Andrew Glass Presents Vivasure Medical at LSI Europe '23

Transcription

Andrew Glass  0:05  
Hi, my name is Andy Glass on the CEO of Vivasure Medical. We are in the process of enabling success, for many invasive cardiovascular therapies. We're revolutionizing large hole closure for some of the fastest growing medical device markets in the world a bit of a story. I grew up in Houston, proud Texan. And my grandfather went to grammar school with Denton Cooley. In fact, when my grandfather needed to have his cabbage, he went to Texas Heart Institute, and he said, okay, I need a cabbage can you know, I know, Denton, can he do my surgery, and they said, Mr. Glass, we have many good young surgeons here at the Texas Heart Institute, because at that time, didn't because he was 75 years old. He's still doing procedures, but Denton Cooley and his is known for the a lot of different things. And he's considered one of the greatest surgeons all time. But he was an interesting man in the sense that he pushed the envelope many times and actually, this is what got him in trouble the first time. So he actually did the first LVAD device in the history of mankind. And this LVAD device was developed there, the Texas Heart Institute, that Michael DeBakey, who was the chair of the department said, don't do anything. Well, we'll get to it when I'm back. But it didn't Cooley had a patient. And over his superiors instructions, he implanted it. And this is the patient who survived for days on this device. But when Debakey came back, he fired Cooley and Cooley went across the street to start the Texas Heart Institute, and started one of the great rivalries in surgery. In fact, this picture is in my office, the feud between Michael DeBakey and Denton Cooley and indeed heart surgeons for for ages were kings of the hill in terms of medical innovation. But times changed, of course. And actually, heart surgery is probably the last area of surgery that went minimally invasive, and over the past 15 to 20 years, almost all heart surgery procedures can be done in a minimally invasive way. And in fact, this innovation that transcatheter aortic valve replacement, which is one of the biggest medical device markets in the world has changed cardiac surgery entirely. In fact, most of these cases are not being done by surgeons, they're being done by cardiologists now. But all these procedures go through the leg. And so because this market is growing so fast, what we've seen is actually the ancillary products related to this market have also grown tremendously as well. So large hole closure, the closure of the leg access is an exploding market. So right now, it's about $400 million market. But because of all these innovations that are coming in, so many people in this room are developing, we expect this will be a billion dollar market by the end of the decade, just for the closure aspect of the market. And it's interesting that in transcatheter aortic valve replacement, the most common complication has nothing to do with the heart is with the access and closure. And you can look at many different data. These are sample data that I pulled, but you always see that vascular complications go between five to 15%, depending upon operator device and dynamics remains a huge complication issue for current procedures. So these less than ideal clinical outcomes are caused by the technologies to use either suture based or collagen based. And they really haven't evolved much in 20 something years. And that's where we come into play. So Viva sure we've developed a technology called PerQseal. It has amazing safety record. We've done many procedures without complications. We've done many trials where we had zero rate of a percent rate of minor and major device complications. It's a very easy delivery and streamlines the closure step because closure procedure because there's no pre procedure step anymore. Viva sure is based in the medical device hub in Galway. We are an ISO 13485 company. Of note we are fully MDR certified, we got on the MDR bandwagon at the beginning and as long as you got a bit delayed, but we're very proud of the quality organization. There. We closed our series D last year, so we're proud to Heaminetics lead it was just around 50 million euros, the series D. We have a great group of investors, we won a Horizon 2020 Grant and that's fully been paid. So we've got a very good financial runway into 2024. I won't walk you through the procedure too much but it's a very straightforward delivery system. This is our device that goes into a sheath that goes into the leg. There's one rotation which brings the sheath back and then once the patch is is opened up in the vessel, we bring it back to the vessel wall. And at this point, the operator can decide how they're going to move it adjusted so forth, and they pull their wire. And the final step is to unlock the system. One final rotation that puts a pin to hold the patch in place and releases the system. The system is 100% bioresorbable were the only fully bioresorbable solution on the market and returns the vessel to its native state at the end. And actually, you can see in these pictures here that we return the vessel to its native state in about six months. We've done seven completed clinical trials. And we are now running two more clinical trials to date. We've got a fantastic safety record across our trials, which I'm quite proud of. What you see, as I mentioned before, we have a very low complication rate, you compare us to some of the other devices in the marketplace, we tend to have much lower complication rates than the competition. And now with the money that we raised last year, we are running our US IDE, we're about a third of the way through completing the IDE, we expect enrollment to complete around the end of this year. And that will allow us to file our PMA probably early next year. And then in 2024, have us approval. And then you can see here, the first patient that was done by Dr. Ire in Buffalo. And we're coming full circle one of the sites that we're going to be using in our pivotal is a Texas Heart Institute. So there's a bit of irony that the areas surgery now we can go back to and say we have a very good solution to support minimally invasive cardiovascular procedures. But we're not stopping there. We're now working on a full portfolio of products that can simplify and make the procedure even quicker. So we're quite proud of our PerQseal Elite, which will any day now have its first in man, it's going to improve deliverability be used also for Venus applications up to 30 French ananomys and like I said we any day now we'll do our first and man and commercialization we are commercial in Europe in a limited fashion. The thought is in 2024 is picked up particularly with the US approval that will really ramp up our commercial activities, both here in Europe and in the United States. And that is VivaSure Medical. Thank you so much for your time and I really appreciate the insights. If any questions don't hesitate to reach out to me. Thank you