Joseph Rafferty, VESTECK - Endovascular Aortic Repair Grafts | LSI Europe '22

Transcription

Joseph Rafferty  0:08  

So again, Joe Rafferty from VESTECK, the CEO of this tech, we raised 5.96. Today we're raising 16 in the B round. And we are looking for a lead investor of our Series A round, approximately four and a half to five of that round will follow on in the in the series B. The catheter is called the suture tight. And what we do is we secure endovascular aortic grafts to the aorta, either at the time, they're initially implanted or when they come back for repair, which is becoming a quite a dirty little secret around the world that these grafts are falling and leaking. And it's about a million grafts out there that are coming back patients coming back to be repaired. And it's important to remember we're not selling the grafts we're not trying to upset Medtronic cook or we're selling a catheter system that will help those grafts last longer, patients last longer, live longer. We've completed eight clinical trials for categoric cases, and we're getting ready to do our first in humans. In just in a couple of weeks, we've got a device, it's much faster, safer, it's been designed by physicians to fit into their clinical procedural workflow. And that's been done on purpose. It's a platform technology with quite a number of devices that we can address. The challenge in these little black boxes is very simple. In the open surgical repair, the graft is attached to the aorta. The challenge is if you get on the table, with any comorbidities, there's about a 20% chance you may not get off. In addition to the painful surgical procedure, the recovery time is quite long. But 80% of the patients in the world have what's called an endovascular repair to small arteriotomy is in the groin arteries and the graft is inserted. The challenge is if you look up in the endovascular repair, there's nothing really holding that graft in place other than friction, a little radio force should that aorta continue to dilate and they do the graph leaks it migrates and you're back to square one re pressurizing the aortic sac. And, and it can rupture 80% of the patients around the world and their doctors opt for this procedure. So why is this become a big issue now, again, 80% of the patients around the world. Number two, the global reimbursements are switching from paper fee for service to quality initiatives. And in places like the UK, the NIC has shut off use of this ER procedure except for very specific patients because they did not want to pay for the recurring repair procedures, the costs associated with it. We've calculated that if this device was used at an index procedure when they did the initial implant globally, we could save the healthcare community about a billion dollars a year. And solution is VESTECK. It's a big market, almost $5 billion by 2028. We feel that we can bring in the right sales back about a billion dollars of incremental global revenue. There was a clear 510 K pathway. We've had three pre submission meetings with FDA they've agreed to our predicate device, existing DRGs and CPT codes so the hospitals get paid and the physicians give hate targeting two markets, the initial implant market and the repair market. There are about a million of these graphs, people walking around with a million of these graphs implanted in them, and they're failing at a quite an alarming rate. So this is the device itself. On the left, you'll see the hand slide it expands the biasing mesh. The biasing mesh is up in the top left square there you can see the catheter gets held against the wall of the graft. These are pictures of the sutures that graft that catheter has for those sutures stretched out in the distal aspect. So the mesh goes up. In this particular case, the physician doesn't like the location of this suture can pull it back retracted into the catheter, reposition the catheter and then deliver it again. With this video will will deliver four sutures in about 60 seconds so it's very fast, very precise. The lumen of the graft from the top left you can see it laying flat. The suture laying flat top right it's through the Advent tissue which is the strongest part of the aorta. The bottom left there is a Medtronic graft, I believe and then categoric tissue. The picture on the left is post preclinical case Dr. Di Yamanouchi was showing off a little bit, he put the initial sutures up at that proximal cuff there. And then he wanted to demonstrate how accurately he could position the other sutures in between the the stent graft rings. The lower right is interesting in that when these graphs fail, oftentimes physicians have to go back in and put a patch inside the existing graph. So what we've done there is we've sutured the new patch to the old graph, so that neither will move. And you can see that they've gone through the aorta, they're there, the top picture. It's a platform technology, as we've been coached to say by this week by many of the leaders, we're going to focus on one device first, the ER or the abdominal aortic repair businesses the biggest opportunity, we'll develop that device first and then earn the right to move on to different markets. One competitor, Medtronic, to their credit is plowing our green fields, they're spending a lot of time and money to publicize the fact that when these endo anchors go in, patients do better short term and long term. The challenge with the Medtronic product, it is old, that corkscrew is actually a co opted hernia mesh tact that they brought to the aortic space. 30% of these grafts are these health effects are now deployed and not useful by reporting in the peer reviewed literature. By design, the physicians that have founded this company have designed and a great deal of clinical flexibility. The seat, we're under CDA with many of the global strategics they know who we are and what we're doing. There's been an awful lot of very large m&a opportunity, that opportunity has been exit in the last few years. We've begun stacking new IP on top of the existing IP, we filed two very comprehensive patents on that distal segment of the catheter. So potential acquirer would have a long runway. Again, very efficient use of the series A funding Manufacturing Office in Carlsbad, California. R&D, we've done the preclinical work and the categoric work. First in humans is really next week, we're going to use the $16 million for the series B of Series B for our clinical trial, and that'll take us to July 2025. The leadership's got deep, cardiovascular endovascular experience. Bob Mitchell was the CEO of LX that was acquired by EndoLogics. Bob stayed on there and was president for quite a while. Ken Stocker and Ted Wolfman are former guidance people worked with me there, Darcy Abel 35 years with the FDA, a fantastic advisory board. They're on the podiums internationally. But more importantly, they're on SAP's of everybody that would want to acquire our company. So we've got a fantastic team a technology that is second to none. There's a global unmet need. That's significant, providing a tremendous opportunity. Again, we're raising 60 million of Series B preferred equity, and we're looking for a lead investor. Thanks