Andrew Glass, Vivasure Medical - Advanced Polymer Implants | LSI Europe '22

Transcription

Andrew Glass  0:06  

First of all, thank you very much for the opportunity to come present to you via your medical story. Where we are. Our job is to enable minimally invasive cardiovascular procedures, and a bit of a story. As you could probably tell, I'm not from around here. I grew up in Houston, Texas, and in Houston when I was growing up, the kings of medicine were the cardiac surgeons. In particular, the story around these two gentlemen, Denton Cooley and Michael DeBakey, who always had battles there, the Texas Medical Center, and Houston, Texas. And the first cardiac surgery that I saw in the year 2000 was nothing but blood. At that point in time he did a sternotomy opened up and we were putting on the heart lung machine, there was a ton of blood and all these patients would require transfusions to be successful. But it is an interesting story that this great field of cardiac surgery was the last field of cardio of surgery in general to go minimally invasive. And that's changed over 20 years now. And in fact, medical devices me the technology is by innovators in this building today, have transformed the field of cardiac surgery and made it predominantly minimally invasive to the point that today, you actually have stamps and countries that are celebrating these innovations. And in fact, today, the largest medical device market in the world is transcatheter aortic valve replacement, which is minimally invasive treatment for uric valve disease. So we've seen an evolution of cardiac surgery going from open procedures, a sternotomy. In fact, one cardiologist called me a sternotomy, a major complication to now minimally invasive procedures for patients who go home the next day. And in fact, what has happened is there's been a huge rise in the access needed, all these procedures tend to go through the leg in the body. And in fact, large hole closure, the closing of the hole in the leg has become a very fast growing market. And that's where we play. The technologies, however, have not evolved particularly well. Despite the lack of new technologies, this market is going to grow to be over a billion dollars. And this is real revenue today, and large hole closure. Today, it's about 300 million in that market has tripled in the last five years, largely because of these minimally invasive procedures that surgeons are now using through the leg. Because the closure solutions have not evolved over time, the most common complication of these procedures actually is related to closing the hole the leg and not treatment of the heart or any sort of other aspect of treatment of the heart. As you can see here, in any study, you go into the space for transcatheter aortic valve replacement. Now you'll see that yes, the most common complication relates to vascular complications, in other words, closing the hole in the leg. And we all know that these complications are associated with increased mortality, poor quality of life, longer length of stay and greater cost in the hospital. This is a recent trial that was presented about a year ago, focusing purely on closure. And you can see the two main solutions that cardiologists and surgeons have today to close these holes still have a 10 to 20% range of complications. In other words, either one in 10 to one in five of these patients are going to have a complication related to closing that hole in the leg. We really sure think we can do better. And that's why we developed the perky seal technology to address large hole closure for oops, oops, these procedures. We have a patch bay system that returns the artery to its natural state, we close from the inside we minimize these complications, we eliminate a lot of the pre procedure steps sorry, there's an issue with my slide. And we have a very simple control delivery, which means that more operators can use our technology going forward. Real quickly, we'll go through a procedure here what we do is we do a sheath exchange and over the wire we put in our sheath and this is our sheet that we have. In the procedure we ask them to go back four centimeters to make sure that they're fully in the vessel and then they push forward for and that makes sure that when they deploy the device, they're gonna be completely within the vessel. And at this point, what we'll do is we'll ask them to take out the introducer for the sheath. And the after this procedure here by the way, this is a a triple A procedure that was done by a surgeon. You bring down our device you can see the patch inside the cannula there which connects to our sheath At this point, the operator will bring the patch down to the end of the sheath. And the first step here is to rotate. And that will bring the sheath back and opens up the patch inside the vessel. And you can see the sheath come back. And at this point the the patch is now open in the vessel. And the clinician will bring the patch back to the vessel wall, closing the hole. And they will move it around and adjust as needed. You can see there's very little blood coming out at this point in the procedure. If you were to see other closures done for these procedures, you'll see a ton of blood coming out it's quite a messy This is a very controlled safe procedure. Once the clinician is satisfied with where things are, they're going to essentially deploy our patch at this point unlock the system. And it's simple rotation of the device. And after they have decided that they're ready to remove the patch, remove the device, they'll do a final twist and bring it out. Again, simple, easy, very little blood during the procedure. And we have a lot of success here in Europe with a procedure. Our patch is 100% bioresorbable. So the data you see here is that 30 days to patches into the allies and then over a period of six months it goes away. This is the only solution that's fully bioresorbable in the market. We have a great group of clinicians that have helped us both here in Europe and in in the United States. Vivasure as you may or may not know is based in Galway in Ireland. So we are across the street from Medtronic, you may or may not be familiar with the fact that 90% of the world's stents are made in Galway in Ireland. And we were able to leverage a lot of the talent that's there in the west coast of Ireland. We have 14 patent families strong freedom to operate. My team wanted to make sure you saw this because it took a lot of effort. But we are fully MDR certified and have CE mark under MDR for our products. In Europe, we're less than 15% of small and medium enterprises that have achieved that to date. We have had done over 300 closures in clinical trials we've done close to 1000 commercial implants. And in our clinical trials, you can see our complication rates actually look favorable to current solutions. We're gearing up for our US IDE. So Bill Gray and Sean Lydon will be our PIs for our US ID. We're anticipating starting this year and completing enrollment by the end of next year, submitting our PMA and then having approval sometime in middle of 2024. In the United States. We have a full pipeline of products due for your time, I won't spend too much on what we're doing here, but you also addressing a lot of these venous procedures that are there in the market. In terms of our financial backing, we have a A list of investors who put money into the company. We did we win a prestigious horizon 2020 grant a few years ago, and back in May we close our series D of up to 52 million led by strategic with an option to buy the company upon certain milestones. So that's the Vivasure story. And what we're trying to do. I'll leave you with a bit of a story. You know, Denton Cooley was an interesting surgeon. And, you know, he said once that successful surgeon should be a man who when asked to name the three best surgeons in the world, it would have difficulty deciding on the other two. And the reality is that what we've seen over the past 20 years is that the ability of surgeons has been taken away. And now the common average cardiologist and surgeon can utilize these medical technologies to treat their patients effectively. But the key aspect to that is you need to get access to the body and you need to close it. And unfortunately closure technology has not evolved and we believe we have a great solution to solve that problem and enable these minimally invasive cardiovascular procedures. Thank you very much for your time.