Medsider: Learn from Medtech and Healthtech Founders and CEOs - Why Focusing on Pain Killers is Imperative for Medical Device Startups: Interview with Daniel Hawkins, CEO of Shockwave Medical

Episode Date: April 6, 2017

Daniel Hawkins is the President and CEO of Shockwave Medical. He began his career in marketing and business development roles for Advanced Cardiovascular Systems, otherwise known as ACS, which is now part of Abbott Vascular. Following ACS, he held senior roles in general management, marketing, and business development with a number of private and public...[read more]Related StoriesWhy Intersect ENT is an Example of Hope for the Medtech IndustryAre Medical Device Models the Key to Building a Lean Medtech Startup?Substantial and Sustainable – 2 Words That Medtech Companies Should Get Used To 

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Medsider, grab that blueprint. Okay, on to the episode. On today's program, we have Daniel Hawkins, who is the president and CEO of Shockwave Medical. He began his career in marketing and business development roles for advanced cardiovascular systems, otherwise known as ACS, which is now part of Abbott Vascular, following ACSEL's senior roles in general management, marketing, and business development with a number of private and public companies. Daniel started the marketing department at Intuitive Surgical, where he guided product feature development for the DaVinci Surgical Robot and developed key foundational marketing strategies for the company. He has also held senior leadership and or founder roles with Indologics in Calibre Medical, which is now part of J&J. Daniel has an MBA from Stanford,

a BS in economics from Wharton, and is a named inventor on over 100 patents and applications. Here are a few of the things we're going to learn in this interview with Daniel. How his early upbringing gave rise to his entrepreneurial spirit, while focusing on pain killers is imperative for med tech startups. Daniel's early experiences at intuitive surgical and some of the most important lessons he learned commercializing the first surgical robot? A question every med tech entrepreneur should ask themselves. Does your product have natural pull? The importance of removing complexity and constraints when making key decisions?

How Daniel and his team came up with a concept for applying lithotripsy to arterial plaque. Daniel's approach to raising money for shockwave and how he was able to convince early investors during a tumultuous economic time. In Daniel's favorite business book, the CEO he most admires and what he tell his 30-year-old self. So without further ado, let's get to the interview with Daniel. Hey, Daniel, welcome to the Medsider program. Appreciate you coming on. Certainly, very happy to. All right, so let's get started with Shockwave. You co-founded the company you're currently running

with John Adams and Todd Brightened back in, I think, the 2009 timeframe, really to address what it seems like is, you know, as an unmet need when it comes to a peripheral vascular disease or peripheral ulterior disease, however you want to define it. But, you know, when you look at the peripheral landscape, it's, you know, it would seem from an outside his perspective, it would be flooded with, you know, sort of a wide variety of different treatment options, you know, from self-expanding stents to plain old balloon angioplasty, a threctomy, drug-coated balloons, etc. So I'm curious, you know, if you want to take us back to that time frame, you know, what did you see in the peripheral space that sort of led,

led to this concept that you're developing at shockwave now? Sure, happy to. So for perspective, in 2009, drug-coded balloons were emerging. They were not yet in the fore that they are today. Back then, predominantly, there was varying versions of scoring balloons, i.e. the angioscore balloon, other types of specialty balloons, high-pressure balloons, and antherectomy. Then, of course, there were stents of balloon expandable and self-expanding. The challenges with all of the non-stent technologies, they'll say, is they're really not addressing, and this is what we identified in 2009.

They are not addressing the fundamental issue of calcification embedded in the vessel wall. Balloons put pressure on the calcification but really overstretched the soft tissue on the other side of the vessel and then create vessel injury. That ultimately leads to a healing response that everybody calls restinosis. Or if you really injure it a lot acutely, then you end up having to put in a stent. The other reason to put in a stent is because those fundamental technologies can't take. take a blockage in a vessel that might be 70, 75, or 80% blockage, and get it down to under 30%. If it is calcified, those technologies struggle mightily to be able to do that. And really 30% residual blockage is what is a clinically meaningful marker.

So what happens then is they end up putting in stents. Atherectomy showed a capability of reducing the volume of plaque in a vessel. But there are a lot of risks associated with atherectomy, and quite plainly, its mechanism of action is to grind up the inside of a vessel, and that's a lot of injury. That gets a lot of injury response, and that then ultimately leads to restinosis. What we realized with shock wave is that the physics of high-pressure, high-speed pressure waves, I should say, is completely different than constant high-pressure that you get in regular. balloons and high-speed pressure waves travel through the soft tissue and do not disrupt it, do not create the injury that is very common with, either scoring balloons or high-pressure balloons, but it actually creates cracks in the calcification. You can think of them a little bit as expansion

joints. We create a crack at a very low constant pressure in a balloon, non-dilative pressure in a balloon, and then we inflate the balloon just a little bit, frankly gently. And And what we're doing is expanding those cracks and therefore we're able to get a large vessel loom in without the injury that everybody else gets and we're in fact getting stent-like results without stents. Great. Now let's kind of set the stage for the audience, Daniel, if you will. You're the CEO of Shockwave.

You raised a $45 million series C this past November and we're recording this in early 2017. Received FDA clearance last fall, last September, I think to be specific. Again, to set the stage for the audience, where are you at with respect to clinical data and commercialization. So we are CE marked in Europe. We are FDA cleared in the United States. Around the time period of the financing, we had six months results in our second peripheral vascular study in 60 patients done in Europe and New Zealand, 17 or 18 different operators.

And we were at that point, had achieved a 30-day outcome in our first coronary study using lithoplastity for the treatment of coronary vascular disease prior to stead placement. Lastly, we had begun our early commercial activities in Germany in the peripheral vascular space. So from the standpoint of regulatory and commercialization as well as data gathering, that was where we were at that time. That's great. And we're certainly going to come back to Shockwave and really dig into sort of the early times at the company and how you sort of got it to where it's at now. but let's take a step back and really rewind the clock and focus a little bit more on your early career.

So what first brought you into the med tech space? So I actually grew up in a medical household, medical and entrepreneurial household. My dad is a primary care physician, hung a shingle immediately after medical school and started his own practice that, you know, frankly, was in the first floor of the house we lived in in West Philadelphia. I grew up in Philadelphia, Pennsylvania. And his practice was on the first floor. Ours was a house that was exposed to health care very early. He treated a lot of Department of Public Assistance patients, and one of the jobs that me and my brother and my sisters had

was to make sure the coding on the DPA forms was correct. So we were in and around that regularly. It was a small business house, if you will. I went on to personally doing some small business-related things and everything from door-to-door sales of literally clippings from a holly tree in our backyard around Christmas time to, in college, operating soda machines to put myself through Wharton undergrad. I became along the way a bit fascinated with the combination of science and

medicine. Didn't really know what to do with any of it, but I had always been scientifically minded, attracted to chemistry and biology in high school and the like. But I was really driven to go into business because I was fascinated with how businesses get created and was fortunate enough to be accepted at Wharton undergrad. It was intending on pursuing a pre-med and Wharton undergrad simultaneously until the dean of both schools suggested I might want to reconsider that thought, quite a bit of work. So I ultimately opted not to do that, but really I held on to the goal of somehow combining business and medicine and ultimately discovered what is venture capital. I didn't know it existed at the time. It ended up joining out of Wharton a,

leveraged buyout house that had about 50 or 60% of their business in venture capital and was attracted to the deals that were involving med tech. The prospect of being able to to move the clinical needle on millions of patients versus one at a time that my father did was compelling for me, very compelling. What was not compelling is staying in a financial, you know, engineering kind of an environment, if you will, and leverage buyouts. And I ultimately elected to go back to business school and was fortunate enough to get into Stanford. And following Stanford, I looked immediately at medical technologies, med tech, med devices as an area of interest. At that time period, angioplasty balloons were $600 apiece. Since hadn't been invented yet in the hottest areas

back in 1993 were orthopedics and interventional vascular. I was fortunate enough to get, and it had a position in marketing at ACS, advanced cardiovascular systems. It was a division of Eli Lilly at the time. I joined there pre-Palma shot stent. So that was a little time ago. The first indication of that stent was abrupt closure or threatened abrupt closure that comes from high pressure dilation of a vessel due to calcium. And the IVS studies, intracular ultrasound studies in the mid-90s, confirmed all of that.

And really, that laid the groundwork for what I later traded. on when I came up with the notion for what is now lithoplastic to avoid those dissections and see if we can get better results long term. But I became fascinated with the space back in 1993. I've stayed in it and been involved and fortunate enough to be involved in the number of significant startups along the way. So such a great story looking back and sort of connecting those dots, even to your early days growing up, watching your dad, who's a physician, sort of run his own business right at home. So very cool to hear that story. And, you know, That serves as sort of a nice segue into my next question, which is really about sort of the arc of

your career, you know, looking at, you know, the first, you know, sort of operational role, if you want to call it that, at ACS, which was later sold to guidance. You're at Calibra, which I think is how that's pronounced, which was acquired by J&J, then Omni-Sel and then, you know, intuitive surgical. So I'm sure, you know, this question is a little bit broad, so to speak, but I'm sure you've learned a ton across those experiences with those, you know, early stage med tech companies. But are there a few things that really stand out or, you know, samples or situations you recall that really had a profound impact on your career and, you know, that you still look back on that enables you to make certain decisions now, even at Shockwave?

Yeah, there absolutely are. You know, you don't realize when you're in the midst of career shifts, if you will, or shifts in your experience, I should say, that the meaning of those. So I think it's very appropriate to look back at some of those. fundamentally what I discovered more than anything else is useful in MedTech is to focus on the true needs. Not the wants, not the desires, if you will, not the vitamin pills. You need the painkillers. The ones that are so fundamentally needed and are solved by technologies that are fundamentally effective

while avoiding a bunch of the issues you might otherwise want to avoid, in our case, avoidance of vascular injury. by way of example. They become, if you will, intuitive. No pun intended to the name of that company, but that is the place where I, in fact, learned that. The intersection of focusing on true needs and keeping the usability, the function of whatever technology it is, very, very simple.

Those two together will drive adoption. At intuitive surgical, the robot was incredibly complicated. It started off, I'm sure it's many more parts now, but it started off with 2,700 parts on the bomb, on the bill of materials. It had 1.1 million lines of software code. Now, mind you, this is back in 1999. So that was a watershed of activity, right? So that's a lot of complexity. But in the end, what it was is something the surgeon looked into, saw the operative field, put their finger-deaf,

tips into the tip of a controller and move their hands like they're operating with their fingers. What we really did is use complexity to make the experience simple. Now, what problem did we actually solve? The problem we solved in that particular example is we allowed the physician to operate in an open surgical environment, but do it through the size of a trocar. Trocar-based surgery or minimally invasive surgery is fascinating stuff, truly enabling. However, there were lots of compromises in what the physician needed to do, and therefore their capabilities because of the restriction of that tiny hole. Intuitive removed the restriction, that was a painkiller, and they made it incredibly

easy to use, and that's the reason why it ultimately took off. I've got a fundamental belief that great products are purchased and not sold. If you create a fantastic product, users will come to you, and of course it is your job to sell properly, and you've got to do all the marketing and everything else. But the great products have a pull to them. If you know you're working with a technology in a company when there is that pull, when the activity is more than you can handle, that is exactly what we had at an intuitive surgical, and frankly, it's exactly what I'm seeing here.

at chocolate. One of the other things that I've learned more than really anything else, mistakes made early or changes in judgment made at point A. By the time you get to point D, you learn what mistake you made back at point A, but you're a mile away from where you should be. You've got to start early when you're making a decision and to go down an essential path. You've got to check your core assumptions. Make sure the correct ones, and they're the relevant ones before you proceed. One of the things I find more often than anything else is when there's disagreement among very bright, experienced people about a direction or a pathway to go down. Very often they're operating under different core assumptions. So one of the things I will often do

is get back to what are your assumptions? They'll list them and I'll say, take away that constraint, take away that other constraint. Now what would you do? And meanwhile, I will know in my back of my mind, how to get rid of those two constraints. And now we're in a very different solution set. That's exactly how we ended up with the device that we did at intuitive, because my engineers were saying there was a constraint we couldn't do, we couldn't get more than one emitter in a balloon. I asked them to remove a couple constraints, now it's limitless. I didn't know how to solve it. They did. All I really did was remove that constraint. So those are some of the more significant elements that have popped up now and again throughout career. And there's certainly

more examples of those. Really good points. And as you sort of answered that question, I was Johnny on several notes, really good anecdotes to kind of pull through, you know, the concept of really solving for a painkiller versus something that's just fits, you know, a superficial need. I think that's great. And it seems like you've got a knack for sort of stripping away the complexity, you know, not only in, you know, product or even messaging per se, but even sort of like the way you explain that latter part of the answer with respect to removing constraints, you know, simplifying the challenge or problem ahead and removing those constraints. It seems like maybe I'm not sure if that's a, you know, something that just comes natural to you or something you've learned

over time. That certainly seems to be an important lesson for sure. It's something I actually learned watching Fred Moll through a decision process. So if I can, I'll share a little bit of an anecdote from one of the earlier at the company moments at Intuitive Surgical. There's a small group of us, 7-8 thereabouts, I think it grew at 1.12, that would meet every Tuesday morning, and we would run through critical elements in the way towards our milestones. The meeting was called a Critical Path meeting. They were representatives from each of the subsets of the technical areas. Mind you, we had large order mechanical, small order mechanical software vision. We had electrical. All of those subsystem groups would have a representative

and sometimes one would represent two or three of those functional areas. There was always marketing. That was me. The CEO was always there. At the time it was Lonnie Smith. The current CEO, Gary Goodhart, was always there. He was senior member of the engineering team. And of course, Fred Ball was there. There were a number of times during that, that we would have things pop up. and we'd solve them through and you'd leave the meeting a little uncomfortable or maybe a lot uncomfortable and two meetings later we'd have a solution for it. We thought we were pretty far along, frankly quite far along, centering down to our final design, if you will.

And Fred came into the meeting, I'll never forget this day, and said, I think we have a problem. I think our vision system is inadequate. That was a very material statement. to make at that point because we were marching along with a set of presumptions. And a discussion ensued for 45 minutes to an hour. The meeting ran long that day. We ended up ordering in food. The issue was very fundamental.

And this gets back to what I described on keep it incredibly simple, make the user experience simple. For a physician to be able to trust a robot, they need to be able to see perfectly, be able to discern tissue edges in the different tissue planes, and the resolution was not there. The problem is that there was no existing camera system at the time that could solve a problem. We literally had purchased one of every camera system available worldwide, and none of them was good enough. So Fred put out there that we should create our own, as if we didn't have enough to do, right? Fred put out there we need to create our own, and then a discussion came through and said, what makes us think we can do that and we were concerned about it.

It was a hand-wringing time period. And one of the folks in the room said something that triggered something in Fred's mind. Fred said, wait a minute, isn't the real reason why none of these cameras work is because they need to make them lightweight because the procedures are an hour or two hours long and a human has to hold it? we don't have that constraint. We can make this thing 30 pounds because we have a robot holding it. The second that statement was made, everything changed.

100% of the goal was to get optics and we removed weight. And when that happened, we were able to fast forward to the best vision system available, laparoscopic vision system available on the market that you'd never use in any other system other than intuitive because it weighed way too much. But we didn't care. And the second we were able to make that and put it in the system, it became crystal clear what you were looking at. And the physician community raved about the vision system

and their sense of control and accuracy. Fred was 100% right that that was a need, and he was 100% right to test the assumption. Such a great story. I often try to ask for examples of certain things. that you've learned along the way, and I didn't even have to answer that or ask that question. You answered it for me with that great example. But I think it really helps, you know, and I sincerely hope that it helps, you know, the folks that are listening to this really get

a good idea of great decision making in process, you know, to that concept of really stripping away all of those assumptions and trying to really understand the core problem. But such a great example. So let, you know, for the sake of time, let's shift to kind of not necessarily the current day, but, you know, current company in Shockwave. Can you take us back? You were an entrepreneur in residence at Three Arch, I think, when you came up with the concept for, you know, applying a lithotripsy to arterial plaque. Daniel, can you kind of give us an idea of kind of sort of what you were doing at the time that sort of induced that light bulb moment, if you will?

And then in parallel, I guess, with that, maybe help us understand, you know, you've got this great idea, which seems like it really has legs. How did you begin alongside, you know, John and Todd to really build out this initial prototype? Sure, yeah. So the late bold moment was after a series of different events. John Adams and I were busy in Belhew, Washington, trying to come up with the next great thing. John is fantastic experience. He's one of the very first engineers.

In fact, he ran the engineering department at Medtronic back of the early pacemaker days. Great understanding of electrical engineering. He happened to be working on identifying the root cause for a product failure. and part of that investigation had him put the two leads for a pacemaker in a beaker full of water to test what happened out in the field of an arc happening between those two beakers or between those two leads. As it turns out, he created lithotrypsy, but he didn't know what it was at the time. He ended up researching and discovering it, but what he definitely discovered is when he did that, he shattered the beaker and there was, you know, 30 or 40 ounces worth of water all over a high voltage table.

So he realized he had a problem. and he figured out ultimately that it was lithotripsy. He shared that anecdote with me, and while I found it interesting, because I'm technically interested in learning different technical things, there was no particular utility at that time. Fast forward about six months, and I happened to be looking at the angioplasty market. My job as an entrepreneur in residence was to look at unmet clinical needs and with John either invent or in-licensed technology to solve those needs,

and then three arch and prospect at the time would fund a company around that if everybody agreed. I happened to be looking at angioplasty and came across some specialty balloons that claimed that they were able to, with differential pressure, crack calcium. And I'm not a physicist. I'm not a scientist. But again, being scientifically minded and frankly taking a page out of some of the learning I got from John, that didn't make good sense, physics-wise to me. And I started wondering what would actually crack the calcium.

And then I remembered John broke the beaker with electricity. So I looked at lithotripsy a little bit, and I frankly just dropped some breadcrumbs between the two, suggested it to John. And I asked him if he thought it would work. And he said, not only will it work, it'll work great. And the pressure waves will be so fast. They're faster than the speed of sound I came to discover, or learned, I should say. They're so fast, they won't pop the balloon. So we built a very crude prototype.

John spent three quarters of a day, putting wires down the length of a standard angioplasty balloon into the fluid in the base of the balloon, and then we drilled a hole in a piece of chalk and tried it out. It worked great. So from there to how we got to a first man, along the way, Todd Britton joined us to help guide us clinically. We identified the opportunities in the peripheral vascular space as an area of interest initially. And then we created a prototype that leveraged a lot of existing technologies. We were

able to do it quickly and cheaply because we leveraged those technologies. But that is not a small effort, right? So I managed all that process from a position as CEO of the company back in the early days, but I really was program managing at all. We did not have a VP of engineering at the time. We had two engineers and a technician. John Adams in Seattle, I was, at that point, I was down in the Bay Area. We had done some work up in Seattle, but it became clear that we were not going to be able to attract the catheter engineers we needed, so we moved down to the Bay Area. But our initial catheter work was really borrowing off of existing lithotripsy technology and building a balloon around it, which is exactly what we did.

Todd's role in all of that was to help us with the clinical view of the performance requirements, as well as, of course, very much help us with designing the protocol for First and Man and developing the relationships with the clinicians along the way. John helped keep us pointed straight technically, and I served, if you will, as program manager and head of marketing and CEO and all of that together to drive the creation of the first prototype, the builds, the testing, the verification, the animal testing, and the like, which, you know, the animal testing, Todd did directly. And once we finished all of that, we went into the clinic and had it a very successful person in experience. And then if we fast forward into sort of the life cycle of shockwave, I know in a previous interview you did with MedTech strategist, you mentioned the decision to move into the peripheral space, you know, against the advice from your investors. And I think if my memory serves me correct, you initially had this idea sort of to treat arterial plaque and we're maybe even positioning it for the use in other vessel beds. but then wanted to move into the peripheral space, you know, against, like I said, against the advice from your investor. So sometimes like those types of decisions, you know, it's somewhat easy to gloss over,

but if you can take us back to sort of that decision-making process and, you know, when you've got your investor saying one thing, but your core team believes in a different approach, how did you approach that and where did you end up landing? Sure. So for clarity, the statements around, gee, you shouldn't start with the periphery. it's a graveyard of dead technologies. Those actually were from a number of investors that passed on the idea in 2008. Between 2008 and 2009, we actually acquired the intellectual property out of the incubator because Three Arch and Prospect did not move forward with the idea.

That was a very difficult time for startups and nothing really was getting funded. So we acquired the intellectual property personally and then moved forward from there. So the thought to not go into peripheral came from really a number of folks in OA. Having said that, it was definitely a departure. It was a departure from the conventional wisdom. As an entrepreneur, you've got to listen to advice that other people have, and you've got to gather all the data you possibly can, and then very often you need to deliberately not follow it.

This is exactly one of those circumstances. Why did we do that? Well, fundamentally, it was going to be difficult to create a device that had lithotripsy in it and make it deliverable, make it small enough to get through the vasculature, through a blockage, and be able to deliver the therapy. Peripheral vessels are bigger, so it's going to inherently be easier to create one.

Because of the risk profile, peripheral vasculature had a greater chance of a 510K pathway versus a PMA pathway. Chances are because there's such an enormous need in the periphery and devices, current devices, back then are still the same ones today, being traditional balloons, specialty balloons, atherectomy, and stents, have such poor results in calcium that we had a very wide margin of potential benefit.

So if we were able to go halfway to optimal, given how wide that margin was, we would be incredibly successful. In the coronaries, the margin is a lot tighter because devices have gotten better and the like, not that they can necessarily deal with calcium, particularly well, but the burden of proof is immediately higher in the coronaries because of it, because of how good all those devices are and how large the studies have been, et cetera. In the periphery, we had greater opportunity to be able to create a solution that we could show in, and with a relatively speaking lower bar of activity, we could show a benefit.

That's the reason why we chose that. And you're right, it was against the advice of many, many, very smart people, and they had great reasons for doing that, but we trusted our gut and forged it on the path we felt was right. Hearing you explain that, it sounds very clear, very simple, and I'm sure it wasn't, but back to your kind of your concept of really stripping away everything to really the core, you know, the core assumptions and addressing each and every one of those. I think that kind of speaks to maybe that process that you followed even early in the early days of shockwave. But I love the fact that the founding team, you know, believes so much in what they've developed

in its ability to address any of the market that you sort of, you know, you're right. with that against maybe the advice of other folks. So very cool to hear that story. So let's fast forward just and spend a few minutes just talking about the financing for Shockwave. And I know you, you know, there was a lot of interest in your most recent rounds of financing, which was a pretty, pretty stark difference. It sounds like from your early days at Shockwave back in that 2008, 2009 timeframe. But I'd like to ask you really kind of a couple of questions. First, I know you've, in your most recent rounds, you raised money from sort of several different types of investors, from traditional VCs to large strategics to crossover investors.

So I'd like to get your take on that and sort of the thought process around getting that variety of investors involved. And then really anything that you can add that sort of really helped you solidify that investor interest as well. If you can speak to that, that would be great. Sure. So when we were raising, I guess we'd have to rewind to the series B round, the first institutional investor was Sophie Novo out of Paris.

They were the first money in Corvalves and great visionary group. They were our first institutional investor. When we broadened our footprint in the Series B in 2015, that's when we first brought in strategics and we brought in crossovers and the like. We had, in fact, strategic offers for the entire round in a non-diluted fashion. We were in a business that is very, very strategically significant. So we had an offer on the table for that. 11th hour of those terms got inserted into that that were not attracted to us.

We walked away from it. What we tried to do from the very beginning is lay the groundwork for a long-term play in the company. We believe we've got a company that has staying power. We believe we have an opportunity to be a very successful standalone organization. Along the way with that, of course, not only you need financing, but you need strategic advice, if you will. We'd love to learn from strategic relationships. And if those lead to something they do, but that's not the primary goal. While we did want to have strategic involved, what we did not want to do is have just one.

That's really the reason why we ultimately ended up with two different strategics. But you had asked also about crossovers. We have traditional financial investors. The reason why you bring in crossovers, if you have opportunity to, of course, is to set up for future rounds of financing, not the least of which is a public offering. In our Series B, we brought in quite a number of crossover funds. As it turns out, our Series C, there was a great interest to complete the round from inside investors, and the only new investor we brought in was T.R. Price, again, for the exact same reason

of setting ourselves up properly for a future public offering. So that's one of the goals, if you will, in structuring. I'm a believer that the round your... raising is actually setting you up for the next round you're going to raise. So in some respects, you're raising two rounds every time you are raising one. So we try to keep that in mind going forward. Such good insight there. I think there's going to be a lot of how you derive from just that relatively short answer for a lot of those med tech entrepreneurs that are looking to raise their next round. And I'd love the, not only the strategy, but just the insight that went

into that strategy for your two most recent rounds. It gives you plenty of options moving forward, it sounds like. So a very good lesson to learn. I know we've only got a few minutes left. So I want to ask you one more question with respect to Shockwave, and then we'll get into the last three rapid-fire questions. So I know, and you just mentioned this fact, but a lot of, you know, a lot of your investors have also been, you know, publicly quoted as saying they believe Shockwave can become a company that is able to sustain itself, you know, versus, you know, traditional MedTech startups that are, that are gobbled up even earlier in their life cycle anymore. So with that said, give us a little, maybe a brief answer in regards to what's next for Shockwave.

So really, our future is going to be defined by how. we perform clinically and of course how we perform commercially. In the very near term, we're going to start what turns out to be histories first, randomized controlled study in peripheral vascular calcified lesions. So really, our specialty is calcium. In the legs, there's lots of it. Half of patients have it. Surprisingly, there's never been a randomized controlled trial of one technology against another

one to treat those patients. I didn't realize that we were going to be the first one until some reporter told us. that, frankly. We think it's the right thing to do. We're doing the right clinical work going forward. That'll be 330 patients kicking off very shortly. With that, we intend to demonstrate the capabilities and usability of the lithoplasty system versus angioplasty and recognize those differences across a very broad patient set. What's in the future for us additionally near term is commercialization in Europe and in the United States for our peripheral vascular system. And in the second half of 2017, we would anticipate entering the coronary vascular system commercialization in Europe.

In more than medium and longer term, a logical next step for us would be an initial public offering. The markets will determine the timing of that and whether or not we do that in the near term or if the market cycles aren't there, then we'll raise additional funds privately. But really our goal here is to play for the end game, if you will, and to build this into, a standard of care level of technology and a long-term sustainable franchise around lithoplasty technology. Very cool. It'll be exciting to watch what you do with Shockwave, not only in the near future, but also sort of along that medium to long-term time frame as well.

So because we're short on time, I'll ask you the last three. We'll conclude here with the last three rapid-fire questions here, if you don't mind, Daniel. So we'll start with number one. What is your favorite business book? The 22 immutable laws of marketing. There's great clarity in there. It's really outstanding, and one of my favorite parts of that is if you're not number one in a category, create a category in which you could be number one in.

That allows you to shift markets and change the dialogue. At Intuitive, we turn that into one of the other laws, and forgetting which one, says that a single word in the minds of customers, no two companies can own the same word. If you combine the two of those and look back into the history of intuitive, we created the end of risk. That became coined directly, long robotic surgery and therefore were able to create the beginnings of a departure from

existing technologies and ultimately ended up winning over that entire industry from the capability as well as the positioning. So that would certainly be the number one. Yeah, such a great book. Glad you answered with that in that fashion. Number two, is there a CEO that you're following or one that you really admire? So there's a couple of different ones. Briefly, I'd say Fred Moll, terrific visionary. He's the inventor of the safety trocar, continues to identify the painkillers and remove barriers, as I had mentioned a little bit earlier. You know, I'd have to say within my space, Omar Isrich from Medtronic, I've been extremely impressed with the culture that he's been able to create

the quality of people in that organization and the consistency of the messaging and the capabilities within the organization. I think he's got an incredible vision for the value-oriented future of healthcare. I'd say Mike Mahoney over at Boston Scientific for what he's been able to do in terms of the turnaround he's done for Boston Scientific and launched them into the number one position in Stents and push the entire franchise, the entire business forward, I'd be remiss if I did not mention Mike Massolum. Again, within my space, we do have the aerotic valve concentration as well, but I've had some exposure to Mike. And I'd have to say that his vision for what became Taver and

acquiring Sapien early, and then the management of that has been nothing short of spectacular. It's created an incredible amount of value for shareholders and incredible therapy categories for patients. Great. Four CEOs that are definitely worth their salt for sure. So last question before we end the conversation. If you had the chance to rewind the clock, Daniel, is there any advice that you give to your 30-year-old self? Number one, two, three, four, and five is trust your gut. Your gut is never truly wrong.

When you trust your gut properly at those high-intensity moments, it won't fail you. it won't fail you. Great piece of advice to end the discussion. So I'll have you hold on the line, Daniel, if you don't mind for a minute. But we'll go ahead and conclude there. And for those listening to the interview, thanks for your attention. And until the next episode of MedSider, everyone, take care. Thanks again, ladies and gents, for listening.

This episode has been brought to you from the WCG Studios here in Minneapolis. And don't forget to grab your Panoptic stacking blueprint by visiting reachfiredigital.com 4.m.4.Medsider. Again, that's reachfiredigital.com forward slash Medsider. Okay, bye for now.