Structural Heart Innovation in Medtech's Era of Change | LSI USA '24

This panel discussed the future of structural heart solutions, envisioning a convergence of surgical and cardiology technologies, democratization of access, leveraging AI for imaging and workflow improvement, and addressing challenges in post-procedural care and patient access for startups.
Speakers
JD Friedland
JD Friedland
, Cleveland Clinic Ventures
Maggie Nixon
Maggie Nixon
, Capstan Medical
Donald Bobo
Donald Bobo
, Edwards Lifesciences
Jacques Essinger
Jacques Essinger
, Polares Medical
William Phillips
William Phillips
, Alruna Advisors

Speaker 2  0:04  
Good morning, everyone. I'm JD friedlin, from Cleveland Clinic ventures. And I'm really thrilled to moderate this panel on structural heart with me are Don    Bobo from Edwards Jacques    Essinger, from Polares, Medical Bill Phillips from Alruna Advisors, and Maggie    Nixon from Capstan medical. So we're really thrilled to have this conversation with you this morning. I'm gonna just walk us through a few topics. And hopefully we can have a very spirited and productive discussion. So as you just heard, now's a very exciting time and structural heart. We're witnessing the expansion and transition from solutions for aortic stenosis, for additional transcatheter applications in both mitral and tricuspid valves, across structural heart. So I'd love to hear from a couple of our panelists on what we expect the near future to bring. And just given all the news, I've been reading lately about ebooks, why don't we start with done?

Speaker 2  1:00  
Thanks, JD. Thanks for everybody for being here. Oh, can you guys hear me okay? In the back? Good. All right, perfect. So we recently many of you know, received approval of our evoke tricuspid valve both in the US and Europe, the first transcatheter tricuspid valve to hit the market. For those of you think it's a linear path from conception, to approval, it's not. It's quite a few twists and turns, it's a lot of learning about the patient, a lot of learning about the clinical pathway, your technology, how to get them delivered, how to image, all of that has to come together and fly in formation for these to be implanted successfully. And these things don't take, these aren't two year development programs. These are long running programs, where you're constantly learning and iterating on those learnings. But we're thrilled to be in a position to bring this forward to the marketplace, both in the US and Europe. A shout out to the regulatory agencies who saw the need these patients today, I have no options. They're really not surgical candidates. There's no medicine that helps them. And so we had great partnership, both providing input on the trials, but also being active willing partners, to make sure these products came through a process that was rigorous, but also allowed them to get the patients so good to be at this stage. But it's really only the beginning. For those who think well, great, you're there. It's done. Not really there's a long way to go for this to be a standard of care therapy for patients.

Speaker 1  2:37  
Thanks, Dan. I know Jack, is there anything you want to add to that?

Speaker 3  2:41  
Well, I can concur that there's nothing like a linear development in the structure of heart. I'm currently heading a mitral program, we have our first in men and 290. And I thought it would be coming close to a slam dunk. And now in 223, we're a second iteration and we're building an app. And the challenge is indeed, as we have been moving from the our tech to the other valves is the endpoint and much harder to get much software takes much longer time to get. And also, especially in the module, we don't have a good animal model on which we can develop. So you have to go into the clinic with all the respect for the patient's patients first is what we say. But at the same time, you know, you're going to learn and you have to iterate. And this is where it takes a lot of time, a lot of energy and for investors a lot of money.

Speaker 1  3:39  
Thank you. So you're like, I'm privileged to be part of Cleveland Clinic. And we've certainly seen firsthand with all these innovations and structural heart. Organizations like ourselves are seeing adverse impact on the ability to treat many of these patients because of the resource and staffing constraints that our hospitals and many other hospitals are facing. And one of the corollaries to that is, the longer the gap between diagnosis and treatment. The worst the outcomes are for patients. So it's great to have these new modalities, these new treatment methodologies, but we need to have the resources to support them. And we also need to move these patients quickly from diagnosis to treatment. So, so Bill, from your perspective, is this driven by where we are in terms of introduction of new devices? Is this the procedures themselves? are the other factors that are involved for your perspective?

Speaker 4  4:36  
Yeah, I think from an investor perspective, you know, it's a, I really empathize with the folks in the crowd today because the access to capital, it's tough. And you compound that in the structural heartspace, where the procedure times though they're coming down from historical levels, the advent of COVID and then particularly United States, you look at the challenges that the IDs are facing from a funding perspective. They don't have the resources in place to be able to support these types of cases. So you have, you're stuck in one end, where you're at the mercy of having institutional challenges of being able to drive patient flow. And that goes all the way back to the diagnostic end. So when I look at it and look at the current situation, particularly as an investor supporting early stage companies is how does how does an early stage company in this space pivot, where you try to address, you maybe shrink your overall market scope, and you try to go very deep in areas that you can provide value. So maybe you go to a Cleveland Clinic, maybe you go to an NYU, maybe you spend your more maybe time, I'll be biased. Cedars Sinai here in Los Angeles, versus historically, you say, I want to build a team of 5, 10, or 15, clinical teams to go in and support that you really need to take a pivot back and help that institution, understand how you're going to improve your process flow. Because today with the way the CPT codes are set up, and the struggles that they're facing at the administrative level, you've got to find a way to improve procedure time to improve the patient flow. If you don't do that the institutions and the purchasing procurement teams are going to really struggle on saying what value are you going to provide to me? And why should I include you into my into my usage? Continue on?

Speaker 1  6:15  
That's great. Done. I love you. If there's anything you want to add to that.

Speaker 2  6:20  
A thought struck me as you're asked the question that has been answered it, you kind of have two ends that create pressure. Today, in probably one of the most successful therapies transcatheter aortic valves in 2024 will treat we as an industry will treat 13 of the 100 that have ACC Ajay guideline disease. Now 10 years ago, we treated six. So we've made progress. You combine that with and there's a lot of chaos with how patients get detected, diagnosed, lost, handed off or not. Then you combine that with the pressure that systems have you mentioned, where is a really capacity to bring the kind of treatment to aortic, then mitral and tricuspid. And I think there's both ends of this, that's going to require many of us to bring innovation to really give patients what they really want. And that is timely therapy.

Unknown Speaker  7:16  
Yeah, no, that's great.

Speaker 5  7:17  
I'd love to chime in, please go ahead. One thing that I really liked seeing I started my career in the surgical side of cardiac, I started at intuitive on the original cardiac team, which we we pivoted shot for the heart hit the prostate. And, and so, so I started working with cardiac surgeons, but one of the really neat things shifting over into the cardiology space now is seeing the concept of heart teams, really building out in a powerful way in in the the hospitals and seeing the triage of patients come in with the imager, the cardiac surgeon, the cardiologist, all sitting right next to each other to push them through and find the ideal solution space is is awesome, because I do think it's going to change the timelines by which patients move through. Now I think from industry, our job is to give them a good robust set of tools to optimize that patient treatment all the way through. No, that's great.

Speaker 4  8:18  
Yeah, I think what you bring up on that one as well, because that 13 to 100. If you go back and EP, an EP really struggled for a long period of time, it had to be the set of tools, it had to be the the institution mindset, it had to be the certification of the right set of electrophysiologist, to take that 13 To now 30. And I think that there needs to be a structural mindset, because the hard part is you we can do these things in large institutions. But when you're trying to spread them across, you know, where you really need to drive patient access. That's where I think innovation needs to really rethink and, and drive that in. But it's also that focused element in terms of how you're going to support that patient workflow into that institution.

Speaker 1  8:54  
Absolutely. And so Magga haven't been ignoring you. The next question is definitely right up your alley. So one of the other areas of innovation we're seeing in structural heart is the introduction of complementary tools and technologies to support exactly some of the challenges that we just talked about. So that can be everything from enhancing visualization, in increasing placement, accuracy, as well as incorporating robotic assisted surgical solutions, which will all be critical to advancing the level of comfort and the adoption rate of some of these solutions. So let me ask both Jack and Maggie to maybe comment a little bit on what you think the pace and the impact of the incorporation of such technologies will be, and then how important it is going to be for the incorporation these technologies for the eventual adoption of these procedures across a broader set of clinicians.

Speaker 5  9:45  
You have such as you just have such a history and the structural heartspace I'm still new there. So at Capstan Medical, so I'm on my second company, my first company I was at Intuitive Surgical from 2000 to 2022. So 22 years with intuitive and it was amazing to me that robotics had not really entered the structural heart space in a powerful way. And at capsule medical, we're trying to bring novel implant technology that is enabled through robotic delivery and deployment. And so this is a place where, where development teams working shoulder to shoulder can bring these novel concepts to market, if you've got a highly capable delivery system, you can do different things with your implant, you can do different geometries that that accommodate more patient anatomies, and what not if you've got the precision and control of robotics behind it. But with that being said, these development pipe timelines are extensive, going all the way through the implant, you know, clinic clinical burden, all the way through a complex piece of software controlled hardware. Right. And so it's, it's not for the faint of heart, bringing together structural heart and robotics is not for the faint of heart. But I think it's the right solution to really be bringing, you know, options to these patients that are underserved right now.

Speaker 1  11:07  
So that's the second point up as I don't think I'm going to call you out on that one. So

Speaker 3  11:12  
I would add that there is also has been very big change and improvement on all the imaging modality, especially even for your robot without imaging does nothing and if you think that Tebow was done, basically just on the basis of NGO, now take mitral and tricuspid, it is all a Kobe's 3d Aiko. And I can see in the future, other technologies, other imaging modalities that just going to be making the procedure much more easier, much more visible for physicians, I'm still still surprised when we get a call for a mitral, there's still a little bit of a debate, what are we seeing here? Is it this? Or is it that so in order to further improve, we will need also significant and they're coming improvement on the imaging side?

Speaker 1  12:08  
Just your thoughts on the timing? Obviously, we've seen, you know, relatively long timelines because of the regulatory process for the introduction of the strength camp transcatheter solutions for structural heart. Do you anticipate a similar timeline for some of the complementary tools? Or do you feel like there's going to be a more rapid adopt regulatory and adoption pathway for those solutions?

Speaker 3  12:28  
I think for the for the imaging tools, it's a question of having them available, developed being used, I don't see your regulatory hurdles that might be a logistic hurdle within the hospital and then just think if we could be doing a TAVR or mitral inside an MRI, having 4d access online, that would be a big change. Yeah. Are we going to be able to get that tomorrow? No, in the future? Maybe. Great.

Speaker 1  13:01  
So Dan, I want to come back to a topic you raised before, which I think is really critically important. We've been talking about, I think, for much of this panel. There's some amazing innovations that are coming out, and really addressing the need in the space. But as we've all experience, to some degree, there's a gauntlet of regulatory commercial adoption and clinical hurdles. You know, how can companies align themselves with the appropriate regulatory agencies, with hospitals like Cleveland Clinic, with the payer community to address some of these expected reimbursement pathways and adoption pathways to create less friction, from great innovation to standardization and adoption of these technologies? And so, Bill, why don't I have you start first? And then Maggie, I'd love to have you comment as well.

Speaker 4  13:51  
I was hoping somebody else is going to answer this in first. Ladies first, ladies first. So So you know, it is it is really true, I will give a compliment, because I think it's Do I think that the FDA is really trying, you know, if we look historically along my career, you know, the US has always FDA was last you would do you first and then maybe Asia, Asian markets, and then the US would always follow today, I think that the FDA is really understood that the changes in overall regulatory guidelines that they're there to central point, to be able to figure out how they're going to support innovation. Now, as an investor, and obviously the folks who are on the on the innovation side, there's probably always continued frustration, whether it's the regulatory pathway or the definitions, or the definitions, particularly as it relates to remote management care or digital therapies. Because as every patient wants to do today, they want to be involved from a digital perspective and they want to be you know, whether other comorbidities that come into it, but the FDA is just behind. I think what happens now is that going into these groups, and particularly from From an from an early stage firm, is the depth that you have to think about where you're going to go in your regulatory journey. And then the second part of it is, is what is your reimbursement? I think sometimes we don't spend enough time on beyond the first question of the of why that CPT code is that CPT code, I think you need to really spend a lot of time thinking through what are the avenues that you can navigate. And then when you go in and prepare for your presale, but your other meetings, you're you're actively going in and leading a discussion, versus you're you're trying to go into some discussion points and try to lead with questions. So in this regards today, and I'm going to stay with the FDA, because other countries are now kind of somewhat following. The FDA is really trying to figure out particularly for early stage companies, to tap into other initiatives, how to support innovation in the United States, to be able to export that our job now from an investor into support you and you as an innovator, as a company, is how to really focus in and streamline on where you want to go and how you want to go. But you have to be able to be flexible to pivot. I've been in I'm really early in my own investment cycle here. But in some of the companies that I've worked with, and I've said no to is that they're coming back and saying no, I'm really stuck on, this is the avenue that I need to go because the FDA has said as a predicate, ABCD and E. And that doesn't necessarily mean today, when these new innovations coming through, you know, Edwards can spend $100 million in an advocate spend $100 million on big name platforms. But as a startup, you really need to go in and be very specific, but you need to be aggressive. And think about how do you partner and navigate and pivot? That's how I kind of think about it now. Because I think it's a it's a different environment that we're living in than even what we were 12 months ago.

Unknown Speaker  16:54  
Yeah, I think you're right.

Speaker 5  16:56  
And I'll echo the comments on, you know, I think all of us have seen that breakthrough designation did not quite have the impact to timelines and and so on, that we had anticipated, but at least it's been acknowledged. And that's why there's, you know, kind of the pilot of the TAP program was pretty successful last year. And, and, and they're obviously focusing on, you know, the cardiovascular space, the neurovascular space, which is, it has fewer options in that market right now. And so I think the key thing that you're saying is being proactive, engaging really early on both kind of what is the regulatory pathway, and the reimbursement pathway is important. I think on the flip side, from the innovation side, you know, what the bar is going to be from a clinical target space, one thing I'm focusing on is, is making sure our inclusion is going to be strong enough so that you can get recruitment of the patients, it is my job to deliver a solution that has sufficient inclusion to to really drive those numbers to get that clinical data. So that happens in partnership, right? That's like being really thoughtful on the disease, state the needs of the market and understanding and providing something that's close to it, and then working with those regulators to put a robust plan together. So

Speaker 1  18:14  
I'm gonna throw you guys a little bit of a curveball, because Bill brought it up. Could you comment a little bit on the foreign regulatory bodies and how the company's strategy ought to take into account some of the other large markets outside the US?

Speaker 4  18:30  
Yeah, so. So today, and in some of the firms that I'm partnering with, is that I've really asked for them because you can look at a larger, you look at the pie of the globe and say, Well, I love to be in all those markets. But today, to be honest, MDR is tough. If I was, you know, if I was an innovator looking at certain markets to go to MDR would be the last place I would put $1. You know, I would love to strategics go with that. Let them spend that time and money to build those markets. But as an early stage player, I would think about these following markets. Number one, Japan, Japan is now pivoting again through through MHL W, through some of the regulatory pieces, because they want to catch back up on innovation, because having a highly aged population, but the reimbursement if you're at the right reimbursement code, and you bring the right set of clinical data, you can establish a dedicated code that will completely differentiate you for for five to seven years, that will drive your gross margin values that will help position the valuation of your company. Secondly, I would look at Australia. It is the TGA has, has historically even back in 2017 and 2018 have always been progressive to want to be able to be involved in early stage clinical work. If you look at at at you know the team down in Australia, Steve, his name has not slipped my mind on structural heart did a lot of the tabIe work a lot of the mitral work. But but Australia and the TGA have always been aggressive because they want to be part of the forefront of clinical work. And then you now look at you know, I've seen some recent pivots probably in the last six months or so. If you look at Chile If you look at some of the markets from a clinical perspective, those markets as well are wanting to be involved. But it's an issue of affordability. So if I today were to spend my dollars, I would go to Japan, I would go heavily in Australia as an early stage. And then I would figure out if I have my dollars in place, can I build enough patent protection in China? To be able to assess where, what and how I'm going to to, to play into that market?

Speaker 3  20:24  
Great well, being probably the only European on the panel, sorry, I have to step up here. Well, let me first say, I agree with you. The MDR is a real nightmare. And I think that we have seen it over and over in Europe, they have that ability, unique ability from swinging from one extreme to another extreme, and we can go back what has been driving, driving the change from the from to the MDR. So the number of really unspeakable drama in the medical device, but I am not as SMS pessimistic as you are, because I think that there's a lot of talk that the MDR is being going too far, they would like to basically have almost an FDA like that without having the centralized of the FDA. So it is going to swing back. So I would say, I keep looking at running some of our studies in Europe, I still look at getting a CE mark. But contrary to the past, I'm running full steam in the US. So that's a little bit to change.

Speaker 1  21:38  
Great. So my last formal question. And I'll maybe start, but I'd love to hear all the panelists comment on this. You know, what does the future hold for us to instructional heart one of the things you know, when I have observed other disease modalities, where we've had minimally invasive, and other interventional solutions, we start to see procedures move from multi day procedures to single day procedures to same day procedure. So is there a future where a structural heart solution can be delivered by either outpatient or by an ASC type model? One of the challenges I mentioned earlier that Cleveland Clinic and pretty much every hospital system in the world is dealing with is the supply demand and balance of labor and other critical resources. And if we're able to leverage other capabilities and accelerate our turnaround times, we can serve more patients. Again, we can address that gap between diagnosis and treatment and get patients treated faster. But you know, we'd love to get each of the panelists perception on what is the 5, 10, 15 years from now? What is the care model? And what is the business model look like for structural heart? So why don't we start with Maggie, and we'll work our way down.

Speaker 5  22:53  
That's a lot, a lot of questions in there. So I think I'll start from the technology side, I think we're going to have an intersect between the capabilities in the surgical space and the capabilities in the cardiac or cardiology space, I think a set of tools will come in to let you do some things that you typically would only have done surgically trying to have, you know, the valve leaflet modifications, but do it with cardiology, catheter based tools, and so on. So I think you're gonna have a set of technology that brings pieces of surgery and cardiology together. And so that will give you options like different ways to treat all the variable anatomy. And when you're in the mitral and tricuspid space, you're operating in 3d space, you're not operating in a tube. And so though, that kind of technology is really needed. And so I think that's, that's a key part. And then, to your point, I think we need to like surgery where you go in and you treat a mitral and tricuspid on the same day. At the same time, I think we need to get to a technology model and a reimbursement model that lets you do that so that the patient can be completely served on a single intervention. And I think that's in the best interest of the patients. Right. And I think there's limitations that need to be addressed, especially on the reimbursement side.

Unknown Speaker  24:13  
Yeah, that's a great point. Done.

Speaker 2  24:15  
Very good list. Maggie, I'll go a little bit a different direction. I think in the last 1015 years, we've seen the emergence of implants that can be delivered by catheters to fix valves to repair valves, to quite frankly, intervene in nonvalvular Structural Heart, think of heart failure. So if I take your question and say, okay, in 10 years, what is it going to look like? I think we'll have a series of interventions that can largely address mitral tricuspid, aortic pulmonic disease with catheter based techniques. I think there'll be enough different kinds of interventions so you'll be able to cover the majority of etiologies of the disease. And I think Today that's not true. I think in 10 years that becomes true. Importantly, though, I think we're gonna see a lot of other innovation come alongside these implants. You mentioned Imaging, imaging, there's a lot of sophistication, you can bring the imaging, where you're able to conflate different imaging modalities, have it on the screen, have it guide your intervention, know where you're at, know where you're going, know what the issues are. That's something that I think if it was in the future, it's going to significantly simplify and speed up these procedures. I think there's going to be accessories that allow operators, all say, average operators, that people that aren't always at academic centers doing 200 a year to do have similarly great outcomes, which is going to open up the access for a lot of patients that today don't have the access to the Cleveland clinic's the Mayo Clinic. So Cedars Sinai, to get the kind of breadth of intervention that we that the academic center has. So 10 years, I think we're gonna see a lot more opportunity for innovation, to speed diagnosis, detection, treatment, and to make it much more widely available. I

Speaker 1  26:14  
love that idea of democratizing the, and improving access to these solutions, because the markets are huge. If there's only five to 10, centers of excellence that can service them, we're never going to address the market so substantially, Chuck. Yeah. So

Speaker 3  26:31  
you were asking, Can we do structural art in an outpatient? I think from a procedural standpoint, it can be done. The one big question is the aftercare, we should not forget the importance of the aftercare. From an experience going into some countries that you have said Chile, you are Paraguay, we can do the procedure. But this is where the aftercare is hurting. So, I think that if there's a possibility to be providing in an outpatient form, the kind of aftercare monitoring that will allow the patient to go home, but still being some kind of monitored, so patient could be interacted very quickly. This could be it, but the aftercare should not be forgotten.

Unknown Speaker  27:19  
I have a follow up question on that. But let's come back. So

Speaker 4  27:23  
every time you add the word AI to something, people cringe, and I don't want to cringe on this one. But I think that there is a very relevant point that relates to imaging. I think that the machine learning data sets and the speed of which certain AI modules are being developed at institutions across the globe, are going to leap. And what we imagined today, in terms of the the imaging modeling that we have, versus what potentially could be, I think it's going to really fundamentally change the access of structural heart. And so I am excited about those elements of AI. And I'm also interested in terms of how those support some elements of development, but I also look at the hospital system, this process workflow, I think that there's going to be opportunities, particularly within leading institutions, they're going to be able to provide workflow models, they're going to improve processes and drive work through. And then then I think the United States, this is where the ASC has become very interesting. Because now, the aftercare aspect, if you're a Banner Health Care, and you're already running your own owned ASC, or the Cleveland Clinic, you have the access to the patient flow, you can run them to the ASC. And then you can have an adjunct institution that if something unfortunately, if it does go wrong, you have maybe some sort of access to be able to kind of manage that activity. But I do believe that there is going to be a a rapid movement over the next probably 48 to 60 months, where you're going to see the FDA saying, where else can we bring in these codes into outpatient settings, that are going to provide value and set the foundation of skill development and learning. Because it goes back to the skill of who's in that room, if you don't have that skill level on the room, doesn't matter what you say, you're not going to be able to do the case. So it's going to take time for them to build that skill level in the room. But when that skill level and capacity gets there, I think you'll start seeing a reimbursement pricing strategies pivot to start encouraging that type of move.

Speaker 1  29:17  
So I want to come back to this great, thank you, Bill. I want I want to come back to a thought that jack your response gave to me and you know, as a healthcare institution, Cleveland Clinic, we identify even today patients who are coming in for a procedure, they're getting discharged, we hand them discharge instructions that read like TV antenna installation instructions, the the compliance, post surgical follow up is I mean, here, here, we've done this, like, put this innovative solution into the patient that will change the way their life proceeds. Many of them absolutely follow their post surgical follow up but a lot of them don't And so what kinds of solutions, you're going to be critical, particularly, if, in fact, these procedures are going to move to I'll call a lighter touch and ASC or an outpatient environment, that post surgical follow up and making sure that the patient remains there's a level of engagement that remains between the patient and the and the clinical community. Are there solutions you guys are seeing out there that you're imagining that are going to allow that stickiness to remain so that the patient you have stays healthy? And is getting the follow up that they need? Anyone want to go first? Okay.

Speaker 3  30:32  
Well, I think I would make a difference between the short term after care. So the 4872 hours, and the longer term? Yeah. So in the 4872 hours, I think that there will be an should be technologies that are able to effectively monitor better the patients when we send them home. If you send them home after a when outpatients. There'll be one set for the long run, I think is will it come to digital health and different tools to be able to remind patients, I can name a case of patients where we have to call the patient's almost every month to remind her that she has to take her anticoagulation drugs. That should be done differently. Yeah.

Speaker 5  31:21  
I mean, I think it's an interesting, when you point out how do the some of these new things fit into the, you know, the healthcare ecosystem? Right. I mean, I think one of the few benefits of COVID was how pervasive telemedicine has become, it's become like, touch points that have become more acceptable, right in in the COVID. world, but also new technologies that are helping monitor, you know, kind of patients stats in a different way. test kits that are sent home, right, those sorts of things. So I think there's an ecosystem that we're that you're seeing through all the tendrils of what we're saying, this is imaging companies working with device manufacturers to integrate, you know, imaging registered devices and bring these things together and work in a cohesive fashion. I think all of the pieces need to be done in that holistic view.

Speaker 4  32:11  
I think that Pharma is already leading that way. Right. And so you get the digital therapeutic alliance, that's, you know, aggressively trying to engage with the FDA on reimbursement. But I think that Pharma is really leading the area as it relates to that, and for CBT, right, there is, there's an avenue for us to be able to try to learn from that quickly and apply that into the medical device side. But I'm going to make one small caveat on this one as well. Because I think sometimes we get so passionate about the industry or the products that we sell into the institution, sometimes we don't think of the after effect, or the impact that it's having on the workflow. And we think what we bought that we brought in the best technology brought the best widget but that that patient treatment continue or how that's going to fit into the other devices and be part of that procedure. Sometimes we need to take a step back somewhat and think about where does that fit within the value chain. And so what, as it relates to procurement and an administration and in that value component, Bill,

Speaker 2  33:03  
maybe at that point, I think, broadening our lens on innovation and not just be the implant, but to think about how to innovate the aftercare. And that whole process? And look, I agree with the comments, there's going to be a lot of digital tools that are make that easier. The other thing I'll put on the table, and we've seen this, I don't know, if in 10 years, you won't have a lot of devices that are implants that are a lot smarter than today, with integrated sensors, and the ability to communicate both both with the patients and to at the right time. Connect with the caregiver when things change.

Speaker 1  33:41  
No, that's great. So we have a few extra minutes, maybe I don't know if our panelists have final thoughts for emerging companies in the structural heart space that we want to share. I know Bill, you had some good thoughts on, like, geographies to go after. But um, yeah, there's obviously a challenging market. This is market with long lead times in terms of development, and it's not cheap. But, you know, given the current environment that we're facing, and the likely environment we're facing in the future, any last words of advice? Yeah,

Speaker 4  34:13  
my only perspective is really around the the commitment to deliver to the time goals that you've set. You know, people sometimes build out, I always encourage the companies I invest in, I need to see a six quarter timeline in terms of what they're going to do, why they're going to do it. And what does that actually mean for the end goal? That's not easy to do, because most of the time, you're thinking about how do I get through next week? And so it forces coming from a big strategic side, it forces me to think about what must I do that's going to push this value to be able to deliver the result to support patient care? That's one. The second one is, is I've really kind of taken a big pause maybe over the last four months, I really thought that the capital markets would have freed up. At least that's what Paul violet told me last year. This is Bill Don't worry. Jump into this at the end. markets will be open and you'll be off to the races. And it's not really worked out that way. So far. Well,

Unknown Speaker  35:04  
you might have said, 2024, we still have

Speaker 4  35:07  
24. But I really would have hoped by this time that there would have been a free up of capital, that would have been coming into the earlier stage medical device side. And I think that kind of coming back to this meaning, there is still a challenge in that end, what I say to that is, is if you're raising your early rounds, you need if you're getting your money, and you got that money, take a quick breath. But think about what is your next round? What does that need to look like? And what are those deliverables that you need to get that you're showing value to those future investors, that you can actually do what needs to get done, because that I think is going to change where that check is going to go to which company that is going to advance the innovation that they believe is going to be able to deliver it forward?

Speaker 1  35:49  
Yeah, I mean, this is a really important point. And maybe the advice I would bolt on to that is, what Bill's talking about his value inflection points, correct. Show me as an investor, how you're going to use this round of capital, to demonstrate a discrete advancement, that's going to direct the opportunity. And then also show me that you do it within the timeframe, and within the budget that you expect, and obviously things happen that no one can predict. But you know, show me what you're gonna do, and then go do it, and then show me that you did it. And then that creates an environment for me as an investor to get a lot more excited about investing in the company. Jackie looks like you want to say something

Speaker 3  36:28  
I didn't mean to. But I think one of the big challenges, especially for a startup is, is when you're running clinical studies is to be able to access to the right patients, especially if you're running other EMFs in the US or trying to do early feasibility study in Europe, where I speak to myself in the Montreal space, you have the mitral clip, you have the Pascal there. So naturally for physicians, they are just going to give you the worst of the worst patients, the patients that nobody would want to treat. And this is probably the worst place where you want to take and start innovating. So you are forced to go into other jurisdictions where such devices are not available. And then you are confronted with the issue of patients environment after care. And this is I think, what has changed between what I'm doing today and what I did. 15 years ago, when I started symmetries in the tavern. I would no longer be able today in Europe to access the patients that I would have that I had access 15 years ago. I think this is a big, big difference for startup access to patients for early feasibility studies. Really

Speaker 1  37:44  
good point. So I want to we're just about out of time here. I want to thank my panelists. I feel them a couple of unscripted questions, and they performed admirably so thank you all for your time. And I will thank everyone on the audit in the audience for for joining us here today.

 

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