Video Transcription
Robert Whirley 00:00
Well, good morning. Thanks
Robert Whirley 00:05
everybody for coming by to learn about Arterica and our closure device for a next generation large bore vascular closure. Arterica aims to reduce the high rate of complications in a very large market of closing the access hole after large bore vascular closure. Standard of care in this space is a first generation technology. It's been around a long time. It has a very high complication rate, upwards of 25%. There are more than 1.2 million procedures done in this space that require closure, and we're talking about closure of the femoral access site. So when used for procedures such as transcatheter valves, aortic repair procedures, or mechanical circulatory support, like small embedded pumps, the Arterica closure device has been used in a first-in-human clinical study. We had great safety and performance results. We had 100% technical success, no late complications, with six issued patents, included in the United States, including one in Japan and China, and it is a class three device with a very clear regulatory path. The company has 13 million, and about 75% of that is from a large strategic. We are now raising a ten million Series B to advance our US clinical data set and submit our FDA IDE that will be followed by a 10 to 15 million investment to cover the pivotal trial. We have a strong team around the company. My background is I've been a serial entrepreneur, mostly in cardiovascular for about 25 years. Prior to Arterica, I co-founded a company called TriVascular that developed an aortic repair device, and that company, we did an IPO on NASDAQ in 2014. Our chief medical officer, Thomas Larsen, is a key opinion leading vascular surgeon. He's a pioneer in the technology that underlies the Arterica device. We have a strong board around us, including Dr. Thorsten Cees, he's executive vice president at J&J Med Tech and Chief Technology Officer for Abiomed. And on our Medical Advisory Board, we have Dr. Kraser, who's been a co-PI on the pivotal trials for both FDA-approved large bore closure devices. So we've got a very strong team around the company. A bit of kind of how we got into this space back in 2010-2011 in my TriVascular days, I was flying around the world working with physicians on how to do these aortic repair cases, and it was frustrating because we could put a life-saving aortic implant in in 30 to 35 minutes, but sometimes it took us an hour to get the access closed, and that's when I saw this really frustrating. There's got to be a better way. At the time, I had no idea I'd be involved in that solution. So be careful what you ask for; you might get it. The market-leading device provides inconsistent results, and at the end of the day, it simply doesn't stop the bleeding. At the end of the case, in a disappointingly large fraction of cases, it requires pre-placement, so you can't use that device on any case that's an emergency or an urgent case; you just don't have time. You got to get in and deal with the patient's immediate needs. It gives unpredictable procedure times that cause trouble with the doctor's schedule, also in the cath lab, or if you have a procedure you expected to take 10 minutes, and it ends up taking an hour. Now you've got patients waiting out in the hall. You've got nurses on overtime. That has significant impacts for the hospital. So solving these problems, it's a billion-dollar opportunity. Today, it's growing to 2 billion. There's a large number of percutaneous cases forecast to reach 1.4 million just in the transcatheter valve and the aortic space. By 2029, you can see a range of case volumes during the projected growth of the transcatheter valves. All of these are shown in thousands of cases. Transcatheter valves are growing about 10% a year. The aortic repairs in the second line, a very large space even today, and the mechanical circulatory support space is growing very quickly. In addition to the large bore space, there's a so-called mid-bore space of 10 to 14 French that's a little bit smaller than large bore, but still a very substantial market, and that's forecast to be a billion in the out years. That's additive to this space, and we've shown that our technology works well in that space as well. Our target customers are interventional cardiologists for the transcatheter valves and the mechanical circulatory support, and vascular surgeons, primarily for the aortic repair. In addition to that market, there's another angle here, and that's the strategic value of an easy-to-use device. As one person summarized it, it's having a robust $700 device that helps you sell a $20,000 to $24,000 device. A good example of that is in the mechanical circulatory support space. That is an $11 billion market today. It's only 12% penetrated, and Abiomed has 90% of that space today. And Abiomed said in their 2022 10-K that their focus for growth included not only developing additional circulatory products but an emphasis on improving access and closure. And so that's an example where the market leader has said improving closure technology can substantially improve their access and growth in the market. Here's an animation just to give you a sense of how our technology works. We use the fascia layer, that's the gray layer just above the artery here, and we'll take the skin and subcutaneous tissue away. The device comes in over a guide wire. We deploy a foot seat that foot against the anterior wall of the artery. Then deploy four anchors through the fascia, but not through the vessel. Use that to wrap the fascia tissue around the vessel, deploy a clip to hold that in place, cut the sutures, and the device comes out. So it's an extravascular closure using tissue that's already in place in the body, comparing our device against the market-leading device on the far left and two devices that are already in clinical studies, we can see with the market-leading device. That device operates by pushing four needles through the tissue of the artery. You have to go through the artery wall, so if that artery has atherosclerosis or calcification, those needles can divert. And that is the genesis of a lot of the challenges with that device. The other two devices leave material inside the common femoral artery, which clinical data has shown. Leaving things in the common femoral artery, when it flexes so much, creates a number of challenges. Our device is fascia-based, so it's purely extravascular. We leave nothing in the vessel. It does not require replacement. We leave nothing inside. And therefore, we're agnostic to the presence of calcification or atherosclerosis in those patients. The dimensions of winning in the large bore space are really versatility and ease of use, and we've really focused on that throughout the development of the device. Our first-in-human study showed excellent safety and performance. We did 13 cases with 13 successful closures. 11 of those gave hemostasis almost immediately. Two of the cases took slightly longer; they were learning curve. One case, we hit the skin. One case, we didn't get the device positioned right. All the remaining cases went very smoothly. They took typically two to three minutes. During that study, we had zero surgical conversions, zero ancillary devices, zero access site stenosis at 30 days, or narrowing of the vessel. Actually, when the patients came back, we got CT scans, and you can see very uniform healing of the vessel. We had no other complications when we brought the patients back. Very good overall results. We're now raising a 10 million Series B that will help us take the latest generation of the device, complete the FDA testing requirements, file for the IDE, and expand our clinical data set with an additional 50 patients outside the US. There are three exit paths for a company like Arterica. We see there's first, the obvious one with the global strategics that have large bore devices, as shown here on the far left in the middle, targets with strategic leverage, like I gave the example of mechanical circulatory support. But there are others where a robust closure device drives adoption of a high ASP device, and the third are the mid-market accessory suppliers that may not immediately come to mind when you think about exit opportunities. For example, Humanetics acquired Cardiva, which had a small bore closure device for 435 million just a few years ago. So that's the Arterica story. I'll be around afterwards. I'd love to chat with someone if this sounds of interest to you.
