Medsider: Learn from Medtech and Healthtech Founders and CEOs - Company Building Starts with Discipline: Interview with Evident Vascular CEO Howard Rosen

Episode Date: August 26, 2025

In this episode of Medsider Radio, we sat down with Howard Rosen, co-Founder and CEO of Evident Vascular, a company developing an AI-powered intravascular ultrasound (IVUS) platform to improve vascular imaging and intervention. Before co-founding Evident, Howard held senior leadership roles at Intact Vascular and Vesper Medical, guiding both companies through successful acquisitions by Philips. He also served in executive roles at Haemonetics and BG Medicine, and spent over two decades at Boston Scientific, where he held a range of leadership positions across the peripheral and cardiovascular franchises.In this interview, Howard shares why launching right — not fast — is the key to success in medtech. He breaks down how Evident built early momentum by investing in deep market validation, engaging KOLs as true collaborators, and resisting scope creep at every turn. Howard also unpacks the company’s deliberate regulatory strategy, using early FDA engagement as a tool to de-risk development. On the fundraising front, he explains why board composition matters more than valuation, and why strategic acquirers respond best to credibility, not cold outreach.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 Howard Rosen.

We made decision very early on what truly would go into first-gen and we were maniacal about prevention of scope creep. I've seen too many companies and technologies in my lifetime spin themselves into a hole and then become paralyzed because they don't know how to work their way out of their problem. Welcome to MedSider, where you can learn from the brightest founders and CEOs in medical devices and health technology. 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 at Scott, this episode of MedSider, I sat down with Howard Rosen, co-founder, and CEO of Evident Vascular, a company developing an AI-powered intravascular ultrasound platform to improve vascular imaging and intervention. Prior to co-founding Evident, Howard held senior leadership roles of intact vascular and Vesper Medical, guiding both companies through successful acquisitions by Phillips. He also served in executive roles at humanetics and BG medicine and spent over two decades at Boston Scientific, where he held a range of leadership positions across the peripheral and cardiovascular franchises.

Here, a few of the key things that we discussed in this conversation. First, go slow early so you can go fast later. In MedTech, rushing product development often leads to misfires with regulators, customers, or commercial teams. Evident invested its first year in validating the problem, assessing the market, assembling the right KOLs, and staying laser focused on what truly belonged in their first-gen system. Second, de-risking starts long before submission. Had evident multiple pre-submission meetings helped shape a smarter, more confident regulatory path, even without clinical trials. For Howard, early engagement with FDA wasn't optional.

It was a deliberate way to de-risk development, align expectations, and avoid surprises down the road. Third, your board isn't just oversight, it's strategy. The right partners bring more than capital. They bring patience, trust, and alignment when things inevitably get hard. A strong board sets the tone for how you operate and how you're perceived. The same goes for strategics. Don't just seek attention, build relationships early, and show up with a clear, credible message. All right, before we dive into this episode, I'm pumped to share that volume seven 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 Safion 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 ebook 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 treasured 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 in in the interview. Howard, welcome to Medsider Radio. Appreciate you coming on, man. Thanks, Scott.

Thanks for having me. Yeah, very much looking forward to this conversation. I think it's been a long time coming. We operate in kind of the very small world of the vascular space, really more specific to the peripheral vascular space, but let's start there. I provided a like a very short bio at the outset of this episode, but your journey goes beyond that for sure. So let's start there. I'd like to hear it kind of like from the horse's mouth, so to speak. So maybe provide us with a, I don't know, one, two, three minute overview of kind of where you've been leading up to taking on the,

co-founding evident and taking on the CEO role. Well, thank you, Scott. My journey in the vascular space actually started in 1993. I was in sales for Boston Scientific. It was called the Meditech division back then, and I was in sales in Detroit, Michigan for four years, and then went into marketing and spent a total of 21 years at Boston Scientific, mainly in the vascular space, and mostly in marketing, doing all sorts of upstream projects, downstream projects, and mainly in the implant world. And my last role was in the carotid stent space. That is nice to see how that has evolved the last several years. And then after leaving Boston Scientific after 21 years, spent some time in a heart failure, startup company, spent some time in humanetics, and then got

pulled back into the Vasker space to join Bruce Shook and the Intact Investor team back in 2017. And it was really was a wonderful journey with that. And we edited both those companies to Phillips. And after my one year assignment of integrating Intact within Phillips, I was approached by Vensonic Capital to learn more about an idea that they were ideating about an Ivis Nucco idea and asked me to be the CEO and join my co-founders, Patrick Phillips and Danielle Piazza back in the end of 2021. So here I am. Here you are. We're recording this in Q2 of 2025. So, you know, sounds like a little over four years kind of in the making.

Yeah, you know, we started the company in 21, the very end of 21 we incorporated. Then we really got the company going, I would say, probably four to five months later. I mean, this was a true back of the napkin idea that Vensana Capital ideated. And we can get into that. I think it's a great story how Vensana Capo came up with the Ivis Nucco idea that eventually turned into evident. and moved into the facility where we are right here in May of 22, and then we were off to the races. Got it, cool.

Well, on that note, I'm looking at the website now, which is Evident vascular, just as it sounds. So if you're listening to this interview and don't get a chance to read the full write-up on MedSider, and you want to check out the company and the technology and really the team behind it, Evidentvascular.com is the website, just as it sounds, evident vascular. But yeah, tell us a little bit more. You mentioned Ivis. So for those of us, for those listening that aren't as maybe familiar with us,

or have the opportunity to kind of operate in the space. Tell us a little bit more about Ivis and really kind of what makes evident and unique in your kind of approach and the technology. If you want, maybe kind of latter in kind of the touch on the founding story, because I think that is quite interesting, right? That the company was kind of iterated or kind of spun out of Vitsana. Let's go back in time.

So originally Boston Scientific Purchase, back in the early 90s and then Volcano purchased by Phillips. Both those technologies have been around a long time. there hasn't been a significant amount of innovation throughout time. And these technologies were originally designed for coronary vascular intervention to guide therapy specifically as stents really became to the forefront back in the, my goodness, in the late 90s, if I get my timing right. And over time, intervascular ultrasound started to become more prevalent in the peripheral vascular vascular space. And that's when Vansana came into the story. As they were making multiple

investments in the vascular space, they saw that intervascular ultrasound was used quite often to guide therapeutic decisions, whether that be stenting or other types of therapeutic device choice to optimize outcomes. And they saw that physicians really struggled with image interpretation and they struggled with ease of use. And there are some companies that really focus on ease of use and some companies focus on image quality, but no one company could do both. And so they saw how the vascular space, peripheral vascular space now speed forward into 2021-22. There are around two million procedures in the vascular space compared to a million PCIs. And they saw that a lot of physicians in the peripheral vascular space were using Ivis to guide their therapy, but yet they really struggled

with image interpretation. So they thought, hey, let's go out and try to find something to invest in because that's what they do. They have deep domain experience in the vascular space, having invested in intact vascular, Vesper Medical, two prior companies in Lutonics and Nari with several folks from Vansana. And they said, you know what, we can't find anything that really addresses what the true needs are, why don't we go spin out a company ourselves? And so they had these two very talented technical leaders, Patrick Phillips and Danielle Piazza, that were with Vitronis, that ultimately sold to J&J that Justin Klein was on the board of. Justin and I got to know each other on the intact and Vesper board.

And so he said, hey, let's bring you all together and let's design this. What do you say, let's go? And so that was at the very end of 2021. and we spent the next really six months really developing the story. And we have developed over the last several years and enough now where we have line of sight to submit to FDA later this year, a new platform that will bring together the best of all, which is essentially we'll have a very easy-to-use system that maximizes overall usability, ease of use, with an image that is so much better than what's out there that leaves no doubt in a physician's mind what they're looking at.

And on top of that, we'll have AI to really help with image interpretation as the program advances. And what's also different about evident is that we started with peripheral vascular first. All the other imaging companies start with coronary. I understood that. We all understood that from years ago. But when you look at the fact that there's really one dominant player in the peripheral vascular space, then Sondon made the decision to start peripheral first. And that was a great decision that they made.

So we've had been head down and really focusing on our first generation. We're very pleased with the progress we've made. Yeah, well, certainly interested in kind of double-clicking into some of the aspects of that story here in a bit. But for those that aren't familiar with Ivis or intravascular ultrasound, just to kind of even zoom out a little bit, these are catheters that, in essence, sort of help a physician gauge, you know, vessel size, disease in the vessel, et cetera. Thanks for bringing that back up because I didn't explain that. So predominantly angiography has been the gold standard for all vascular intervention.

You know, contrast eye is shot down into your arteries, veins, and you see a two-dimensional view. But really, that's only part of the story. I mean, we're talking about balloons. We're talking about stents, atherectomy, IVL therapy that's got, you know exceptionally well. And you need to really understand what's truly going on inside of the vessel in a three-dimensional perspective. To help you understand what the true lumen size is, but to also help you understand what the plaque morphology is so that physicians can understand what therapeutic devices they need to use to optimize outcome, truly guide their therapy. And it's been proven time and time again that when physicians do that, and they can truly see what's going on and optimize the

therapeutic device that they use, they will get better outcomes. And that's what Ivis provides. The challenge historically has been that physicians have a tough time understanding what they're looking at. And that's been an impediment to the adoption of this technology. That's where evident comes into play is that we have a system that we believe will not only improve the usability for the core users, but also will bring along new users that are reluctant to use Ivis. Yeah, it sounds like those two areas of focus are huge because as you and I both know, but for those listening that maybe haven't spent as much time like in the Cath Lab, you're right. I mean, it's, I would say existing equipment is kind of safe to say it's kind of clunky, right?

difficult to use. And then if a physician isn't either trained or doesn't have a lot of experience with Ivis or OCT, it's just they need someone else to really come in and help and help them, right? And so. And therein lies a huge challenge, right, is that it's not just the physician that has, that may be uncomfortable and maybe their support staff or some labs want to rely on a rep to come in and help them. We want to disrupt that. That's inefficient. I mean, there's technology and innovation that's out there today that's available to just take that challenge away. Not that that's a bad thing to have everyone in the room as someone who used to sell. And I think of that. I know the value of what it means to be in the lab, but you shouldn't have to rely on that.

That's antiquated thinking. Yeah, no doubt, no doubt. But yeah, as you and I both know, you've certainly been around the blocks when it comes to startups. I mean, timing is so, so important, right? And I think timing is very much on your side here. I mean, it feels like, gosh, going back even 15 years ago, Ivis was like something that once every blue moon, you know, we get pulled into into a case and people would kind of stumble around with it. But now it's like, you know, especially when PCI, but even more so in the peripheral space, like becoming kind of frontline tool of choice because of the importance, right, of properly preparing a vessel before further intervention. And so, yeah, I mean, it seems like this is a space that definitely getting a lot of

attention. Well, that's exactly right. And your technology is driving that as well, Scott. I mean, I think that there's the complex procedures that are now being done because, of the therapeutic device innovation, whether that be IVL or aderectomy stents, you name it, has required physicians to understand more about what's going on inside of the vessel to select the right device to use, both in the peripheral vascular space, but also on the coronary space. And so we've seen, and your comment about timing is spot on, because when we started evident, the market data suggested that Ivis utilization in the purple vascular space was in the 15%, 12, 15%, where now today in below the knee, SFA, these complex, and deep venous, you're talking

about 35% utilization in all sites of care. So you've seen an increase in the need to use intervascular imaging to guide therapy despite a lack of innovation. So we're really thrilled that the market is moving in that direction. I think if evident were to have started 15 years ago, maybe a little bit more, that'd been more of an uphill challenge, but some of the other companies have done a wonderful job at paving the way. Yeah, no doubt. Well, Well, let's dive into some kind of, I would say, more cross-functional, you know, questions, right? That any startup is going to have to kind of, you know, cross at some point to experience some level of success. But before we get there, in terms of kind of stage, I think you touched on this just a few minutes ago.

But evident right now kind of in actively sort of preparing or at least in the near term horizon, you know, going to be submitting for 510K. So I would presume fast forward sometime in 2026, you'll be probably at a point where you're commercializing the technology in some basis. That's exactly the stage that we're in right now. Got it. Got it. Okay. It's been an incredible journey to go from an idea from Vansana to a white piece of paper to a platform that is designed, frozen, and all the things that go with what we're doing.

We've been very focused on that and we feel great about the position that we're in right now. Oh, yeah. I mean, moving at seemingly a pretty rapid pace, too. I mean, if you really, I'm just trying to connect the dots here, but if you really started kind of really accelerating development, you know, in what, the first half of 20, and we're sitting at the first half of 25, you know, to be this far along, yeah. Well, that's exactly right. I mean, therein lies the uniqueness of our story, right?

I mean, Vansana approached us on this idea. They funded our Series A. We stayed stealth for a while. We had our heads down just validating the thesis, doing our voice of customer work with all the different stakeholders that, you know, we identified earlier. And then once we moved into this facility here in California in the May timeframe in 2022, essentially three years and a couple of months. months later, here we are talking about getting ready to submit later this year. It's really been a

remarkable journey, very fast, considering we started from scratch with every component of our system. Yeah, yeah. These systems are like not for the faint of heart, right, to develop. It's not like you're not to not to underappreciate like a catheter, right? But when you're dealing with, you know, a full system, that's a different, different beast. I love the description. It's not for the faint of heart. I say that to a lot of people that say, hey, well, I'm thinking about getting into being a startup CEO, it is not for the faint of heart, right? Yeah. But you are right.

I mean, designing catheters from scratch, systems from scratch, software from scratch, all the different things that we're doing, the imaging capabilities and all the different designs that go into that. It's been an incredible journey. Yeah. And I give, you know, my team a tremendous amount of credit, you know, led by Patrick and Danielo. And the team that we've built here is just first class.

And they've done a wonderful job. Yeah. And I definitely want to circle back around here later in the conversation to your point about having the right investors around the table because, you know, we obviously that's a key usually a key discussion point in a lot of these these interviews from Medsider. But I mean, it does speak, if you have the right investors, especially early on, it does allow your team to move. I would already get a much, much faster pace. So we'll maybe dive into that in a little bit more detail. But again, Evidencevascular.com is the website. If you're listening to this and don't get a chance

to get to the write-up, evidentvascular.com, we'll link to it in the full write-up. But for that said, first question I'd like to kind of dive into a little bit deeper and deeper detail with Howard is is on really device development. Right. So you've been, you left Boston Scientific, you know, spent 20, a little over 20 years ago, then went into, you know, various, various startups had a couple exits with Intact and Vesper. So you know, and especially at early stages. So you know kind of the challenges of trying to do a lot with a little, right? and those kind of working through your early concepts and alpha and then moving on to beta, et cetera. So give us a sense for maybe your key learnings over the years and how to basically move fast or ideally move fast with not a lot of resources in those early years. Yeah, it's a great question. I think it's the old adage, go slow to go fast.

And at the very beginning, what I mean by that is we took our time to really assess the market because, again, we started with an idea. This is a true back of the napkin. and startup. We didn't have a prototype that we approached Vansana with. They approached us with the idea and the initial funding, and then we went. And so we really spent our time from the ground up assessing the market and just doing all the basic things that you need to do to address what it is you need to do to come up with a unique design that's differentiated. I think the first thing we did, and it's something that's innate to me growing up in this space. And I've got such great relationships with some of these physicians that you and I both know, Scott, that I've known well

since 1993. The first is surround yourself with a fantastic group of KOLs and collaborators that are really enthusiastic about the idea of what you're doing, and they want to collaborate along every step of the way. And this small group of physicians really helped us, and that was absolutely paramount. And they were very much instrumental in the early stage development of evident with every single thing that we developed. And the other thing I would say from a lesson perspective was to go, you know,

go slow to go fast is we made our decision very early on of what's going to go into the first gen product because you know as a as a product that has software and other bells and whistles it's very easy to have scope creep and so we made decision very early on what truly would go into first gen and we were maniacal about prevention of scope creep i've seen too many companies and technologies in my lifetime spin themselves into a hole and then become paralyzed because they don't don't know how to work their way out of their problem, but we were maniacal from day one. And I think that was one of the biggest things. And what we did within all of that, we spent the first year really derisking as many technical hurdles as we could. And then when we got to certain points where we

were developing true value creation milestones, where you can physically see things that we were building, that really put a lot of wind in ourselves. You mentioned a couple, a couple like really good points, but a few that sort of resonate with me is really that you touched on kind of the KOL team. that you surround yourself at those early stages. So, so crucial. I mean, I'm actually looking at your team, right? Aaron Armstrong, Vanita, Chandra, Jay Matthews, you know, Peter Snyder, Eric. I mean, a lot of these folks are on our side of Fast Wave, too,

but it's so, so crucial to find, not just like the big names, right? But if you can kind of find folks that truly have influence, but also are willing to roll up their sleeves and really dive in and respond quickly. I mean, those are the types of people that you should be, yeah, you should be looking for, you know, those early stages. That's really it. And the other element to the layer of the selection of the individuals is growing up in the old vascular grizzly veterans, understand the Meditech Division of Boston Scientific was the original name before they turned it into into Perlval

interventions. It was important to me growing up in the multi-specialty turf wars that used to, and still to some degree exist in Perferal. I wanted to have representation from all the three different specialties from IRs to ICs to Vasco surgeons and also diversity in where they practice from a hospital base, academic, private, and also OBL ASC. And so we had that diversity from the very beginning. And that is incredibly important for this technology we're developing, but also just their different experience with utilizing Ivis. And so all of that brought it together for us. Yeah. I mean, it seems like a really balanced team. I mean, I see Eric, as can see John run back. Yeah, I mean, this is like a who's who in the peripheral space, but all really, all really good people,

all really, really sharp, but also, you know, hard, hard workers out a lot of value. Yeah, and incredibly responsive. Yeah. And passionate about what we're doing. Just all of them have been out here, you know, very early on, which is, you know, I think important for CEOs, at least that I learned early on, is I had each of them address the team early on in our journey. You know, before we even moved in here, and there were just a couple of us. And then, you know, we're now up to 30 people.

I would have each of these individuals, each of the physicians come in physically, talk to our group, talk about the cases, talk about the impact of Ivis to their patients and why they need a new, you know, innovative solution. And that created just a very strong foundational aspect to our culture here at this company. That just developed organically from these types of things. And they're all very committed to that. And I love that. Yeah, that's a really smart approach, right?

to not just have the relationship be sort of one-to-one, like meeting you and the KOL, but also introducing them to the broader team as early as possible. That's a really smart, really smart play. I want to get on the next question I have for you, but really quick on scope creep, that's so tough because it's easy to talk about in retrospect I often find, right? It's like sort of revisionist history, but like when you're in the throes of trying to make, you know, decisive decisions, you know, and you're surrounded by really smart, like technical engineers, like it's very easy to like, you know, let's try to do all of it in essence, right?

And but your point about being like going into certain decision making process, knowing that you're going to likely encounter that and you're going to have to say no, I think it's just, you know, it's really prudent advice to anyone kind of who's operating in those early stages. Yeah, I mean, I started saying no is a complete sentence. And so, you know, I heard that on some podcast somewhere and it just really resonated with me. But I do think back to my years, you know, I spent, you know, several years in sales and then went into marketing in 97. And I didn't know the first thing about product development and all the different things that marketers went, that came from sales went in.

And you learned these things over time. And I've been scarred so many times of just, no, let's just add this one more future. Let's just add. And with this technology, I really sense that that was a danger zone for us. And it wasn't also just our very talented engineering team. It was also our very ambitious. an enthusiastic scientific advisory board, right? Well, what if we did this? Well, what if we did this? I said, yes, we can do these things, but not in the first gen. Yeah. Let's put together a very legitimate pipeline and idea creation for what we can do down the road. And you can get to that, but you've got to be maniacally focused. You have to have that North Star and really point to it. And it's hard. It's really hard to do that. It's easy to say, hard to practice.

Yeah, no doubt. I got to think that your commercial background, right, sales and marketing. And I say your background, but I mean, I get the sense that you're still very much like in the weeds close to the customer, which I think is arguably, you know, most important regardless of your background, whether you have a deep engineering background or more of a commercial background, staying as close to the customers as possible, allows you to know whether or not something is really going to move the needle, another feature, you know, another, another, another bit of this is really going to move the needle. Or it's just going to be kind of a nice to have that's going to add unnecessary distraction, right, when you need to be nically focused, as you mentioned. Yeah, I agree 100%. Yeah, cool. Let's move on to the next topic, which is really around capital, capital raising. And we kind of hinted at this earlier, but, you know, this spin out of Vincana. Obviously, Vincana is a really strong MedTech VC, maybe, you know, kind of top tier, really. I think most people would put them in that in that category.

I know Justin and Cynthia, specific, you know, really, really sharp investors. Obviously, that's helps you, right? Move it at a certain cadence. But talk to us a little bit more about just your experience, fundraising. maybe if you want to frame that up with evidence specifically or even prior, you know, your prior roles at Intact and Vesper. But, you know, this is arguably one of the hardest, you know, or maybe highest hurdles, right, to cross for any early stage, you know, med tech company is, you know, kind of

extending your one way, right? Keeping enough capital in the bank to kind of hit the next milestone. So, you know, what are you, what are some of the things that stand out, right, based on your experience, kind of on this topic? 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.

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