Video Transcription
Joseph Rafferty 00:02
Joe Rafferty, I'm the CEO of VESTECK, and after seeing some pictures from last year, I've got to remember to smile. We are raising $16 million for our Series B investment. This is the catheter; it's called the Suture Tight Catheter. What it does is we've got four pairs of nitinol sutures loaded into this catheter. The first market we'll go after is aortic repair. Physicians put in an aortic endovascular graft, and the challenges are that they tend to leak and migrate. So we'll use our device to suture those grafts in place to obviate those challenges. Physicians see this, and they say they want to take it to structural heart. They also want to move into the peripheral vasculature and also the venous indications. They're putting venous stents in from a third nurse, and frankly, they're ending up in the right heart. So there's probably an indication there. I was introduced to this technology years ago; the founders, who were well ahead of their time, said that there's an issue with these grafts moving, migrating, and leaking, and I didn't know about it. So I called some of my vascular surgeon friends, and they said, "Joe, if the device does what you say it's going to do, it's going to be a home run because it's a very, very big problem." Fast forward from 2019 to now, many of these international meetings are now posing these point-counterpoint conversations about whether this is a failed procedure. The fact that it's on the podium as the endovascular graft implants—80% of the patients around the world are getting them. Is it a failed procedure? The fact that they're even discussing it, I think, comments on how challenging this market has gotten. Anyway, we've de-risked this device. Investors are looking at placing bets. We've de-risked this; we've got 14 cases done. Patients are doing very, very well in Canada, Australia, and Latvia. KOLs around the world are in alignment. They're on the podium on our behalf. Around the world, it will become the standard of care at the initial implant and for repair procedures. We've had five pre-sub meetings with the FDA. We know that we only have to do 100 patients. We know that it is a predicate device, the Aptus device, and only a 12-month follow-up. There are existing DRGs and CPT codes in the US. We've got our Australian LLC set up; we'll do half of our 100 patients in Australia and leverage that R&D investment credit that they're providing. It's a rebate of 43.7%, and then we've got our global IP strategy executed. We've got three new patents and two existing ones, and we're covered all across the world. These 14 cases—the real wonderful part about the 14 cases is that the patients are doing very well, six months, 12 months, and 18 months out. Now, eight different physicians performed these cases, so it wasn't one particular rock star that did all of them. Again, back to betting. All of the VCs are here because they're placing bets. Why have Medtronic, Boston Scientific, and Sofinnova placed big bets in this aortic repair market? Recently, Medtronic is arguably going to spend somewhere around $300 million on three very large studies and 1,000 patients. It's because the market, the aortic repair market, is growing by leaps and bounds. The patient population is getting older, with morbid obesity, diabetes, and cardiovascular disease. It's a perfect storm for aortic degeneration, and oh, by the way, 42% of the US population is obese. We'll target two markets initially: the initial implant market, so when the aortic graft gets put in, we'll secure it to minimize patients coming back. But also, there are about a million patients around the world that have these grafts implanted. Peer-reviewed literature says that about five years later, they're coming back for repairs. If you talk to the high-volume clinicians, they're saying it's quite a bit more than that and quite earlier in the patient's life cycle than that. So we'll take advantage of that. How will we make money? An M&A tuck-in is an option. Licensing is an option. I'm culturally a commercial person, so I'd like nothing more than to commercialize this. The recent acquisitions in M&A are big and profitable. Many of these companies had no FDA clearance and no revenue, and they're still generating very, very large returns for investors. Some early numbers—they are big. And despite our predicate device's lack of success in the market, clinicians tell us they need a device that does this. Back to some of the anatomical challenges. If a family member or friend was diagnosed with an aortic aneurysm, they have two therapeutic options: one, open surgery. They get on the table, and with any comorbidities, there's about a 20% chance they're not going to get off the table. 80% of the patients around the world have two small holes created in the femoral arteries, and the physician puts guide wires and sheaths in, and they deliver this endovascular graft. If you look up in the little black box there at the top, there's nothing holding that graft in place other than some radial force on already diseased tissue. And it's a diseased tissue that's going to continue to progress. As the elastin transitions to collagen, it's going to get worse. So what we do is over the very same guide wire, through the same sheath, we put sutures up in the neck to hold it there. Really simple. And when physicians see it, they say, "We've been doing this forever." The platform can be used from the aortic valve all the way down into the iliacs. We'll focus on the aortic repair in the abdominal area for right now, but very simply, the biasing mesh has a sliding handle. The handle opens up the mesh, and the mesh is held against the wall of the graft. We've got four sutures preloaded in the distal part of that catheter. So this is in the lumen of the graft now, over the same wire, through the same sheath. You can see very quickly when physicians see this, it's just like them with their needle driver. This is modeled after what's called an SH needle. It goes through and through, through the aorta, through the graft, through the aorta, very quickly. They love this part in that it can be almost delivered. If they don't like the location, they can retract it, reposition it, and then continue moving forward. That's key if you're running into things like calcium or thrombus or a stent strut. The picture in the middle—this is a Cook graft, and you can see our sutures, the rings there. This is cadaveric tissue, and this is the important part. We're going not only through and through the graft but through and through the aortic tissue. There's really only one competitor out there right now on the market, and that's Medtronic. It was a co-opted hernia mesh tack that was repurposed in the aortic space. There's another company out there, Enduron. We haven't heard much at all out of Israel. This device was very specifically designed to fit in the workflow of the current procedure over the same guide wire, through the same sheath. A physician in Australia performed the first case, placing four sutures exactly where he wanted them in four minutes, and we were done with four pairs of sutures. We've got a history of hitting milestones. We'll have this FDA cleared with funding. We'll have this FDA cleared by Q2/Q3 of 2027. We've got a robust SAB group that is on the podiums around the world. They are the who's who of vascular surgeons. They have a very, very strong opinion. We've got a team that has extensive experience in the endovascular space. They know how to commercialize, and they know how to execute and exit. As I said, we're raising $16 million, and we'd love to have a conversation about how we can work together.
