Transcription
Robert Kieval 0:05
Good afternoon. And as you've heard cardiovascular disease remains a leading cause of death and disability worldwide claiming over 18 million lives annually according to the WHO, and costing the global economy more than $1 trillion. It's also one of the largest sectors in medtech. And according to some sources, the cardiovascular device market will surpass an estimated $65 billion in 2023. With this backdrop, good afternoon, and thanks for joining this discussion of the current status and future opportunities in cardiovascular devices. Time permitting, we'll be talking structural heart ablation, peripheral vascular hypertension, heart failure, and of course, AI. As you've heard, I'm Rob Keival, Executive Vice President for Strategic Partnerships at their annex. I'm a cardiovascular physiologist by training, and have spent the last 30 years developing and commercializing cardiovascular medical devices. Varon X is a unique purpose built provider of global end to end integrated product development and commercialization services dedicated to the medtech industry. We've got specialized capabilities in cardiovascular products. So if you're working in the cardiovascular space, we're your partner of choice, and we'd welcome an opportunity to prove that to you. So thanks for coming. Now, let's meet our panelists. We have Chris Eso so from Medtronic, Devon Bream, from GE Healthcare, Howard Levin from Deerfield catalyst, and Mrigasha Patel from HSBC. Chris, would you introduce yourself?
Chris Eso 1:49
Good afternoon, everybody, Christ. So I lead business development and strategy for our cardiovascular portfolio. Been with Medtronic going on 13 years now all in a business development m&a strategy capacity. Prior to Medtronic, I ran a clinical stage biotech contract biologic manufacturing company, and had a lot of m&a and strategy work from the pharma and biotech side of the world. Nice to meet you.
Mrigasha Patel 2:18
Thanks, Chris. Gotcha, Patel. I've been in medtech mostly in interventional cardiology for about 14 years. And then I'm left industry to go into banking. Don't ask me why. But most people leave banking to go to industry. And I started seeing some pockets of, you know, innovation. And I thought it would be fun to be around companies like such as the ones here today. And so I've been in banking since about 2018. And, you know, advice, then it's executed on 25 billion plus dollars worth of transactions. 80% of that has been mostly on the sell side m&a, and then 20% call it IPOs and capital advisory type things. So looking forward to this discussion with everybody.
Howard Levin 3:00
Thanks. My name is Howard Levin. I'm the CEO Chief Medical Officer of Deerfield Catalyst. We're an early stage medical device incubator part of Deerfield management. I'm a heart failure cardiologist by training. Prior to doing a JV with Deerfield management, we were Coridia a early stage and medical device company. We've sold or started and sold, with our companies returning over 1.6 billion for their investors. And as far as I can tell, Chris still owes us money.
Devon Bream 3:42
Hi, my name is Devon Bream, I'm the president and general manager of GE Healthcare Invasive Cardiology. As many of you know, GE spun off the health care division earlier in the year. And it's been a really, really exciting last few months, less than last year with all the renewed focus in health care. And my group and particularly is the cardiovascular side, and electrophysiology. So really happy to be part of the panel. Also want to thank Vera annex for being great partners. They're just fantastic to work with. And you've helped us on so many things. So thank you very much.
Robert Kieval 4:20
Appreciate that, Devon. So thank you all we've got a great diversity of perspectives for you today. But we thought it might be useful to help get us started for magashule to give us a quick snapshot of the current investment landscape in the cardiovascular space.
Mrigasha Patel 4:35
So one of the things that we're noticing all the interventional cardiology companies still trade a lot better than the overall medtech sector. Now. You know, there's this new, there's a new category called high growth medtech, which started in the 2018 call it window. And that was really because of a lot of companies going public in that single product companies. So we saw, you know, Shockwave, Inari, Silk Road and some of these newer companies that went public in that window. And that that created this new category called high growth medtech. Now, this multiple on an LTM revenue basis, as you can see, there's this large peak, right, that was the pandemic, which turned out to be a great time for the equity capital markets. But even though it's resetting now, it's still trading well above large cap medtech, smids and the s&p, right. And this is all in the cardiovascular sector. Now, if we take a step back and look at sort of q1 and q2 earnings, even, you know, I've got all the strategics here, and I'd love to hear from them. But you know, they posted really good growth in some of the sector. And, and this is largely because the procedures are coming back, I, you know, I don't care what my research analyst says, But you know, GLP ones are not going to disrupt any of these businesses, the patient populations way too complex. And you know, you have to think about this, these patients really show up at such a difficult time in their kind of journey, that they sometimes have no other options, besides some of the devices that are in these portfolios. So you know, there's strong growth coming out of the cardiovascular sector, we're seeing a lot of momentum in TAVR. TMTT and even EP ablation and afib, you know, unfortunately, mitral replacement hasn't turned out to be the way you know, we thought it was going to be we're still not seeing anything, you know, commercially viable there. But it's still early, there's an you know, just out of, you know, kind of innovation, r&d takes a lot of time in that sector. So hopefully we'll see something there. And then CRM is sort of the part that continues to grow at a at a modest rate, but it's still, you know, a pretty great portion of the business. And then LVAD picked up a little bit worldwide that helped Abbott sales a little bit, there's still a lot of unmet need there. And then you know, lastly, what I'll touch on is I don't want to discount the fact that India and China are basically on, on on, on the on the track to become the second largest medtech markets in the world. It says a decade, but I'm seeing more momentum over there than I've ever seen before. So, you know, that's sort of the state of the market here. And then, you know, talk about the m&a precedent transactions. I think everybody knows some of these. But you know, kudos to Chris for getting a lot done here. In the past year Cordus, and Medallions did a DCB deal. That was pretty monumental. And then obviously J&J and Abiomed, everybody knows about that transaction, I think, you know, Abbott, buy out of CSI was a little was a little on the lower end in terms of the multiple but you know, the company had been around for a while, the procedures weren't really coming back, and the company was struggling. So I think that valuation made sense over there. But you know, the last thing I'll touch on this page is if you look at the multiples on these, on these, right, higher than equity capital markets, higher than, you know, FTM, revenue multiples, some of the best we see continually in this in this sector. So I'm really excited for the next five years for you know, companies that either the mid stage or at least stage and you know, how they can sort of address strategic gaps in portfolios. So, you know, we're really, we're really sort of optimistic about this particular sector, at the very least right now. And then, you know, I'll touch on the capital markets, we're seeing a window of opportunity come up for IPOs. I mean, if you look at the last sort of calendar, right, the US healthcare IPO calendar, we're starting to see things price, things launch. And you know, q2, q2 is, it's been a little quieter, but we've just sort of, you know, got the data, and we'll see how that goes. But, you know, the capital markets are opening up, there might be some opportunities for companies that are doing, you know, quarter over quarter sort of getting their revenue performance, and there might be opportunities for them to go public, if there's enough conviction in the revenue growth. And then, you know, lastly, I want to touch on GE sort of spin off and how that's performed. I mean, as Devin said, it's gone really well for the company. Right? So historical GE still trading at that one, one and a half a little turn since the spin off, but you know, GE now is trading GE Healthcare now is trading well above that. And I think it's worked out great for both parties because now GE can focus on the industrials and chemicals and sort of the things that they're really good at and allows Devon and team to really laser focus on the healthcare business for growth. So and that would that you know, the last thing I think I talked about this on the last panel, I won't go into too much but you know, there's there's deals are getting done in the private placement sector. So I do want to make sure that all of you who are in that phase are not discouraged that there isn't capital out there, early stages a little bit you know, Tough the series A and B, but we still saw about $200 million of capital get allocated to some of the companies in that portion. So that's not, you know, discouraging at all, from my perspective, it's where and how you get creative to structure some of your deals. And where you find capital is the challenging part, right. But if you're a, if you're a company that's executing, meeting your milestones, and really sort of focused on the technology and the clinical data, in my mind, that's not a you know, that positions you really well to start discussions with strategics, and even start discussions with investors, because it gives them conviction that you you're going to get you're going to get to where you're promising you're going to be. And then late stage, we're seeing a lot of the venture capital money move towards the late stage. And I think this is just because of the risks associated with this sector. And, you know, I've noticed that a lot of VCs are constantly asking for more data, more data, more data that used to be a strategic thing, I think, in the past, but even VCs are, I want to see this data, I want to see that data, right. So they're getting smarter. But one thing I will add here is that we're not seeing any new money in the sector, right, it's the same funds that have done the same deals coming to the table. And I think it's time that changes a little bit, because, you know, they, they've got a lot of portfolio overhang as well, they need to probably exit some of their existing companies. So I think, you know, that's something I'll end this slide with is that we hope that we'll see some more new investor activity in this sector.
Robert Kieval 11:34
Super, Mrigasha. Thanks. That's a super helpful introduction. And one quick follow up question within hspcs med tech advisory practice? How do you identify and select companies to follow that you feel have, you know, good long term potential with strategics?
Mrigasha Patel 11:47
Yeah, I mean, I've so the $25 billion of deals that I've done, right, I, there were others deals, so I wouldn't comment on those. But I just started originating and I've just started executing and or originating together and you know, med tech is very new for the bank. And so is TMT. And one of the things that you know, I've started doing personally along with the our team at HSBC is we spent a lot of time doing diligence on these companies, to the point where we even go into the procedure, look at the procedure, and get to the point where we're really getting ahead of the curve. So when it comes time for the company to either go public, or you know, do another raise, or either exit through an m&a transaction, we are helping buyers get to the point efficiently, right. So we're not really, we're not really focused on, you know, helping the company and the strategic get to know each other, right, like, like, over time, but we want to make it efficient, where we're giving all the data that strategics need, we've identified the gaps for the buyer. And then ultimately, we want to get the get get a good transaction to the point where we're, you know, we're not letting strategics overpay for some of these transactions, because that's never a good outcome either. And then we're not letting the seller get too excited about, you know, have it about getting a deal done, but rather, how can you help them understand what you've achieved, what gaps you've fulfilled, and how you're getting getting, helping them in the next five years to fulfill their portfolio. So, you know, we're not really just advisors for the sellers. But you know, we're really kind of always keep staying very close to the buyers as well, to make sure that we're not bringing some, you know, some random thing to them and something that hasn't been vetted properly. And we haven't really done our work.
Robert Kieval 13:39
Fantastic. Super. Okay, so that's the state of the cardiovascular market. Now, let's talk about the state of cardiovascular innovation. So Howard, it's rumored that in 1899, then Commissioner of Patents, Charles duel said that we'd soon no longer need a patent office because, quote, everything that can be invented has been invented. So it turns out that he never actually said this. But in all seriousness, to your observation, has there been any slowing in the pace of cardiovascular device innovation in, you know, in recent times, and not just talking about incremental next generation products, but truly novel, disruptive products? Is there anything out there that you're particularly excited about?
Howard Levin 14:23
So I think that what we've been seeing recently in the cardiovascular field has been essentially more evolutionary than revolutionary. But there's always you know, you never know when this revolutionary stuff is going to come, but there are things that make a big difference. Right? So you know, you know, in half in the heart failure field, there's always innovation, you know, it two steps forward, one step back type thing, but there's there's a lot of innovation EP fields always hot. You know, Uh, the structural heart is always hot. You know, the these things in the cardiovascular field are, are gonna drive revolutionary things at some point, you know, TAVR was revolutionary, you know, certain other things were revolutionary. The question is getting to him regardless point, there is very little early stage money available, or lower amount of early stage money available to make those revolutionary things able to be generated in the start. So I think that's one of the big limitations, although I do see, and since we had the strategic people here, I have seen increased investment by certain strategics earlier, like, really early to some parts, in some cases. And I was just wondering if you think that something that is going to continue? Or do you think that strategics are still going to look for the more big things that are going to occur?
Devon Bream 16:17
Yeah. So I think it's a great question. And it's always a balancing act. At GE, what we're really keen and focused on is developing companies that have actually been able to deliver a product that has clinical outcomes, proven efficiencies, and then the real trick of it is, how to monetize it. And how do you make a business case for that for that acquisition or that target? So So to answer your question, I think it's a balancing act, we'd like to get in early, but we also need to make sure that they've, they've really proven that the technology is meaningful and worthwhile.
Chris Eso 16:56
Yeah, and I would agree with that. I think the other piece that I would add is, it also depends on the market and the opportunity. Obviously, you saw a lot of the strategics, back in 2015 2016 Go into mitral really early, I think I was telling somebody, I think the most patients that was treated at the time with one device was 14, when all of those and everybody else was less than that. And all of those went off the board. Now we're all investing in developing those those technologies today. And as as was said, right, it hasn't come to fruition yet on the mitral replacement. But that is a big investment. And so when we see opportunities like that, that are game changing, and changing the way care is provided, and the potential of basically eliminating MR. That's where strategics will go in early if they think they have the right capabilities to bring that to the to fruition. In other markets, where there's, you know, a lot of other activities, then we'll probably, you know, hang back and wait and let let the VCs fund it to a certain stage where there's actual human data, maybe even, you know, even further along and some commercial adoption, if they, you know, are able to get get to a, an approval standpoint, like CathWorks, right. They they actually got approval in US and Japan in Europe started some commercial. And that's when we transacted. So it just kind of depends on the opportunity in the market.
Robert Kieval 18:33
Cool. So sticking with structural heart for the moment, you know, when I began working at what was IMR, IMR, which is now very next, preclinical services back in 2019, we had, you know, just laser focus on surgical and transcatheter valve repair and replacement. And, you know, I was concerned that the structural heart market might be maturing, and we'd need to diversify into new therapeutic areas. Fast forward to 2023. It seems like it's still going strong, even in TAVR, where it all started. The third and fourth generation devices, new biomaterials bio resorbable. Chris, do you see any evidence that structural heart is maturing in any segments? And conversely, are there segments that you think are poised for disruption with new and emerging technologies?
Chris Eso 19:18
Yeah, so maybe we start with how we define kind of structural heart, right. So we think about it as the four valves, shunts and LAA and so when you think about those four, those six segments, all our growth growing at least double digit, right, and the you don't see a full section segment like that, that all segments are growing at that level. So in our view, it is a very exciting, continued high growth and focus of us to continue to evolve and iterate on our technology but also supplement our portfolio and that's what we look for externally and So when I talked about TAVI, right, everybody's, you know, right now talking about TAVI is, you know maturing, we don't see it. Obviously, during COVID, there was procedures were down. But that was across the board. It's been a little bit slower to recover. But you're starting to see that recovery and TAVI procedures and our growth rates are, you know, still in the double digit. And so when I think about that segment, a double digit growth growing in a in a $7 billion market that that is high growth for us,
Robert Kieval 20:31
Indeed, for I would say that's for, for most of us. Okay, one other thing that we observed, as focus started to shift toward the tricuspid, Valve was attempts to use devices that had been optimized for use on the left side of the heart over on the right side of the heart, like mitral clip, and you know, and others, are you and Howard, please chime in here. Are you seeing success here with that? Or is this just a totally different are a new r&d challenge? I mean, the right heart is very different from the left heart, the anatomy is different, the geometry is different. And certainly the hemodynamic profiles are different. So what what's been the experience to date?
Chris Eso 21:10
Let me start. Yeah, so I mean, I was just meeting with a company and they're, you know, been focused on a micro company, and I said, you actually should contemplate starting on the tricuspid. side. To me, I look at the technology, and I think it can be interchangeable. Now, that isn't like taking it and just moving in and putting in there, you're gonna have to modify it, you're gonna have to adjust the development of that product, but you're not doing a full development program you're modifying you're adjusting. Case in point, we're taking intrepid that was designed for mitral and have treated over 50 patients on the tricuspid side with it. So it actually can happen, we have to obviously modify our valve slightly, to ultimately make it a commercially viable product, as well as developing a delivery system specifically for the tricuspid side. But it is very transferable when you think about it, even though the the anatomy is is much different than the environment in neither valve is is much different, so.
Howard Levin 22:13
You know, I think the criticism exactly right, everything is transferable from the engineering point of view, I think, want to point out one thing, you don't have to have a revolutionary project to be a huge market. And tricuspid here, I think is going to be like the the poster child for that in the sense where you have, we know in heart failure that we've known since the 80s and heart failure, that your RVEF, and your TR is more related to new mortality than your left sided parameters. And but nobody ever fixed the right side of the heart because they nobody wants to do a surgical procedure for just, quote unquote, just fixing the tricuspid I personally think there's gonna be a huge uptake on on the right side with the tricuspid, even strangely more than the mitral. I mean, getting into MR is very important. But if we can work on that tricuspid. And I think that's just the beginning of working on the right side, pulmonary valve was there already. But there's going to be that even though it's not revolutionary, it's an evolutionary thing, it's going to be a really big deal.
Mrigasha Patel 23:30
So if a banker is allowed to add to this, you're absolutely right. Like what we're seeing, right, we're seeing companies that started in the mitral space, and then they realized access is so much easier on the right side. And so they've pivoted their strategy. And now that's why you're seeing this growth and tricuspid regurgitation solutions. But you know, I do want to I do have a question for Howard. I think, you know, imaging is still such a challenge in this space, right? What are sort of what are some things you guys are seeing inside the cath lab when it comes to, you know, imaging for within the sector, because we see companies, you know, come out with really elegant solutions, really great things, but then, you know, physicians are struggling because they can they can't image properly and you need this team of like, what, eight or nine people now right to just do that. So I'm curious to hear your thoughts on that. Howard?
Howard Levin 24:20
I think that's a really big issue. You're absolutely correct. And we should all blame GE Healthcare for that but it's separate from GE the real issue is is there are technologies that are theoretically available. There were things on the left side with cameras for afib ablation being able to look and there is some forward looking ultrasound that now catheters you can see. They're really two issues, right. One is there was never a drive to develop them for this particular indication everybody was using te they We used to add reimbursements in place, or made it simple that way, but what I think needs to happen is a change in the interventional cardiologists approach to things they have to want to, you know, yes OCT. And yes, IVs are used, but it's not like, you know, you need to get a, I don't want to say next generation, but you need to get Interventional Cardiologist to take advantage of, or there needs to be things to be able to show that you set the valve in right place, or there's a leak, or there's this or that to make that procedure easier within like not having those extra five people in the room that you need. So it makes it more cost effective, it makes a better procedure. But you have to do then. So it's the chicken and the egg, you have to have the devices to for people to be able to use but yet that people will be able to use them to be able to use the devices.
Mrigasha Patel 26:00
So Devon.
Devon Bream 26:02
Yeah, so the image insights fascinating. And I was very fortunate yesterday, to go in and see our very first installation in the entire world happened to be at the clinic in Barcelona. So thank you, LSI, for having the conference here. It was great timing. But it was our first installation for our new 3d stent technology, which is the first on the market to allow 3d visualization once the stents placed. And it's a great example of what you're saying. Because it's not just basic imaging, what we're really focused on now is taking imaging, and then laying layering over additional technologies that make the imaging that much more enhanced with the ultimate goal of allowing better procedural access, but also reducing the number of people that are required to do the imaging. So very good observation by you. And, and that's what our focus is. So we used to do one new product introduction a year, we're almost 10 times that from where we were two years ago. And it's all on these image enhancement type opportunities.
Howard Levin 27:07
Devon, do you think that like there was this spiking in activity for like MRI guided EP, or a spike of CT? You know, whatever. Do you think that? You know, with all that money spent on Cath Lab infrastructure based on fluoroscopy? And other things? Is there ever going to be a move towards more, you know, things that could give you more information, but are not, you know, part of the installed base right now? Is it just too expensive? Yeah,
Devon Bream 27:41
and I think we're going to be talking about some of that later in the discussion. But in particular, AI, AI is just playing a huge role in what we do our future roadmap, and there's some really exciting new startup companies and innovations that our friends at Varenex are actually helping us with, that are going to really enhance that imaging and really allow physicians to see and do things that they could never have done before.
Robert Kieval 28:09
So sticking with the GE, topic for a second, GE Healthcare, I'm just watching the time this is just flying by. But you know, when we talked about your new role in focusing invasive cardiology, you know, you left immediately toward EP ablation and specifically PFA. And now there's been some recent clinical trial results that have been announced and published from Boston Scientific had been trial. So can you just catch us up on on what you're excited about there?
Devon Bream 28:36
Yeah, absolutely. PFA is a game changer. It's been well received and adopted here in Europe, and all the major device partners expect, you know, sometime mid to late next year for all their FDA approvals. But what's fascinating about AFib and why PFA is so important, Rob, is is in the US alone, there's about two and a half million patients, and only 15% of those are being treated, patients are waiting 12 13 14 months to get in to have an AFib procedure done. And so with a technology like PFA pulse field ablation, that's going to really allow more clinicians to do the procedures, it's going to allow the procedures to be done quicker. So taking a procedure that would take six to four hours, maybe down to one and a half, two hours, which then allows more of those patients to come through. So we really see PFA as a great game changer. We're not in the device businesses, as we all know, wish we were, but from an imaging standpoint, we're gonna play a key role in the PFA adoption.
Robert Kieval 29:46
Yeah, great.
Mrigasha Patel 29:46
Sorry, I just want to make a comment on PFA. Right so there's so much hype around PFA, and rightfully so, but the one area that we haven't touched in ablation is VTAC. Now, you know, many years ago, I did a lot of work in that space and PFA, we started the program in VTAC. And, you know, the biggest challenge, and I'm curious to hear Chris's thoughts on this is the, you know, the, it's a very small market, right? The VTAC market isn't something that's, that's like, you know, got this large Tam, or growth or anything. But you know, I'm a firm believer that you don't walk in to you don't walk into large TAMs, you create large TAMs, right. And so we don't still have a great technology to address this. Because, you know, I mean, I think I've heard Doc's do like, I'm doing, like, one VT case a week, because I'm so tired of, you know, doing these six, seven hour procedures. So I'm curious to hear kind of, you know, at least Chris's thoughts around that, and how you guys are looking at it.
Chris Eso 30:46
Yeah, I mean, it it, obviously, you know, that next horizon is that PFA, right. And that's what they're going to be learning and developing and building that skill set. And then it's going to be going on from there. The challenge that that Devon was talking about, about, you know, capacity in the EP Lab is a real thing, right. And so the six hour cases is not something that they're going to go after right now, that needs to come down, that needs to be reduced to a point where it actually can be manageable in the in the EP lab, and they can have enough pull through or follow through of the patients in the in the lab and actually be able to do some of their other cases as well.
Howard Levin 31:30
But you know, you bring up a really important point. markets aren't markets until, you know, they're made, you can't market research market that doesn't exist, because, you know, everybody will just give you their opinion, you know, VT will become a really big market, when there are things that can be used to treat VT in a timely fashion in the workflow that, you know, and, you know, I wish I could work in the VT area of the ventricular in the area in general, just because it's gonna become really big. The question is, who's gonna, you know, take that first step and start building the market, as I heard yesterday, from somebody, the afib was not a market until there was enough afib stuff to make it a market.
Robert Kieval 32:19
Nice. Okay. Couple more topics to try to squeeze in in the last seven minutes. So like to just focus on treatment of peripheral vascular disease for for a minute or two. And whether this is a specialty for the endovascularly trained vascular surgeon or it really is the purview of the interventionalists, the interventional radiologist, interventional cardiologist first, Devon. In your experience, you know, are there important evolving trends in the cath lab environment? Are we seeing cases that historically were completed in the cath lab being moved to ambulatory surgical centers or office space labs? Or is that not a big trend? What are your observations?
Devon Bream 32:59
So we're hoping that it is a trend, I think, as Chris pointed out, the capacity issue right now, especially in EP is just unbelievable. And so we're waiting for for HRS, the society's, American College of Cardiology, to come down with some decisions that allow more of those procedures to go to outpatient. And then we're well positioned and ready with our portfolio to help build out those cath labs for ASCs. So we absolutely think that's going to be the future, just like many other procedures have migrated to outpatient. And with things like PFA that allow the procedure to be quicker, easier, safer, it really makes a lot of sense to migrate some of those procedures.
Robert Kieval 33:43
Okay, great. We got 30 seconds, do we do we see the potential for you know, you're able to take a an ablation procedure from three hours, four hours to one hour? I think, Howard, you brought this up on one of our calls, you know, is there any reimbursement risk associated with that, that our values might go down associated with the procedure? Or they don't pay for reduce anymore?
Howard Levin 34:04
So I think I think, yeah, there there are two issues want, you know, the redo issue, and unbundling is always gonna be a big issue. But the yet to separate out two issues. One is, are they going to get paid less for the device or more for the device? Are they going to get paid, the physician get paid less for the procedure, or more than for procedure, if you shorten a procedure from three hours to one hour, there's a risk that the physician is going to get paid less for that procedure, therefore, it becomes less attractive to them. And you know, you have to make it up in volume, but nobody really wants to make it up in volume. They want to keep the same thing and do more cases. So I don't know which way the answer is gonna go. But it's certainly a real concern that hasn't been yet. I think played out. I don't know you guys may know more.
Chris Eso 34:54
But I would agree with that. It still needs some time to to percolate and develop about and what what's going to be kind of the end end state here?
Robert Kieval 35:03
Okay, thanks. Well, this could be a long conversation or a short conversation. So with, with growing endovascular solutions from EVAR all the way down to the toe, is there, is there competition between vascular surgeons who are endovascularly trained or not? On the one hand and intervention lists on the other? Do we see different patient outcomes depending on which specialties are doing the treatments? Will the interventional list ever let go of these procedures? Is there is there enough of a bag of products to really engage vascular surgeons? Chris, what are your What are your observations?
Chris Eso 35:40
Yeah, I mean, so it's an interesting question, right? Because when you think about the physician specialty subsets, the vascular surgeon and the cardiac surgeon are still very critically important in in the overall procedures, the vast amount of interventional cardiologists and IRs is a hard challenge to overcome, right. And so as things become easier, as capacity becomes an issue, and you need to get things more simplified and easier, they are moving more to the interventional cardiologist side of the equation. But there's still those those cases that are so complex that you do need that that surgeon expertise, in my opinion.
Howard Levin 36:28
Yeah, I think that the vascular surgeons are starting to suck up more of the procedures, you know, they started with er, you know, they made that transition, they're going peripheral in the leg. The question that I'm going to be interested to see is how are the strategic skin to deal with that? Because you have, as Chris said, on one side, interventional cardiologists were certain procedures are becoming more commodity, quote, unquote, and they're looking for new revenue streams, etc. And historically, ICS have taken away things from everybody. So they went from the heart to the kidneys, to the brain, to their carotid to the leg. And so, you know, can you democratize these procedures enough by developing technologies that allow the ICS to take the business away, instead of from the IRs now from the vascular surgeons? Or do you have enough a vascular surgery call point that is happy to it's important to keep those people happy?
Chris Eso 37:27
I gave a little bit more political answer, because they're my customers.
Robert Kieval 37:30
Yeah, Indeed, indeed. Okay. All right. We have the last two minutes, we talked about touching on AI. So why don't we? Why don't we do that? You know, Devin, you talked about AI in the cath lab? You know, Chris, I'd be really interested to hear your thoughts about AI and implanted devices and, and what opportunities there may be, what risks there may be to, to mitigate there, should it be relegated to a clinical decision support tool by aggregating data to try to predict and prevent, you know, events before they happen? What's going on in implantables? Right now?
Chris Eso 38:03
Yeah, I mean, so, you know, I think a lot of people are talking about AI. Right. And, and it's a very interesting space. And I think it's actually bigger than most people give it credit for. If you think about the potential that it can be used in cardiovascular, better deployment, you know, the right deployment, pre case planning, clinical trials and addressing, you know, underserved patient populations, robotics, you know, we have a digital surgery play, CathWorks is using an AI. And so these are all, you know, potential opportunities. And so a specific example, in the cardiovascular side, you know, if you take our Accurythm link with our AI technology, it is actually using that to reduce the amount of false alerts by 50%. And so, and maintaining that sensitivity above 99%, so we're actually getting better results and our outcomes because of that algorithm that is learning. Now, I take another another area that I think a lot of people know about outside of cardiovascular, you know, colonoscopies standard of care, obviously, as colonoscopies, we have the ability to actually use our GI genius technology and our appeal cam and identify 50% More polyps that can be identified than traditional colonoscopy. And so we're building a huge database, we have over 1.5 million ECGs in our database that we're building algorithms off and so it's a significant effort that we're doing within Medtronic, specifically in cardiovascular
Robert Kieval 39:49
Nice. Okay, well, we're 30 seconds over Howard, would you like the last word here?
Howard Levin 39:53
I can give Devin the last word on AI because I have I know less about AI than I do about genetics so.
Devon Bream 40:02
So AI is as exciting as PFA for imaging. I think AI is already proven on the radiology side, the ability to prioritize which images radiologists needs to read when they start their day, every day, right. So it's proven itself out really well, we're super excited about what it can do and will do in the cardiovascular space. The challenge is how to monetize it. And again, our friends at Veranex have been great partners in trying to help us model it so that it doesn't become just a giveaway. I keep pitching. It's shameless. They are great. But the business model of AI is really a challenge, I think, for our whole industry, so that it doesn't just become a giveaway or a nice to have. I always equate it to my kids, right? When they started driving, of course, I wanted to have all the safety features in the car and backup cameras. And now those are all just standard products that are on cars. And so is that what AI is going to be for imaging? We hope not we'd like to figure out a way that it actually adds enough value to the procedure by doing the procedure faster, safer, that there's value to the hospital and some way to monetize that.
Robert Kieval 41:17
Great. Okay, I think we'll end it there. Thank you everybody, for coming. And please join me in thanking our panelists for an engaging conversation.
Chris joined Medtronic as the Senior Manager of Business Development in August of 2011. He oversaw Medtronic’s global inorganic growth strategies and opportunities for Coronary business, and was promoted in June of 2012 to expand his Business Development responsibilities to include the Renal Denervation business. In April of 2013, Chris was promoted to Director, overseeing Business Development functions and leading a team of professionals. In September of 2014, Chris was promoted to Senior Director, Business Development for the Coronary and Structural Heart business unit for Medtronic, and in February of 2016, Chris was promoted to Vice President of Corporate Development.
Chris has more than 18 years of successful professional experience, of increasing responsibilities, with the majority of his experience in a business/corporate development and strategy capacity within the pharmaceutical and medical device industries, in addition to Medtronic, including Allergan, Watson, Agilent Technologies and Peregrine Pharmaceuticals, where he was Vice President of Business Operations.
Chris holds an MBA from Concordia University and BA in Public Relations, Communications from California State University, Fullerton.
Chris joined Medtronic as the Senior Manager of Business Development in August of 2011. He oversaw Medtronic’s global inorganic growth strategies and opportunities for Coronary business, and was promoted in June of 2012 to expand his Business Development responsibilities to include the Renal Denervation business. In April of 2013, Chris was promoted to Director, overseeing Business Development functions and leading a team of professionals. In September of 2014, Chris was promoted to Senior Director, Business Development for the Coronary and Structural Heart business unit for Medtronic, and in February of 2016, Chris was promoted to Vice President of Corporate Development.
Chris has more than 18 years of successful professional experience, of increasing responsibilities, with the majority of his experience in a business/corporate development and strategy capacity within the pharmaceutical and medical device industries, in addition to Medtronic, including Allergan, Watson, Agilent Technologies and Peregrine Pharmaceuticals, where he was Vice President of Business Operations.
Chris holds an MBA from Concordia University and BA in Public Relations, Communications from California State University, Fullerton.
Howard Levin, M.D., a heart failure transplant cardiologist by training, is an expert in creating novel therapies for cardiac, respiratory, neuro, and renal patients.
Howard Levin, M.D., a heart failure transplant cardiologist by training, is an expert in creating novel therapies for cardiac, respiratory, neuro, and renal patients.
Experienced Global Executive with a demonstrated history of working in the medical device industry. Skilled in Executive Management, Medical Devices, M&A, Sales Management, and Global Management. Strong information technology professional with a Master's Degree focused in Healthcare Administration- School of Public Health from University of California, Los Angeles. Fellow American College Healthcare Executives.
Experienced Global Executive with a demonstrated history of working in the medical device industry. Skilled in Executive Management, Medical Devices, M&A, Sales Management, and Global Management. Strong information technology professional with a Master's Degree focused in Healthcare Administration- School of Public Health from University of California, Los Angeles. Fellow American College Healthcare Executives.
Transcription
Robert Kieval 0:05
Good afternoon. And as you've heard cardiovascular disease remains a leading cause of death and disability worldwide claiming over 18 million lives annually according to the WHO, and costing the global economy more than $1 trillion. It's also one of the largest sectors in medtech. And according to some sources, the cardiovascular device market will surpass an estimated $65 billion in 2023. With this backdrop, good afternoon, and thanks for joining this discussion of the current status and future opportunities in cardiovascular devices. Time permitting, we'll be talking structural heart ablation, peripheral vascular hypertension, heart failure, and of course, AI. As you've heard, I'm Rob Keival, Executive Vice President for Strategic Partnerships at their annex. I'm a cardiovascular physiologist by training, and have spent the last 30 years developing and commercializing cardiovascular medical devices. Varon X is a unique purpose built provider of global end to end integrated product development and commercialization services dedicated to the medtech industry. We've got specialized capabilities in cardiovascular products. So if you're working in the cardiovascular space, we're your partner of choice, and we'd welcome an opportunity to prove that to you. So thanks for coming. Now, let's meet our panelists. We have Chris Eso so from Medtronic, Devon Bream, from GE Healthcare, Howard Levin from Deerfield catalyst, and Mrigasha Patel from HSBC. Chris, would you introduce yourself?
Chris Eso 1:49
Good afternoon, everybody, Christ. So I lead business development and strategy for our cardiovascular portfolio. Been with Medtronic going on 13 years now all in a business development m&a strategy capacity. Prior to Medtronic, I ran a clinical stage biotech contract biologic manufacturing company, and had a lot of m&a and strategy work from the pharma and biotech side of the world. Nice to meet you.
Mrigasha Patel 2:18
Thanks, Chris. Gotcha, Patel. I've been in medtech mostly in interventional cardiology for about 14 years. And then I'm left industry to go into banking. Don't ask me why. But most people leave banking to go to industry. And I started seeing some pockets of, you know, innovation. And I thought it would be fun to be around companies like such as the ones here today. And so I've been in banking since about 2018. And, you know, advice, then it's executed on 25 billion plus dollars worth of transactions. 80% of that has been mostly on the sell side m&a, and then 20% call it IPOs and capital advisory type things. So looking forward to this discussion with everybody.
Howard Levin 3:00
Thanks. My name is Howard Levin. I'm the CEO Chief Medical Officer of Deerfield Catalyst. We're an early stage medical device incubator part of Deerfield management. I'm a heart failure cardiologist by training. Prior to doing a JV with Deerfield management, we were Coridia a early stage and medical device company. We've sold or started and sold, with our companies returning over 1.6 billion for their investors. And as far as I can tell, Chris still owes us money.
Devon Bream 3:42
Hi, my name is Devon Bream, I'm the president and general manager of GE Healthcare Invasive Cardiology. As many of you know, GE spun off the health care division earlier in the year. And it's been a really, really exciting last few months, less than last year with all the renewed focus in health care. And my group and particularly is the cardiovascular side, and electrophysiology. So really happy to be part of the panel. Also want to thank Vera annex for being great partners. They're just fantastic to work with. And you've helped us on so many things. So thank you very much.
Robert Kieval 4:20
Appreciate that, Devon. So thank you all we've got a great diversity of perspectives for you today. But we thought it might be useful to help get us started for magashule to give us a quick snapshot of the current investment landscape in the cardiovascular space.
Mrigasha Patel 4:35
So one of the things that we're noticing all the interventional cardiology companies still trade a lot better than the overall medtech sector. Now. You know, there's this new, there's a new category called high growth medtech, which started in the 2018 call it window. And that was really because of a lot of companies going public in that single product companies. So we saw, you know, Shockwave, Inari, Silk Road and some of these newer companies that went public in that window. And that that created this new category called high growth medtech. Now, this multiple on an LTM revenue basis, as you can see, there's this large peak, right, that was the pandemic, which turned out to be a great time for the equity capital markets. But even though it's resetting now, it's still trading well above large cap medtech, smids and the s&p, right. And this is all in the cardiovascular sector. Now, if we take a step back and look at sort of q1 and q2 earnings, even, you know, I've got all the strategics here, and I'd love to hear from them. But you know, they posted really good growth in some of the sector. And, and this is largely because the procedures are coming back, I, you know, I don't care what my research analyst says, But you know, GLP ones are not going to disrupt any of these businesses, the patient populations way too complex. And you know, you have to think about this, these patients really show up at such a difficult time in their kind of journey, that they sometimes have no other options, besides some of the devices that are in these portfolios. So you know, there's strong growth coming out of the cardiovascular sector, we're seeing a lot of momentum in TAVR. TMTT and even EP ablation and afib, you know, unfortunately, mitral replacement hasn't turned out to be the way you know, we thought it was going to be we're still not seeing anything, you know, commercially viable there. But it's still early, there's an you know, just out of, you know, kind of innovation, r&d takes a lot of time in that sector. So hopefully we'll see something there. And then CRM is sort of the part that continues to grow at a at a modest rate, but it's still, you know, a pretty great portion of the business. And then LVAD picked up a little bit worldwide that helped Abbott sales a little bit, there's still a lot of unmet need there. And then you know, lastly, what I'll touch on is I don't want to discount the fact that India and China are basically on, on on, on the on the track to become the second largest medtech markets in the world. It says a decade, but I'm seeing more momentum over there than I've ever seen before. So, you know, that's sort of the state of the market here. And then, you know, talk about the m&a precedent transactions. I think everybody knows some of these. But you know, kudos to Chris for getting a lot done here. In the past year Cordus, and Medallions did a DCB deal. That was pretty monumental. And then obviously J&J and Abiomed, everybody knows about that transaction, I think, you know, Abbott, buy out of CSI was a little was a little on the lower end in terms of the multiple but you know, the company had been around for a while, the procedures weren't really coming back, and the company was struggling. So I think that valuation made sense over there. But you know, the last thing I'll touch on this page is if you look at the multiples on these, on these, right, higher than equity capital markets, higher than, you know, FTM, revenue multiples, some of the best we see continually in this in this sector. So I'm really excited for the next five years for you know, companies that either the mid stage or at least stage and you know, how they can sort of address strategic gaps in portfolios. So, you know, we're really, we're really sort of optimistic about this particular sector, at the very least right now. And then, you know, I'll touch on the capital markets, we're seeing a window of opportunity come up for IPOs. I mean, if you look at the last sort of calendar, right, the US healthcare IPO calendar, we're starting to see things price, things launch. And you know, q2, q2 is, it's been a little quieter, but we've just sort of, you know, got the data, and we'll see how that goes. But, you know, the capital markets are opening up, there might be some opportunities for companies that are doing, you know, quarter over quarter sort of getting their revenue performance, and there might be opportunities for them to go public, if there's enough conviction in the revenue growth. And then, you know, lastly, I want to touch on GE sort of spin off and how that's performed. I mean, as Devin said, it's gone really well for the company. Right? So historical GE still trading at that one, one and a half a little turn since the spin off, but you know, GE now is trading GE Healthcare now is trading well above that. And I think it's worked out great for both parties because now GE can focus on the industrials and chemicals and sort of the things that they're really good at and allows Devon and team to really laser focus on the healthcare business for growth. So and that would that you know, the last thing I think I talked about this on the last panel, I won't go into too much but you know, there's there's deals are getting done in the private placement sector. So I do want to make sure that all of you who are in that phase are not discouraged that there isn't capital out there, early stages a little bit you know, Tough the series A and B, but we still saw about $200 million of capital get allocated to some of the companies in that portion. So that's not, you know, discouraging at all, from my perspective, it's where and how you get creative to structure some of your deals. And where you find capital is the challenging part, right. But if you're a, if you're a company that's executing, meeting your milestones, and really sort of focused on the technology and the clinical data, in my mind, that's not a you know, that positions you really well to start discussions with strategics, and even start discussions with investors, because it gives them conviction that you you're going to get you're going to get to where you're promising you're going to be. And then late stage, we're seeing a lot of the venture capital money move towards the late stage. And I think this is just because of the risks associated with this sector. And, you know, I've noticed that a lot of VCs are constantly asking for more data, more data, more data that used to be a strategic thing, I think, in the past, but even VCs are, I want to see this data, I want to see that data, right. So they're getting smarter. But one thing I will add here is that we're not seeing any new money in the sector, right, it's the same funds that have done the same deals coming to the table. And I think it's time that changes a little bit, because, you know, they, they've got a lot of portfolio overhang as well, they need to probably exit some of their existing companies. So I think, you know, that's something I'll end this slide with is that we hope that we'll see some more new investor activity in this sector.
Robert Kieval 11:34
Super, Mrigasha. Thanks. That's a super helpful introduction. And one quick follow up question within hspcs med tech advisory practice? How do you identify and select companies to follow that you feel have, you know, good long term potential with strategics?
Mrigasha Patel 11:47
Yeah, I mean, I've so the $25 billion of deals that I've done, right, I, there were others deals, so I wouldn't comment on those. But I just started originating and I've just started executing and or originating together and you know, med tech is very new for the bank. And so is TMT. And one of the things that you know, I've started doing personally along with the our team at HSBC is we spent a lot of time doing diligence on these companies, to the point where we even go into the procedure, look at the procedure, and get to the point where we're really getting ahead of the curve. So when it comes time for the company to either go public, or you know, do another raise, or either exit through an m&a transaction, we are helping buyers get to the point efficiently, right. So we're not really, we're not really focused on, you know, helping the company and the strategic get to know each other, right, like, like, over time, but we want to make it efficient, where we're giving all the data that strategics need, we've identified the gaps for the buyer. And then ultimately, we want to get the get get a good transaction to the point where we're, you know, we're not letting strategics overpay for some of these transactions, because that's never a good outcome either. And then we're not letting the seller get too excited about, you know, have it about getting a deal done, but rather, how can you help them understand what you've achieved, what gaps you've fulfilled, and how you're getting getting, helping them in the next five years to fulfill their portfolio. So, you know, we're not really just advisors for the sellers. But you know, we're really kind of always keep staying very close to the buyers as well, to make sure that we're not bringing some, you know, some random thing to them and something that hasn't been vetted properly. And we haven't really done our work.
Robert Kieval 13:39
Fantastic. Super. Okay, so that's the state of the cardiovascular market. Now, let's talk about the state of cardiovascular innovation. So Howard, it's rumored that in 1899, then Commissioner of Patents, Charles duel said that we'd soon no longer need a patent office because, quote, everything that can be invented has been invented. So it turns out that he never actually said this. But in all seriousness, to your observation, has there been any slowing in the pace of cardiovascular device innovation in, you know, in recent times, and not just talking about incremental next generation products, but truly novel, disruptive products? Is there anything out there that you're particularly excited about?
Howard Levin 14:23
So I think that what we've been seeing recently in the cardiovascular field has been essentially more evolutionary than revolutionary. But there's always you know, you never know when this revolutionary stuff is going to come, but there are things that make a big difference. Right? So you know, you know, in half in the heart failure field, there's always innovation, you know, it two steps forward, one step back type thing, but there's there's a lot of innovation EP fields always hot. You know, Uh, the structural heart is always hot. You know, the these things in the cardiovascular field are, are gonna drive revolutionary things at some point, you know, TAVR was revolutionary, you know, certain other things were revolutionary. The question is getting to him regardless point, there is very little early stage money available, or lower amount of early stage money available to make those revolutionary things able to be generated in the start. So I think that's one of the big limitations, although I do see, and since we had the strategic people here, I have seen increased investment by certain strategics earlier, like, really early to some parts, in some cases. And I was just wondering if you think that something that is going to continue? Or do you think that strategics are still going to look for the more big things that are going to occur?
Devon Bream 16:17
Yeah. So I think it's a great question. And it's always a balancing act. At GE, what we're really keen and focused on is developing companies that have actually been able to deliver a product that has clinical outcomes, proven efficiencies, and then the real trick of it is, how to monetize it. And how do you make a business case for that for that acquisition or that target? So So to answer your question, I think it's a balancing act, we'd like to get in early, but we also need to make sure that they've, they've really proven that the technology is meaningful and worthwhile.
Chris Eso 16:56
Yeah, and I would agree with that. I think the other piece that I would add is, it also depends on the market and the opportunity. Obviously, you saw a lot of the strategics, back in 2015 2016 Go into mitral really early, I think I was telling somebody, I think the most patients that was treated at the time with one device was 14, when all of those and everybody else was less than that. And all of those went off the board. Now we're all investing in developing those those technologies today. And as as was said, right, it hasn't come to fruition yet on the mitral replacement. But that is a big investment. And so when we see opportunities like that, that are game changing, and changing the way care is provided, and the potential of basically eliminating MR. That's where strategics will go in early if they think they have the right capabilities to bring that to the to fruition. In other markets, where there's, you know, a lot of other activities, then we'll probably, you know, hang back and wait and let let the VCs fund it to a certain stage where there's actual human data, maybe even, you know, even further along and some commercial adoption, if they, you know, are able to get get to a, an approval standpoint, like CathWorks, right. They they actually got approval in US and Japan in Europe started some commercial. And that's when we transacted. So it just kind of depends on the opportunity in the market.
Robert Kieval 18:33
Cool. So sticking with structural heart for the moment, you know, when I began working at what was IMR, IMR, which is now very next, preclinical services back in 2019, we had, you know, just laser focus on surgical and transcatheter valve repair and replacement. And, you know, I was concerned that the structural heart market might be maturing, and we'd need to diversify into new therapeutic areas. Fast forward to 2023. It seems like it's still going strong, even in TAVR, where it all started. The third and fourth generation devices, new biomaterials bio resorbable. Chris, do you see any evidence that structural heart is maturing in any segments? And conversely, are there segments that you think are poised for disruption with new and emerging technologies?
Chris Eso 19:18
Yeah, so maybe we start with how we define kind of structural heart, right. So we think about it as the four valves, shunts and LAA and so when you think about those four, those six segments, all our growth growing at least double digit, right, and the you don't see a full section segment like that, that all segments are growing at that level. So in our view, it is a very exciting, continued high growth and focus of us to continue to evolve and iterate on our technology but also supplement our portfolio and that's what we look for externally and So when I talked about TAVI, right, everybody's, you know, right now talking about TAVI is, you know maturing, we don't see it. Obviously, during COVID, there was procedures were down. But that was across the board. It's been a little bit slower to recover. But you're starting to see that recovery and TAVI procedures and our growth rates are, you know, still in the double digit. And so when I think about that segment, a double digit growth growing in a in a $7 billion market that that is high growth for us,
Robert Kieval 20:31
Indeed, for I would say that's for, for most of us. Okay, one other thing that we observed, as focus started to shift toward the tricuspid, Valve was attempts to use devices that had been optimized for use on the left side of the heart over on the right side of the heart, like mitral clip, and you know, and others, are you and Howard, please chime in here. Are you seeing success here with that? Or is this just a totally different are a new r&d challenge? I mean, the right heart is very different from the left heart, the anatomy is different, the geometry is different. And certainly the hemodynamic profiles are different. So what what's been the experience to date?
Chris Eso 21:10
Let me start. Yeah, so I mean, I was just meeting with a company and they're, you know, been focused on a micro company, and I said, you actually should contemplate starting on the tricuspid. side. To me, I look at the technology, and I think it can be interchangeable. Now, that isn't like taking it and just moving in and putting in there, you're gonna have to modify it, you're gonna have to adjust the development of that product, but you're not doing a full development program you're modifying you're adjusting. Case in point, we're taking intrepid that was designed for mitral and have treated over 50 patients on the tricuspid side with it. So it actually can happen, we have to obviously modify our valve slightly, to ultimately make it a commercially viable product, as well as developing a delivery system specifically for the tricuspid side. But it is very transferable when you think about it, even though the the anatomy is is much different than the environment in neither valve is is much different, so.
Howard Levin 22:13
You know, I think the criticism exactly right, everything is transferable from the engineering point of view, I think, want to point out one thing, you don't have to have a revolutionary project to be a huge market. And tricuspid here, I think is going to be like the the poster child for that in the sense where you have, we know in heart failure that we've known since the 80s and heart failure, that your RVEF, and your TR is more related to new mortality than your left sided parameters. And but nobody ever fixed the right side of the heart because they nobody wants to do a surgical procedure for just, quote unquote, just fixing the tricuspid I personally think there's gonna be a huge uptake on on the right side with the tricuspid, even strangely more than the mitral. I mean, getting into MR is very important. But if we can work on that tricuspid. And I think that's just the beginning of working on the right side, pulmonary valve was there already. But there's going to be that even though it's not revolutionary, it's an evolutionary thing, it's going to be a really big deal.
Mrigasha Patel 23:30
So if a banker is allowed to add to this, you're absolutely right. Like what we're seeing, right, we're seeing companies that started in the mitral space, and then they realized access is so much easier on the right side. And so they've pivoted their strategy. And now that's why you're seeing this growth and tricuspid regurgitation solutions. But you know, I do want to I do have a question for Howard. I think, you know, imaging is still such a challenge in this space, right? What are sort of what are some things you guys are seeing inside the cath lab when it comes to, you know, imaging for within the sector, because we see companies, you know, come out with really elegant solutions, really great things, but then, you know, physicians are struggling because they can they can't image properly and you need this team of like, what, eight or nine people now right to just do that. So I'm curious to hear your thoughts on that. Howard?
Howard Levin 24:20
I think that's a really big issue. You're absolutely correct. And we should all blame GE Healthcare for that but it's separate from GE the real issue is is there are technologies that are theoretically available. There were things on the left side with cameras for afib ablation being able to look and there is some forward looking ultrasound that now catheters you can see. They're really two issues, right. One is there was never a drive to develop them for this particular indication everybody was using te they We used to add reimbursements in place, or made it simple that way, but what I think needs to happen is a change in the interventional cardiologists approach to things they have to want to, you know, yes OCT. And yes, IVs are used, but it's not like, you know, you need to get a, I don't want to say next generation, but you need to get Interventional Cardiologist to take advantage of, or there needs to be things to be able to show that you set the valve in right place, or there's a leak, or there's this or that to make that procedure easier within like not having those extra five people in the room that you need. So it makes it more cost effective, it makes a better procedure. But you have to do then. So it's the chicken and the egg, you have to have the devices to for people to be able to use but yet that people will be able to use them to be able to use the devices.
Mrigasha Patel 26:00
So Devon.
Devon Bream 26:02
Yeah, so the image insights fascinating. And I was very fortunate yesterday, to go in and see our very first installation in the entire world happened to be at the clinic in Barcelona. So thank you, LSI, for having the conference here. It was great timing. But it was our first installation for our new 3d stent technology, which is the first on the market to allow 3d visualization once the stents placed. And it's a great example of what you're saying. Because it's not just basic imaging, what we're really focused on now is taking imaging, and then laying layering over additional technologies that make the imaging that much more enhanced with the ultimate goal of allowing better procedural access, but also reducing the number of people that are required to do the imaging. So very good observation by you. And, and that's what our focus is. So we used to do one new product introduction a year, we're almost 10 times that from where we were two years ago. And it's all on these image enhancement type opportunities.
Howard Levin 27:07
Devon, do you think that like there was this spiking in activity for like MRI guided EP, or a spike of CT? You know, whatever. Do you think that? You know, with all that money spent on Cath Lab infrastructure based on fluoroscopy? And other things? Is there ever going to be a move towards more, you know, things that could give you more information, but are not, you know, part of the installed base right now? Is it just too expensive? Yeah,
Devon Bream 27:41
and I think we're going to be talking about some of that later in the discussion. But in particular, AI, AI is just playing a huge role in what we do our future roadmap, and there's some really exciting new startup companies and innovations that our friends at Varenex are actually helping us with, that are going to really enhance that imaging and really allow physicians to see and do things that they could never have done before.
Robert Kieval 28:09
So sticking with the GE, topic for a second, GE Healthcare, I'm just watching the time this is just flying by. But you know, when we talked about your new role in focusing invasive cardiology, you know, you left immediately toward EP ablation and specifically PFA. And now there's been some recent clinical trial results that have been announced and published from Boston Scientific had been trial. So can you just catch us up on on what you're excited about there?
Devon Bream 28:36
Yeah, absolutely. PFA is a game changer. It's been well received and adopted here in Europe, and all the major device partners expect, you know, sometime mid to late next year for all their FDA approvals. But what's fascinating about AFib and why PFA is so important, Rob, is is in the US alone, there's about two and a half million patients, and only 15% of those are being treated, patients are waiting 12 13 14 months to get in to have an AFib procedure done. And so with a technology like PFA pulse field ablation, that's going to really allow more clinicians to do the procedures, it's going to allow the procedures to be done quicker. So taking a procedure that would take six to four hours, maybe down to one and a half, two hours, which then allows more of those patients to come through. So we really see PFA as a great game changer. We're not in the device businesses, as we all know, wish we were, but from an imaging standpoint, we're gonna play a key role in the PFA adoption.
Robert Kieval 29:46
Yeah, great.
Mrigasha Patel 29:46
Sorry, I just want to make a comment on PFA. Right so there's so much hype around PFA, and rightfully so, but the one area that we haven't touched in ablation is VTAC. Now, you know, many years ago, I did a lot of work in that space and PFA, we started the program in VTAC. And, you know, the biggest challenge, and I'm curious to hear Chris's thoughts on this is the, you know, the, it's a very small market, right? The VTAC market isn't something that's, that's like, you know, got this large Tam, or growth or anything. But you know, I'm a firm believer that you don't walk in to you don't walk into large TAMs, you create large TAMs, right. And so we don't still have a great technology to address this. Because, you know, I mean, I think I've heard Doc's do like, I'm doing, like, one VT case a week, because I'm so tired of, you know, doing these six, seven hour procedures. So I'm curious to hear kind of, you know, at least Chris's thoughts around that, and how you guys are looking at it.
Chris Eso 30:46
Yeah, I mean, it it, obviously, you know, that next horizon is that PFA, right. And that's what they're going to be learning and developing and building that skill set. And then it's going to be going on from there. The challenge that that Devon was talking about, about, you know, capacity in the EP Lab is a real thing, right. And so the six hour cases is not something that they're going to go after right now, that needs to come down, that needs to be reduced to a point where it actually can be manageable in the in the EP lab, and they can have enough pull through or follow through of the patients in the in the lab and actually be able to do some of their other cases as well.
Howard Levin 31:30
But you know, you bring up a really important point. markets aren't markets until, you know, they're made, you can't market research market that doesn't exist, because, you know, everybody will just give you their opinion, you know, VT will become a really big market, when there are things that can be used to treat VT in a timely fashion in the workflow that, you know, and, you know, I wish I could work in the VT area of the ventricular in the area in general, just because it's gonna become really big. The question is, who's gonna, you know, take that first step and start building the market, as I heard yesterday, from somebody, the afib was not a market until there was enough afib stuff to make it a market.
Robert Kieval 32:19
Nice. Okay. Couple more topics to try to squeeze in in the last seven minutes. So like to just focus on treatment of peripheral vascular disease for for a minute or two. And whether this is a specialty for the endovascularly trained vascular surgeon or it really is the purview of the interventionalists, the interventional radiologist, interventional cardiologist first, Devon. In your experience, you know, are there important evolving trends in the cath lab environment? Are we seeing cases that historically were completed in the cath lab being moved to ambulatory surgical centers or office space labs? Or is that not a big trend? What are your observations?
Devon Bream 32:59
So we're hoping that it is a trend, I think, as Chris pointed out, the capacity issue right now, especially in EP is just unbelievable. And so we're waiting for for HRS, the society's, American College of Cardiology, to come down with some decisions that allow more of those procedures to go to outpatient. And then we're well positioned and ready with our portfolio to help build out those cath labs for ASCs. So we absolutely think that's going to be the future, just like many other procedures have migrated to outpatient. And with things like PFA that allow the procedure to be quicker, easier, safer, it really makes a lot of sense to migrate some of those procedures.
Robert Kieval 33:43
Okay, great. We got 30 seconds, do we do we see the potential for you know, you're able to take a an ablation procedure from three hours, four hours to one hour? I think, Howard, you brought this up on one of our calls, you know, is there any reimbursement risk associated with that, that our values might go down associated with the procedure? Or they don't pay for reduce anymore?
Howard Levin 34:04
So I think I think, yeah, there there are two issues want, you know, the redo issue, and unbundling is always gonna be a big issue. But the yet to separate out two issues. One is, are they going to get paid less for the device or more for the device? Are they going to get paid, the physician get paid less for the procedure, or more than for procedure, if you shorten a procedure from three hours to one hour, there's a risk that the physician is going to get paid less for that procedure, therefore, it becomes less attractive to them. And you know, you have to make it up in volume, but nobody really wants to make it up in volume. They want to keep the same thing and do more cases. So I don't know which way the answer is gonna go. But it's certainly a real concern that hasn't been yet. I think played out. I don't know you guys may know more.
Chris Eso 34:54
But I would agree with that. It still needs some time to to percolate and develop about and what what's going to be kind of the end end state here?
Robert Kieval 35:03
Okay, thanks. Well, this could be a long conversation or a short conversation. So with, with growing endovascular solutions from EVAR all the way down to the toe, is there, is there competition between vascular surgeons who are endovascularly trained or not? On the one hand and intervention lists on the other? Do we see different patient outcomes depending on which specialties are doing the treatments? Will the interventional list ever let go of these procedures? Is there is there enough of a bag of products to really engage vascular surgeons? Chris, what are your What are your observations?
Chris Eso 35:40
Yeah, I mean, so it's an interesting question, right? Because when you think about the physician specialty subsets, the vascular surgeon and the cardiac surgeon are still very critically important in in the overall procedures, the vast amount of interventional cardiologists and IRs is a hard challenge to overcome, right. And so as things become easier, as capacity becomes an issue, and you need to get things more simplified and easier, they are moving more to the interventional cardiologist side of the equation. But there's still those those cases that are so complex that you do need that that surgeon expertise, in my opinion.
Howard Levin 36:28
Yeah, I think that the vascular surgeons are starting to suck up more of the procedures, you know, they started with er, you know, they made that transition, they're going peripheral in the leg. The question that I'm going to be interested to see is how are the strategic skin to deal with that? Because you have, as Chris said, on one side, interventional cardiologists were certain procedures are becoming more commodity, quote, unquote, and they're looking for new revenue streams, etc. And historically, ICS have taken away things from everybody. So they went from the heart to the kidneys, to the brain, to their carotid to the leg. And so, you know, can you democratize these procedures enough by developing technologies that allow the ICS to take the business away, instead of from the IRs now from the vascular surgeons? Or do you have enough a vascular surgery call point that is happy to it's important to keep those people happy?
Chris Eso 37:27
I gave a little bit more political answer, because they're my customers.
Robert Kieval 37:30
Yeah, Indeed, indeed. Okay. All right. We have the last two minutes, we talked about touching on AI. So why don't we? Why don't we do that? You know, Devin, you talked about AI in the cath lab? You know, Chris, I'd be really interested to hear your thoughts about AI and implanted devices and, and what opportunities there may be, what risks there may be to, to mitigate there, should it be relegated to a clinical decision support tool by aggregating data to try to predict and prevent, you know, events before they happen? What's going on in implantables? Right now?
Chris Eso 38:03
Yeah, I mean, so, you know, I think a lot of people are talking about AI. Right. And, and it's a very interesting space. And I think it's actually bigger than most people give it credit for. If you think about the potential that it can be used in cardiovascular, better deployment, you know, the right deployment, pre case planning, clinical trials and addressing, you know, underserved patient populations, robotics, you know, we have a digital surgery play, CathWorks is using an AI. And so these are all, you know, potential opportunities. And so a specific example, in the cardiovascular side, you know, if you take our Accurythm link with our AI technology, it is actually using that to reduce the amount of false alerts by 50%. And so, and maintaining that sensitivity above 99%, so we're actually getting better results and our outcomes because of that algorithm that is learning. Now, I take another another area that I think a lot of people know about outside of cardiovascular, you know, colonoscopies standard of care, obviously, as colonoscopies, we have the ability to actually use our GI genius technology and our appeal cam and identify 50% More polyps that can be identified than traditional colonoscopy. And so we're building a huge database, we have over 1.5 million ECGs in our database that we're building algorithms off and so it's a significant effort that we're doing within Medtronic, specifically in cardiovascular
Robert Kieval 39:49
Nice. Okay, well, we're 30 seconds over Howard, would you like the last word here?
Howard Levin 39:53
I can give Devin the last word on AI because I have I know less about AI than I do about genetics so.
Devon Bream 40:02
So AI is as exciting as PFA for imaging. I think AI is already proven on the radiology side, the ability to prioritize which images radiologists needs to read when they start their day, every day, right. So it's proven itself out really well, we're super excited about what it can do and will do in the cardiovascular space. The challenge is how to monetize it. And again, our friends at Veranex have been great partners in trying to help us model it so that it doesn't become just a giveaway. I keep pitching. It's shameless. They are great. But the business model of AI is really a challenge, I think, for our whole industry, so that it doesn't just become a giveaway or a nice to have. I always equate it to my kids, right? When they started driving, of course, I wanted to have all the safety features in the car and backup cameras. And now those are all just standard products that are on cars. And so is that what AI is going to be for imaging? We hope not we'd like to figure out a way that it actually adds enough value to the procedure by doing the procedure faster, safer, that there's value to the hospital and some way to monetize that.
Robert Kieval 41:17
Great. Okay, I think we'll end it there. Thank you everybody, for coming. And please join me in thanking our panelists for an engaging conversation.
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