Medsider: Learn from Medtech and Healthtech Founders and CEOs - The Four-Risk Framework for Evaluating Medtech Opportunities: Interview with SonoVascular CEO Daniel Estay

Episode Date: March 23, 2026

In this episode of Medsider Radio, we sat down with Daniel Estay, founder and CEO of SonoVascular.SonoVascular has developed a novel mechanical-pharmaco ultrasound facilitated thrombectomy system, SonoThrombectomy, that utilizes microbubble-mediated cavitation as a core enabling mechanism to remove blood clots more effectively.Dan has over 35 years of global medtech experience, including business development roles at Johnson & Johnson, where he worked on deals that helped create the world's first drug-eluting stent, and six years leading Abbott's cardiovascular device business across Asia-Pacific and Japan. He also serves as a Mentor-in-Residence at Duke University's New Ventures group.In this interview, Dan discusses how to evaluate whether a medtech opportunity is commercially viable beyond technical feasibility, how trust and long-standing relationships matter more than geography when selecting first-in-human sites, and why cap table strategy requires deliberate thinking from the earliest stages — including when to transition from convertible notes to priced rounds.Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you’re ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Daniel Estay.KEY MOMENTS FROM THE INTERVIEW(02:52) - An overview of Dan Estay’s background and the journey that led him to SonoVascular (08:04) - The core idea behind SonoVascular — combining mechanical and pharmacological therapy to treat thrombosis (13:33) - Why differentiation alone isn’t enough, and how Dan evaluates market size and viability before building (18:38) - The four risks every medtech founder should assess: technical, clinical, regulatory, and market (21:55) - Why Dan chose Chile for SonoVascular's FIH study and what he looks for in a clinical trial site (29:05) - Why Dan would rethink his use of convertible notes and approach the cap table more strategically (38:28) - Why grants should supplement your funding strategy, not lead it (42:46) - What Dan looks for when hiring for startups

You always kind of go through that checklist of, okay, what's the technical risk, what's the clinical risk, what's the regulatory risk, and what's the market risk, which is what we're talking about. A lot of people get so caught up on those other risks, they don't think about the market risk. In other words, how big is it? Can you really penetrate that market? And you definitely have to ask that question up front because you're right. You can do all the right things from a technical, clinical, and regulatory point of view and then get there and go, well, really, the market's not that big. Welcome to MedSider, where you can learn from the brightest founders and CEOs in medical devices and health technology. Join tens of thousands of ambitious doers as we unpack the insights, tactics, and secrets behind the most successful life science startups in the world. Now here's your host, Scott Nelson.

Hey, everyone. In this episode of MedSider, I sat down with Daniel Estay, founder and CEO of Sonovascular, a company developing a combination, for venous and arterial thrombosis. Dan has over 35 years of global med tech experience, including business development roles at Johnson & Johnson, where he worked on deals that helped create the world's first drug-eluding stent and six years leading Abbott's cardiovascular device business across Asia Pacific and Japan. He also serves as a mentor in residence at Duke University's New Ventures Group. Here are a few topics we explored in this conversation. First, how do you choose the right beachhead indication when your technology has multiple potential applications? Second, what signals indicate a market is large enough to support a venture-backed MedTech company.

Third, how should founders balance speed to first inhuman with maintaining data quality and regulatory rigor? And last, when should CEOs use convertible notes? And when is it time to move to a priced round? Before we dive into the full episode, if you're a MedTech founder or CEO preparing to raise capital, you should check out the MedSiter fundraising cohort. This four-week live workshop combines small group sessions with real-time feedback to help you sharpen your investor story. build a targeted investor pipeline and run a focused fundraising sprint instead of a never-ending slog. Over the month, you'll walk away with an investor-ready narrative and deck,

outreach scripts that actually get responses, a refreshed LinkedIn profile, a simple content plan that keeps you on investors' radar, and a repeatable system for running your raise. You can join the waitlist at Medsider.com forward slash fundraising cohort. Again, that's medsider.com forward slash fundraising cohort. All right, let's get to the interview. And welcome to Medsiter Radio. Appreciate you coming on. Good to be here.

Thanks, Scott. The people listening are going to, are listening just to the audio, but I see the devices in the background, right? So this is like a good, good background shot for this conversation. But that said, I recorded a very brief overview, abbreviated version of your bio. But let's start there. You know, maybe, maybe, you know, in a minute or two, right, rock us to your background leading up to starting. Sinovascular. Sure.

I got started early in my career, really out of college. even before if you conclude summer jobs. So my mom and dad are from Chile, and my dad had a business distributing medical devices in Latin America for many years. So I started working for him, summers, you know, in warehouse, unpacking boxes of medical devices. And then when I graduated, decided to go work for him. And I spent nine years in that business. It was a great learning experience. I always tell people, if you can do business in Latin America, you can do business anywhere in the world. You see a lot of different things, ups and downs. And, you know, our, job was to develop the Latin American market working through a network of sub-distributors, in some

cases direct to hospitals for MedTech companies. And, you know, one of the things we're proudest of was establishing Boston Scientific in Latin America back in the day, St. Jude Medical as well. And it was a great business to my dad and to the family. I ended up getting out because with all the consolidation taking place in MedTech back in the in the 90s, distributors were disintermediated. It was very difficult to sustain that model. And, you know, you do a lot of good work. And I would say, you know, you get rewarded by losing the contract because they go direct on you. So I said, I need a different rhythm here. And lucky for me, one of the gentlemen I was working with at St. Jude went over to Jane J.

and J. as the president of the Cordes Division, shortly after J&J acquired a courtes. And he offered me the opportunity to join Jane J and actually get my MBA at the same time. So I was doing that on weekends at the University of Miami. And that was a great experience. I went into the business development group there doing M&A deals and licensing. deal, something I'd never done before, but where I can help the group was I brought a lot of knowledge about the products and the market. So my boss at the time, who now works for me in sandovascular, always joke about that. He was an M&A expert because he worked in investment banking

before joining J&J. So he taught me M&A and I taught him about cardiovascular devices. And it was an exciting time because it was, again, about a year and a half after Jane J. Bought Cordes. The company was already starting to lose share for Palmaw shots because Guyton had launched. And so there was a lot of panic about what's next. And we worked on the deals together with the broader team that ultimately created the cyphersonat, the world's first drug with an extent. So I think working through that and modeling the future was quite exciting. And that went out to become a $4 billion franchise before other companies jumped in and took share away.

So spent a couple of years there. And then just to give the shorter version, after doing a couple of different. jobs, ended up working for Abbott for about 11 years. The first five, I was in the broader business development groups, also doing deals, and it was based both in Columbus, Ohio, as well as in Chicago, Illinois. And then about a year after we acquired the guided vascular business, when Boston Scientific bought guided but had to divest the vascular assets, Abbott picked that up, I was offered the opportunity to go run Asia Pack in Japan for that vascular business. So, you know, I jumped on that because it was an awesome opportunity.

a big change moving to Asia and we ended up living in Tokyo. So, you know, I was, of course, married and had two young daughters. So it was quite the professional and personal experience. You know, the girls weren't thrilled to be going there. You know, they kept asking, when are we going back? But after six months of being there, never heard that again because they loved it. And it was a great experience for all of us. And it was the great years when DES pricing were still above $1,500, in some cases, over 2000.

And so that business in Asia grew from under $200 million to approaching a million dollars over the course of five, six years. So it was a great ride. It was one of the most professional experiences in my life as well as personal. And Tokyo is a great place to live and had a great team and spent a lot of time traveling because those were the years when we didn't have things like Zoom. Right. So my team was all over the region. So I probably spent eight months of the year on the road, which is pretty intense. So great experience there.

It was time to get back to the U.S. I had one daughter already in college, and so I was offered the opportunity to run a med tech company out of Seattle. Did that for about two to three years. And then we wanted to get back east because our family, our daughters were living back east. Our family is. My wife is also from Chile, so her family was down in Chile. So Seattle was still kind of far away. And we ended up coming to Chapel Hill, North Carolina.

Had never been here before, had no previous connection other than a good friend of mine as a surgeon here and showed us around and were like, this is pretty nice. So I started consulting for a company. And while I was here, I came across the underlying concept, which is now Sondovascular, which came out of the Joint Department of Biomedical Engineering between NC State and UNC at Chapel Hill. And I've been doing that now for the last several years and been here for nine years, the longest we've been in any given city. So that's a little bit of the worldwind of my career. Something's going right in North Carolina, right, for you to kind hang there for more than a decade now. But that's a super helpful over. You've got a ton of experiences. You could probably spend the whole hour, right, just talking about like various moves and transitions

in your time in Japan and Asia during kind of a booming market. It seems like every device company, you know, has like circling Asia as the next growth opportunity. Things have certainly changed quite a bit since then. But let's talk about some vascular. And maybe frame this up as if, you and I are both in the space, right? So we could kind of go into the weeds quite quickly. But maybe zoom out and for those listening that maybe are in ortho or some other, you know, some other sector of the device space, like what is it? What do you, what do you saw it for? What's different about the catheter? We're going up to the broader market of both venous and arterial thrombosis. And our first focus is on venous thrombosis of both dvety and pulmonary embolism. And we have a

catheter that effectively delivers ultrasound through the distal tip as you engage the clot. And while we're doing that, we're infusing a mixture of microbubbles, which serve as mechanical amplifiers once they're activated by the ultrasound. And to the same channel, we're refusing thrumplet or drug or TPA to enhance the effect. So it is a combination of therapy. It's a dual mechanistic approach, both mechanical and pharmacological. And that's really what attracted me to it, because I kind of go back to my days of the drug-living stint, you know, how do you combine a mechanical mechanism with the pharmacological mechanism to really get the best and safest outcome? And so that's what really was the early attraction to this technology. So far we're seeing in our first human

study is a very safe device and also a very effective device that could, again, pull on both of those levers. Yeah, and we'll go back and learn a little bit more about kind of what you've, lessons learned not only throughout your career, but like building sonovascular, but I'm on the website now, sonovascular.com. I say sono, just because it's easier to spell for those listening, but so no, sonovascular.com. So just kind of like what you think, sonovascular.com. We'll link to it in the full write-up, but highly encourage you everyone to kind of check it out. It's a really cool, really cool device. And I want to ask you one follow-up question in regards to the mechanism, though.

You mentioned the micro bubbles. Yeah. Touch on that, because I think that's pretty unique, right? Because you're using ultrasound and then also this micro bubble kind of like amplifier, I think is what you called it. But yeah, like what's the rationale? How does that help dissolve or solve, solve or lead to more efficacy when it comes to this? First thing I'd say is they've been on the market for over 20 years now for diagnostic imaging. So we work with the number one company, a company called Lantheus that makes the definitivey micro bubble.

And so those bubbles are infused systemically today, and then they basically put an ultrasound probe so you get a better image. So the bubbles are active to give you a better resolution in simple terms. Those same bubbles, if you hit them with a different frequency, different acoustic parameters, they become therapeutic in nature. They become resonators. And so to your question, what happens is the bubbles begin to oscillate and rupture, creating both stable and inertial cavitation.

And so that begins to break down the fiber and in the clot, or debulk the clot. But it also enhances the permeation of the drug that you. using. So we're able to use a lower dose of the drug, but to get a bigger effect because of the capitation. Okay, got it. That's super interesting. And then we're recording this in early 26, based on your LinkedIn profile, which we'll link to it in the show notes as well. Looks like you started the company almost exactly five years ago to the month or close to it anyway. Yeah, I call it the practical founding date. I mean, if you go back legally, it was 2018, but that was just in the early days so I could take the license to the underlying IP from the universities.

Okay. But for the first several years, it really, the work was being done. within the academic setting funded by NIH academic grants. And it wasn't until 2021 that we sort of took it out, raised our first money, did our first proof of concept on an animal, and then sort of to raise more money and hire our first engineers. Okay, got it. So a little over, I mean, longer than five years, but like five kind of, I guess, more practical years, if you will.

So like, where's the company at in terms of, you mentioned a feasibility study. Where are we at today and kind of what's that look like over the next year? Sure. So we completed enrollment in our first. person, human study, which we did down in Chile, connection there. Obviously, you get my background. And that we completed enrollment last fall, and we have six-month follow-up now on seven of the ten patients.

The other three are coming back here in the next few weeks. This was a big year for us because we're doing two things. One is we're looking to get approval of our IDE to start the DVT pivotal study in the U.S. So we've been, we just had a pre-sub with FDA that was very positive a few weeks ago. And the second thing is we're going to do a feasibility study in our second indication, which is pulmonary amyism. So we'll be doing that in the second half of the year. So a lot of work right now on our second generation catheter.

So taking the learnings from the first study and how do we make it better to use that now, both for the PE study as well as the upcoming pivotal study later this year. Okay, got it. And the first inhuman feasibility study for PE, you plan on doing that in Chile as well? Not Chile. You know, we're still looking at different sites to make a final determination, but it'll be overseas. Okay. Got it.

Got, okay, super helpful. So definitely fun stage, right? Not that you're all the way through development, per se, but in patients is a, certainly a huge inflection point for any, any startup in med tech. No doubt about it. I know, I used to like, so, I mean, earlier in my career, just gloss over that fact, right, of like, you know, some random startup that I'd see, you know, in vascular today or something. It would announce, you know, first in human study, it's like, ah, you know, but it's like to get to that point is huge, you know? I would say that that first patient that was the most anxious and excited. confident, but anxious and excited I've ever been in my life. I mean, it really, so all that work comes to life, really, that moment. No doubt, no doubt. Fun year ahead,

it sounds like in 2006. But let's transition and go back in time and spend the next maybe 20, 30 minutes kind of covering some key functional areas that every startup is going to kind of have to master or at least, you know, overcome, you know, if they're going to, they're going to experience any sort of semblance of success. And I guess the first one I want to touch on is, is take us back to kind of like that 2020-ish maybe time frame, you've seen a lot of ideas, right? Whether in your previous kind of M&A roles with large strategics or even, you know, you've done, you've been involved in the kind of startup ecosystem for a while. So we've seen a lot of things, but you decided to pursue this one. So what was it about this particular idea and maybe kind of, you know, speak to the other,

the other, maybe physicians or other entrepreneurs out there that are kind of thinking about that same same thing. They're like, I think this idea has legs, but I don't know whether to go all in. And you chose to go in on the son of vascular. So help us understand why. I think for me, it really got down to differentiation, right? Something that was truly unique. I go back to my days when I was in Asia for Abbott. And when we had the most fun was when we had really unique differentiated products,

once things got commoditized, it was a very challenging market environment. Sort of the red ocean prices took a hit. And so you're always looking for what's next, what's truly different that can make a difference for patients. But also that could be a growth driver that's a strong. sustainable for the business. So that's the first lens I sort of apply is, is this different and unique? Am I solving something that has not been solved before? And sort of guarding against, I don't want to sort of, there's a lot of herd mentality in MetTech oftentimes. So, so, especially when people are chasing big markets. And sometimes you've got to go against the grain a little

bit. That may make a more uphill battle, but ultimately, I think you're rewarded if you sort of stick to your conviction that this will make a difference and sort of separate yourself from the pack later on. So that's the first thing I look for. You know, of course, you need to be solved for a meaningful unmet need. And that sort of dovetails to differentiation, right? I mean, is it different enough that it's addressing the drawbacks limitations that doctors currently have with what they're using? And so, and the third thing is for me is, again, given my background, having worked on drug-eluting stents, it was that, okay, leveraging more than one mechanism, right? The mechanical aspect, but as well as the pharmacological, if you can make that work in a, in this case, a, in this case,

true cath-flat-based intervention procedure, that should really make a difference down the road. So those are the things that I was looking for early on that attracted me to this. Yeah, all very good points. And sometimes it's hard to gauge differentiation, right? Because in a hot space that you're in, right, which is kind of this thrombectomy, you know, thrombolysis kind of arena, especially with a potential PE application, you know, on the near term, I would say in your term horizon. Sometimes it's hard to gauge like how hot a market will be, right when you start working on something, you know, five, six years ago now at this, at this point in time. So how big is, is the market or how, like, how do you choose, like, are you focused on that early on when you see a, when you see a particular device that appears to be different? I mean, are you, do you, do you sort of gravitate towards like, well, I mean, is this even a market that is, that could support a venture back startup in the Mentech space, as an example. No, no question. I, you know, one of the things I also do, I think it's on my, my LinkedIn profile is I help out as a mentor in here at Duke University. And that's the first question I asked faculty that I mentor is that,

you know, you really have to convince yourself that this is big enough that's commercially viable that it's going to track investment dollars because, you know, it may, I've seen a lot of good ideas that will really help patients, but ultimately it's more of an inch. It's not big enough to stay on its own. So I think really answering that question is key up front. And so in this case, this is a large market, multi-billion dollar in scope. It's the projection. And I think if you look at other interventional categories over the last 30 years. There's a good reason to believe that this one will sort of play out, you know, very similarly going forward. So I think that's a good comparable for this business. And the other challenge is really, where do you start? Because we do

see it as a platform technology that could be both in arterial, right? So there's a lot going on for acute systemic stroke. There's an arterial thrombosis, you know, peripheral vascular. And so we sort of said, well, what's the current size of device, you know, because if you're going to go into the brain, it's got to be a lot smaller. And as you and I both know, is, you know, is a It takes more engineering to take something that's a 12 French catheter and take it down to five French catheters. So which are the larger markets right now. And so you go through that screen, you process and it was pretty clear that the broader

Venus throng Wemble is the market was where to start. So as the beachhead and sort of that build out from from there. Got it. Yeah. Yeah. The reason I emphasize market size because sometimes it's sometimes you could you could go after the wrong device just because the market size is so big, right? And kind of artificially chase something.

But it's such an important thing because at the end of the day, like, unless you're at that stage in your career or, you know, I've had the, are in a situation where you can fund a company yourselves. I mean, almost every single project that eventually turns into a company in MedTech requires a fair amount of investment dollars, right? And if the market's not big enough, you're going to have to probably chase different types of capital, in essence, right, to maybe get to a certain inflection point. So it's just, it's, sometimes it's just really hard at those at those earlier stages because you could be stuck on this, what appears to be a really, really great idea. And it is solving for a need, but maybe the market is just not big enough. And that could change the trajectory of the startup pretty quickly. No doubt about it. I try to pull on my experience in business development because our job was to sort of assess technologies, assess companies. You're working with the cross-functional team. And so you always kind of go through that checklist of, okay, what's the technical risk, what's the clinical risk, what's the regulatory risk, and what's the market risk, which is what we're talking about. A lot of people get so caught up on those other risks, they don't think about the market risk.

In other words, how big is it, can you really penetrate that market? And you definitely have to ask that question up front because you're right. You can do all the right things from a technical, clinical, and regulatory point of view and then get there and go, well, really, the market's not that big. Yeah, yeah. Let's transition somewhat to the, you know, kind of still focusing on the early days of sonobascular. And I don't want to get necessarily into the weeds on, you know, what technical decisions do you make, you know, trying to try to iterate or pivot on a certain device. But really more curious, especially considering kind of your roles mentoring other. other entrepreneurs at Duke, where do you think most early stage CEOs or founders go wrong

when it comes to trying to deploy limited capital, you know, at a prototype, the alpha prototype, right, where, you know, again, funds are limited at that stage, but you need to sort of make some meaningful progress. Like, what do you think most people get wrong at that stage? I can tell you what I look back on and say, you know, could I've done something differently and talking to other CEOs? I think, you know, when it's that early and you have limited capital, it's like, well, how do I get the right expertise and that balance, between going externally versus being able to leverage internal resources, right? You know, if you're working with contractors, they're expensive, you know.

And so there's that tension between what you can afford to spend versus what you need and what, you know, and what it's costing. So I think that's the early on. That's the challenge. I mean, you know, I'm not an engineer. So I've met CEOs that are engineers and they can do a lot of work on their own as CEOs, right, early on and not having to rely on an external vendor. In my case, we had to hire good engineers.

we had to work with external groups to be able to sort of translate the idea into a sort of a minimally viable product. So I think that's, you know, early on, that's the challenge is how do you balance that, you know, get the right people on board in a way that that you're not burning excessive cash, but getting, you know, de-risking what you're doing and building value. So it sort of facilitates fundraising going forward because ultimately, if you're not making progress, as you know, it's going to be difficult to get that next round. And particularly in an environment where it seems like the investors are moving, the goalposts will keep moving to later stage, right? I'm sure, like me, you've heard many times, we love what you're doing, come back and, you know, when you have this. And then you come back with that and like, well, great, but now we want to see something else. It's just really challenging in that regard. Oh, no doubt.

And I don't think that trend is going to stop anytime soon, right? This concept of goalpost shifting later later. I mean, sometimes you look at the pure dollars that are going into. to MedTech VC right now. And it can look promising, right? But the reality is like most of those, the majority of that, that capital is being, you know, deployed to later stage companies that are further de-risk, right? So that leaves this gap, right, for companies at this sort of stage, right? Fastwave included, right, in my shoes where it's like there's, there's not, you know, capital is hard to come by, right, at those, even if you're making meaningful progress and in patience,

it's still, it's still challenging. No, no, no doubt about it. For sure. Yeah. I want to circle back around to your first in human feasibility study in Chile in in Chile. So it sounds like you had a connection, right, because you, you know, you spent so much time there earlier in your, earlier in your life. But walk us through kind of whether, whether you want to focus on kind of the decision to go there and kind of learnings from doing a first in human study in Chile or maybe even the thought process with respect to PE, right? Because it sounds like you're evaluating, you know, kind of going through the same process again and, you know, geography is still kind of up in the air at this point. But, you know, what are a few things, few lessons learned, you know, that maybe other,

other CEOs that have not gone through this before and have not done a first in human feasibility study. Are there a couple things that you think would be especially helpful for them to know? Sure. I mean, I think it starts with speed, right? Getting to the clinic as quickly as possible, particularly in this fundraising environment where it's tough to find investors, large investors that would invest in preclinical assets. So getting there quickly was key for us. And even though FD, I think, has done a great job with the EFS program and you can get there earlier. for us as a company, the challenge was it was on one hand, everyone's saying we really like what you're doing. It's differentiated, but it is a very novel approach, right? It's not an aspiration catheter. It's not a basket capturing clot. And so I almost feel like we had a higher bar in terms of having to prove to investors that this is really going to work. And so we said, we've got to get into the clinic because if we can't show some effectiveness in humans, this uphill battle of raising money is just going to get more daunting. And so I said, well, okay, well, well, so, we got to go quickly. Where is there a country that, you know, we can get there quickly? But also,

then, you want to have, you know, quality. So it's the facility, you know, operating under GCP. And then do you have a team that you can trust that's responsive, right? Because even though it's an acute procedure, we want to follow these patients out to six months. I've gotten feedback from friends of mine that have done studies in other parts of Latin America. And it was a bit of a mixed review. Some had good experience. Others didn't. And when it was a bad experience, again, it was sort of a lack of responsiveness and follow through, and it got back to sort of the trust factor. So being able to work with someone I've known for 30 years, who was one of the top vascular surgeons on America, and then the mini-CRO we used, who had a close relationship

with him, sort of brought it all together, right? We can move quickly. It's a group we trust, very responsive, and ultimately, I think that would allow us to execute very well. The last thing I'd say, and for us, it was, you know, there were times where we're like, wow, enrollment's really slow is you're trying to find sites that can enroll patients quickly. And sometimes it'll look, you know, you have to be a little bit lucky. But so for us, we sort of got out really quickly and then things slowed and we sort of hit the summer months down in Latin America. And it's like much was happening. And then once people came back from the beach, it sort of picked up again. But, you know, hindsight, it would have been nice to have something a little bit more consistent,

right? Where you're getting those two, three patients a month over time. Yeah. Yeah. Was there anything specifically you did to like try to ramp up enrollment? again, or is that literally just an issue related to seasonality, right? And the patients were literally, it was the summer and they're at the beach and, you know, just didn't see a lot. Yeah, I mean, I think that's part of it. I mean, sometimes it's just luck too, right? Because we screened out several patients. So there were months where we were busy screening and just, you know, none meant the criteria. You know, we, we were treating in Chile in one site, but the patients are coming from all over the, most of the capital city, but in some cases outside of that. And so, you know,

the team looked at a good job of getting the word out. And all the patients were coming from the public health care sector, right? So patients that in most cases would not get treatment where they were because they didn't have the technology of the expertise, nor could they afford it. So if they come to our study, everything's being paid for and you're getting treated by some of the best physicians in the country. So I think there was the team did a good job of getting that word out. So referring physicians to say, hey, look, here's a patient. We bring them in, screen them, and then hopefully they would enroll. But it gets back to it gets back to. you have to have a team that you can trust because you are, you're several thousand miles away,

right? And so as much as you can be there in person, you're not there most of the time. And so having that level of ongoing communication was key. Okay. And then with respect to the regulatory process in Chile, for maybe someone listening that, that, you know, is considering, you know, possibly going there, what does that timeline look like, you know, in terms of getting ethics approval? Is it reasonably, sounds like it was reasonably quick. Hey, everyone. Let's take a quick break to talk about fast wave medical. company I co-founded and lead as CEO. We're developing next generation intravascular lithotripsy or IVL systems to tackle complex calcific disease. Over the last few years, we've closed a series

of oversubscribed funding rounds, bringing the total investment into FastWave to over $50 million. Corporate interest in the IVL space is growing to the $900 million acquisition of Bolt Medical and Johnson and Johnson's $13 billion acquisition of Shockwave Medical signal a lot of attention on emerging IVL startups like FastWave, and we're making serious progress. In addition to recently receiving our ninth patent, we've successfully completed peripheral and coronary feasibility studies and are gearing up for pivotal trials. If you're interested in investing in the fast-growing IVL market, head over to fastwavemedical.com forward slash invest.

Again, that's fastwavemedical.com forward slash invest. Now, let's get back to the conversation. It was less than three months from the time we applied. Okay. So there was, depending on. depending on the hospital. So we went to one ethics committee that sort of governed several hospitals, and that was relatively quick. And then you have to get through the ethics committee at the hospital itself. And originally we had, we had two sites selected, ended up just using one

site. You know, the other site, they were asked for things in the agreement that just didn't make any sense to us. So we ended up just having the one site. Yeah. One of the other things that, I guess you mentioned that is, I think, worth, like, emphasizing to is the follow-up, right? because you're going to follow these patients out to six months. And sometimes I think that sounds maybe obvious, but sometimes you can get sort of solely focused on enrollment. How fast can we enroll this study, right? And don't get me wrong.

Like that's important for sure. You don't want to just burning cash, enrolling, you know, with, you know, sites that are enrolling slow. But you could end up in a scenario where, hey, you enroll extremely quickly. It only takes you maybe a month or two to enroll, you know, your fully enroll your feasibility study. But if you're losing patients on the back end, it's just like a leaky bucket, right? And so, you know, being mindful of, you know, the coordination and follow through.

you know, and how good are these clinics actually at getting their patients back, right? That's so, so important. And definitely worth going into detail on if you're pursuing, you know, markets that you're not familiar with. No, that about it. And there, like I said, we work with the, I call it miniser. It's a CRO, but a small group that I've known for many years. And they did a fantastic job.

So basically, we were sending a van to pick up the patients, right? So it was almost like a conscious service, right? So between the site and the CRO, there was really good coordination. to make sure those patients were coming back. And so I think some people opt to, well, I'm going to deal directly with the site. You can do that, but you start seeing a lot of intangibles, right? They don't anticipate. And that's where a good Sierra locally, especially overseas, can really make the difference,

as was the case for us. Yeah, that's super helpful advice. Let's spend a little bit a little bit of time talking about fundraising, right? Because I think you guys just announced maybe that you closed on, I think, looks like the maybe. First closed. First close. First close are your Series A? Is this your Series A?

It's our first price round. Okay, first price round. Okay, got it. Yeah, so that's a big inflection point, I think, for any start. So you made it this far without a price round. Okay, that's capital efficiency, right? Well, there's some lessons learned there, which I'm happy to share, but, yeah. Yeah, well, let's talk about those, right?

Like, what do you know now at this stage, right, after having gone through kind of the fundraising gaunt that you wish you knew maybe two or three years ago? Yeah, I think if I do something differently, it would have been to approach the cap table more strategically. I mean, you have a, you know, you have a strategy for other aspects. of the business, perhaps when it came to thinking about the longer-term financing strategy and how that impacts the cap table on the balance sheet, I would have done a bit differently. So we raised prior to this round, we raised $10.3 million through a series of convertible notes. That made sense early on.

I think looking back, we probably should have gone sooner with a price round. Because ultimately, you know, you got a lot on the balance sheet that accrued interest is eating at you. It's dilutive. And so now, it was also a function of at that time, we wanted to move quickly. The fundraising markets are difficult. What's the easiest way? And so if you sort of easily fall into that,

but let's just bring it on the convertible note, right? But they start to, they start to sort of, you know, complicate things. And for us, the big part of the first close was converting all that. So the good news is, you know, we've converted all the outstanding notes. So as of the end of the last year,

our cap table is really clean. It's the preferred in the common. Our balance sheets a lot cleaner. And that matters because now we're going out for new investment. People want to see that, right? People, I look at your cap table and your balance sheet said, wow, you got over 10 million dollars of principal and accrued interest, you know, and that's sitting on top of everything

else, that makes people nervous. So I think, you know, looking back, perhaps being a bit more strategic about, about, you know, when to use a convertible note and when to say, you know, it's now it's time, even if it's a small around than you want to start to do, to price the company, basically. Yeah. That's such a good point because I think it's so easy to gloss over and not really spend a lot of time thinking through, even at the early stages, because you're so focus on, hey, we just need money in the door, right? Money in the door. And don't get me wrong. Like, ultimately, you got to get, you got to find, find money to keep these, these companies alive. So I don't want, I mean, I certainly appreciate that. But at some point, you know,

I think, I think the takeaway here is don't keep kicking the can down, down the road, right? At some time, you need to address, address kind of this, this issue sooner or rather later. And it will, it will bite you. I mean, undoubtedly, like, if you end up in a scenario where you've got too much convertible debt in your catch table, it does, it hurts, right? You know, institutional investors, you're not like, they don't necessarily like that. you know, as you pointed out. But let's talk about raising a price round in these early stages, because ultimately, you need a lead. And a lot of times, you know, just like natural human behavior, right, people want to follow people. And it's sometimes it can be hard to find a lead that steps out and

prices the round. So what's, generally speaking, what's your take? I mean, do you wait for an investor to price it? Are you okay with pricing it yourself in those early years? Like, what's your general take on that? Well, it was a price was a bit of a hybrid because our lead investor is also our largest investors, it's group called Harbright Ventures here out of the southeast. And they're not your traditional venture group. I mean, they have a fund, but it's a small fund. Most of what they invest is they'll aggregate their limited partners or their network into SPV special purpose vehicles. And that's how they've raised most of them. They also manage the angel network for NC State. And so, you know, they have quite a bit of investment into the company already. And so as we were

thinking about this first price round, again, in a challenging firm is where I said, well, you know, if it's hard to get a sort of well-established institutional lead right now to raise, let's say 15 million, well, what's the minimum we need to raise to get some meaningful milestones, what I talked about earlier. In our case, getting the PE data and then getting the IDE for DVT approved. We said, okay, well, six million with up to eight, that's what we need. We need six, but we'll go to eight if that's available. And they said, okay, well, then who can lead this? Do we need the traditional VC to lead? That's a small round. We said Harbright can lead, and they were willing to lead. They've been terrific partners for us. And so we negotiated with them. And it was a fairly

lengthy negotiation in the end, even though they were our existing partners to get to terms which were satisfactory for them and to us. And you have to understand, I understand, that they have to act on behalf of the A investors, right? So they want to make sure that the market, that the rates are within the market in terms of valuation and all the other rights that are coming with it. So that's the approach. Again, they've been terrific partners. We may have a co-lead emerge as well. So we're in discussions with a few groups right now that have expressed an interest. So again, it was it was priced around, size it to get to those next meaningful milestones and then provide enough runway so we can raise the subsequent round. But in our case, saying,

let's not make it so big that we have to rely on someone who's going to write a $5 million check, right? Yeah, yeah. That was the calculation we made in this round. All of that makes sense. And give us a sense for like kind of the, and every investor is going to be different. But kind of the time it took to kind of get to terms, right? Because I, I, the reason I bring that up is sometimes other CEOs I talk to are like, you know, they're kind of going through the same process. Or it's a dance. Do I need to find a new lead? Can one of our existing investors step up and lead, et cetera? They don't factor in enough time, right, to get to get something like that done. So give us a sense for kind of what that was like for you.

You know, it kind of reminds me my days working in business development, right? I always tell people the easy part was agreeing on on the acquisition price. Once you got into the contracts, the devil's in the detail. There were a lot of, in the case of an MNA deal, reps of warranties and covenants and all these things. It was somewhat similar here, right? I mean, the easy part is really agreeing on what's your pre-money value. But getting into that, talking about the investor rights that go with it and everything else, you know, that's where it ends up dragging out and taking longer than you thought it would. Again, I thought it'd be done 30 days. It took closer to 60 to 75 days by the time we had an executable agreement.

So it's really just, it's the details, right? It's getting into things that And as a first time, you know, CEO of a startup, I'd not been through this process, right? So, so I've done a lot of contracts, but not this kind of contract. And so, again, once you get into it, you realize, okay, now I understand all these different things that we have to look at that the other side may want. And what does it mean for us as, in my case, as the founder or, you know, on behalf of the existing shareholders in terms of, you know, their participation rights going with this, et cetera, right?

And, you know, one of the liquidation preferences, all these things that, you know, I knew about, but once you get into the negotiation, you're seeing it in the contract, it really brings it to life and you realize that that's what takes the time to get to something that's executable. Yeah. Listening to kind of hear you, hearing you riff on that is like the rule in MedTac, right, is like everything takes twice as long and is twice as expensive. It kind of applies to, you know, to even even getting through a, you know, identifying initial lead and coming into terms on what the round, round looks like. So, yeah, speaking, so I was just looking at the, the, the, the legal bills the other day. There's no question it probably was two times more expensive.

So for sure, not just longer, but more expensive. But so crucial, I mean, we're laughing about it, but so crucial to find right counsel, right, experienced counsel that can, that can support that process. Because if you, you know, if you get the wrong people around the table, can come back, another one of those things that can come back to bite you certainly. So I think that, but I think it's a great point because, because if you work with firms that are doing enough of this in our space, they really know what the going rates are. They can tell you what's market and what's not. And that can really make it a shorter process and a less cost of process too. So I would definitely encourage people to work with a group that, again, does enough of these things that they really

understand, have a good pulse on the market. Yeah, yeah, because it's not just sort of the legal verbiage, right? And, you know, whether it's a certain rep or a warranty that you're making or whatever, like there's a lot of lawyers that could do that. But the experience and understanding kind of the you know, the market terms, right? That you, you know, data that you wouldn't, or, you know, info or data that you wouldn't otherwise have unless you're doing a lot of transactions. Like, that's super, super helpful. On that note, before we kind of get to the next topic, anything else when it comes to fundraising that you can think of, whether it's, you know, pitching investors or trying to even find investors to pitch, like anything else that stands out and kind of things that

you picked up on, you know, raising capital over the last couple years? A couple of things. One is, is just you really have to work hard at telling the story. And, you know, I find myself every few months, I'm sort of modifying the pitch deck. You know, what did I learn from the last several pitches that I could do better to make sure the story is appreciated? You're getting the key points. And, you know, sometimes they give you nine minutes. You know, they give you five minutes. They get 20 minutes. And so it's, it's, that's the biggest challenge is getting the story across in a compelling way when you have very little time. So I think, you know, just giving yourself enough time to prepare and have different versions of your deck depending on how long

and who the audience may be because you may have an audience early and really early investing with angels. They're more generalists, right? They're not met tech experts. And so you can quickly lose them if you get into the weeds on the clinical technical aspects versus if you're talking to a very sophisticated VC that does a lot of met tech deals as in the vascular space, they're going to want to focus more on the detail. So that's one thing. The second thing is I'd say is really exhaust all non-dilutive options. You know, we've applied for some grants on you, I share with you that unfortunately last year we got disqualified by one grant for a foreign risk assessment, even though we're not aware of any foreign risk, but that's a topic for a different day. And people sort of tend

to focus on SGIR grants. But there are so many different agencies out there with different grants. What I recommend to people is spend a little money and have a grant expert, do an assessment of your company, your technology, and come back to you with, okay, what's out there in terms of What can you apply to? It's not just NIH. It's not just SBIRs. There's so many different things. So to understand that.

And then strategically say, okay, we're going to apply to, you know, X, Y, and Z. Because there is money out there. It does take time, you know, more time than cost. I don't recommend leaning with that. You know, when I mentor people at Duke, I go, always focus first on your private equity finance. It's like sort of getting money from the private sector. But certainly try to supplement that with non-dolid of funding as opposed to the way around.

Because if you try to rely on unfunded funding, it's just going to take you too long and you may miss your commercial window. The flip side is, is even though you're focused on the private market, don't lose sight of there's real dollars out there. Notwithstanding the current interruptions, obviously, because given some of the disruption right now with the SPIR program, there's delays. But I still think over time, you want to make sure that you understand every possible funding source that's out there. And you're going to need an expert to really, you know, make that assessment. viewing it as a supplement, I think that's a great framework and super, super helpful, right? It should hopefully supplements, right? You're diluted funding.

And I'm glad you brought up kind of the first starting off with more like an analysis, right, of what's available because sometimes it's easier just to, well, we're going to go to NIH. We're going to go to SBIR, right? And to your point, like, there's a lot of other potential options, right, available. And so that's super smart to kind of start out with that kind of that macro kind of overview of what's, what's available based on kind of the company and the technology you're working on. So really, really good advice. Just going back to your comment about story, we all hear that, right? Like eventually, you know, whether it's an institutional investor or a physician sitting on the other side of the

table, like ultimately people are buying stories, buying into your story. But the timing that you mentioned, right, I think is so crucial because they're kind of interrelated. Like, if you've only got 20, 30 minutes max, right, with a venture investor and you could easily get lost, maybe they start out, the pitch starts out and they've got a bunch of questions. right you could you could be 20 minutes in or 25 minutes in only have five minutes left and you haven't hit any any of like the main points that you want to cover in your story like it's just super you want to be mindful of that right as you kind of go through these pitches of like what are the what are the top like what are the top three things that I really need to get across to get to the next meeting right

and making sure that you at least at the very least touch on those and if if you can get through your whole deck great but oftentimes you're not able to you know and need to be mindful of of being able to you know tell your story in a longer longer version or in a abbreviation version. It was a struggle for me a bit because coming from working for companies like Abbott and J&J, you know, we were trained to, you come in with a hundred page deck. God forbid you had anything less than that. With a lot of detail, you know, you may not get through it, but you expected to have it. And then in this setting where, again, you have, you know, 10 minutes and you got max 15 slides and you've got to get a lot of information across. And hopefully the outcome

is that they're willing to take the next meeting, right? Or talk some more about about the technology. Yeah, and that should always be the goal in most cases is getting into the next meeting, like pushing the ball, you know, further down the, or kicking the ball, further down the, down the field with each, each meeting. You're not going to get a, I'm going to get a yes, you know, the first couple, the first couple pitches. Yeah, yeah, yeah, pretty rare. So with that said, I want to leave enough time for the rapid fire portion in the interview, but, but I would be remiss if I didn't kind of touch on this, the topic of like, of recruiting talent and hiring. You've built out so many teams, you know, throughout your career, big and then now, you know,

smaller teams at Son of Ascular, including a lot of mentorship, right, throughout your, throughout your journey as well. So are there, are there a few things that like really come to mind in terms of whether you want to, you know, specifically talk about recruiting and finding talent or even just like hiring and building out a team? Like what are, what are a couple things that you think are especially impactful, you know, for other other, other tech CEOs? I mean, like any job, I think cultural fit. And what I mean by that is, is people who are going to do well in a startup environment. It's not for everybody. And I've had the good fortune of working for large companies as well as small companies and now a startup. And it's very different.

So it's a little bit of the wild wild west, right, where it's not as structured as the big company. So people that are comfortable in that environment, you know, where things are changing quickly. And then there's a certain amount of stress, right? I mean, there's no guarantee that a year from now there's a paycheck, right, because the fundraising environment. So someone's going to be really comfortable in that setting. That's the first thing I look for. And it doesn't mean they've, it doesn't mean you can't make that transition from a big company to a startup. You just have to make sure that that person has that ability. Not everyone can.

And vice versa. Some people who have worked in startups would never survive in a big company because they sort of get lost in the bureaucracy and the politics of it. So that's the first thing. The second thing is your functional hedge making sure that they can run independently. Speaking of the CEO, I'm so consumed by fundraising that I don't spend as much time as I like on execution of the business, right, working with them closely. And so you're going to get pulled away, especially the early you are with fundraising,

which is almost feels like 100% of your time. And so making sure that people that are leading engineering and product development are leading your clinical reg efforts, you know, that they are seasoned enough that, you know, yes, they're checking in with you, but they can really run independently. I think that's key. And the third thing I'd say is, especially for those key roles, is you have to be co-located. So coming now, and maybe that sounds old school, but, but, but. But now looking back at what it was like pre-COVID, right?

We went through COVID being on Zoom. And now, you know, we had some experiences here at Sonobasker where some people were remote versus, and it was just very difficult. You know, ultimately, we have to be together for a number of different reasons. And so those are the sort of the key things that I'm looking for. I'd be reluctant to say differently. I'd be reluctant to hire someone who I don't think can, you know, sort of operate well or comfortably within a startup. I'm not going to hire someone for key functions that can't collocate with us, right? that just my lessons tell me that that's over time it's going to present a problem.

Yeah, those are really good pieces of a device. Let's get to the rapid fire portion of the interview. But again, for everyone listening, sonovascular.com, S-O-N-O-V-A-S-Q-U-L-A-R v-A-R v-U-L-A-R vascular. So sonovascular.com. We'll link to it in the full write-up on MedSiter. If you knew to MedSiter interviews and maybe this is your first time listening, these audio podcasts are accompanied by a longer form write-up that really touch on a lot of the key lessons that our guests share, including a lot of the real lessons.

valuable insights that Dan's given us throughout the past hour or so. So I highly encourage everyone to check out the longer form article. And then if you don't get there, head on over to sunovascular.com. So with that said, Dan, let's get the rapid fire portion of the interview. First question is, what is the one thing that you're most excited about over the next 12 months at sonovascular? For sure. It's getting into the clinic for PE and then getting our application into FDA for the ID study. Those are the two things that we're most excited about and most focused on. All right. Since founding the company, you know, your five plus years in now, what's the most surprising or maybe the most unexpected thing that you learned? You know, I think for me,

in this case, this is something that came out of academia. And looking back, I probably underestimated the amount of work that was needed to take something, even though a lot of work and research have been done to the point where this is really a minimally viable product that could one day be commercialized. That's the biggest learning for me was just how much of the hill did we have to climb. It wasn't, you know, just given my lack of experience in doing this, it wasn't evident at the start. But over time, it became clearly evident that, wow, I underestimated how much work and effort we need to get this to really to a point where, okay, now we think we have something that can really fly. All right. Let's say we just finished up dinner or we're finishing up dinner,

a small, small intimate setting there in Chapel Hill maybe with a group of other MetTech entrepreneurs and you want to leave them with one thing, right? Like a billboard type of message that they really need to get right or understand if they're going to have experience any any, any semblance of success. What would that be? Well, you've probably heard this before many times, but I'd say that, you know, from my experience, this has been the most rewarding journey of my career, but it's been the most challenging, right? I mean, it's hard, as it should be, right? So I say, I would say, you know, resilience, patience. perseverance and just conviction, right? I mean, you're going to get so many nose along the way.

It's easy to sort of fall into that trap of doubting yourself, doubting your technology. And so I think you have to understand that the path to success is not linear. It's not just sloping up. It's going to be like a roller coaster with a lot of twists and turns. And so just being able to sort of get through that and not lose sight of what you believe. with my colleague, we kind of joking, I gave him credit for this one. Every time we get a no, rather than dwell on it, we just, we have the saying, step up or step aside. Someone says, no, step aside. Our journey continues. And so that's, you have to fuel yourself. And so, you know, stay positive, even though, even though it's,

you know, the reality is, you know, for fundraising, most often you're going to get a no. And oftentimes, the no doesn't come with a lot of explanation, right? So you're sort of left to wonder what the issue is. So, you know, again, you probably heard this many times, but I'd say that that's just patience, resilience, conviction, you know, don't lose sight of what you believe. And that will take you through most, if not all, the challenging times. Yeah, I like that phrase, step up or step aside, right? We're moving on either way. That's good stuff. All right. Last question. Take us back to your, you know, late 20s, maybe early 30s, your career's like, you know, probably, you know, starting to really take off at that point.

anything you'd whisper in the ears of the younger, the younger version of yourself? I would say, build the best and broadest network you possibly can. I mean, there's no question that, especially, you know, MetTech is a big market, but it's also a small market. And I think that if I look at the success that we've been able to enjoy here at some of Ascle as an example, you know, building that network, you know, not just investors, but other people that help and support us. I mean, that really makes a huge difference.

So if I can go back, I'd be even more proactive about building the network and just because it takes work, right? And it's easy to sort of fall into your own sort of cocoon and say, you know, I'm happy where I am. But I'd say, you know, regardless for the job you're in, always look to broaden your network. And I think that's going to really pay dividends down the road. So I wish I've done a lot of that, but I wish I would have done more. Yeah. And more often. Yeah.

You and be both. And you certainly have to be intentional about it, right? it's not like people are just going to come find you really especially earlier in your career so yeah that's really really good way to kind of round out the interview i should say but uh dan i can't thank you enough for coming on the program this is uh this is this has been fun oh it's my pleasure scott thanks for inviting me yeah super cool technology you know i geek out on the cardiovascular stuff so obviously i'm biased but uh but if you're not familiar this is really cool really cool technology it's definitely differentiated uh in this uh in in what is a pretty hot space and kind of the thrombectomy and

thrombulis arena so soda vascular dot com s-o nes so and o vascular. So sonovascular.com is the website. And then you can also, we'll also link to it in the full write-up on Medsider. We'll also link to Dan's LinkedIn profile as well. So feel to feel free to reach out to him there. So Dan, I'll have you hold on the line. But for everyone listening, thanks as always for your attention until the next episode of Medsider was live. Everyone, take care. Hey, it's Scott again. One quick thing before you go. You see, I love bringing you insightful conversations with the best founders and CEOs of medical device and health technology startups. But here's the thing. I'd be super grateful if you could help me reach

even more ambitious doers who share our passion. So if you found value in this podcast, if you found yourself nodding your head while listening, or if you simply enjoy what we're doing with Medsider, please take a moment to leave us a review. It's super easy. Just open your Apple podcast app or the podcast app of your choice, search for our show and scroll down to the ratings and review section.

Leave your honest thoughts and hit that five-star rating if you think we're worthy. Your feedback is incredibly important, and so the best way to ensure we keep bringing you awesome discussions with leading founders and CEOs. So take a moment to be a good friend and leave that review today. As always, thanks for being a part of our journey and for helping Medsider continue to grow and evolve. Your support is greatly appreciated. All right, enough talk about reviews.

Stay tuned for another informative episode coming at you soon.