Andrew Glass, Vivasure Medical - Spotlight Interview | LSI Europe ‘23

Transcription

Nick Talamantes  0:16  
I'm here at LSI Europe in Barcelona with Andrew Glass, Vivasure. Thank you so much for joining me.

Andrew Glass  0:21  
Thank you taking the time, I really appreciate it.

Nick Talamantes  0:23  
So why don't you tell me a little bit about what you're doing at Vivasure.

Andrew Glass  0:26  
Yeah. So Vivasure is a very innovative company, we are changing the way that large hole closure is being done in the marketplace. So, as you may know, some of the hottest markets of the last 10 years and medical devices have been transcatheter, aortic valve replacement, transcatheter, mitral valve repair or replacement. And all these procedures require very large holes. And so the market now, just for the closure of those holes itself is about $500 million, and has been growing at double digits. But the technology for the large hole closure is still the same technology people use 20 years ago. And so if you're to look at these procedures, in terms of complications, the most common complication has very little to do with the heart, but actually is all related to the actual closure of the large hole that is being created. So we have a very innovative approach, we're doing a fully bioresorbable patch. So typically, now, cardiologists and surgeons will use sutures, which have their own challenges, or a collagen plug. But we've got an innovative, fully bioresorbable patch that can be used to to close the hole, and we get fantastic data. It's very quick and easy to use. And yeah, we're on our way now.

Nick Talamantes  1:38  
So it's my understanding that there are about a million transcatheter structural heart procedures being performed globally each year. Is there a specific one that your technology is indicated for can be useful? 

Andrew Glass  1:50  
It's, no, it's agnostic. So we're agnostic to the procedure, any large hole arterial closure we can do? 

Nick Talamantes  1:56  
Is it for all cardiovascular procedures? 

Andrew Glass  2:00  
They're all cardiovascular. So it includes like, you know, ers and T VARs, for example, that we can close this actually, actually some of our biggest fans here in Europe are surgeons and not cardiologists, for ers and TVARS.

Nick Talamantes  2:13  
What are your fans saying about your technology, they liked it, it's fully by resorbable?

Andrew Glass  2:17  
They liked it, there's no pre procedure technique. So currently, if you sutures or collagen based approaches, you need to do measurement or put in the sutures before you start your procedure was with ours, you can do the main procedure and then just show up and close. So quickly for acute cases where you've got, you know, time is of the essence to do all this pre procedure prep. It's a real challenge for cardiologists and surgeons, so we're able to remove that step and get going. So yeah, these are the things that people really like about our product. 

Nick Talamantes  2:49  
What are the advantages of a bio resorbable, plug over collagen.

Andrew Glass  2:55  
So collagen is, as you know, is really good at clotting. But the challenge that you have often with collagen plugs is that sometimes they can clock the whole artery, right. And so when you're putting in a very large hole, a lot of collagen, you have a risk of closing the whole artery down. And so while it's very easy to use the product, and when things go bad, they can go very bad very quickly as with our product, because you see, we have a very low footprint in the vessel. We're not ever including the order. In fact, we've done over 1200 cases we never had once an occlusion of the vessel. And so we're able to avoid those complications that collagen brings in these large old procedures.

Nick Talamantes  3:39  
How does PercuSeal compare to vasca aid from hemonetics? 

Andrew Glass  3:44  
Yeah, so it's vascade is primarily for small hole closure. So they have an indication up to kind of 12 to 14 fringe depending upon if it's a venous or artery procedure, what we're as we're focused on the larger holes, so we go up all the way to on the venous side, we're going to go up to 30 fringe, which is quite large. And on the other side, we go to 26 fringe. So we're on the higher end of that scale, and we don't do small hole procedures. So that's where the the main differences is they have a different application, they use a very interesting approach of closing the hole with a nitinol. And then they have a bit of college in there. It's very low footprint, and they've obviously done extremely well. But the main differences is the applications of what they're going after.

Nick Talamantes  4:32  
Yeah, it actually sounds like it's quite different when you consider that it's nitinol collagen and small, small hole closure. Are you guys looking at you know, maybe down the road taking perky sail into that territory as well?

Andrew Glass  4:45  
No, we've gotten lots of questions about Aren't you going to do a small hole and really, as we look at the market that is an attractive market, the small hole but there's a lot more competition there. And the real clinical need is in these virtual procedures where effectively as I mentioned to you the technology hasn't evolved over 20 years. And this market is continuing to grow. So as you mentioned, now there's a million procedures is going to continue to grow at least double digits. And again, as I mentioned to you, the technology is still about is outdated with higher complication rates, more complexity, long learning curves, etc. So that's where we're addressing. ,

Nick Talamantes  5:24  
We talked briefly about Hemonetics Vasque a product, it's my understanding that they've also made an investment in your company. Yes. Could you talk a little bit about what that process has been like? And what Hemonetics is bringing to your, your in your business?

Andrew Glass  5:39  
Yeah, so really, I've said it many times, I don't think it's any secret that we found, I think, the perfect partner in Hemonetics. So hemonetics, as you mentioned, they have a small hole closure portfolio from cartiva is doing extremely well, you can you can go to the financial reports and see just how it's changing the nature of the company. And, you know, they were interested in a large foreclosure solution. And we were interested in raising big round for us pivotal. And so that's how the conversation got off and running. And, you know, they did their diligence, and they came back and say, Look, you know, we really want to lead this round, but we would like to, you know, have the right to buy you, after you complete your pivotal. So that's how the structure went. And it was very exciting for us, because not only are we getting the financial aspect to it, but they have a lot of experience and closure, they have a lot of experience running pivotal studies in the US. And furthermore, you know, they have experience on the venous side, which is something that we were starting to get into. So they were bringing a lot to us in terms of knowledge experience in the marketplace. And obviously, they've done extremely well commercializing. So the partnership was was well received by the board, and we're very excited to work with them.

Nick Talamantes  6:52  
I'm sure the board was very excited knowing that Hemonetics acquired cartiva for 500 million as well. So that option to acquire you guys as well, must be very exciting to everyone that you're working with. 

Andrew Glass  7:04  
Yes, yeah. Yeah. I mean, everybody likes an exit.

Nick Talamantes  7:08  
 So are you is that the plan then to go for an exit? Or are you guys looking to grow the company still, um,

Andrew Glass  7:13  
I think the preference right now for the company would be to exits. We have thought about once we get the FDA approval, you know, assuming the human addicts piece, you know, for whatever reason doesn't work out. And, yeah, we'd have to go raise some funds and commercialize in the US and outside the US. So. But I think the preference right now is, you know, we've got a great partner, great valuation from Hemonetics. And so we're, we're excited to move forward with that.

Nick Talamantes  7:38  
You know, Andy, I know that you were at LSI. Europe last year, you're talking about this US pivotal trial, what's sort of new with your company? Is it focused largely on this US pivotal trial that you've got going on? 

Andrew Glass  7:51  
Yeah, I mean, we've really had to pivot to the US and interacting with the FDA. That's been a huge shift over the past year with the company. The other thing that's happening for us as well, we're not just resting on our laurels, we're developing a newer product. So we have our PercuSeal elite, that's going to be doing its first unmanned any day now. And that's going to be intended for arterial and venous. And it's got a lot of simplifications and improvements and the delivery mechanism of our patch. So that's going on in the background. But yes, the main focus has been the US Pivotal, working with the FDA getting it approved all these things that go into that. And it's been a huge task. And we've managed to do that, you know, very proud of the team for working through a lot of the different dynamics. And we've also started to build up a bit of a team in the US not just for regulatory and clinical reasons, but also to support the cases as we're doing them there as well. So, yes, the company has really started to shift more and more to the US over the past year since we met in London.

Nick Talamantes  8:50  
How far out are you guys from having or obtaining that regulatory clearance? If all goes well, 

Andrew Glass  8:55  
So it's a PMA submission. So we are expecting by the end of the year that will complete the pivotal, it's a 30 day follow up. And then so sometime at the beginning of next year, we would submit and then that starts the clock with the FDA.

Nick Talamantes  9:07  
So it sounds like we have some exciting news to look forward to in the near future, then.

Andrew Glass  9:11  
Yeah, hopefully, I mean, goodness, you know, fingers crossed by a year from now we're where are we meeting in 2025? Or 2024? For, Europe? 

Nick Talamantes  9:20  
Yeah. Oh, I don't know yet. We'll have to wait and wait for that announcement.

Andrew Glass  9:24  
But by that time, you know, hopefully we will have you we'd be looking at getting FDA approval for PercuSeal family in the US.

Nick Talamantes  9:33  
I know that you've been to LSI. This is your second LSI. Is it? What brings you back?

Andrew Glass  9:38  
Well, a couple of things about LSI. One is I think this has really become the meeting for networking and connecting here in Europe. You know, I would say last year, there was a fair amount of people but this year I've just been amazed of how many people you've gotten to come here, not just from Europe, but also from the United States in terms of investors and companies. It's very impressive. So I think, particularly for here in Europe, if you are a company that's looking to build your name, get into the community, it's probably the meeting, you have to go to now to make the connections and start to build a report and also find funding, which is a critical piece of all med tech,

Nick Talamantes  10:18  
as an LSI alumni. Now, is there any advice you could give to a company that's maybe considering coming to an LSI event in the future? 

Andrew Glass  10:26  
Well, yeah, I would say come, but I think you make the most of the time. I mean, you know, it's a great structure, you have to connect with people see other companies, I think you've learned a lot, not just from the investor meetings you have, but when you talk to other CEOs about what they're going through what they're dealing with, we have a lot of conversations about MDR, which is a fun topic now. Downstairs, and I think it's just it's really helpful to get a sense of okay, yeah, you're doing, you're seeing that it we're seeing this and the knowledge is powered really helps you as you're trying to guide these companies. The changes medicine?

Nick Talamantes  11:01  
Yeah, I've heard a few innovators mentioned that the camaraderie with their peers is an especially important element of these events. You know, you mentioned that the MDR, how have you guys been handling that? Has it been a tremendous pain for you? Or is it something you were prepared for?

Andrew Glass  11:22  
We, we actually jumped quite on the bandwagon to switch to MDR. Because you, we have a very a great quality team. And we felt like we could get this done, let's get out of the way. And so when we got our full MDR certification last summer, as a company, we were, you know, the stats were less than 10% of companies have gotten the MDR certification. And of the small companies, it was even smaller percentage. So we were very proud of that. And then obviously, things change with MDR. So we kind of, you know, scratched our head. But I think, you know, there's a bit of frustration, because there's some nice things about MDR. Right. So for example, running clinical trials in Europe, you wouldn't have to, you know, currently in the old structure, and then still today, you have to go to each country's competent authority to get approval. So if you're running a trial, say in three or four countries, you got to go to three or four competent authorities get approval. One nice thing about MDR, when it's finally implemented is you get one, it's good for all of Europe. But that's not implemented yet. Right. So were some of the good things I think people are expecting from MDR are not in place just yet. And the other thing that's really challenging is the see bodies that are now reviewing your applications, as well as trying to get the previous applications approved and work through, they are overwhelmed with this. And and so you start interacting with your CE marking body and they're like, Well, okay, yeah, but that's going to take us a year, or that's going to take us this amount of time. And it's just because they're overwhelmed with the amount of work that's happened. So that's the bigger frustration for us is just getting an interaction with them. And then when you start interacting with them, they're still trying to figure out some of this. So the big frustration MDR, I don't think necessarily is the rules themselves, I think we're fine with the rules, everybody seems, you know, thinks they make sense. But the implementation of them and interpretation of them is where things are really slowing down. So, you know, in the old days, you'd expect to see Mark and a few months. And now, you know, we were talking internally, maybe a year is a fair assumption for when you submit, you know, it's hard to say, right? So it's, that's what's really slowing down. And I talked to a lot of companies, you know that, oh, well, we wanted to upgrade or change this. But we have to get a new see Mark for that. But you know, the timelines just keep getting pushed out or not out. So I think that's the frustration for people is there's a lot of great innovations you want to bring to patients. Unfortunately, they're being slowed down by the paperwork and the implementation of it right now. So yeah, you know, I think I think a lot of people are frustrated with that. Another thing that's quite interesting is, she talked a lot of companies downstairs is that they look, there's a lot more kind of us first mentality amongst European companies. So you, historically you would start here, get things going and then go to the US. And now I think a lot of people are saying, You know what, not necessarily because they think it's going to be easier to go to the US but because there's more certainty about the process, and they know exactly what they need to do to get there. And obviously the US is the biggest market and medical devices. So people are very much like hey, well let's just start with kind of a US based approach. Start working with the FDA early engage with them, and they get going on that whereas dealing with you know pick your see body and Ross is here in Europe. You don't know how long it will take or what the result will be. 

Nick Talamantes  15:05  
So there's certainly been a lot of doom and gloom with the MDR that's been permeating the the Zeitgeist and The discussion about med tech industry. It's great. And to hear that there's there are advantages to it as well. So I thank you for sharing that with us. And it sounds like your proactiveness to just dive into MDR and get prepared is going to serve you and your company. Well, Andy, thank you so much for joining me in the studio today.

Andrew Glass  15:29  
Thanks so much. Really appreciate it.