Medsider: Learn from Medtech and Healthtech Founders and CEOs - Why Great Data Isn’t Enough to Drive Adoption: Interview with Adagio Medical CEO Todd Usen

Episode Date: June 12, 2025

In this episode of Medsider Radio, we sat down with Todd Usen, CEO of Adagio Medical.Adagio specializes in catheter-based ablation technologies for the treatment of cardiac arrhythmias, with a focus on ventricular tachycardia (VT).  Todd has over three decades of leadership experience in the medical technology industry, with particular expertise in commercial strategy, operational performance, and business transformation. Before joining Adagio, Todd served as CEO of Minerva Surgical, a women's health company, and as CEO of Activ Surgical, a digital surgery startup. Todd has also served in executive positions at Olympus, United States Orthopedics, Smith and Nephew, and Boston Scientific.In this interview, Todd shares insights on making usability central to commercialization strategy, leveraging breakthrough designation beyond regulatory validation, and assembling effective boards by carefully selecting both investor and independent members who bring operational expertise.Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You’ll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Todd Usen.

The techs, the nurses, the staff, the people in the room are really not less. They're equally as important. I've chalked it up to if you're in a case and a physician walks into a case expecting to use my product because I have a great relationship or we've earned our right clinically. But the staff thinks it's difficult to set up, think it's a real problem to use. All of a sudden the physician walks into the room saying, I'd like to use such and such and they say, oh, we don't have that right now. if you want to wait 15 minutes, we'll go set it up.

It's going to take a little while because it's a real trouble. And the Dasse is saying, no, no, just use what you have. And we'll get it next time. They're the real gatekeepers. 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 Nelly. Nelson. Hey everyone, it's Scott. In this episode of Medsider, I sat down with Todd, Uss, CEO of Adajo Medical and MedSec Company specializing in catheter-based ablation technologies for the treatment of cardiac arrhythmias with a focus on ventricular tachycardia, or VT. Todd has over three decades of leadership experience in the MedTech space, with particular expertise in commercial strategy, operational performance, and business transformation. Before joining Adagio, Todd served as CEO of Minerva Surgical, a women's health company, and CEO of Active Surgical, a Digital Surgery startup.

Todd also served in executive positions at Olympus, United States Orthopedics, Smith & Nephew, and Boston Scientific. Here are few of the key things that we discussed in this conversation. First, make usability a cornerstone of your commercial strategy. Todd's go-to-market advice centers on more than clinical performance alone, understand where procedures are done, how the device fits into actual workflows, and who's really using it. Second, make breakthrough status work for you by anchoring it to the relevant problem.

Todd sees breakthrough designation not as a symbolic milestone, but as a strategic asset. The value of breakthrough starts before you apply by choosing a clinical need where your tech truly stands apart. Third, tie your fundraising campaigns to measurable milestones and show how each dollar drives progress. In today's med tech landscape, raising money means more than selling a vision. It means proving how that vision gets de-risk. All right, before we dive into this episode, I'm pumped to share that volume 7 of MedSider Mentors is now live. This latest edition highlights key takeaways from recent Medsider interviews. with incredible entrepreneurs like Bill Hunter, CEO of Canary Medical,

Brian Lord, CEO of Pristine Surgical, Don Crawford, co-founder of Safian and current CEO of Corvista Health, and other proven medtech founders and CEOs. Look, we get it. Keeping up with every MedSider interview isn't easy. That's why we created Medsider Mentors. These e-book volumes distill the best practices and insider secrets from top founders and CEOs,

all in a downloadable, easy-to-digest format. To check the latest volume out, head over to Medsider Radio.com forward slash mentors, Premium members get free access to all past and future volumes plus a treasure trove of other resources. If you're not a premium member yet, you should definitely consider signing up. We recently revamped Medsider with swanky new features, especially for our premium members. In addition to every volume of MedSider mentors, you'll get full access to our entire interview library dating back to 2010. You'll also get MedSider playbooks, curated guides packed with actionable insights and topics like fundraising, regulatory challenges, reimbursement strategies, and more.

And if you're fundraising, don't miss our exclusive investor database, featuring over 750 life science VCs, family offices, and angels. We've even created three custom packages to help you with your next fundraise. Learn more about Medsider Mentors and our premium memberships by visiting MedsiderRadio.com forward slash mentors. All right, without further ado, let's dive into the interview. All right, Todd, welcome to Medsider Radio. Appreciate it coming on. I really appreciate. Thanks for having me, Scott.

And everyone listening doesn't get to see your awesome video backdrop, right? which is, as we were laughing about earlier, a flex for what you guys are doing at Adagio. So I like it. Yeah, it's, you know, and we get a chance to be on the NASDAQ tower because of the breakthrough designation. We took advantage of it,

and then it was thrown into our backdrop. So, yeah, I was told I'm flexing. So that's a funny, funny term. That's actually not who I am, but I'm actually proud of the company for doing the work. Yeah, it's a good flex. It's a healthy flex.

We'll leave it out. Yeah. Well, I reported a short bio, kind of at the outset of this interview, but I always like to start here, kind of hear it from the horse's mouth, so to speak. But you've got like a pre-prolific career in MedTech, right? First, what, 15, 20 years with large strategics and then, you know, over the back half of kind of your career, a lot of early-stage startup work.

So let's start there. Give us maybe like a two-minute overview or, you know, your kind of elevator-style sort of pitch on Tadu said kind of leading up to what you're doing with the DAGio. I've been in MedTech for three plus decades. You know, it's the only thing I've ever done right out of college. So I was very lucky. I really cut my teeth, if also scientific, and spent about 13. years there in different divisions. My last role I ran the U.S. and the commercial division

in their neurovascular division. Move from there, I went over to Smith and Nephew and orthopedics, spent a good eight years, great space, really loved it, great doctors. My last role there, I became the president of all orthopedics, which is sports med, trauma, total joint divisions, a great experience. And I learned what was right to do, what's not right to do. So it was like my batting cage of a presidency, you know, and go practice because then from there, I moved over to, I was recruited to Olympus as the president of all the medical divisions at Olympus. And at the time, there were six. When I left, there was 11 through adjacencies, M&A, new markets. It was a great experience reporting directly to Japan, which was a wonderful experience

to me in learning the culture. And then, like you said, I didn't go to the dark side. I went to the startup world, though, and it was really interesting. I went to a technology company called Active Surgical. It was first fully autophobic. autonomous robotic surgery of soft tissue, but really focused on advanced visualization and AI, and that's what we focused on. Instead of going to build a robot, we took the opportunity to go focus on this advanced visualization. We raised about $100 million.

I went through the FDA CE mark, and now the product is being utilized commercially and around the world, partnering with different scopes and robotic technologies so physicians can see things that they couldn't see otherwise. And then after that, I had a chance to go back to a larger, still small, but company publicly traded women's health company that had just been, had recently gone public maybe two years prior. And it was technology I knew from when I was at Olympus was a company that we had looked at closely when we were building out our women's health division. So I knew the people. And basically what the goal was to help get the company right and right size the organization, build the

portfolio out. We set ourselves up, I guess, well. And we were acquired by private equity, who was able to take the company private from that point. So it was a successful exit and companies doing well and wish them well, great people. And then focusing on some board work. And then all of a sudden, I get this call from Adagio, and we can talk about that. But great technology. The electrophysiology space is outstanding right now. And it was really a lot of things coming to a head, which led me here that I'm happy to talk about as we get. So it's been a nice career. And Adagio is a publicly traded electrophysiology company, focus on ventricular tachycardia ablation, which is, you know, obviously a seriously ill patient that we want to make sure that they get better because, as you know,

heart disease is a real problem in the world. Yeah, I want to touch on your core technology at Adagio, at least a high level kind of understanding of it. Sure, sure. Tell us a little bit more about like what brought you to the company. And I'm sure you mentioned you're serving on a lot of a lot of boards probably had, you know, could be sort of choosy at this point in your career and where you land next. But obviously something intrigued you about Adagio. So yeah, I love to learn a little bit more about that. And it was funny because I wasn't necessarily saying I needed to get something. I'm a little antsy, so I wasn't ready to just say I'm just going to be a board member. But I'm a big believer in are we solving a problem? So all of a sudden, you know, there's so

many great technologies out there that are solutions that are looking for a problem. You know, this one was a solution that's solving a real problem. And the problem was in ventricular tachycardia. A-fib is getting all the treatment and great technology and great attention, but VT patients are very ill and very sick. And right now for many years, drugs were the number one treatment option. And the reason ablation didn't kick in as fast as maybe an AFIB is because VT ablation was a second line treatment. So a couple things came together, Scott. First is there was some clinical data a few years before me starting that says with the right VT ablation technology, VT could become first line of treatment. So that means now we're going to open up a market opportunity.

for VT ablation. There's certain clinical needs that are within the technology. When you're within the heart, you want to stay within the heart. And oftentimes, many times certain ablation needs to come from outside the heart, which not every doctor loves to do. And that's called epicardial ablation. I'm not going to get this, make this a clinical, a nut job case here. But we want to stay inside the heart with this endocardial ablation. And this is a technology that can go as deep as you need to and do everything from inside the heart. So that was a real positive, and that was our goal. There was a two-year clinical head start because this product was already approved in Europe when I got here based on clinical studies. And it was the first purpose-built

VT ablation catheter as opposed to a repurposed, a fib catheter. And finally, it's a public company, but it had tremendous support from a group called Perceptive Advisors. It's one of the biggest PE firms in the industry. They don't make investments in companies unless they really believe in it. I was drawn to the leader, perceptive, that leader from our company that was on the board here, or Lee Mishan, and we just hit it off in our communication. I hadn't worked with them in the past, but the combination of electrophysiology, the need for VT ablation, the market saying VT ablation can be first-line treatment. We had a two-year head start on other people if we can just focus on the right things. And I had great backing and support from a system, made this like, it's going to be a tough one to pass up.

And that's why I'm here. Got it. That's helpful. And your particular technology, let's touch on that real quick, before we kind of dive into more of the substance of the interview and learning a little bit more about your background. But it's cry about actually, because I think most people that are maybe loosely familiar with the space, they're aware of like Boston's significant run

with PFA, with PFO with Pulse Field Appalach recently. So give us maybe, without like getting too nerdy. Give us it an overview of kind of how your technology differs from something like maybe PFA that some people kind of are aware. Yeah, and sometimes I'd love to get too nerdy. I'm actually not smart enough, Scott. I'm not an engineer. I'm not a scientist. So, you know, I can give you the, you know, really the baseline, human to human conversation of why this makes a difference. Ultra low temperature cryooblation

catheter. There's been cryo ablation all throughout medicine for years, just like there's been RF ablation all throughout other anatomies as well. The ultra low temperature cryo is different than you. It's not your mother or father's cryo. It's not a balloon. It's a catheter. It's technology that allows you to achieve depth, you can't achieve with an RF technology. It allows you to avoid needing irrigation, which or any thermal effects of what's called microbubbles or that migrate to the carotid arteries and into the brain, which is some things that they've seen in different technologies, even with pulse field in the ventricles. This is not trying to compete with the pulse field in the Boston. I'm a Boston person. I believe in them. We're not coming out

to say we're going to take this right into AFIP and compete with pulse field. That's okay. but pulse field right now is not necessarily the ideal solution in VT and it hasn't been proven. We do have a technology, which is the last reason I'm here, is we've been able to demonstrate how to make pulse field work, and it works well in an ice bubble, which is we have the asset of IP on pulse field cryo ablation is actually one of our assets that we have some published data on that. So I like to keep that in my asset file because that's an important one to have, but it's really the ultra-low temperature cryo allows physicians to achieve the depth that they need with the safety mechanisms. We had clinical data, which was zero percent adverse events

in our early studies. Like I said, no irrigation, no thermal effect that we're really worried about with, like I said, microbubbles or things as such. So there are some major differences in the technology with liquid nitrogen. And when it's ultra low, normal cryooblation might be about a negative 86 degrees Celsius. This starts at about 140, negative 140 at the tip. And it goes up to about negative 196 and future technologies will even be colder. Got it. So it truly is ultra, ultra low. Yeah.

Yeah. So when I say something, it's super cool or ultra cool, I'm actually just, I mean it. It's actually, it really is. It's a cool technology. And it sounds like those extremely low temps allow, allow physicians to kind of overcome a lot of the drawbacks with traditional cryo then for, for oblation. Potentially, yes. And we're not focused on traditional cryo in certain parts of anatomy.

There's pros and cons. One of the advantages here with this cry on a catheter tip is that stability. Actually, it's, you know, I go back oftentimes and I think about my mentality in the movie, dumb and dumber. You know, I don't know when one of the dumb guys put his tongue on an ice cold street sign hole, and it was stuck there because of it's frozen. So one of the things, it sounds crazy that it's an advantage of this frozen is we know when you're in contact with the tissue, when you're freezing, you don't have to worry about stability concerns. which is actually a concern oftentimes when you're down in the ventricles. So there are some advantages of the ultra low temperature cryo as well.

Got it. Sounds like maybe something you can work and do an ad at some point in the future which are commercial, right? Yeah, yeah. No, and I'm not sure the world wants me to start using dumb and dumber as my ads, but it's kind of my speed and maybe I. I think most people can sort of, they've seen the movie, or at least most people have seen the movie, guys.

It's a good analogy to get a reference. Before we kind of get to a couple of the. these kind of more questions about kind of key learnings that you've learned along your career. Gives us a sense where the company's at in terms of lifecycle. You mentioned the breakthrough designation. Obviously, that's a huge, huge milestone that you've achieved recently. But yeah, give us a kind of high level overview where you're at. Yeah, and that breakthrough was really a big deal. To get that breakthrough, the FDA is saying that you have a technology that does something or is different than anything that's currently available. So that's a nice thing. And in this case,

we can treat BT ventricular chakocardia with ablation from inside the heart, endocardially, because of the depth that we can achieve without any of the side effects, without increasing amps or doing other things. We're able to do that at this particular point. So that was nice with breakthrough. So the company went public last August, August of 24. I came on in December of 24 to take the company to its next levels to really focus on the clinical but we're in a middle of a U.S. clinical trial, which is very exciting.

We're well more than halfway through enrollment. And when we achieve that six months after the final patient is enrolled, we'll have our primary endpoints. And that technology then can be submitted to the FDA for PMA approval. We already have our European approval, our CE mark, based on clinical data that's been done. And this study that we're doing now in the U.S. is using the same product at the same inclusion criteria, just more patients. So we're excited about that.

We're at the stage now that we're really focusing on usability. I'm a big usability guy. It's just I'm a more marketing person. You know, technology and clinical data is one thing and people can get a lot out of it. But if no one wants to use it because you have to use Band-Aids and duct tape to make something work, you know, it doesn't make it. So the combination of our focus on this IDE Pivotal Trial and then focusing on what we call product design optimization program and plan is where we're pooling all of our resources

in the organization. And the goal was to come in instead of trying to be good at a hundred things, Scott, I want to be great at one or two. And we're pooling everything to focus on these key things. And the product design optimization plan is going to allow us to deliver to iterate and innovate at a faster pace, more cost effectively, which means we can pass on better pricing to our customers and treat these serious issues, which we have in patience. So right now we are at the stage once we get our, like I said, our PMA, you know, we already have commercial. in Europe and the technology will be commercial in the United States. Got it. Yeah. Sounds like some pretty pivotal clinical work that you're in the midst of right now.

I used to so underappreciate even getting something like a breakthrough designation or even just an IDE approval, right, for a significant kind of U.S. trial. And it's like those are such huge milestones to achieve. And so yeah, kudos to you and your team for kind of getting to this point. But I'm glad you touched on the usability factor because I think that's maybe it's easier for you and I, right? Because I grew up kind of more on the commercialization. side of MetTech. And we both know that, like, don't get me wrong, like, good clinical data is entry into the game. But the reality is, like, if that alone is not going to lead to adoption at all, actually. And so if you're asking, you know, someone to wheel out a huge box, you know,

into their cat lab and it's going to take 20 minutes to set up, like, it's not just the physician. It's the techs and the nurses that see that is very painful, too. And so, yeah, I'm glad, you touched on how important the kind of the workflow and the usability is because it's crucial. I learned that, you know, it's one of the things that the techs, the nurses, the staff, the people in the room are really not less, they're equally as important. There's so many companies for whatever the specialty, you focus on the doctor, focus on the surgeon, he or she makes all these decisions. Well, not always. I've chalked it up to if you're in a case and a physician walks into a case expecting to use my product because I have a great relationship or they, we've earned our right clinically. but the staff thinks it's difficult to set up, think it's a real problem to use.

All of a sudden the physician walked into the room saying, I'd like to use such and such. And they say, oh, we don't have that right now. But if you want to wait, 15 minutes, we'll go set it up. It's going to take a little while because it's a real trouble. And the doctors say, no, no, just use what you have. And we'll get it next time. They're the real gatekeepers.

They have to make sure that it's a technology that makes sense and it's usable. And like I said, just because you get clinical, and there's a lot of studies out there with amazing clinical data, But you don't want to necessarily use. And I chalk it up. If I needed to call you on the phone right now, I can go get a rotary dial phone and achieve the same outcome that I went by just pressing your name on my smartphone, right? One's a lot easier to do than the other. And I don't need to know your number on the other, but I need to know what, you know.

So you can get the same outcomes, but there's a lot easier way to get there. And I tried to really bring that when I'm with, you know, engineering teams. it's something that I've learned a long time ago is to make sure that usability is part of this. Don't design something because of the clinical outcome, even though, don't get me wrong. We got to cure patients and make them better, but we also have to delight the customer in using the products and they have to be really excited to use it. Yeah, yeah, and there's no doubt. I was having this, I was doing this interview that was more fast wave related, right,

which is where the company I spent most of my time on. But we were talking about like a key thing that I think most, most, it's not just startups either. It's strategics, too, but you can always. an engineering team that has kind of slowly kind of moved further away from the customer, right? Because they begin to make decisions that aren't truly rooted in what happens clinically, what happens every day, you know, in the cap lab and OR. And it's just so, so important to stay as close to the customer and the user as possible because you just, you don't, you don't pick up on these, these source of insights, right, that you're, that you're driving home here.

So absolutely. Yeah. With that, with that said, I'll mention the website here before we get to some of the other questions, but it's a dajio medical. So AD, B-A-G-I-O, so adagio-medical.com. We'll link to it in the full write-up on Medsider as well as Todd's LinkedIn profile as well, so you can learn a little bit more about his background, too. But with that said, let's get at the first question on the docket, which is, you know, you're kind of in a unique experience where you've had, you know, significant leadership positions at large strategics. Then you spent time at smaller startups, right, that are, you know, well-capitalized. Now you're at, I would say a startup, but that's publicly traded,

right? So give us a sense kind of thinking through those various experiences, you know, what is it really, like, are there a couple things that, like, you really need to get right in order to see success in kind of in both, both as a publicly traded company as well as, you know, a private, maybe venture back startup. Yeah, and it's interesting. And no matter what size the company is, it comes down to a couple things. People, number one, it doesn't matter if I have a really small company or a really large company. If I have great people around me and that I can empower and they can be forced multipliers to do more than just one thing, I'm going to win. I truly have always believed no matter how good the technology is a great technology with average people, in my opinion,

my opinion, again, will always lose to a pretty good technology with superstars, you know, because superstars are going to make things happen. They're going to get you to the point, and then you can continue to improve the technology. It's really hard to improve the skills of a person after they've been doing something for 100 years. So developing people is really important. And then to be honest and have true, honest, clear communication, no matter smaller, large. So if you're in a big company, you just have to make sure that people have ability to hear the real message from the top, whether it's from the CEO, the president, the business unit director, whatever that level is, it has to be crystal clear and understanding.

Because if people understand what the goal is and how to be held accountable to that goal, I think you win. I didn't say a word just now. You have to understand how much money you have. You have to understand how to get investment dollars or shareholders are all important. If you have really good people and you really communicate the very, vision and the mission, no matter what your size is and everyone is aware of it, fighting for the same things and they're on the same, we're all doing the same work because we understand the initiative. I really believe that clear direction and communication to these people are the two things I found. And that's why I've never been, I feel that

the jobs have different goals and there are different, obviously very different, big differences, I should say, between a startup and something that's really well established. But people and understand communication don't change. And if you do both of those well, you're going to, you can still win. Two such good foundational kind of things to focus on. I make sure you really, you really nail. I'm right there with you in terms of comms. In fact, I mentioned something I underappreciated early in my career, but comms is also one of those things that sometimes I'll still underappreciate, right? It's just the importance of making sure everyone has a full understanding of kind of where you're going, right, where the company's headed. Because they may not

totally agree or they may, you know, they may disagree with maybe some of the decisions. But as long as they feel like they have an open line of communication, a chance to kind of voice their opinion. Typically, a lot of that, you know, drama, for lack of a better description, is usually overcome, right, if the communication lines are open and clear. And I think within that, big and small companies, you probably learn it a little more in a small company that if you really want to be successful, some people fall in love with their titles really too quick. And, you know, I'm really cool because I've made it.

Because, you know, when you're the CEO of a brand new startup company, yeah, you have to have certain skills. If you're a director at a major big, huge company, you've probably been trained just to get to those levels is very different than, you know, understanding titles. They don't always mean something. But at the end of the day, if you communicate and people know that they have, they can walk into your office and talk to you and communicate to you no matter what your title is. And they can hear it, make sure I understand the mission, division, what our goals are, what we're really being judged on. And I think that's good. And, and I, like I said before a little, sometimes people focus on we could do so many amazing things

with our technology. So I'm going to do this, this, this, this, this and this. I can't wait to share this with all the customers out there. But at the end of the day, don't try to be good at 100 things. Be great at one or two. And by magic, you're going to be great at that first one. Then you have a chance to be great at another one. No one is waiting for the future technology if the first ones were never any good. So, you know, it's also streamlining your focus. And that's part of that communication, making sure everyone understands why we're focusing on a few things versus so many exciting engineering things that we could be building and growing with. Anyway, those are just my thoughts.

Doesn't mean they're right, but that's something that I've always believed in. Yeah, that's good stuff. Hey there, it's Scott. And thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider premium members. If you're not a premium member yet, you should definitely consider signing up. Here's why.

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