Jordan Pollack, VeinWay - Venous Recanalization, Controlled | LSI Europe '24

Jordan Pollack 00:02
Good morning, everyone. Jordan Pollack, CEO of VeinWay. I would like to introduce you, first and foremost, to a couple of patients that are near and dear to my heart. Meet Sophie. Sophie is a 39-year-old mother who had a blockage in her upper right arm, in her veins, that was so painful that she couldn't even carry her kids. The physician had tried multiple times to intervene on her in order to open it up and actually failed until our solution came along. I'd like you to meet Suzie. Suzie had been intervened on four times for a blockage in her leg, in her veins, by physicians, and she was in so much pain that she was begging them to amputate her legs. Fortunately for her, the physicians called us up and said, "Wait, we're going to give this one more shot with your device to cross, to open and to help her out." And I'd like you to meet Steve. Steve also, after five hours of trying to open this blockage and failing, then the physicians finally called us up to come in and help out.

So what is this that I'm talking about? I'm talking about Traversa. Traversa is the first device designed for crossing and opening blockages in veins. Yes, veins, not arteries. Big difference there. The important thing is that our device has a steerable Foley, steerable needle. It can be rotated 360 degrees around, bent from zero to 60 degrees, and advanced forward and backward. It also has an inflatable balloon that acts as an anchor to hold the device in place while advancing the needle forward. We have demonstrated already in seven successful clinical cases that we can cross any length of occlusion from three to 30 centimeters. We cross in under 30 minutes, and we've crossed 100% of the time, demonstrating full success compared to everything else on the market.

So what are these blockages that I'm talking about? Chronic occlusions in veins. These are blockages that start as acute DVT. Everyone's heard of DVT, right? Raise your hand if you've heard of it. You know somebody who's had it, yeah. So when these DVTs are not treated, within two to three weeks, the clot becomes chronic, the body lays down collagen and fibrin, becoming a complete blockage that now these patients suffer with. The healthcare system is not set up to deal with them. They can't walk, swollen legs, edema, ulcers, and they're given compression stockings and told to go home and suffer. And when physicians do try to intervene on them, mostly interventional radiologists, they will spend hours doing so because it's much like watching an episode of MacGyver. Everyone, anyone remembers that show, right? Like duct tape, chewing gum, super glue. That's what they're doing in the cath lab in order to try to actually place a guide wire across these occlusions. And in over 30% of the cases, they will fail and send the patients home without effectively treating them. I ask you, is this the kind of healthcare that we want to deliver? I don't think so.

So we have Traversa. The way it works: you start by inflating the balloon, you advance the needle forward. You then deflate the balloon and then advance the catheter over the needle. You then repeat this step as many times as needed to cross the occlusion. May it be a short occlusion one or two times, or may it be a long occlusion; you may have to do it 30 times, but it doesn't matter. We have that ability additionally, because of the steerable needle. And actually, the gentleman who spoke before me was talking about steering in the vasculature. We can navigate in anything because we can change directions. We don't need to have fixed, angled catheters, things like that. We can actually change the way that we work through the occlusions.

We've done seven successful cases so far, another one at Stanford, two more with Dr. Human Jalal and Akin, and two with Dr. Steven Black in London, who is the premier vascular surgeon doing veins. Traversa is a 510(k) device with clinical data. So we're going to be doing a 30-patient first-in-human trial that does not include the seven compassionate use cases we've done to demonstrate technical success and safety, meaning placing a guide wire across the occlusion and demonstrating safety. We're going to be starting with lower limb occlusions from the fem-pop region up to the IVC. These are probably the most severe that we see. These also include occluded stents. The more vena stents that are placed, the more that will occlude. It seems to be pretty logical that we're going to have more of those issues.

In addition, as I mentioned, one of our patients, there are upper limb occlusions for dialysis access. A third of dialysis patients will end up with blockages in their veins up top here, and that can actually be fatal. So besides Sophie, Suzie, and Steve, there are another 3 million patients in the US and Europe suffering from what we call post-thrombotic syndrome, which does represent a very large market opportunity at $4.6 billion TAM. Many of these patients are not treated; they're undiagnosed, underdiagnosed. This represents a significant opportunity for us to open up the venous market because I'll reiterate, Traversa is the first device designed for crossing chronic occlusions quickly, safely, and consistently.

The vascular space is ripe with acquisitions. Okay. In the venous space, we've seen Boston Scientific pick up Voro, pick up Veniti, which was a venous stent. We've seen Philips acquire Vesper, which was another major venous stent that they've used. And one of my favorite companies, Anari Medical, which has really been changing the way that we talk about venous disease, with an incredible portfolio of venous products. To date, there are few devices that get used here, such as Baylis Power Wire. Cook has the Triforce catheter, and Bentley has B Back. But all of these lack the steerability and pushability that Traversa has, which is significant because many of these devices were actually designed for arterial crossing and not for the veins.

I think it speaks for itself that besides just crossing and ensuring higher rates of recanalization and reduced procedure time, that's great, and Traversa does that, but what it also does is it allows more physicians to participate. Right now, the best KOLs have waiting times of a year and a half, which means these patients are suffering for a year and a half at home and aren't being treated. But we give them Traversa, and now they can do 3, 4, 5 procedures a day instead of one, and more physicians can do these procedures. This is critical for getting more patients treated, and that is why we are here today at this conference.

As I mentioned before, the ability to treat more patients, but the reimbursement is also important. When the procedure pays out $10,000 and you spend an exorbitant amount of time and effort in these cases, you've lost all that reimbursement. So not only do we ensure that you get that revenue as a hospital, but we ensure that you can do many more procedures, getting many more patients effectively treated.

We're backed by the best physicians in the industry. You probably know many of these names. Many of them are here, not here at LSI, but they're at C, which is down in Lisbon right now. Michael Lichtenberg just gave a talk on Traversa this morning. Human Jalal, you've done cases with Jerry O'Sullivan. If you ever want to have a beer with the best Irish doctor ever, that's him. Dr. Steven Black in London, who is the number one vascular surgeon, and in Israel, Adam Ayal, US Marc, and Bob Beasley. Myself, I'm a Boston Scientific alum and a University of Michigan alum. I worked there for four years in arterial devices. My partner, Ben Friesem, is the best CTO there ever is. He can honestly say he designed a whole implant at Restore Medical for heart failure. We are backed by an excellent CFO in Nam and an excellent head of quality in Yaron.

So where are we headed today? We have a $7 million round open. We have $3 million already committed, including from a major strategic, so we're looking for $4 million to bring us home. This is going to fund our first-in-human trial that starts at the beginning of next year. It will take us about six to nine months to get to 510(k) clearance, at which point we have a good inflection point for an acquisition there, or would you another series round to get us through early commercialization and launch?

So with that, thank you for your time. Come find me afterwards if you have any questions.