Christopher Haig, Efemoral Medical - Drug-Eluting Bioresorbable Scaffold | LSI USA '24

Christopher Haig  0:04  
My name is Christopher Haig. I'm the CEO of Efemoral Medical. And it's my pleasure to be here with you today. So let's talk about peripheral arterial disease. Everybody's heard of this. It's simply the buildup of plaque in the arteries outside of heart as we age. I think what many people don't appreciate is how common this is. There are over 200 million people worldwide that suffer from this condition, almost 20 million those are in the US here alone and enormous economic burden to society. It comes in a couple of different forms claudication, which is basically a built debilitating pain in the leg or the foot or critical limb ischemia, the more severe form in which the actual viability of the limb is threatened, many of these patients end up having to go amputation. So I think every medical device entrepreneur at this at this conference knows that building a company is hard. Raising money is hard. Building a team is hard. Building a product is hard finding product market fit is hard. Figuring out your clinical strategy is hard. So you need to have your Why Why? Why are we doing this? So this is our first why here. If you look at the see if I can get the if you look at the failure rates of angioplasty and stenting for coronary stents, they're incredibly low coronary stents, I would argue one of the most successful medical device interventions over the past 25 years or so. But it's simply not the case. For the interventional rates for peripheral vessels. If you look there, they start high and they grow over time whether using a balloon or a stent, it doesn't matter. These vessels just do not respond to stenting or interventions in the same way because the disease is more complex. And the the motion of a leg is more complex, of course than the heart. And here's our second why. For CLI patients. This is the most common medical condition requiring amputation. There are 150,000 Americans under every year that undergo CLI related amputation. And if you look here, what basically these are generally elderly patients, when they when they undergo amputation, they kind of lose their will to live, they never get out of a wheelchair. And the actual two year survival rate is worse than many forms of cancer and even congestive heart failure. So the good news of the interventional market just in the US alone is already a large existing market. You see, they're the areas that we're focused on, we're going after the femoral popliteal artery, the tibial arteries, but there's also opportunity in the iliac and AV access indications. But with the right device with the right technology that actually works that provides durable outcomes, there's an enormous growth opportunity. Similar to what happened when stents went from uncoated to coated there was enormous growth in the potential for that to for that market, and we see the same potential for the peripheral market. So here's an image of our device. For those of you who are familiar with stents and stent design, you'll know that this looks a little bit different from other peripheral stents, most peripheral stents today are self expanding nitinol stents. And the reason why they're nitinol is because they can accommodate the motion of the leg, which is much more complex than the motion of the heart. The problem with nitinol is number one, it doesn't have much radial strength. And number two is it constantly interacts with the vessel, so the vessel never has a chance to heal. And these are some of the reasons why the outcomes of peripheral stenting are so disappointing. So we've taken a different approach here. This is a balloon expandable device in which we have a series of independent virus horrible scaffolds that are cramped side by side. And they're engineered each one to be very rigid, very strong. When you expand the the balloon delivery system, this the each scaffold shortens by design and creates these inner scaffolds spaces. And this inner scaffold spaces allow us as you see in the next image on the left here for the overall system to be flexible and accommodate the leg motion. So you can't put a long rigid stent in the leg because as soon as you bend your leg or sit down, it's going to break. This is the way we've solved that issue is having a very rigid implant, but short ones that are very close to each other with inner scaffold spaces kind of like the train going around the curve in a train track, if you will. We're using our our material is a combination of PLLA but not one of the percent we put in a copolymer in that the copolymer lends ductility to the stent. And it also lends the ability to be resorbed more rapidly. So if you think about 100% PLLA device takes about five years to resorb. Our device takes between one and two years to resorb. So there's an enormous advantage to that. And then finally, we have a proprietary ceramic coating. Many of you know sirolimus has been used as a drug coating. It's an anti inflammatory coating, been used on coronary stents very safely and effectively for many years. And it's off patent and available to us. I'm happy to announce that we did get the most innovative reward for cardiovascular therapy at the VT conference in 2002. For this for this device. So we're in a first inhuman study in Australia, New Zealand at four different sites. It's a typical similar sense. It's a typical first advanced studies for the treatment of claudication and the femoral popliteal artery. You see, there are a principal investigator there on the right Dr. Andrew Holden. To date we've enrolled 17 patients acutely they've all done well. And the follow up some of these patients have been followed up to two years, many out to one year and we have no incidences of any complications, no incidence of target lesion, revascularization or instant restenosis. So here's one of Dr. Holden's early patients you can see there on the left in that first panel that's a fully occluded Did are almost fully occluded, superficial femoral artery, Dr. Holden in the second panel cracked cross of the wire, he restored the blood flow. And then he did an angioplasty in the third image there you see the balloon image. And that obviously there's more flow that that arteries open now, but you can see it's not really fully opened it has also has two sections in that. And when you see an image like that, it's often a predictor of very soon needing to have a secondary procedure that Ardra will not stay open very long. Luckily, in this particular case, this patient was enrolled in our femoral one study. So they implanted Dr. Holden implanted in femoral device scaffold. And you see there, the final result, completely restored the lumen of this vessel, fix the sections that were created by the balloon, and this patient now has a much better opportunity for a long term and durable outcome. So we have a very experienced team in place. My background is art in cardiovascular medical devices. I started my career guidance, spent many years at Abbotts. It's an Abbott that I met her my co founder, and also our chief medical officer Luke Schwartz here is a vascular surgeon. Lou has as an unusual combination of industry experience, but he is a practicing surgeon. And this idea really comes after the frustration in his practice of treating his patients and the limitations of the products that he has available today. And we have a very experienced, technical team in place. These are individuals that I've worked with personally for many years, who have domain expertise in areas of endovascular device development of polymer science, regulatory affairs, drug coding, clinical trial operations, and so on. We have a who's who in terms of our advisory board, these are individuals that are not only treating patients with this disease, but they're also involved in the research in pushing the boundaries of science here and on the podium, often announcing the results of clinical trials, and also often connected to and on the advisory boards of the potential acquirers of a company such as ours. So let's talk a little bit about the category bioresorbable is this category is pioneered by Abbott about 10 years ago with their buyers horrible coronary device known as absorb. That was a great device it was it was approved worldwide, but it just wasn't quite as good as the existing coronary drug eluting stents available as I showed you, very early drug eluting stents in the coronaries worked really well. So it was very hard to improve upon those results. So they would choose that product from the market. And other companies that were developing coronary scaffolds did the same thing. And now many of them have been reborn as tibial devices, which is, I think, an actually much better application in peripherals there's much more of an unmet need. But although those devices were originally developed as a coronary device that's now been adapted to the tibial vessel, which is a similar diameter our device is not, it's because it's been developed as a peripheral first device, we can go into a lot more different applications with it. So we have a fanpop indication, we do have a tibial device. By the way, we just got breakthrough device designation from FDA for that device. And as I mentioned, our devices absorb between one and two years, we're able to treat very long lesions because of the modular concept of our device. So we have significant advantages over the competition. So just to kind of recap here, these are the indications we're going after we have data on our SFA popliteal device. And we just got a breakthrough designation on our typical device. It'll be a little bit later working on iliac and AV Fishel applications. But if you step back and open up the aperture a little bit, there's a number of areas in the body where this platform technology could be could be used. So in summary, here, we've raised over $9 million in equity funding to date, we've gotten two separate SBIR grants for to $2 million of non dilutive funding, and we're fully funded to get to our next major milestone, and that's 30 patients with follow up. And based upon that we intend to raise our series B later this year for $25 million, which would fund all the activities here you see the GLP, preclinical studies, the device testing and any additional clinical testing that would get us to ID approval in the second half of 2026. So I thank you very much for your attention.