Elevating IVL Delivery with Scott Nelson of FastWave Medical — The Medtech Impact Podcast

Ladies and gentlemen, welcome to the MedTech Impact Podcast, where you get to hear from leaders and innovators who are shaping the future of medical technology.

I'm Kyle Cruz, and I'm Richard Mikkeljohn, and we're your hosts of the show.

Today we have with us Scott Nelson. Co-founder, president, and CEO of FastWave Medical. Scott, welcome to the show.

That's one of the better intros, right, that I've come across, and I've done it. I've, you know, been on a fair number of podcasts, so pleasure to be on, guys. Really looking forward to the chat.

Oh man, thanks. Yeah, no, absolutely. We're thrilled to have you. And yeah, we've got to make this exciting. We got to have some fun here, you know, trying to, you know, bring some new energy, no pun intended, to the the medtech industry and community. So with that said, tell us what FastWave Medical is doing. What is the problem that you are trying to solve?

Yeah, so, so, so FastWave is a relatively young company, right? Uh, a little over 2 years in the making, and we are designing and developing intravascular lithotripsy systems, or IVL is the acronym that's often used. Um, and I'll, I'll kind of paint the picture as if, uh, the listeners aren't like super in the weeds with respect to cardiovascular, the cardiovascular space. So what this technology does, the end goal is to modify calcific plaque in an artery in order to sort of open up the pipe, so to speak. So the best analogy is to think about plumbing, right? You've got a clogged pipe. What we're talking about here is that that clog is largely related to difficult calcific disease that's oftentimes difficult to treat. We're trying to crack that, that plaque to get it to open up, right? So we can, you know, deliver blood adequately through, through, through, through the blood vessels. And so that's a super high-level overview, right? Obviously, I can— we can certainly get into the weeds from a technical perspective if needed. But that's sort of— that's sort of— hopefully that provides sort of a high-level overview of kind of what we're doing at FastWave.

Sure. Absolutely. Maybe an analogy is Liquid Drano, even though that you're using energy to do— to clear those pipes. Or, you know, we'll get into more about the technology there. But what is, I guess, the current standard of care in this area?

Well, that analogy of like liquid drainage, right? Like if you go to the Home Depot store, you see, you know, you go to that section, right? Or that, that, that, that kind of, you know, that, that department, if you will, that plumbing department. And there's like just a lot of choices, right? I mean, you can choose like, like some hot chemicals, you can choose like, you know, traditional Drano, etc. Sort of, sort of applicable, right, to what we're talking about in the sense that a lot of physicians interventional cardiologists, vascular surgeons, some interventional radiologists still do this type of work. There's a lot of tools to use these days, right? You've got traditional balloon angioplasty, which has been around for decades. You've got stents. You've got specialty balloons, right? When I say specialty balloons, I'm talking about angioplastic balloons that have scoring elements, et cetera. Then you've got a whole set of different atherectomy tools. And atherectomy, for those that aren't familiar, these are kind of cutting or ablating tools that are used to kind of like sand down or extract plaque out of a, out of a vessel. All of those different modalities, they come with pros and cons just like everything else. But when it comes to calcific disease especially, right, we're talking about hard calcific plaque that's oftentimes diffuse. Those modalities I just mentioned are, they really struggle with that specific disease. And there's not— they're either kind of difficult to use. Maybe they work okay at best. Some don't really work at all. And so intravascular lithotripsy is a reasonably, you know, a relatively new, I should say, modality. The category itself, IVL category, was created by a company called Shockwave Medical. And the inventors of that device were Dan Hawkins and Tom Britton. And they created this category. And in essence, what this technology does is it produces shockwaves inside of angioplasty balloon that are then delivered through the balloon into the vessel in order to create fissures or cracks in the calcium. And the idea there is you want to modify or increase the compliance of the calcium in order to get the vessel to expand. And so in essence, that's what we're doing is we're delivering energy inside of a balloon that creates shockwaves that are then delivered to the actual plaque in order to break it up.

And, and you must—

yeah, so Richard, sorry, go ahead. I wanted to just jump in real quick, and I know we're, we're going to get more into that solution, but this is fascinating to me because, you know, you, you— Shockwave Medical, to, you know, you, you mentioned them, and obviously I think a lot of us in the industry have seen how, um, successful they've been in the market over the last 5 years with their technology. But you must have saw you know, an opportunity though with that technology for it to maybe be better and enhance the way the technology works. I mean, kind of what led you to realize that, you know, FastWave needed to develop, you know, whatever it was that was going to be the differentiating factor in an effort to really improve outcomes in these areas?

Yeah, yes, it's a great point. So kind of going back in time, um, this was, um, I mentioned FastWave is, you know, a little bit over, over 2 years at this— 2 years old at this point, you know, slightly longer than that. But we actually started working on the project when I say project, it wasn't actually a company at the time. We started working on this in mid-2020 and we decided to pursue it with more rigor largely because of two things. One is that as a team, we had been tracking the intravascular lithotripsy space for quite some time, but this was before, you know, mid to early kind of first half of 2020. This was before Shockwave had a PMA for coronary applications. So it was kind of before the company really started taking off. And we had an underlying belief that the utilization of IVL as a tool would only increase from here. Right. Again, this was kind of first half of 2020, that kind of timeframe. So again, that was kind of one core belief is that, you know, we expected that. And I don't know if that was, you know, I mean, I don't think it was an atypical belief, but I don't— I think a lot of people have been surprised at how, how fast IVL has taken off. So that was one sort of underlying belief. And then the other thing, which is kind of your classic why now moment, right, which is, you know, typically occurs in any sort of startup, is we were also following CSI's effort or Cardiovascular Systems, which is now quite, you know, has recently been acquired by Abbott. They initiated what's called an IPR or an Inter-Party Review Process. And I don't think we need to go terribly into the weeds here, but in essence, their goal was to invalidate Shockwave, several of Shockwave's foundational patents. And so we've been kind of watching that and kind of tracking against that. And when the USPTO overwhelmingly ruled in CSI's favor in mid-2020, we thought, huh, you know, there's probably probably a little bit more freedom to kind of play around here than what most people perceive. And so that's why I say it was kind of our classic why now moment. So that's at that point, that's when we decided as a founding team to really, really pursue this project with more rigor, started prototyping the back half of 2020, really liked kind of the progress we were making. And that's when we decided to spin out the project at the time into a standalone Delaware C corp and then pursue a Series A round of financing.

Brilliant. I love it. And I love that analogy you were using earlier because you made it crystal clear for the audience to think about that problem you're facing. I wonder if you, if it's possible now to do a little bit of the same, you know, thinking about that solution and how that's applied inside the body. I know you spoke about the calcifications, you know, how did your technology breaking that down?

Yeah. How does it, how does our technology differ maybe from, from shockwave? Is that kind of the, the question?

Yeah. How did it differ? And yeah, just in general, how's it working? Just to sort of that step-by-step guide for the audience to understand. This technology in use?

Yep. Yep. So I'll start with kind of a broader overview and then talk a little bit more about maybe, you know, so directionally kind of where we're headed and how FastWave is different. So for those that aren't familiar, angioplasty balloons, I think generally speaking, probably most people that are listening have kind of heard of that, right? They maybe have never seen a procedure, but you're in essence delivering sort of a catheter, traversing a catheter through a blood vessel, right, to the to the diseased vessel, right? And when I say diseased vessel, it's a pipe, right, with blockages, right? So you want to try to address these blockages and really kind of clear the way, right? Open up the vessel so you can establish blood flow again. And so what we're doing is with an angioplasty balloon, you know, we're delivering that to the diseased vessel and then with an energy generator, right, we're producing what's called cavitation inside a balloon. So these are like vapor bubbles, right, that rapidly collapse, almost, almost kind of picture like a nuclear bomb. Like everyone's seen those, those images. That's kind of what it looks like under, under high-speed imaging. It's like a nuclear bomb that explodes within the balloon, rapidly collapses, and then that rapid collapse produces these shockwaves. So that's, that's traditional lithotripsy, intravascular lithotripsy. You want to create cavitation inside the balloon and that rapid collapse of those cavitation bubbles generates the shockwaves right, that then acoustically kind of vibrate through the balloon and hit the plaque. And what's really kind of really the kind of the cool or like compelling elements of intravascular lithotripsy is that it's a very— it's incredibly safe technology and it's very, very easy to use. And so when most people think about, you know, generating a nuclear bomb inside a balloon, they're like, well, that kind of sounds dangerous. Well, in reality, these shockwaves are incredibly safe to soft tissue. They don't do any— they don't do any harm to soft tissue. They only— they only produce a result against hard, hard, hard kind of material, if you will. Right. And so calcium being one of them, right. As an example, if I had the balloon in my mouth, right, and I was delivering shockwaves against my teeth, I mean, I probably could crack my tooth as an example. Right. So the— that's— it's really— it's really interesting technology in the sense that it's really, really safe. And the shockwaves really only impact that hard, that hard kind of material, that hard calcific plaque in this, in this particular application. And then the other thing, Richard, that I mentioned is it's incredibly easy to use. And so this is just, this is, you know, most physicians, which I think is what you want to be thinking, you know, if you're an entrepreneur listening to this and you're thinking about, you know, your own technology for, for something to be truly adopted, it needs to be incredibly easy to use. And that's why IVL, that's one of the reasons IVL has taken off the way it has. Because it's so easy. Unlike atherectomy, as an example, that is fairly technical, requires a reasonably steep learning curve, right? With IVL, there is very little learning curve at all. I mean, this is like— this is the equivalent of using an angioplasty balloon and hitting a button, right, in essence. So it's really easy, really, really easy to use. So like that kind of— that trifecta, it works well, right? It's clinically efficacious, extremely safe, and maybe again, most importantly, it's very, very easy to use. That's one of the, you know, kind of the 3 core reasons why the technology has really, really taken off over the past half decade or so.

Kyle, Scott is really an expert, I'm getting the sense here, of explaining potentially really complex things into really understandable and simple terms. So this is a brilliant start. I'm wondering now about how all this translates as you move to market. You know, how are you going to take this forward?

Yeah, yeah. So I guess this kind of parleys into your second question, which I hadn't addressed yet, which is how FastWave is different and how we're kind of approaching kind clinical efforts and eventual commercialization is I think what's unique about, about FastWave is that we're developing multiple intravascular lithotripsy systems. And when I say multiple IVL systems that are built on different energy platforms, right? So we've got a peripheral system that we, that we feel is differentiated versus Shockwave, although it is kind of built on a similar type of energy platform, similar mechanism of action, we think solves for some, some clear gaps. In their platform. And then in addition, we've also got a coronary system that is completely differentiated, right, is built on a totally different energy system that we think inherently solves for a lot of the technical constraints that you run into with an electric-based IVL system. I say electric-based IVL system because that's, that's, that's what Shockwave's platform is. And so we've got kind of two different shots on goal, so to speak. I think, Kyle, you'll like that analogy, right? You know, so I think that's what, that's what unique, that's what that's what's unique about kind of what we're doing. And I think the counter to that argument, you know, that for those, you know, that are experienced in startups that are listening, like, geez, that seems like a lot, right? You're doing two different systems. Why not focus on one? And to kind of touch on that, it's an interesting kind of story. And I think it might be helpful for everyone listening is that when we first started FastWave, we thought electric-based IVL, right? There's, there's very— it's, it's, it's there's demonstrated clinical efficacy, right? Shockwave has done a great job with that, demonstrating that over, over multiple clinical studies. There's a— it's a reasonably straightforward REICLIN pathway, right? And so it kind of represented a sort of a fast track to market clearance, right? If we, if we could truly address some of the gaps that perceived gaps in Shockwave's platform, which I think we've done with our, with our peripheral electric system. But in addition, there's, there's also some clear technical constraints, right, that, that you just inherently run into with any electric-based based IBL platform, and we knew that. And so we thought another energy— utilizing another energy source, right, to accomplish the same thing may allow us to overcome some of those hurdles, some of those technical hurdles that are just almost insurmountable with electric-based IBL. And so we started working on this, you know, that secondary system, that sort of next-gen system, you know, gosh, 18— almost 2 years— 18 months, almost 2 years ago now. But we didn't know if it was going to work, right? It was a science project at that point. But as we've methodically burned down risk, we now have kind of two platforms to run with. And so our kind of our coronary system is this, you know, kind of next-gen IVL platform, whereas our kind of our fast-track, you know, path to market clearance is our peripheral system.

Are they both 510(k) pathways?

No, the peripheral is 510(k). And that would be the same regardless of which type of energy system we chose. Right. Peripheral is always going to be a 510(k), but it is a clinical 510(k). So FDA does require clinical data.

Sure.

Coronary, the— for coronary applications, that's a PMA, you know, so that's your— that's a much more intense sort of lift, especially on the clinical side. Right. We'll have to do, you know, early kind of pilot feasibility studies before we even commence on a larger PMA pivotal trial.

Sure. Yeah. No, there's no doubt that the PMA pathway obviously is a lot more— it's longer, far more complex. It's a grueling process, but You know, that's what it— that's what's required, obviously, when you have something unique that doesn't exist right in the market. And it's really cool to hear how you have those two technologies because I think a lot of times, you know, you obviously have great experience being on the investing side as well. And a lot of these investors are looking for that ROI. You know, they want to get to market fast and start generating revenue. So you're doing that, but you're also giving them a look into the future and you're working on that now. So it just shows, it just shows a much greater vision. Really impressive. You know, can you tell us too real quick about the, you know, you refer to Shockwave as that electrical energy or whatnot. How is it? Hold on. I just, I might have missed something or I'm not connecting the dots, but then if— are you not leveraging electricity then, or how, how, what's your then energy like? Yeah, I guess.

Yeah. Yeah. I mean, I guess without going too far into the weeds, I don't want to get myself in trouble with the rest of our team or my board at FastWave. But yeah, so, so yes, when I say electricity, I'm talking about the energy that's used to create cavitation. Right. Which we discussed, you know, a few minutes ago. What energy is used to create cavitation? That's kind of the main difference between the two systems. And when I say electric-based IVL, it's current running down a catheter, right, that is then fired into, you know, when I say fire, delivered into, you know, the contrast saline mix inside the angioplasty balloon to generate these cavitation bubbles. And so that's sort of electric, you know, IVL. But there's a whole host of other different energy sources that you could potentially use to generate the same type of cavitation. And that's kind of circling back around to 18 months to, you know, 2 years ago now. We had a kind of a thesis that, you know, some alternative energy sources might be better, right, to generate cavitation. And, you know, look, you know, here we are, right, again, you know, nearly 2 years later. And, you know, fortunately, we were right. There are some better energy sources to generate cavitation. And so, yeah, we feel good about kind of where we're at with that approach. And I think that even more so in this market, there's, there's money is very difficult to come by, right? Capital to fund your startup. And so kind of our, our kind of from a business perspective, our thought of getting to market quickly, right, with a peripheral electric IVL system that we feel is still differentiated versus, versus Shockwave, yet having kind of a next-gen kind of pipeline product, it is a, is a nice play. It's a nice kind of, it's a nice position to be in. And it kind of represents, you know, again, that kind of two shots on goal for any investors that are interested in partnering with FastWave. So it's a bit of a unique approach, but we feel good about kind of where we're at. And I think if I say all that because it is definitely more resource intensive, right, running multiple PDPs in parallel. There's also a lot of synergy, you know, in doing that too. And so, you know, if there wasn't the synergy, you know, we may, you know, I may have different feelings about the approach as well. But there is, there's a lot of synergy in kind of moving both programs. Along in parallel.

That's great. And I guess like, so here you are, you know, you've got your product built here, you're on your way to commercialization. I know we've talked in the past, you mentioned maybe in the next 18 months. So kind of what's the approach to your clinical initiatives? And tell us kind of your mindset for patient enrollment for— and your strategy for these clinicals.

Yeah, yeah. And so we're— I mean, I don't think we'll probably go too deep into how we're approaching kind of our go-to-market strategy, right? Because as you mentioned, we still got to get through our pivotal, our pivotal trial on our peripheral program. And that obviously is different than even the PMA pivotal for our coronary system. So, you know, we're still, we're still a ways out for sure. But I think the important point for, you know, founders, you know, entrepreneurs that are listening to this, to the show is that, you need to be thinking about your go-to-market strategy very early on in the process, right? Even as early as when you're starting to bring on physician advisors, you know, because there's a lot of— you want to make sure kind of like that physician advisory team is balanced when, you know, in terms of, you know, a couple examples would be in our case, right? Do they practice in an OBL or ASC or do they practice predominantly in a hospital? What are— where do they really drive influence, right? Do they drive influence kind of with below the knee? Peripheral applications, or are they more of a peripheral generalist, or are they a high-risk PCI? Do they have a lot of influence when it comes to high-risk, you know, PCI applications? So you just want to be thinking about kind of a well-rounded advisory team that could eventually help you when it does come to not only enrolling in clinical trials, but also, you know, in commercialization and getting through value analysis committees, right, and helping to drive some of that early utilization out of the gate. And then, you know, with respect to kind of clinical trials, which is probably more pertinent to kind of where we're at, is, you know, I grew up kind of in commercialization functions, right, in the device space. So maybe it's a little bit— I lean a little bit more towards thinking that way. But I very much view how we approach our clinical trials kind of from a sales mindset, right? And the most, you know, where a lot of startups get burned, so to speak, when it comes to clinical trials is just they cannot— enrollment is is really, really slow. And when you think back and kind of reverse engineer why enrollment would be slow, maybe they selected the wrong sites. Maybe they didn't create enough— maybe they didn't build enough kind of relationship at that specific site, et cetera. There's a number of reasons why enrollment could be slow. But for any startup, you really want to optimize around enrollment in your trials. I mean, if you can get through enrollment incredibly fast, you can get on to kind of the next stage of your next initiative. And so for us, A lot of what we're doing now is thinking about how do we optimize and plan in advance to really enhance and accelerate enrollment through our trials. And adopting kind of a sales mindset and the sales approach is, I think, really, really important. In fact, it's one of the things I remember interviewing Duke Rolin, gosh, years ago. And it's one of the things that he mentioned. We were talking a little bit about Stellarex, which was I'm trying to remember the company name, but anyways, a drug called Obloni. He was talking about their approach to clinical trials and he mentioned something. He was like, one of the things that we did really well with that particular trial is like we were very, very kind of aware or cognizant of trying to build relationships at each local site, like really, really good relationships. Like he or someone from his team would go out, right, to do the onboarding for that particular site in order to really foster really good relationships. And so I think, you know, that kind of circles back around to having kind of a sales mindset around How do we effectively drive commercialization or enrollment in a clinical trial? Well, it's sort of like soft launching your device, really, you know, in terms of eventual commercialization. So I think thinking about clinical trials in that sort of capacity is really, really important. And, you know, some sort of haters, so to speak, maybe, or critiques of that belief would say, oh no, you need to separate the two. You know, your kind of sales and marketing needs to be separate from clinical. And it's like, I don't really buy into that approach, right? I don't— I think you need to be fully aware of how you're collecting and managing and running your trial. But to completely distinctly separate clinical from kind of business and sales, I mean, I think is foolish and a mistake that, you know, some startups make.

Super insightful.

Yeah, go ahead, Richard.

Yeah, absolutely. I was going to say, and I guess connected to this, Scott, is the whole reimbursement part. I wondered what the sort of approach— and you could tell the audience a little bit more how you're thinking like the regulatory bar is one and often the payer bar is a different bar. So like, what's that approach been like for you as a team and thinking about your go-to-market?

Yeah, it's a really good point. And fortunately for us, the reimbursement kind of pathway has already been, I guess, trodden by Shockwave, right? They've built that and their team has done a phenomenal job. And in fact, in kind of the back half of 2023, CMS actually introduced new DRG codes specific for IVL coronary applications, which these are the first new DRG codes and I think in close to 20 years within the field of PCI or coronary intervention, which is, you know, a really, really kind of major milestone. So kudos to their team. But they've kind of— they've sort of done that, right, so to speak. They've built that kind of reimbursement pathway. So it's less of a concern for us. But I think, Richard, to your point about thinking about reimbursement as early as possible, that's huge. And from my perspective, I think it's probably the biggest hurdle to cross outside of reg and clinical, I think, is reimbursement. In fact, one of my good friends, Nick Anderson, who's spent most of his career kind of in health economics and market access, you know, he— I remember him mentioning something to me one time. He was like, you know, one of the things that I often see with startups is that they may have a great board, right, or a great team around them with really, really strong KOLs or really deep engineering team, maybe some senior management that has, you know, been there, done that. But they've literally got no stakeholders that represent payers. And he's like, I see it time and time again. If you don't have existing reimbursement, you need to be thinking about your KOLs, so to speak, that represent payers, that represent coverage and reimbursement. And if you're not thinking about that very early on, it's a huge, huge mistake. And so, in fact, it's one of the things that I see, you know, with various ideas that kind of come across my desk is that it could be an amazing technology, amazing idea that solves a really, really important need, a really big need. And there's really nothing else available in the market to do this one thing. But like, one of the biggest, biggest questions I often have is like, how is this going to get paid? Who pays for this? Right? And if that's not clear, if you can't succinctly answer that, that question, man, that's a really long road. And I think that's, that's, that's again, that's probably the biggest hurdle that you're going to face beyond, you know, Reg and FINRA.

100%. I think if there's anything to take away from today's discussion, it's just to have that upfront. As you say, it's got to be the number one thing you're thinking about from day one is how am I going to get paid?

Yeah.

If that's not on the agenda, then, you know, you're potentially going to trip yourself up further down the line.

Yep. Yep. 100%. And I think, you know, kind of circling back around to what I mentioned, Nick had told me is like he oftentimes recommends, you know, and he has a lot of conversations with startups that are kind of trying to think through, you know, coverage and reimbursement early on. And are doing the smart thing. And one of the, one of the, one of the sort of, you know, hacks or tactics that he encourages them to do is like, hey, if there's, if there's an opportunity to bring on someone from Optum, someone from United, someone from Blue Cross into your board or into your advisor team early on, he's like, do it. Take full advantage if you have some sort of relationship there, or maybe they're, you know, acutely familiar with your therapeutic arena and it just, it makes sense anyway for them to, you know, you know, proactively kind of, kind of, you know, be thinking about, you know, who are your KOLs, who are your influencers, right, on the, on the, on the payer and kind of reimbursement side of the equation.

Well, I'm hoping people have got their pens and papers here because there's just knowledge bombs left, right and center. I'm kind of wondering, you guys are obviously a pretty experienced team and, you know, this is not your first rodeo, but are there other challenges, Kyle? We also, we discussed this a lot, you know, and things that you've come across so far. You guys have moved pretty fast in the last 3, 4 years.

Yeah. I mean, with any startup, there's, I would say at a high level, there's always going to be challenges, right? And And if you don't sort of approach startups eyes wide open in the sense that like you may feel good one week and the very next week there's like, you know, 5 to 10 fires that you need to be putting out, you know, that's just the name of the game with startups. In fact, I was having this chat with a buddy of mine recently. It's like, that's probably the biggest thing that I underappreciated when, you know, the first half of my career when I was at large strategics, right? And I had this itch to want to do startups and to be involved in a startup. It's like, I saw kind of all the sexy headlines about startups exiting and raising money and doing cool things. It's like I had no idea how hard it really is, you know? And if you're not, I mean, if you're not, if you've never done it right, that's one thing. But it's just that's part, it's part of the deal, right? Every single day, every single week, there's going to be some sort of challenge. And that's normal. That's normal. You're not doing anything wrong. It's that's just the reality of pushing a boulder up a hill and the friction that comes with that. Yeah, you know, and so that's just kind of a normal kind of reality, you know, and I was, I was actually just reading this, this piece, I think it was even just last night. And I'm trying to remember who, who, who the quote came from. It was someone kind of well known within the startup ecosystem. And they were talking about the role of a CEO in a startup. And they're like, I see, I see so many CEOs that like, you know, once they raise their next round of capital and, you know, they have the opportunity to kind of build out a more round, well-rounded team. They're like, I can kind of take a step back now, right? I've got a team that can kind of execute and do everything for me and then report back in. And he was like, that's so wrong. He's like, as the CEO of a startup, even if you've got kind of a growing team, the onus is on you to continue to drive urgency every day, every week, every month, every quarter. And that really resonated with me because it's so true, right? As kind of the leader of whether a small organization or a large organization, it's kind of on you as the as the CEO or senior management team, right, to really drive the urgency for what you're trying to accomplish. And so I think that's another kind of hard reality of startups. But yeah, but kind of circling back around to your question, Richard, I mean, this sounds cliché, but team is so important. I mean, it's so, so important. And when I say team, it doesn't necessarily have— I'm not necessarily referring to full-time employees. It could be your your close team of consultants, right? They may be part-time consultants, maybe even full-time consultants, but it's so, so crucial. And I think everyone listening has probably heard that over and over again, team, team, team, but it is so, it's so true. And it makes such a, such a huge difference when you have a team that just is focused and can execute. And that's not to say everyone does things flawless by any stretch of the imagination, but it does make a night and day difference when you have a team that kind of understands how startups work, and are, you know, are very, very, you know, highly, you know, dialed in, highly focused on kind of getting to the next milestone. Right. Getting to, you know, nailing the next sort of getting the next sort of inflection point. So really, really crucial thing to be thinking about.

Yeah. Interesting. I'd like to jump in to Richard because, you know, when you're talking about some of these challenges, you know, oftentimes, yeah, going back, you do hear it, you know, almost every company that we have on this show, talk about, you know, reimbursement and fundraising. And I just think it's interesting, though, you know, how, you know, the reimbursement is there already. Right. And the funding side, Scott, you know, I read on your website there that you, I believe, and correct me if I'm wrong, were able to raise $6 million in the first, what, 6 months of— from the inception of your business. I mean, that is remarkable to be able to, you know, bring in that, that type of funding. So while those are challenges for others, it doesn't necessarily sound like they're really the big challenges for you, which is, which I guess is great. And maybe I'm wrong, but, you know, I guess like, like, are you— what about the development side, though, to your technology? Obviously what you've described to us early on, it's like this is a sophisticated piece of technology. There's no doubt. I mean, very easy to use, right? Simple to use, right? But, but very complex. I mean, you're talking about atomic bomb analogies going off in these balloons, right? And how they only impact hard, you know, calcified, you know, calcification rather than soft tissue. And it just sounds amazing to me. And, and you're obviously, you're moving really fast. Speed to market's everything. So are you, are you actually are there challenges on the development side of your technology today? And like, what does that look like?

Yeah, yeah. And I know we talk about kind of like how to, how to like, you know, some things around how to address challenges at a high level, but like just to kind of drill into that and double-click into that, I mean, a couple of things come to mind. One is development related, right? A couple of specific challenges. And the other, the other is fundraising. And I'll tackle the fundraising aspect here in a second. But one common theme, I think, that, that we've experienced over the past couple of years is just the understanding and the notion of going far and wide. And so what I mean by that is from a development standpoint, early on, this was probably, gosh, back half of 2021 through kind of all of 2022. And I think we're seeing some easement of this is supply chain related, right? This is not an uncommon challenge for any engineering folks or manufacturing folks that are listening to this. But the— we ran into significant supply chain issues early on and the onus on us as a team was to not just rely on kind of your traditional kind of go-to players, right? We had to go far and wide, you know, and we did. When I say far and wide, not just here in the US, but, you know, globally to identify, you know, key components that we felt were high risk, right, to our development at that period of time. And so I think that that's really, really crucial is just understanding that, hey, you may have, you know, you may be developing your technology in Boston or Silicon Valley or Minneapolis or, you know, or Houston or whatever. And there may be kind of your, your go-to kind of component suppliers. Right. But I would encourage everyone listening to, you know, talk to people like yourself, Kyle. Right. Go far and wide when trying to identify and address those high-risk kind of components or aspects of your supply chain. So that, you know, and that actually did work out for us. Right. I mean, I think, I think that really helped us kind of get through some significant development hurdles early on is by, by, by, by, you know, having a little bit more of a a global mindset to our supply chain, even though we were a small startup. But to answer the other issue I kind of wanted to address quickly too is fundraising. And you— yeah, so with us specifically, we raised our $12 million Series A within 3 to 4 months, I think, which is pretty quick in medtech, especially—

double than what I—

double.

Okay, my bad.

Yeah, no, no. Well, it did come in two tranches, right? Two $6 million tranches. So, you know, yeah, that's, you know, you're Somewhat accurate. But we did raise that pretty quick. And I think even more maybe interesting or compelling is that we ended up raising almost close to 8 figures in capital in the summer of last year, summer of '23. And we did that in less than a month. And so if you think about raising that amount of capital in that period of time, right, last year was brutal, a brutal fundraising environment. We did it exceptionally quickly. And I think Probably even more interesting is that, you know, a very significant percentage of that fundraise came from physician KOLs. And so, you know, these are, these are docs that either run conferences or active on podium and they're writing, you know, very large personal checks into Fastwave because they not only believe in intravascular lithotripsy, but they, they have a strong confidence in our team, which I think is, you know, we're incredibly grateful for and excited about how, how we can move forward with that, that kind of vested interest right in the company. And so I say all that because fundraising is, is even though what I just, how I just described it may kind of sound easy, it's like it is not easy at all by any stretch of the imagination. And a lot of the interviews that I do, I do for Medsider, we talk about fundraising. And what always amazes me is like I'll be interviewing, you know, someone who's had maybe 3 or 4 exits under their belt, right? Has raised hundreds of millions of dollars of capital and they're in the process of raising maybe their Series A, their Series B. And I'm always amazed by the fact that that they comment on how difficult it is, even though they've done it right. They've exited, they've raised hundreds of millions of dollars, and it's still hard. And, you know, in fact, I was just interviewing Dr. Stephen Michelson, who invented the FaroPulse device, which is kind of getting a lot of buzz these days, you know, especially with Boston Scientific. And now he's on to Field Medical. And I sort of expected— we had the same similar conversation. I was like, you know, he just raised a very large seed round. I think it was like $14 million-ish seed round or something like that. And I was like, you know what, generally speaking, like, how did that go? He was like, well, I mean, maybe a little bit easier because, you know, I've done it before. He's like, but it's not hard. He's like, I mean, it's not easy. It's extremely hard to raise capital. And I think, you know, the kind of similar to what we talked about earlier, you know, Richard, of like kind of thinking about things early on.

Right.

And trying to look around the corner, not just the corner that's a month ahead, but a year ahead, 18 months ahead. You know, you need to be thinking about capital fundraising with that sort of timeline or timeframe in mind, you know. So if historically it's taken, it's taken whatever, 3, 4 months to raise a Series A, right, or a Series B, you want to probably double that timeframe, right? And that's when you're like knee-deep in fundraising. Of course, you probably want to start months, if not quarters ahead of that, building relationships with potential investors. That doesn't mean that you're actively fundraising per se, but I think it's really, really crucial to be talking to a lot of potential companies and firms, family offices, angels, high net worth individuals, traditional VCs. You want to be raising awareness and telling your story as early as possible. I'm a big, big believer in that. You know, there's a, there's, you know, I think you guys have come across a lot of startups that still kind of run in stealth mode. And I don't, I just, I don't, I don't, I think there's very few reasons why you'd want to do that these days. In fact, I think it's, it's, it's it's much, much more important to be telling your story in public, right, as early as possible and kind of your vision and, you know, direction kind of where you're headed. And that's why I think like podcasts like yours, it's huge, huge for startups, right? I mean, to be able to kind of have this type of conversation and talk about kind of what you're building and where you see, you know, the therapy going, it's a huge, huge opportunity. I hope more startups take advantage of like, you know, shows like, like yours, you know. So.

Well, thank you, Scott. And right back at you, man. I mean, something similar the last you know, well, over a decade too, right? And then, um, I think as sales and marketing, you know, folks like us, you know, we realize the power of communicating and telling your story, right? And, and when people get to kind of hear it from you and, and get to, get to really know and see how you work and tick and think, right? That's where you like— that's how you get people to, to come to you, right? You're gonna attract— that's how the universe— like, you're gonna attract people in that universe to you that's going to help you on your journey, you know. And so that's such a great point. I'm so glad you got into that. That's—

yeah. And that surround sound effect. I mean, I think the easiest way to think about this is like if, if, if let's say there's an important conference, right? And you, like most startups, think that if I could just get my doc to talk about the device on stage or something, that's a huge win. But I think what you want to— you want to take it a step further and think about, okay, what happens when that doc goes to dinner with his group of friends? His physician friends, like, what are they talking about at dinner? Is there a part, is there a play where you can be part of that conversation, right, at dinner or offline or off podium? That's where I think, you know, you sort of take it to the next level and kind of creating that surround sound sort of effect and talking about what you're doing and building in the public domain, I think is really, really important. And, you know, it may be a little bit atypical. You know, some people may say, ah, I'm scared of doing that, or I'm going to get in trouble or whatever. It's like, well, I mean, What, what, what, what, I don't know. I think there's way more reward versus risk, you know, in, in kind of telling, telling your story in the, in the public domain.

Yeah. And getting comfortable telling that story. I mean, clearly you've been there and done this before many times, but it's something certainly we try to educate the companies coming through accelerator program is, you know, you need to have a really succinct story. You need to have that messaging done from the branding right down through your company name, your strapline, everything that goes beyond that. And just get used to saying that again and again because you want, to your point, people to be talking about you after they've heard about it. Yeah, again, such great advice.

No doubt. I just published an interview recently with Ken, and I'm going to mispronounce his last name, Marayesh, I believe. Ken, if you're listening, don't kill me for that. But he's the CEO of Synaptico. It's in the neuromodulation space. Really, really thoughtful entrepreneur. Like, it's going to be fun to see what they do. I mean, he brought some juice to that particular conversation, which is really, really fun. But he mentioned something similar. He's like, as a startup, like you need to— if you can't effectively answer this question in like 1 or 2 sentences, you need to kind of go back to the drawing board. It was like, why would I buy this? Right? Why would I buy what you're building? Right? And it could be— put your shoes in the self-investor. Why would I invest in what you're building? Or a doc. Why would I use what you're building? A hospital. Why would I buy what you're building? But if you can effectively answer that question very succinctly, you know, very quickly, then again, you kind of think that you need to— that message needs to be refined. And I think, I mean, Richard, to your point, for any startups, even if you think, gosh, we just have an idea on paper, beginning to kind of think about that and, you know, kind of refine that narrative, I think is really, really important because, you know, you just, you need to be having a lot of conversations, right, to get your thing out of the starting blocks, to get your venture, you know, going. And hopefully, you know, the more you can kind of refine your message and tell a really good story, the more people are going to be leaning in, right, to what you're building versus kind of like, you know, leaning, leaning back.

So you guys are in a great place. As Kyle mentioned earlier, you've got some capital in the bank. I guess, you know, we were speaking a little bit before we started this conversation about it's always busy. You know, you have even a busy Christmas time and you guys have some exciting things coming up. So, you know, you're sitting down now. What does the next 6, 12, 18 months look like for you?

Yeah, yeah, really, really exciting year, but if I'm being honest, kind of daunting too, because it's like, man, there's a lot going on in 2024, no doubt. So, so both kind of fun and exciting, but also a little bit, a little bit scary too. But yeah, so we're recording this, you know, in early, early '24, but we're on the precipice of enrolling our first-in-human patients. And so we'll have that, that study wrapped up within another week. Huge, huge shout out to, you know, Drs. Miguel Montero and Vinky Ramiah, who will be supporting us in that effort. Really, really fun to work with really great partners there. And really, really, you know, kudos to the rest of our team that's led up to this event. So it's a huge milestone for us. So yeah, we're on that. And then that will hopefully segue into our pivotal trial this year as well in 2024 on the peripheral side. And then on the coronary side, you know, making really good progress, really excited about kind of what we're doing with our preclinical efforts. To further demonstrate the performance of our, of our, of our kind of differentiated IVL energy system. And again, we hope to, we hope to be in patients this year too on the coronary side as well. So a lot of, a lot of clinical efforts this year for sure that will really start to ramp up kind of mid, mid '24 towards the back half of the year. And, you know, to the kind of based on kind of what we, what we talked about earlier, you know, we're, we're trying to do our best to really think about one, not only how to optimize for quick enrollment across these studies, but who are our ideal partners, right? Physician partners, hospital partners, clinic partners, right, that can help set the stage for either further clinical studies or commercialization. And so we're not going to do it perfect, right? But I think the fact that we're thinking about it now and really trying to look, peek around the corner is hopefully will yield some, yield some fruit.

And Scott, what about, I guess, 5 years from now, right? Everyone asks this question, but where do you see FastWave being?

Yeah, so if I— it's a great question, and I'll answer it this way, which I think is hopefully a little bit more educational for most people. You— I think there's like, there's two scenarios that most that will play out for most medtech startups, right? Either either an exit to a strategic, right, which is most common in an event, or a potential IPO, right? Or if you're successful enough, you can actually, you know, you could commercialize and be profitable. But that's pretty rare, right? And so we're thinking about, you know, all three of those kind of different scenarios. You know, there's a scenario where FastWave has a longer runway and we raise additional rounds of capital and eventually IPO. So we've got a plan in place for that, for that path, right? That's kind of that 5-year plan, right? Is like, you know, getting in market, building out a sales team, etc. And, you know, we're trying to even on that note, even though we're a little bit further off from commercialization, we're, you know, beginning to loop in some really, really strong sales folks into kind of the fold that can help us kind of navigate, you know, what that looks like, even though it may not be, you know, a year or two, even though, you know, we're a year or two from now from actually launching the devices. So that's kind of the long-term, more 5-year plan. But also we're thinking about, you know, what is it? What is the potential? You know, if there's interest from strategics, which there is, there's a lot of interest in IVL, as you can imagine, with Shockwave being the only, only player. You know, the rest of the cardiovascular strategics do not have an IVL technology in their portfolio. So a lot of, a lot of strategic interest too. So we're, you know, we're having those types of conversations as well with, with, with every, everyone, right, that is potentially interested. So I think the most important point, you know, without sharing too much really is for any startups, founders, CEOs, you know, leaders that are kind of running early-stage companies to be thinking about multiple paths, right? Again, kind of under this theme of going far and far and wide, you need to be thinking about multiple paths and making the necessary kind of, you know, planning and roadmapping for each one. Even though you may have a strong feeling, you know, of how this is likely to go, you need to be having— I mean, if all your eggs are in one basket, I mean, that's likely not going to turn out great, you know. So I think having multiple plans and multiple roadmaps that kind of ladder up to that plan is is, or goals, I should say, is important.

Yeah, I mean, this has been such a fruitful conversation. I mean, full of so many tips and advice, you know, from your go-to-market strategy to fundraising. I mean, everything, right? And developing the technology, being forward-thinking, leadership, you know, I mean, you are the definition of a leader. And it's really cool. It's inspiring to see because you are, you're, I think, the future of what really leadership looks like. And I would imagine it helps you attract great people. So there's probably folks listening, right, to this podcast that would want to work for you and with you. And, you know, how would these people— what's the best way for them to, you know, get in touch with you?

Yeah, well, I mean, before I mention that, I definitely appreciate the kind words. I mean, those mean a lot, especially coming from from you guys that are pretty deep in the medtech space. But I am not without my faults for sure. There's very, very clear gaps, right, where I think I should say known, probably unknown gaps, right? But I do my best to try to address the known gaps and kind of my leadership style. But with that said, yeah, for anyone listening, that's kind of like leaning in, hopefully maybe a little bit or like interested maybe in kind of what we're doing at FastWave. Yeah, the website's fastwavemedical.com just as a as it sounds, fastwavemedical.com. Yeah, encourage everyone to kind of check out the site. You can, you know, our contact information is right there. We've got, you know, options to kind of opt in, I guess, to our email lists, right? Which again is another thing that we maybe didn't talk about for early startups is like, make it easy, make it easy for people to kind of, you know, provide their email address, right? So you can stay in touch with them. I think that's another thing that I think most, a lot of startups don't think about is like, make that easy. For people that kind of have an interest, you know, that you want to communicate with down the road. So again, fastwavemedical.com is the site.

Well, what a way to start the year. I mean, this has been such a great conversation. I feel energized. I feel like there's been so much great advice given through this conversation. Again, I would highly recommend for any early-stage company going and checking out fastwavemedical.com just as a template for like the team you've assembled, the messaging you have, and your whole approach to how you're taking this technology to market. So Thank you again for joining us.

Yeah, I really, really appreciate you guys having me on. And I think for everyone listening, like, highly encourage you to kind of, you know, double-click into shows like this, you know what I mean? Hopefully there's, you know, some nuggets that I shared that may be helpful. But I think the most important thing is just going to be, you know, kind of in the mix, right? You know, listening to programs like yours. I think you guys are doing a great job. I love the energy, you know what I mean? So yeah, the more stories we can tell about people that are building building startups in our, in our space, I think the better.

That's right. Awesome. All right, well, ladies and gentlemen, another huge thank you to Scott Nelson at FastWave Medical, and thank you all for tuning in to another episode of the MedTech Impact Podcast. I'm Kyle Cruz.

And I'm Richard Miklejohn. Until next time, keep innovating. [MUSIC] [MUSIC]