Joseph Rafferty, VESTECK - SUTURE-TIGHT Catheter | LSI USA '24

Joseph Rafferty  0:00  
I'm Joe Rafferty, I'm the CEO of VESTECK. We're a Delaware C corporation based out of Westchester, Pennsylvania, we're raising $16 million for Series B, and that will fund our 510 K clinical trial. The first device we're going to mark it is called the suture tight catheter we're targeting the aortic repair space will load for nitinol sutures. That's the picture on the lower right there. We'll look for nitinol sutures in this catheter. When physicians see it, they're very comfortable. They talk about using it in the peripheral market, the venous market and even structural heart. This was a slide that wasn't in the presentation. And one of the VCs that discussed and ended some coaching earlier today said make sure you get this right up front. We've accomplished 14 First inhuman cases, all the patients are doing well. The sutures are in place, the graphs are in place. Everybody's happy. Eight different physicians implanted this device. So it's not one of those that folks have to be have have exceptional skill sets to do it. Again, significantly, de risked the Kol is around the country around the world really are speaking about it at all the major meetings, we have a very clear 510 K clinical pathway. After six meetings, six pre sub meetings with FDA, there are no questions that are going to delay us and and cause us expensive problems. 100 patients one year follow up. We'll do half of those patients in Australia. And we'll leverage that Australian r&d investment credit through our existing DRGs and CPTs. Yeah, 43.7% and the currency exchange rate, so we spend $1, it cost us about 26 cents. The existing DRGs and CPT codes are there. Thank you Medtronic both for the initial implant. And for the repair procedure. We have three new patents that will give a potential m&a partner 20 years of runway, we've patented this system from end to end, and then about 25 different versions of the sutures. As I said, we mentioned the the Australia LLC has been formed. One of the towels relative to the market is frankly, Medtronic, the largest medical device company in the world has just placed a very significant bet. They're doing three very large clinical trials on this very space, large diameter next with anchors without anchors, etc. So that may be a tell if you're a poker player, there is a significant problem. As you heard earlier, the population is getting older, and sofinnova out of Europe placed a big bet on a company that is probably not going to make it to market in the endovascular repair space. But they're known for doing great due diligence and understanding investment opportunities. There we go the problem. Family Member a friend is diagnosed with an aortic aneurysm, they have two therapeutic options, the first being open surgical repair, obviously, difficult recovery. And if they get on the table with any comorbidities, they've got a almost 20% chance of not getting off. Endovascular repair. 80% of the patients around the world are opting for this along with their physicians. It's a great procedure, patients go home very, very quickly the next day, the challenge is peer reviewed literature would suggest it's not very durable. So if you look at these two little black boxes, the surgical repair has sutures there, the little black box doesn't and has radial force. There's one company out there that doesn't apply radial force to the neck of the aorta. We're going to apply our sutures to all the other companies. Why now, as I said 80% around the world, the peer reviewed literature is documenting that this is a an event a challenge that's happening all over the world. Payers are shifting to quality initiatives. And we've got a solution. This article just came out and frankly, it's it's a bit scary. But they're attributing all of these ruptures, early ruptures and and migration of leaks to the fact that these graphs are moving lower left there, we've got what's called a biasing mesh. The physician will slide that forward, the mesh opens up and it holds the catheter against the wall of the graft. And then we've got a suture delivery window. The physician literally pulls the sutures down into the window very much like holding a needle holder and a needle and suturing the graft in place. So if you can imagine the mesh goes up, the blood can still flow through so we're not causing any arrhythmias. The sutures can be delivered very quickly, very precisely. We just did cases down in Australia, very first time the physician used it placed four sutures exactly where he wanted them in four minutes. So not a lot of radiation time. Not a lot of time. of exposure. This is critical in that physicians love the idea that they can deliver a suture not release it, pull it back into the catheter, reposition it if they want, if they're not in the exact correct spot, I won't play the whole video. But suffice it to say, for sutures in a minute and 10 seconds, the middle picture is a, it's a quick graph. And if you can see around the edges there, there are semi circles or circles, we'll put right now four pair of sutures into the quadrants. And the key lower right there. You can see in that categoric tissue where through and through the admin tissue, so we're going through the graft, we're purchasing the admin tissue, and those grafts are not going anywhere to large markets, the initial implant market, and then there are about a million patients around the world with these grafts. And they're failing at quite an alarming rate. Some would say it's an install base for us to address. There are arguably no tools out there like ours, it's a platform, we can go from the aortic valve all the way down to the iliacs. physicians want to take it into the Venus business. And will will scale in that regard. There have been a lot of very big and lucrative m&a opportunities recently. These folks all have opportunities to tuck best tech into their sales bag, even into logics, which is that one graft company that doesn't put excessive force, they can use it as a leverage to bring business into their, into their bag, to competitors. Medtronic, this device is quite old. It is challenging for the physicians to use the patents are about up. And it would remind you of the old colonial rifles that you have to reload every time you want to use it, that applier has to come out. They pick up a corkscrew and go back in and it's quite challenging. And Iran has an idea at Sofia novice product. The challenge is they're delivering all eight sutures at once. aortas are heterogeneous, not homogeneous, you have calcium thrombus. And bottom line is I don't know that we'll ever see it get to market. We've got a global scientific advisory board, Cleveland Clinic, Arizona heart, Australia, USC, we've got the folks that are on the advisory boards for all of the global strategics and and they're letting us know what we need to do. We've got a leadership team with vast and vast endovascular market knowledge. Bob Mitchell is here our chairman is here. They know how to execute and an exit will have our FDA clearance completed by q1 of 27. Yes, I patted that a bit, it's probably going to be sooner but over promise and under deliver. We've got more clinical applications then than any one device really needs. But that's a great value add to have. This was designed by physicians to fit very smoothly into their workflow. safe, fast, easy to use. So what we've started to say of the tagline is best tech will become the standard of care in this endovascular space. And the case isn't finished until it's super tight. Again, we're raising 16 million and I'm happy to chat with anybody afterwards. Thanks