Joseph Rafferty Presents Vesteck at LSI Europe '23

The company's Suture-Tight catheter secures endovascular aortic grafts to the aorta at the time of implant or during repair procedures.
Speakers
Joseph Rafferty
Joseph Rafferty
CEO, Vesteck

 

Transcription

Joseph Rafferty  0:00  
Vesteck is an early stage actually clinical stage now, cardiovascular startup we're based out of Westchester, Pennsylvania, and we've got a catheter that's preloaded with nitinol sutures. We secure endovascular grafts to the aorta, either at the initial implant or when patients are coming back. And feedback from physicians around the world is that and peer reviewed literature is that these patients are coming back at an alarming rate. So two significant opportunities. The problem family member or friend is diagnosed with an aortic aneurysm a bulging of the of the aorta, weakening of the aorta, they have two therapeutic options. One, the open surgical repair is very durable, but if they get on the table with any comorbidities, they've got about a 20% chance of not getting off. The standard of care around the world is what's called ER or an endovascular repair, femoral access to she's put in guidewires put in and a stent graft is delivered very quick and painless. patients go home the next day. If you look in the two boxes there, there's nothing holding that stent graft in place other than some radial force, and its radial force on already diseased tissue. Remember, that's aneurysm tissue. So in a very short period of time, these patients are coming back. The feedback we're getting from physicians is frankly, they don't have any solutions. Professor Runyon is from the Netherlands, just joined our SAP. His feedback about why he was interested in joining the company was very simply, what we're doing is a definition of insanity. Er is a great procedure, but we need tools to make them last longer. We don't need these patients coming back. It's a significant burden to the healthcare system. Global Kol is high volume physicians are all in alignment. The physician at the top there is Sean Lydon, the chairman at the Cleveland Clinic, he got on board and became our chief medical officer, because they're realizing that these challenges are not going away and nobody's addressing it. So we've got the solution. We are very much globally focused. In this picture, you'll see Andrew Holden from New Zealand, we just brought on a an sav member from Australia, Japan, etc. The Netherlands, Latvia. As I said, why now, it is the standard of care across the world. peer reviewed literature is catching up and and demonstrating there's a challenge around the world where a single single payer system for these patients, they don't want to be bringing them back and absorbing the costs. And when they bring them back, they're taking an or table that could be doing an open heart surgery that's emergent or a cardiac cath. And so we're fortunate in that Medtronic, to their credit has created a market with an older technology a gen one technology, they've created an awareness that when you can get these endo anchors in, there's a benefit to it, and we'll we'll ride maytronics coattails in that regard. It's a platform technology, we can move from the word aortic valve in TAVR, all the way down to the iliacs may be general surgery. We've done seven successful clinical cases Latvia, Canada, patients are out now six months the sutures are in place. The graphs are in place and the patient's is doing well. We've got the CT follow ups there. That is Dr. Shawn Lydon in the left there, and and then in Latvia. In the middle picture, you can see the little circles in the graph. Those are our sutures, holding it fixing it to the aorta. Very simply, we've gotten a biasing mesh handle so we can take large patients or small patients, the mesh goes up and holds the suture delivery window against the wall of the graft. Very quickly, I won't show you the whole video here but we can deliver four or five sutures in about a minute. It's that quick and easy. This suture was designed by surgeons to look exactly like an sh needle, which is the needle they use to suture these grafts in place. So the wising mesh goes up and the blood can still flow through. In this example, the physician begins to deliver the suture doesn't like the location of the suture until it's released. They can retract it, reposition it and continue moving on. So it is really that fast and and easy. Flexibility. We're adding a lot of clinical flexibility to this device. It's very easy. The picture on the left. Dr. Di Yamanouchi is a professor chairman at Fujita University. He he had this in his hand for the very first time and deliver the sutures at the top. He said in Japan, it's all about precision. He said, I'm going to demonstrate and put these sutures in the gaps between the stents. And just so you know that it wasn't a fluke, I'm going to do it again down at the bottom. So he said, I can tell my peers in Japan that this device can be extremely precise. We're initially targeting two large markets. The first is the initial implant. If we suture the grafts in initially, they won't come back. And then there are about a million patients around the world that have graphs implanted, they have to be monitored every year to see if the grafts have moved, or if they're leaking, etc. So we've got a 510 K pathway from FDA, there are existing DRGs for the initial implant, and for the repair procedure, and physicians get paid there are CPT codes for both. If we were to partner with the right global strategic, only 50% of the global tam is about $700 million opportunity. So it's big. Similarly in the US, we're prepared to do a demonstration project. And again, in a very short period of time with five reps we can generate $28 million through our initial clinical trial sites. The single competitor out there is Medtronic, this endo anchor, as it's called, was repurposed. It was a hernia mesh tack that they've repurposed for the aortic aneurysm space. To its credit, when the tacks go in. The patients do well, acutely, they do well, long term, physicians are telling us they need a better tool, they need something that's easier, faster to use, our devices got about an 80% gross margin. So that's a wonderful thing for four partners. Very fast, easy, accurate, again, designed by physicians to overcome all of the existing shortcuts. We've just read patented, from stem to stern, and we've got additional patents to be issued, essentially providing an m&a partner another 20 to 25 years of protection with this device, actually. Additionally, we've just filed in the EU, UK, China, Japan, Australia, New Zealand, Canada. So we've got protections for around the world. We're very accountable group. We build our own devices down in Carlsbad, we leverage the ACS guidance, engineering credibility, five precepts with FDA so we're not going to make any costly mistakes by way of, of Miss stepping there. We've opened up our Australian LLC, so we're taking advantage of that Australian investment credit. We've already gotten some money back there, as I said, we've had seven clinical cases completed. Series B will fund the manufacturing of devices. We are doing that in Carlsbad, and our 100 patient clinical trial, again, we'll leverage to the Australian experience we'll do 50 of our 100 patients in Australia have that benefit, in addition to speeding the enrollment. They know who we are, we're under NDA and materials transfer agreement with all of the competitors are not the competitors of potential m&a partners. The market is big relative to acquisition, the numbers are significant. We've got a great leadership team that has been there done that and exited. And the physicians are driving the solution. They say they need to improve outcomes. We've got to reduce the global health care costs. And frankly, we feel that we've got a significant opportunity for investors and m&a partners to generate some real value. All right. Thanks. Thanks, God.

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