hybrid of full time and part time. We have a public Chinese company as a corporate partner, distributing and with rights to mainland China. We have a broad and deep IP portfolio with over 40 patents. We have two peer reviewed studies published. We've operated under three grants to NIH, one NCI, and we have two grant proposals now in we have device regulatory approvals, which I'll talk about, and we have a hickspicks code specific to our procedure for micro infusion. Joining me on the management team is the original founder of our technology, Kirk Seward. And then we have a part time, public company, tech CFO, Steve Baker. So the device and drug delivery technology that we're working on, we branded as micro infusion, you can see it's a unique ability to locally deliver targeted therapeutics during catheter based interventions in diseases with unresolved needs. So if you look at the evolution of vascular care, you'll see a multitude of cardiovascular devices that we're all familiar with. Most of them include next generations or iterations. But the reality is, is that mechanical therapy doesn't always get the job done by itself. And there's a real opportunity in some of these procedures for local drugs to pick up some of the slack. And so perfect examples wouldn't be of that where there's been success would be the set second generation or next generation, drug eluting stents, Paclitaxel balloons and above the knee arterial disease. But then there's other areas where drugs haven't been incorporated yet to meet unresolved needs, things like below the knee disease on the arterial side, where DCB and DS have failed. And then more recently, in venous interventions, there's nothing been done on the drug delivery side. And here inflammation is the underlying failure mode. So if you look at these two big Tam's in DVT, that opportunity, there's $1.335 billion, it's about 450,000. Cases, considerations for intervention, and thrombectomy. And stents have been growing dramatically here. And yet, those don't offer any treatment for the underlying disease of inflammation to prevent post thrombotic syndrome. And then 50% of the DVT incidents is in the FEM pop segment, which isn't being intervened on currently. Similarly, in PAD, the BTK market has about 350 interventions a year. And a lot of those don't get outstanding results. And the drug of choice Paclitaxel has become somewhat unfavorable. So you can see in the animation here, we have a catheter based technology. Put it down, you take it to the disease segment of the the vein or the artery, you expand the balloon, it an envelope, some micro needle, that needle penetrates the wall and delivers drug to the tissue to the local disease site. In the angiogram in the middle. You can see the darkest circle in the center is actually the balloon, it's 5050 contrast saline. And then we do a 2080 drug mixture. So 20% contrast 80% drug. So inside the dotted circle, there is an actual visual visualization of local drug delivery on this device. The device is very efficient. It's 510 K approved and CE marked. And as I mentioned, we have a CMS code. This really opens up a platform of opportunities. We have the leap frog device, which goes it's cross sectional here of that device. It goes six to 20 millimeters, which is the ideal size to really cover deep vein thrombosis. You know, basically from your knee to the groin. We have a range of small, medium and large of Bullfrog products for the arterial side, opening up below the knees, peripheral artery disease, above the knee disease and even renal denervation. So if you look at DVT and anti inflammation, local steroid treatment is only possible via micro infusion. You can't get enough steroid onto a balloon. or a drug eluting stent to deliver the drug that way. Here you can see in DVT literature and research, inflammation and PTs are intimately linked, that that connection goes on and on and on. So what is post thrombotic syndrome? It's a debilitating set of chronic symptoms that include pain, itching, swelling, tingling, it occurs in 30 to 40% of the patients, despite their catheter based intervention to take the clot out of that vein. And so there's a real opportunity to prevent or delay the progression to pts. And it should be noted that once PTS happens, they're not very successful in treating patients that already have pts. So dexamethasone, anti inflammatory steroid micro infusion treatment really works on three fronts, it treats the underlying disease associated with DVT. It treats the inflammation during the opening of those veins by mechanical tools such as thrombectomy. So those devices are fairly traumatic. So it's nice to have an anti inflammatory in an inflammatory setting, and then last acts as an insurance for patients that don't comply with their anticoagulation meds after a DVT intervention. Here you can see some results from our dexterity clinical trial that we're currently in. It's an acute ilio FEM DVT. These patients have a long segment of DVT DVT, the median here is 35 centimeters. On the left preclinically, we saw an 80% reduction in vein wall thickening, which mechanistically explains why DECA dexamethasone would be a good drug for this application. In this study, we're seeing a reduction in Clinical Biomarkers. Il six is an inflammatory biomarker, and we're lowering that number by 32%. The veins are much more compressible, improved compressibility. Or I guess, lack of non compressibility is a big benefit here. And so at one month, we have 63% improvement in vein compressibility after the intervention. And then the key Crux here is below two scoring. It's the primary component of PTS. And we're reducing the Veilleux to scores which is a big positive by 55% on average. Venous med tech has been a hot space, you're familiar with companies like Inari and penumbra. It's driving corporate strategics to make acquisitions. Here, you can see a handful of acquisitions that happened in late 2021. These these companies minus Vesper, which was in the middle of an IDE trial, these companies have very little clinical data, and really no commercial revenue yet. So consolidation in Venus is happening quickly. So Mercator were a private med tech company. It's got a platform technology targeted to improve outcomes in cardiovascular interventions with unresolved needs. And I really think the company's in the right spot. We're working in the backdrop of peripheral vascular venous interventions, which is a hot space and seeing a lot of m&a activity. We're addressing unmet needs that you can't get through mechanical Therapy Solutions. We are far out in front in drug delivery, for DVT. Nobody else is doing this right now. And we really have a novel approach here. And then we have strong corporate interest in these adjunctive technologies due to corporate interventional venous product portfolios. So thanks for your time. Appreciate it.