Medsider: Learn from Medtech and Healthtech Founders and CEOs - Bridging the Gaps as a Startup Medtech CEO: Interview with Cagent Vascular CEO Carol Burns

Episode Date: April 26, 2023

In this episode of Medsider Radio, we sat down with Carol Burns, CEO of Cagent Vascular, a medical device company focused on developing and commercializing an innovative angioplasty balloon called the Serenator.Carol is a seasoned CEO and serial entrepreneur with a passion for cardiovascular devices. Her tireless energy and proven track record have enabled Carol to excel in all phases of medical device development, from early-stage proof of concept to eventual commercialization. Carol thrives in the fast-paced startup world, leveraging her industry relationships and clinical knowledge to identify technologies with the highest potential for success.In this interview, Carol highlights the importance of establishing the right team to lay the proper foundation for your medtech startup. We further discuss how to prioritize essential product features and their clinical applications for future growth, as well as overcoming fundraising challenges through effective networking. She also highlights the importance of listening to study investigators and designing strategic clinical trials to generate valuable data and drive success.Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced life science leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.

This, the feeling that you need to know it all, you're never as a CEO going to know at all. But what you do need to know is where you have gaps. And you do need to know, recognize you do have a gap there and to pull that expertise in. Welcome to MedSider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson. Hey everyone, it's Scott. In this episode of Medsider, I sat down with Carol Burns, CEO of Cajent Vascular. Carol is a serial entrepreneur with a passion for the cardiovascular space. For tireless energy and proven track record have enabled Carol to excel in all phases of medical device development from early stage proof of concept to eventual commercialization.

Carol thrives in a fast-paced startup world, leveraging her industry relationships and clinical knowledge to identify technologies with the highest potential for success. Here are for the key things that we discussed in this interview. First, a strong, diverse team is the foundation of any successful MedTech startup, having a group of passionate professionals who are committed to the company's vision and ready to contribute their skills and expertise fosters not only innovation, but also quick wins. Second, in the early stages of a MedTech startup, it's crucial to focus on the core aspects of the product and its clinical applications, establishing a solid footing for future development. Third, persistence and strategic thinking are vital during the fundraising process.

nurturing relationships with potential investors and consistently providing them with updates on the company's progress can ultimately yield fruitful connections and secure the necessary funding. Before we jump into this episode, I wanted to let you know that we recently released the second volume of Medsider mentors, which summarizes the key learnings from the most popular Medsider interviews over the last six months or so. Look, it's tough to listen or read every single Medsider interview that comes out, even the best ones. But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create Medsider Mentors. It's the easiest way for you to learn from the world's best medical device and health technology

entrepreneurs in one central place. If you're interested in learning more, head over to medsiderradio.com forward slash mentors. Premium members get free access to all past and future volumes. If you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Erica Rogers, CEO, of Silk Road Medical, Dr. David Albert, founder of a LiveCore, and so many others.

In addition, as a premium member, you'll get to join live interviews with these incredible medtech and health tech entrepreneurs. Learn more by visiting medsiderradio.com forward slash mentors. Again, that's medsider radio.com forward slash mentors. All right, Carol Burns, welcome to Medsider Radio. Appreciate you coming on. Thank you for having me. Yeah, I'm looking at the beautiful Cajent background on the Zoom call. Well, certainly it will be fun to learn a little bit more about kind of what you and your team are building at Cajent. But before we go too deep on that story, get us up to speed on kind of your background leading up to, you know, co-founding the company and leading it as a CEO.

Sure. Well, I first started my career as a critical care nurse working in a hospital. And that was really the baseline for my medical knowledge in developing technologies. And then from there, I went into sales. I carried a bag so I know what it's like to work in a hospital or an account for three months and finally get that PO, super excited about it. And then from there, I was recruited by guidance and moved out to the West Coast. And while it's guidance, I was able to teach international reps how to do a clinical cell.

And then came inside and worked more marketing roles where I learned how to launch a product. as part of a team that launched the first end of vascular AAA device. I learned the interaction with regulatory, with engineering. So that was a good experience to have that Fortune 500 company behind me. So when I transitioned then into the startup world, I knew how to do things based on that experience, you know, at guidance. From there, I got the startup bug. And I followed one of my bosses to my first startup.

which was called Ventrica. And that took me to Europe for a good bit of that job where I executed on a clinical trial. So there, relevant to my experience today, I learned what it was like to ensure protocol adherence, to how to enroll quickly, how to get the investigators to ensure good documentation and follow-ups and all of those things, which is so critical to getting our devices cleared. Then I came back to the U.S. and had a period of time working with international sales and marketing, managing our distributors for an insulin pump therapy company that was acquired by J&J. And then it came back to a startup again working with a husband and wife team who developed a product and with my CEO. and that was really my first job where I was really up front and close with how does this startup really work.

And I was fortunate because my boss at the time, he gave me a lot of latitude and let me really participate in a lot and developing board decks and presenting a board meeting. So I really learned a lot under his leadership how to start a company. And then I was approached by my current partners today, Dr. Peter Schneider. This was a time where I learned that you really need to just pay it forward. My partner is Dr. Peter Schneider and Robert Giazoli, they approached me. They had started the company, which is now intact. And, you know, they kept asking me questions. Well, how would you do this?

How would you do that? And it was all broad us. But then one day, Peter said, well, we'd like you to come. work with us, well, what do you want me to do? Well, we want you to be the CEO. I was like, oh, okay. And I became a CEO, intact became a big success. And then three of us started Cagent Vascular, the three of us again. So that's how I landed this job today. That's awesome. You've touched so many different functions in a, you know, in a medical device company. And I think there's so many people that listen to Medsider that have, you know, a commercial,

background and work inside, you know, large strategics and, you know, because the question comes up a lot is like, well, how do I, how do I take that next step and get more involved in startups? And how do I sort of accelerate my career? And a lot of, a lot of times my answer is you got to, you got to like touch a lot of different things, right? Take a lot of different swings. There's only so much that you can kind of learn from afar before, you know, getting your, getting your hands dirty. And so I love the fact that like when you, when I look, I'm looking at your LinkedIn profile now and it's like all of these different experiences. right, such broad experiences that are, I'm sure have really helped, you know, helped you

kind of in leading intact, right, and that exit to Phillips as well as, as well as Cajent. So awesome background. And I've heard your name referenced so many times, you know, and we're both obviously familiar with Dr. Snyder. He helps with Fast Wave as well, awesome, awesome guy. And so anyway, looking forward to kind of digging in a little bit deeper. But for those listening that aren't familiar with Cajent, the company that you're currently that you're currently building.

Give us an idea of what your product does, the serenator, and then maybe a little bit of background and how the idea for the product even came to be. Sure. What we developed at Cajent is a product called the serenator, which is a truly disruptive way to do angioplasty. And very simply, it is a balloon that has the serrated metal strips on the outside of a balloon, actually embedded into the balloon.

And when the physician uses it in our first entree, peripheral arteries, what these serrations do is it creates point force across the lesion so that the artery opens with a thousand times more force than a plain balloon. The benefit of that is that we're seeing great lumen gain, minimal dissection, and that translates into great flow to the foot. And when Peter started to think about it, he's a visionary, on our team, Peter thought about, how do I make angioplasty better? It's a great procedure, but how do we really advance this field?

And he started thinking about this concept of serrating, and it's in simple household products like a serrated knife in your kitchen or a FedEx envelope where you take the tab and you pull here and it opens the FedEx envelope right along that serrated line. in a very controlled, predictable way. And it's in aircraft, in heavy machinery. It's in all kinds of products. And you started to think, why aren't we using this concept of serration onto a balloon?

And that's how the idea came about. And then it was Robert's task to develop the design of it. And that's how it all came about. Yeah, I love these stories. And it reminds me of actually the story that Bruce Shook shared about Intact back in the day when I had him on the show. And I think he mentioned something similar where Dr. Snyder was like pinning Christmas lights up on his house and was like, why are we doing this for, you know, for arterial applications, you know, which sort of served as the genesis of that device. So yeah, I love those stories. I'm a big fan of Austin Cleon and his book, Steal, Sealing Like an Artist.

And if I had to sum up the book, it's like you see all of these different concepts. and ideas used in other areas and other verticals, right? Other areas of life. You mentioned like the FedEx, the FedEx envelope. Everyone probably listened to this has opened up a FedEx envelope before. And it's like, I love those stories around taking like this idea that's proven. It works. And it's like, why aren't we like, why aren't we like, why aren't we translating this into, you know, into this field?

And so I think there's so much power in that type of approach. So before we kind of, you know, step inside the sort of the medside or time machine and kind of go back and revisit sort of the journey with KJN as well as like some of the other companies you've involved with Carol. Give us a sense for kind of where the company's at currently. I know you're cleared and you're commercial, but, you know, if you can give us a high-level sense of what you're doing now. Sure.

You're right. We have 15K clearance with FDA. We also have CE Mark. We started selling the product in January of 2021 and primarily focused on the U.S. and just a little fit in Germany as well. Got it, got it. And I know we, in kind of the pre-interview for this, we discussed some numbers, but it seems like, and I don't expect you to share those,

but I think it appears the company is doing very well. Is that a good way to put it? Yeah, it is true. Since we started selling with a very small sales force, we have over $7.4 million in total sales, which I think is really excellent. performance, especially considering we launched this thing in the middle of COVID as a no-name company.

No one knew who we were on the commercial side. So in two years, we've had really nice growth. Yeah, yeah, that's great. That's awesome. I love those stories where you're launching in the midst of a major, major challenge, but it's still realizing a lot of success. So that's awesome. And for those listening that don't get a chance to go back to the show notes and summary

for this interview, The website is Cagent Vascular, C-A-G-E-N-T-Vascular, C-A-G-E-N-T-Vascular.com. You can learn a little bit more about the technology as well as who's involved with the company. In fact, when I was looking at the site, which is beautiful, by the way, you got some great kind of like visual kind of ways to describe how the technology is actually working that make a lot of sense. And I think that's super helpful. And I'm surprised other MedTech companies miss that. lot, right, when, you know, trying to explain how, you know, the mechanism of action for their particular device, you know, I love the, I love kind of the parallels and analogies that you

kind of bring, bring to light. So, with that said, let's kind of jump back in time. And kind of, if you can weave in, you know, as you answer some of these questions, I'd love to kind of, I'd love for you to weave in kind of your, your previous experiences at other startups, right, intact. And you listed several of them at kind of at the outset. But it would be, I think it's going to be super useful to not only hear about kind of the latest learnings, right, as you're building Kajent, but also also some of the insights that you picked up over time as well. So with that said, take us back to, you know, kind of early stage, you know, any early stage startup that you've been involved with. And think about like the earliest kind of versions of like

alpha and beta. From your perspective, where do you think most, you know, med tech, health tech entrepreneurs, where do they, what do they go wrong, you know, when try to, develop those first iterations of their products? I think the first thing that I've learned is that you really have to have the right team. And you're constantly reassessing that team when you're building your early prototypes. And with a startup company, it's all about speed and getting and moving the ball down the field. Right. So when in our cases, most of the time in the model we've worked with, we have a core team and then we outsource to a

group to actually build the prototypes. And in that environment, it was really important to constantly assess, are we getting where we need to go with this team? And the difficult decision sometimes is to pivot and to move to another group where they're going to get you where you need to go to the next phase. And we've had to do that a couple of times where we're just not moving this along. We know we can do it, but for whatever reason, it's just not quite working. So I'd say, learning when to pivot and doing quickly rather than keep trying, and we'll give it a little more time, a little more time eventually after they stop, we need to move on to a different group.

And that's what we've had to do a couple of times. And it worked. We finally got where we needed to go. Yeah, that's such valuable advice. And I think a lot of, not a lot, but several other med tech founders and CEOs have mentioned something similar where it's like your team early on, should probably look a lot different than, you know, your team at the next, maybe, you know, inflection point. And that constant sort of evaluation and pivoting is, is crucial, you know,

especially not only just with your internal team, but also, you know, with the partners, the partners you choose as well. And so I think that's probably a key lesson for, for everyone listening is that, you know, you got to be, in the world of startups, got to be, got to be nimble, you know, and willing to flex and iterate, you know, as, as you run up against, you know, certain challenges. That's right. Those, those who can do that. stay on. Those who can't do that, they fall off. It's really important to just what you said. You have to remain agile and to pivot and move to the next, whatever the company needs to do next, need to be able to execute on that. Yeah. It reminds me of a quote that I recently heard

maybe it was a couple months ago from Darmesh Shaw, who's one of the founders of HubSpot. And he mentioned, it's obviously a technology play, but he's pretty pretty well known with in the kind of the peer play tech ecosystem. And he mentioned he's like, the name of the game for, you know, for, you know, founder or CEOs, founders of early state startups is you got to be decision machines. And I really resonated with me because it's like you've got to be always making decisions. And if you're, you know, if you're 80, 90 percent confident, you got to just, you got to run, right?

Because to your point, point you were, you shared earlier, you know, it's speed. You know, you got to be moving fast to get to that next, the next kind of major milestone or inflection point. And that's, I think, I think really, really crucial. Yeah, without a doubt. Yeah. Let's jump to another topic. Because I know the Serenator, your key balloon, balloon platform, angioplasty balloon platform, you receive CE mark back in 2017. And correct me if I'm wrong, this is just kind of based on my research. But and then so CEMARC, 2017, FDA clearance in 2020. So, you know, we got a little bit of a global, a global footprint from this, you know, with this particular technology. When you think about the traditional path, right,

for early stage kind of U.S.-based MedTech startups. The traditional path was get clearant or get C-Mark in Europe, you know, do a trial in Europe, even commercialize in Europe, and then layer, you know, use that data to inform kind of your U.S.-based approach. It seems like the tide is shifting a little bit, right, largely due to the increasing kind of challenges with MDR in Europe. So like what's your take on that? Like if you had to, you know, if you had to build, start from scratch today, right?

we'll still let's see you working on you sell, you know, the, you know, Cajent or, you know, Cajun exits and you had to start from scratch, would you consider, you know, going down that traditional path with the kind of a Europe first approach or would you do things a little bit different? Yeah, I think that's something to really take a look at it again. Right now, we are going through our MDR certification and we're working through that process, but it is really becoming, I guess, burdensome to go through MDR. certification, the bar is constantly, you know, moving and becoming higher and higher. And it's just

becoming a lot more challenging in Europe. And we want to be able to bring new technologies to Europe. And we've had wonderful experience with investigators. But the pathway is becoming expensive to do it that way. So I would really have to take a relook and reevaluate. Historically, that you're right. That's how I've always done. it, go to Europe first. But with the changes, I would have to take a look at that again. So it sounds like it sounds like it's still doable, right? It's just, it requires a lot, maybe more consideration than you historically have, you know, sort of go to that. Yeah, yeah, got it. Yeah, that's super helpful. Anything else, like as you're going through that MDR certification,

right, as a relatively small kind of lean, fast moving team, anything else that stands out, other than, you know, hey, it's going to take time and it's going to be costly? Well, you have to make sure you have the people on your team who have experience going through that process again and a good relationship with your notified body. So you need both. So you need to make sure that you have people in place and can walk you through that process and have that good working relationship with your notified body. Got it, got it.

Yeah. So maybe the key lesson learned is if you, if you're, if you're still, still sort of, you know, if you, if you're working on an early, you know, your preclinical, you know, early stage, you know, med tech startup and still considering Europe, just make sure you're working with people that have, you know, the right expertise, right, to navigate, navigate those, those challenges, if you're going to go down that path. I guess before we move on, I'd like to, I'd like to talk a little bit about the latest, you know, data coming out of your, your most recent study that you, that you announcing preclude BTK, I believe is the name,

prelude, BTC. But before we go to kind of that, that, that's, topic of like just clinical strategy in general. Any other any other kind of just, you know, words of wisdom to other, you know, founders, CEOs and MedSet companies that are trying to navigate, you know, the regulatory waters in general? 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. You'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Renee Ryan, CEO of Cala Health, Nadine Miarid,

CEO of CVRX, and so many others. As a premium member, you'll get to join live interviews with these incredible medical device and health technology entrepreneurs. In addition, you'll get a copy of every volume of Medsider mentors at no additional cost. To learn more, head over to MedsiderRadio.com forward slash premium. Again, that's MedsiderRadio.com forward slash premium.