Medsider: Learn from Medtech and Healthtech Founders and CEOs - Building Fast Without Cutting Corners: Interview with Excision Medical CEO Greg Walters

Episode Date: January 21, 2026

In this episode of Medsider Radio, we sat down with Greg Walters, co-founder & CEO of Excision Medical. Excision is developing a leaflet modification system to enable lifetime management of aortic stenosis.Greg has almost 40 years of experience in cardiovascular devices, holding leadership roles at Kensey Nash Corporation where he led the development of Angio-Seal and several endovascular programs. He later co-founded Essential Medical, which was acquired by Teleflex in 2018, and is an inventor on more than 75 U.S. and European patents.In this interview, Greg discusses why early-stage teams should build to learn rather than to impress, using functional prototypes to generate real feedback and fundraising momentum. He outlines how disciplined safety work — not perfection — defines first-in-human readiness, and what makes a pre-revenue company attractive to strategic acquirers. 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 Greg Walters.

I think the first thing I learned in early startups is that you have to create a prototype that works in a challenging test bed as quickly as you can, right? You know, whether it's you're pasting together, catheter tubes, tiny little pieces, you know, things that you're buying at Home Depot, whatever it takes, you've got to demonstrate the concept in some sort of challenging and but relevant environment. And the best that you can do in the very beginning, it's not going to be an animal study, right? it's going to be some sort of physiological test bed, right? The right thing to do, always in my mind, you know,

do your best to create a workable prototype, test it in a challenging physiologic environment, and then, of course, it's sort of, you know, it's a shuffle step from there. 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 Greg Walters, co-founder and CEO of Excision Medical. Excision is developing a leaflet modification system to enable lifetime management of aortic stenosis. Greg has almost 40 years of experience in cardiovascular devices and has held leadership roles at Kenzie Nash Corporation, where he led the development of angioceal and several other endovascular programs. Before excision, he also co-founded Essential Medical, which was acquired by Teleflex in 2018. He's an inventor on more than 75 U.S. and European patents. Here are a few

topics we explored in this conversation. First, how do you know when you've tested enough to move forward without over-engineering or under-preparing? Second, how do you structure first in human studies to maximize learning while minimizing risk? Third, how do you know when you have enough IP. And last, what does commercial readiness actually mean for a company planning to exit pre-revenue? Before we dive into the full episode, I think you'll want to check out MedSider courses. These new eight-week courses are designed to help you learn winning formulas from world-class CEOs. Medsider courses cover topics like fundraising, device design and development, clinical and regulatory strategy, commercialization, and M&A. Each course covers hard-earned lessons shared by

the MedTech founders and CEOs who join our program. Medsider courses can be purchased individually, or they're included at no additional cost with the Medsider All Access Pass. You can explore Medsider courses at Medsider.com forward slash courses. Again, that's Medsider.com forward slash courses. All right, without further ado, let's dive into the interview. All right, Greg, welcome to Medsider Radio, formally.

I appreciate you coming on. Yeah, hey, my pleasure. Love it. Yeah, very much looking forward to the discussion, especially with the kind of the Pennsylvania startup MedTech Mafia, right? You're like right there in the mix. of like a core group of really good people. Actually, it's a really nice ecosystem here.

So there isn't anything we can't do and anything that we don't have. So maybe others don't think that the Philadelphia area should be on the map from a med tech perspective, but there's a lot here. You're dead on, right? Like, it's very underappreciated. I don't think most people realize like the number of companies and really startups, too, that are kind of burgeoning out of that area. So a lot of good engineering talent for sure. Yeah, there's no question about that. Yeah.

Well, cool. With that said, I recorded a very short bio at the outset of this episode, but I always like to start here. Kind of give us a one, two-minute kind of pitch on your background leading up to the current rule. Okay. Well, look, I'm mostly a development guy, right? So I'm honestly a reluctant CEO. It's come my way just because it's something that was necessary as we, you know, as we created companies and progress. You know, I started working for General Electric. I transitioned into at Kenzie Nash did 17 years at Kenzie Nash, did a whole ton of endovascular programs there. Most importantly, in my beginning years at Kenzie Nash, I did development work for Angiosil.

So I was there for the approval of the eight French device, did work on the 10 French device, and then ultimately helped commercialize the six French product. And, you know, Angiaseel is just a, it's a big product out there. And that was just a really great experience. then went on and did seven endovascular programs at Kenzie Nash, which then ultimately landed with spectronetics, ultimately landed with Phillips. And then 2009, I resigned and went off to create a better angiosil, which was sort of bold because angiosil was such a dominant product, but had a lot of good ideas and there was a lot of patent opportunity. And I know patents is

one of your questions for later. So had a great opportunity to do a step. start up from scratch. I mean, literally took $20,000 out of an account, bought a computer, sat at a cold desk, I mean, this is like no lie, sat at a cold desk shivering in my coat. My son asked me one time on what wasn't a Zoom call at that time, right? He's like, why are you shivering? It's cold. There's no heat in this place. Turned that into about a nine-year run. We turned, you know, just starting from nothing into two, uh, two, great products, which we sold to Teleflex. One was called Xeel and the other was called Manta. I sold that to Teleflex in 2018. So, you know, now by about that time, I'm 30 years or so

into the cardiovascular space. So been doing cardiovascular work for 38 years now. So pretty, you know, it's just a really fascinating place to work as an engineer and I've always been a development guy. So anyway, back to the reluctant CEO, as I started Essential, I really never thought I would continue to be CEO. I just, that was just how you got started, right? But it kept working out. And then after Essential, I took a two-year break and my wife took an international assignment in Vienna. So we really, we lived in Vienna for, well, three and a half years by the time it was all said and done. super great experience and really nice to have that break.

And there is, you know, I think there's some advice coming up in some of your questions later. And one of those is to make sure you take a break and figure out what you really want to do, right? Came back from Vienna started Excision. And we've been doing that for about four years. And so we've got a great suite of RF-enabled products that are capable of structural heart modifications. And we're working to get those in the clinic as quickly as we can. Ironically, I'm back in the space that we created for Essential that now occupy as excision. And that's a really cool story.

And that's my work history in three minutes. That's actually a really good overview, right? I'm looking at your LinkedIn profile, right? We'll link to in the show notes for this interview for those listening. But like you did a really good job of like very quickly kind of working through a, you know, 30 plus year career. Right. I realize that everybody's really interested in the hour-long version. Yeah, yeah.

I mean, for a bit of a cardiovascular geek like myself, I just think it's fascinating, right? I mean, we could probably spend a long time just kind of talking about like these moves, but just even even Ango Seal, right? The fact that it's still used so predominantly in, you know, Kath Labs, not just in the U.S. across the world. I mean, that's just like so. I lost track of the numbers, but it has to be a, it has to be a multi-billion-dollar product. over the years. I mean, it has to be a couple of billion, close to five billion maybe with

30, 40 million implants. I mean, it's up there. Honestly, what's cool is I, you know, as I think the company that we, that we started or that, you know, did the original development work still has a hand in the supply of the product. And that's really cool. And honestly, all of that is here in the Philly area. And, you know, there's a lot of local entrepreneurs around here that we have to thank for that. Yeah. It's just part of this great ecosystem. It really is. It's cool, especially kind of against the backdrop of right of like this kind of renewed kind of interest in reindustrializing like the US. It's like a lot of the, a lot of this stuff in the in the device arena is it's still here, still very much here, right,

those supply chains. So it's kind of cool to see that. Yeah. You know, I had a really good experience with the Ben Franklin Technology Partners group. It's a Pennsylvania based funding. It was my first source of funding. And, you know, if you ever go in there or, or if you ever get a chance to look. I mean, you walk up the stairs into the place and you see the, what has to be 600 companies that have gotten their start with Ben Franklin funding. And it's kind of state-based funding. And it, you know, it is a little bit about that keep it here in Pennsylvania.

And we did that. So it was a pretty cool experience. That's cool. And so you mentioned excision, right, is in the same physical space, right? Is that what you meant as essential, right? Which is central sold to people were tracking, essential sold to teleplex. I am literally sitting at the desk. I assembled 10 years ago.

No, we're kidding. It's a crazy experience. Is there heat this time? Maybe that's the best question. There's heat this time. Yeah. I've got this little heater under my desk. It's like the evolution of a startup guy, right?

Like, you know, on to your second, third startup now. You've got heat. We've got heat finally. When I started at Kenzie Nash, I was probably the 11th person hired. And, you know, that was just such a great experience in terms of, of both living the startup life. And there's something about being an entrepreneur that you either like it or you don't, right?

And that's probably another question for you later. But, you know, I really love sort of the casual, let's roll with it environment. And, you know, Kenzie Nash was that for a long, long time, you know, until you get bigger. And then when you get bigger, then it gets less interesting. Yeah, yeah, no doubt. Just a remarkable experience.

And again, you know, shout out for all the principles at Kenzie Nash just, you know, they gave me and 300 other individuals just this terrific life experience. Yeah, yeah, and we're chatting about, which I now have been able to do for essential and for excision. Yeah, yeah, look, it's hard to sometimes hard to, hard to truly appreciate like early on in your career, right, those types of, those types of people, right, and then until 10, 15, 20 years or late, you know, it's like. Yeah, my, I thought I was crazy on all three career transitions. Right, right. Well, that said, you mentioned, you mentioned excision, right? And the website is excisionmed.com. We'll link to it in the full, the longer form article on Medtider, but

excisionmed.com if you want to check out the technology and the folks behind it. But it's, you've got this RFs enabled kind of suite of suite of devices for Taver. So for those that aren't familiar with Taver, kind of maybe zoom out and give us a sense for kind of what, like, what's the core issue at hand, right, that you're trying to solve? And then maybe tell us a little bit more about the devices? So the core issue is aortic stenosis, right? So aortic stenosis is a giant problem in pretty much every population. And the biggest solution to that, it started with surgical valve replacement, right?

Because you just can't fix the leaflets, they calcify, they fibrosse. And then ultimately you have to do something about the valve. So for years and years, it was a surgical approach that's called SAVR, SABR. then taver was invented, and that's the percutaneous approach where you drop a valve into the aortic position to take care of the aortic stenosis or the aortic regurgitation. And it has been revolutionary, right? So it's, you know, again, it's, there's probably 130,000 tavers a year, probably somewhere around 50,000 savers a year, maybe even more. I'd have to check my numbers on that. But, you know, you have, you know, just a ton of patients that really need this type of therapy.

But what really has begun to happen is that both the saver valves and the taver valves aren't lasting as long as patients need. So that the therapies become so successful that younger and younger patients are getting the therapy. And then there becomes the problem of what's the lifetime management of aerotic stenosis. And so now physicians are starting to plan for not only one redo, but two, redos. In other words, they'll drop a third valve. So it becomes like sort of the nested Russian doll thing. So that has become more and more possible. So we're sort of, we hit the first wave of taver, and now we're hitting the second wave of what they call valve and valve or tab and taff and saff, right, because it's a taver valve and a saver valve. You have to do a taver valve in a prosthetic saver valve

and there, anyway, there's details there. But what we do then, is there becomes the need to modify the leaflets, right? So one of the requirements then when you put a secondary taver is in is that you may have some difficulties with coronary artery collusion or some other complications that are associated with putting a secondary valve in. And so there becomes the need to do leaflet modification. So our company lives in the world of leaflet modification and we also live in the world of treating Hocom patients

or patients that have hypertrophic coronary myopathy. And it's because we started in the world of excision, that's why we're called excision, by removing a piece of the leaflet prior to doing a secondary tavern. We've pivoted to doing laceration. And in the understanding of our capabilities and our technologies, we've also taken on a project of treating Hocom patients. And both of those are really RF-enabled structural heart modifications. That's probably a lot, but ask details if you want to know. I'm tracking. But if I had to sort of, like, like sum this up. In essence, you're trying to modify the valve, make more room for a new

valve to kind of be placed or inserted in essence, right? Yeah. Yeah. I mean, yeah. Making room, you, you know, reduce the risk of thrombosis. You also reduce the risk of coronary artery collusion. Yeah. And honestly, if you think about it, it all dates back to when Taver first started, right? So in the beginning, the expectation was, is that you needed to remove the leaflets before you put in a pertinent valve because it's what the surgeons do, right? But that really never happened. And the whole world of Taver evolved without modifying the original leaflets. So honestly, this whole thing's going to go back around to the modification of native leaflets. Got it. Super interesting. I'm aware of a couple other, a couple other startups in this kind of generally making the space of

making room, right, for, I'm not sure if the technical word for, let's, you know, tafer, taflit modification, if you will. If you don't have competitors, you probably don't have a market. Yeah, exactly, exactly. Yeah, but is it, I mean, do you feel like there's, there's more and more, there's the kind of accelerating kind of activity in this, in this space? Yeah, of course. I mean, I think, you know, and honestly, we're not the first. We're not the first purpose. We're kind of the fast followers. So, you know, that's probably a question for them. Yeah. You know, but the truth is, is there, there are definitely several companies in both the, you know, leaflet modification space and in the treatment of Hocom patients or cardiomyopathy patients.

Got it, got it. Yeah, and I think you brought up a good point, right? And that's the reason I ask is I want to give people a sense for like this is like it's a burgeoning kind of field, right? And this need, you know, for second and third valves, right, these patients is, you know, is getting larger and larger. Yeah. And what's cool about it is it's an evolving market.

But what's challenging about it from a fundraising perspective, which is, again, probably going to be one of your questions is just what's the trajectory, right? So it's sometimes easier as a startup to step into a large market that exists, but then you have to, obviously, you have to deal with bigger competitors. And in the case of starting where a market is just evolving, then there becomes the endless, you know, modeling of what the market's going to do. Yep, got a good, healthy kind of framework to get to look at things. If you're in the, if you've got an idea, right, that you're considering kind of going on all and on. So with that said, before we jump into kind of the meat of the rest of the conversation, here. Give us a sense for where the company's at. You're four, four years in. We're recording this in

Q4 of 25 for someone listening, you know, six months down the road. Like, where, where are you at? Are you, you know, clinical stage? What, where's the company at? We should be in clinic with the first product in this quarter and then we should be in clinic with the next product in the next quarter. Okay. So, yeah, so we, you know, one of your questions I think is, you know, hey, you know, what are you looking forward to in the next 12 months? And for us, it's really, it's really turning the quarter into the clinic. Yeah, yeah, that's a fun. That's a really fun stage to see, you know, four, four plus years of kind of thinking and developing and iterating, you know, finally, finally make its way into the, into patients. One of my, you know, one of my focus is to make sure that

we've done so much work ahead of time that we're not going to be surprised by the clinic. So fingers crossed, right? Yeah. Well, cool. Let's jump into the kind of the, what I would say, kind of the more the cross-functional, you know, series of cross-functional questions, right? kind of that really all point to your experiences, not just even at Excision, but even prior, right, at Essential and even at Kinsey Nash. But again, for everyone listening, excisionmed.com is the website. We'll link to it in the full write-up on Medsider, but Excisionmed.com is the website. We'll also link to Greg's LinkedIn profile too. So first question off the, off the, I guess, just to kind of start here is early stage development,

right? And this is clearly in your wheelhouse as an engineer. And I think is oftentimes the most challenging, right? It can be really fun, right, if you're into this stuff. but also really challenging because you're trying to scrap and find capital, right, and you're still a ways out from hitting meaningful milestones, basically try to do a lot with not very much, right? Not pretty lean resources. So when you think about your 30 plus years, right, of basically doing this,

what are some words of wisdom, right, to other founders, other CEOs that are kind of in those early stages, right? There may be a, there's still a year or two out from clinic and are trying to make really good progress on the development, but, you know, again, with not a lot of of a not a lot of cash at hand. Yeah, well, you know, like there's endless things to talk about there. And then I'll just give a caveat that I'm happy to provide advice, but it's not all perfect. And, you know, the truth is, is that the circumstances are really relevant, right? So I think the first thing I learned in early startups is that you have to create a prototype that works in a

challenging test bed as quickly as you can. Right. So the whether it's, you know, whether it's your, pasting together, catheter tubes, tiny little pieces, you know, things that you're buying at Home Depot, whatever it takes, you've got to demonstrate the concept in some sort of challenging and but relevant environment. And the best that you can do in the very beginning, it's not going to be an animal study, right? It's going to be some sort of physiological test bed, right? So the right thing to do, always in my mind, you know, do your best to create a workable prototype, I test it in a challenging physiologic environment. And then, of course, you'll, you know, it's sort of, you know, it's a shuffle step from there, right?

You improve the model, you improve the device, you improve the model, you improve the device. You improve the model, you improve the device. And then at some point in time, you go into an animal model, right? But the animal models aren't perfect either. So you have to be really careful about what animal model you're using, what it tells you, because you could steer you wrong, you can steer your right, and you have to be careful. about that. And so it's really this sort of iterative loop that you have to get to as quickly as possible. And the truth is that sort of raising funding is, you know, it's sort of pretty, pretty possible

just on your credibility or your understanding to maybe put together $500, a million on a concept, on a patent. But if you want a couple million dollars, you're going to have to demonstrate a prototype in a competitive or rational model, right? And then by that time, hopefully you have a credible enough team around you, even if it's one or two or three people, right? It's sort of like you've done this before. My, you know, the good luck for me was that really nobody doubted that I could create a better closure product or an evolution to the closure product because I'd spent six or eight years doing it, right? It then became questions of market and other, other barriers to entry. But either way, what I learned early on was, man, you got to make a, you got to make a model. You

got to show a prototype and cute videos and cute slide decks, not such a good thing. I like the analogy that you use of shuffling, right? Because it very much feels like that at the, I mean, it feels that way a lot, right, throughout the lifecycle of the startup, but especially in those early days, right, of kind of shuffling from one land duration to the next. The prototype sucks and the model sucks and the prototype's better and then the model's better. And then eventually you get to the point where you're like, I think we got it. Yeah.

And I can tell you that in both products with Essential, I can tell you exactly when I knew we had it. Right. And I feel like with where we are with Excision, I feel the same. It's here or on the horizon shortly. Yeah, yeah, got it. I know David Sacks with, I think most people are familiar with him to the all-end pod now, but like, you know, mostly known as a software entrepreneur now at Kraft Ventures. But he kind of, I heard this maybe, gosh, it feels like a long time ago, five, 10 years ago,

where he was, he popularized this framework as a VC of like, and granted, this is within the world of software, right? Where I don't show me a deck. I actually won't see the product in essence, right? And I think to your point earlier, that's so, so important early on is, yes, you may be able to like, you know, work in, you know, some sort of like animation or whatever to help people kind of better understand it,

but getting to an actual prototype that's semi-functional in a model is so, so crucial at those early stages. Yeah, well, I can tell you, you know, if you read the room when you do these pitches, right, you get the, you know, you get the yawns, you get the people looking around, people looking on their phones, and then you show a prototype. And everybody's paying attention. Yeah, that point holds true even, even at later stages, right, where maybe you're pitching for your series B or your series C having something to show beyond just slides. You know, look, I'm heading the TCT with

prototypes in the bag, right? Yeah, you and me both. You know, not, you know, not prototypes, but legit thing. Yeah, yeah, yeah. It's so, yeah. So, yeah. So I think that's just a, I, a really important thing to highlight is like, you know, people always want to feel in touch, right? That shows so much better than, then, don't get me wrong. I love pretty slides, though. I love those, but the physical item is just believable.

Yeah, yeah, no doubt, no doubt. You know, sometimes it's just a reduction in practice, right? It's just that this is how we're going to do it. People getting it and then seeing that you can make it, right? And then honestly, I can tell you that one of the things that's super compelling for us is when you can use that prototype in a physical, logic model and you can have people come and they can. So I have docs come routine. It feels like they're in a cath lab. They feel like they're using it on a real patient. And to them, it's compelling

and believable. And not only is it compelling and believable, but then it also creates a setting for me where I can get their feedback that I can actually trust, bang on and utilize, right? Because it's a real enough environment. You're like, I get it. You're absolutely right. Yeah. That's the important bit and you should use your first money to do all that stuff. And that's what we did. I think, you know, yeah, I mean, in both in both cases, you know, you raise half a million dollars or something like that. And that's exactly what you do with it. Even just kind of framing it up with like hard numbers, right? That first call it 500K to a million dollars. If that's not your own money and you, you know, you're kind of considering that pre-seed money, it should be mostly allocated towards that.

Because if you're going to go out and expect to raise another three, five million dollars in a seed or maybe even a kind of a pre-A, you're going to have to have something like that to show off, in essence, right, to start attracting, you know. I think you have a chance of getting the next level. Yeah, yeah, no doubt. Yeah, those chances are a few and far between if you don't have something physical. Honestly, the environment's challenging for fundraising, but as far as I can tell, it's always been. I know, I can't remember a time when someone's like, you know, it feels pretty easy, you know?

Right, right, right. Yeah, right. Somebody said, this is a piece of cake. Yeah, yeah, yeah. I don't know. I was able to raise 10, 20, you know, in a week. Yeah. So that said, let's talk a little bit about Clinreg, right? And, you know, you're on the precipice, right, of going into clinic, but you've got a lot of experience kind of with both class two and class three devices. And so various kind of pathways forward for each of those. What are maybe some, when you think about

kind of what you know now, right, about the stage of kind of getting into early feasibility work and how that maybe translates to later stage pivotal trials, what do you know now that maybe wasn't as obvious, right, 10, 15, 20 years ago. Yeah. Well, I think you have to do it stepwise, right? So, and it's kind of the lecture that I have for the team now is that you really have to, you're first in man, first in human studies, they really have to be rational. They can't be all comers. They have to be really selective. We need to learn steadily. We need to make sure that we don't lose the technology and the, you know, in the onslaught of trying to enroll patients that maybe aren't applicable, right? Because every technology has a place where it works. And the worst thing

you want to do is take a technology and try to test it in a place where it probably isn't going to work and, you know, cross your fingers for the best. That's kind of dumb. You really need to make sure that you select those first patients. You need to make sure that you control the protocol. You need to make sure that you're really good with the training. You need to make sure that you get face time with the physicians, either in a physiological model or in an animal setting, cadaver setting, whatever it might be, and make sure that your physicians are trained and well-versed. The biggest harpoon for clinical studies is, you know, patients overestimating their experience or understanding of the device

and getting a wrong patient. So you just have to fight to avoid all that. And in the rush to get into the clinic, there is a lot of forces that will, you know, that will overcome that resistance. There's someone that's, I won't name his name, but pretty well known in our space that I read a comment, I think it was maybe even just the week that said, something along the lines of your device has to be perfect, right? I'm not going to, before you get into clinic, I'm not going to, it has to be, you know, good enough that I would put it in my own mother as an

example. And I, and I, maybe there's some, some additional context there, but I read that and I was like, I don't, I personally, I don't know if I agree with that, right? Don't get me wrong. It's got to be, it's got to feel, there's got to be a degree of confidence, right, getting into patients, but you're also at risk of, you know, waiting too long, in essence, too, right? And so how do you think about that dilemma of wanting to sort of over-engineered an early-stage device so it's, it's, quote-unquote, perfect versus being able to get into clinic? Hey, everyone, let's take a quick break to talk about Fastwave Medical, the company I co-founded and lead as CEO. We're developing next-generation intravascular lithotripsy or IVL systems to tackle

complex calcific disease. In 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 by Boston Scientific in 2025, and Johnson & 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's a really interesting and unique challenge. I mean, I think you also have people on your team that are, they want to have the ultimate and then others want to get on with it.

And so there's always that sort of to and fro, even on a team. The way I look at it is, is that you, as long as it's safe, right it's the grandmother it's not not unlike what you mentioned with your mom you know if we're comfortable using it our grandmother where it's safe then we're good now we also may be using a variant that could be better but we need to learn and there's no there's no harm in learning as long as we're in the safe zone so you know personally that's where i land and you know honestly i think physicians and execs or regulatory folks, well, regulatory folks are never, ever on the cutting edge, right? On the conservative end. And so you listen to them and then you try to push it a little,

but you never, you never want to be in a position where you think you could hurt somebody. Right. So, you know, I mean, we're in the business of making things better. We're not in the business of making things worse. So there's no question we're not starting anything unless we're you know, unless I'm 99% confident that we're not going to hurt somebody. Right, right. That's a really good way to kind of like position that. Because it is a very real challenge, right? And there's always going to be hesitancy across the team of getting into a clinic for the first time. Well, and then, you know, and then there's also then the ongoing dialogue or discussion about where do you do, where do you do studies? Do you do them

offshore? Do you do them in in Georgia? You do them in South America. Should they all be in the U.S. and there are various burdens at various countries, various regions. And, you know, again, I think you have to pick, choose, make sure that you're doing the right thing for the technology you're thinking about, and just make sure that you're doing it safely. Your point around having a very high degree of confidence that it's safe, but could it, could it be more efficacious? Could it work a little bit better? Yeah, probably, right? But the biggest issues, nailing safety. Yeah, and then, you know, I expect tweaks, but I don't want to failures. Right. Yeah. So that's one of the things that, you know, I would say, too,

about anybody trying to run a development program, one of the best ways to make sure that you ever, that you get to the point where you feel like it's safe and that you, you know, maybe you need some tweaks, but, but you've largely solved the problem is that you've spent so much time in your physiologic models, right? So if you think about it, I may, I may get 100 patients or 200 patients ultimately, but my first in human is going to be five or 10, right? Animal studies, you're going to be at a 20 or a 30, right? But before I even get to animal studies, I want to have 500 or 1,000 in a right setting and a right environment where I can control it. I can see it and I can watch it.

And when you do that, I think it improves your probability of each of the next stages and ultimately gets you. Now it might take you a little longer, but it ultimately gets you to, I'm safe with my grant. Yeah, yeah, that's good, good stuff. I guess before we get to fundraising, because I want to get your take on that topic as well, when you think about geographies, right, to do some of this early clinical work, whether it's a true kind of first in human or if maybe you graduated a little bit more like a pre-pivotal kind of feasibility study, do you have any thoughts around geographies now? Like, do you like Eastern Europe?

Do you like Australia, New Zealand, South America? What's your... Well, I like any place that's close and there isn't one. And, you know, we're currently, we're currently heading to do some work in Chile, and then we'll follow up with that with some work in Brazil, and then we'll follow up with that with work in the U.S. and Canada. You know, ultimately, at the moment, it's so complicated in the EU, or at least it's as complicated in the EU as it is in the U.S., maybe more so, that a lot of U.S. companies are not tackling Europe to begin with. And we're like that, too. We're going to be U.S. We're going to be U.S. focused. And so while I'm happy to go to an EU site, I think we're better off sticking to some South American sites before we do some work in the U.S., in an EFS or in special access in Canada. So those are the options available to companies, and you have to kind of weigh them, right? Yeah.

You got to weigh them on a, well, where are we? Where are we with our view on safety? And where can we get some early learning that is valuable? But ultimately, you know, you've got to do a pilot or a pivotal in the U.S. Yeah. Let's transition to the topic of fundraising. My notes show that your Series A was fairly recent. I'm not sure if you can disclose that or want to put a little bit of context to that,

but it looks like it's roughly about $11 million series A. You've got a lot of experience, right, in the world of funding, especially early stage companies. How do you think about whether it's, you know, this newer trend, right, of approaching strategics to invest off their balance sheet and kind of more of a bill to buy model versus the traditional route of going to early stage of BCs. We both know that there's not a lot of those VCs anymore that are going to invest in, you know, in C, series A,

maybe in series B rounds, right? The goalposts keep moving back a little bit. But give us your take on kind of your thoughts about fundraising today and really any words of advice for other CEOs that are kind of in the throes of this, the drunk tackle the run run. Yeah, I think honestly raising money is constant, right? So you're always raising money. And I think if you can raise money with a strategic, I think that can help.

It's always better if you know ultimately what is really needed by the market or really needed by an acquirer. So it's great if you can have a global strategic partner, and we do. So we have a global strategic partner, which I value a lot. And it does take the pressure off of what you need to do with a VC because you're right. the VC horizon is just shifted from, we'll bet on anything, so we're not betting on anything until you've actually had 30 patients. I don't know a world where you get to 30 patients or some number like that without a pretty significant investment, at least in the med device space, right? So then, you know, that leaves you with a really significant bridge from sort of your

early round of investing, which is probably convertible debt or friends and family. redo it, right? But you know, you're, you can stretch the convertible debt into the million to three million range. But after that, it's, it's a bit of an overhang for a business. So, you know, at that point in time, and that isn't necessarily enough, depending on the technology, that isn't necessarily enough to get you into a first in human study or certainly appreciable patients, right? So there needs to be something to bridge the gap. Strategics have done that more and more, at least in at least the way I see it, that's probably happened a lot more in the last 10 years.

But the truth is that you're going to take money where you can find money. Yeah. Yeah. Always be raising is a very, very real thing, I think, especially now. But you made a really good point around who strategics have, I think, for the most part, done a pretty good job of kind of filling that early stage gap because the reality is like, you probably talk to the same VCs that I do is, you know, this idea of feeling like they're coming in early.

It's like, yeah, how close are you to five, in case submission or your, you know, your IDE for your Pivotal, your, your class three pivotal. And you're like, that's not early to me, right? That's fairly late, you know. Everybody wants to be the last investor that gets a 5x, right? And, you know, fewer people, fewer people want to, want to take the chance in the beginning. Yeah, yeah. And, you know, VC's kind of, they, spectrum of them and they, they hit that, that slot.

But, you know, it's, it's not a normal distribution. their their bias toward the later investment. 100%. And this is not a knock on VCs, right? They pay an important, a critically important part of the kind of the ecosystem, right? Because without dollars, without their LPs, right, and dollars coming in, it's hard to, hard to fuel this, the, you know, the startups, right, that make or break MedTech. But it is a, it is a, you know, VC in MedTech is a difficult asset class.

Yeah, their job is to pick the best bet and our job is to make the best device. Yeah. And there's an overlap. And when that happens, we appreciate it. Yeah, yeah, no doubt. Let's move to, I want to touch on IP, but before we get to IP, let's talk about exits, right? Maybe kind of, you know, maybe this is largely rooted in your work with, you know, Kenzie going to spectranetics and then maybe more so recently essential to Teleflex. Are there a few key things really that kind of stand out thinking about those transitions, right? Whether in preparation of a potential M&A, right, or even through that integration to ensure the best outcome for the strategic, like what are your, what are your takes there? My general perspective is that we need to, we sort of need to own the supply line. We need to own how the device is built. We need to be in a position where we can provide the product.

We need to be in a position where we can transition the product to an entity sort of at a commercial level, right? So you really have to anticipate that you have to get there. I mean, I do remember very early on. So, you know, again, reluctant CEO thing. First experience as CEO back at Essential. I thought, oh, God, we just had a great animal study. Oh, my God, we're going to get bought, you know. And then, you know, we had another great animal study.

Oh, my God, we're going to get bought, you know. And it just was, it was, honestly, it was just naive thinking, right? I mean, what it really took, I think, was the expectation that we could go it alone as a company. We could eventually figure out how to do this ourselves. We could hire a sales force. We have a great product. We got approval. And at that point in time, that's when it's interesting to an acquirer.

And Acquira doesn't need more headaches, right? They have enough headaches, but what they need is products that fit into their portfolio that are available for their sales bag and enhance their image and their stretch and their presence in the lab. And so you've got to build the product to a point where that's a fit in for them, right? You know, otherwise it's kind of an asset sale. Yeah, that's so important because you hear this phrase. a lot, right? Like, you don't need to build a company so it's bought, not sold, etc. But even in our world,

right, just cardiovascular, so often most startups are acquired pre-commercial, right? That's like very common. It's the cost of the Salesforce, right? Yeah, exactly. And maybe orthos, obviously, I think in ortho, you tend to have to, you know, begin to show, you know, some semblance of revenue. It's a little bit later, et cetera. But the reality is like even if you operate with that framework, right? The most likely, the most likely outcome for my startup is to be acquired pre-commercial. The reality is like you need to be positioning the company to go commercial so it can more easily tuck in right to a strategic, right? The best way to be acquired is to not need to be acquired.

Yeah, yeah, yeah. But that thinking, right, in that mindset of like how. We can do it ourselves and we're happy to do ourselves. We're, you know, fine. I'll go hire a VP of marketing. I'll go hire a VP of sales and we'll figure it out. And it is honestly what we did back at Essential. We're too early for that right now with excision.

But then you get a real sense of what the business is worth when you're selling it sort of pre-revenue. And if that works for the investors, then that's great. Yeah, it's good stuff. All right, IP, you've got a lot of experience in this topic as well, right? With that, I think my notes, I'm not sure if it's even more than this, but 75 plus patents, I think, right? It's a lot, a lot of IP.

You've got a lot of experience here. Certainly have no stranger to patents. Yeah. So, but there's this interesting, I don't know if it's a, if it's a trend or if it's just something that maybe I'm seeing maybe for the first time. And obviously you hear, you know, folks like Elon talk about, you know, IP is for the week, you know, which I think is quite funny. But then, but then you also, there's a lot more, you know, IPR is happening these days, I think, than ever before. And the PTAB is kind of becoming more of a thing to be aware of. And so when you

think about IP for early stage med tech companies, have your thoughts shifted at all here, you know, against kind of the backdrop of some of these trends? Yeah, for sure. I mean, right now it's a really populated space. Like, there's a lot of IP landscape out there for pretty much. I mean, people have been thinking about conventional cardiology stuff forever and ever, right? So the first thing you have to worry about is you have freedom to operate, right? Because there are so many, you know, in our world, if you're doing class two, maybe it's,

but if you're doing class three, IP is a little bit less of a worry because there's just a lot of barrier is to entry. You've got to make a product that really works. You got to make a product that is accepted. You got to make a product that's all the way through clinical study. And yes, it is absolutely great to have foundational patents. You should have something, but they tend to be more. In my experience, the VCs tend to worry a little more about where you are in terms of unique IP, in terms of protection, where practically I don't know that, I don't know that that matters from a commercial perspective, but for sure you have to navigate the freedom to operate, right?

So, you know, as you wander into your development process, you really need to know the landscape so that you're like, well, I'm bringing unique features, and I also am not trampling on anybody else's IP that's going to get me into trouble later. I don't know. So for me, the IP is probably 80% freedom to operate, but I can tell you whenever we have clever ideas,

We're like, that's pretty cool. But then the struggle comes for a startup in just the cost of that. So, you know, if you think about any patent that you file, if you take it all the way through to issue, it's probably $40,000 to $60,000. And then you, you know, somehow you end up with $15. So, you know, we probably have, I don't know, we probably have 18 filings or something like that.

I mean, that becomes then a weighty patent portfolio to manage from an investment perspective. So you really, you just have to constantly. be vigilant about why am I doing it? Does it really matter? What's important? Honestly, the best advice I would give somebody is build the device you want to build. Make sure you have freedom to operate. And along the way, make sure there are some attributes about it that you can patent. But the broad patents are likely no longer an option in an eventual cardiology space. I mean, it's just, you know, you look up any, I don't know, I'm not sure what the number is, but it's probably in the millions of patents that you have to wait for.

Yeah. I think that thinking right around roughly three-fourths of your focus should be on FTO, right, early on, I think that's a freedom to operate. Well, you're dead otherwise, right? Yeah, yeah, yeah. You got to do that. Yeah, yeah. And from a budget perspective, for those that are new to getting an FTO, right,

how should they think about how much money would I need to get a proper FTO for this idea that I want to pursue? I'll tell you, the way we like to approach it is that we're really good at spanning the landscape, doing the searches ourselves. I mean, you can do a search for $5,000, $10,000. You can get a professional search done. And what you then do as a team is you wade through, you know, all of that and kind of come up with two or three or whatever, maybe a family of patents, that you would need some advice on. And then you pay for the advice there. And that's been my strategy.

and that keeps the cost down. And honestly, there's nobody as good as your team when it comes to really reviewing all this stuff. And there's a lot of great content. People explain a lot in patents, and they should be looking at that anyway. So, you know, my sense is you can probably get a reasonable freedom to operate opinion between $50,000 and $100,000

if you do a lot of diligence yourself, depending on the complexity of the space. can't speak to, you know, chemical analysis or software. Whenever I look at those patents, I go, oh, my God, I don't know. I would not know how to do this. But in the device space, I think that's probably not crazy. But, you know, when you start doing, if you have to do that three or four times in a couple of different technologies, you know, it's a little tough when you've raised $500,000 to do a $100,000 freedom to operate. Yeah, yeah, we're 20% of your, your budgets towards that, yeah. Yeah, yeah, it's good. And even with LLMs, I mean, you can do a lot now more than

you ever could, right, to maybe help accelerate some of that, that early kind of searching and analysis, right, of what's, you know, what's in the IP landscape before you kind of go too deep. So that's good. I want to get to the rapid fire portion of the interview, but I think the other point that that really stood out to me that you mentioned is on the service, on paper, it can feel really good. I've got 20-some, you know, patent filings. I've got five patents. But the reality is Like if that's, if that doesn't sort of ladder up to your foundational design, it can be a lot to manage. It can be very costly to manage, right? So I think that's a really good, good point too, right?

That some people, you know, don't think about enough. If you hone in on what you're building, because that's what you're protecting. I mean, at some level, maybe defensive shield, you want to keep everybody else out. But at the end of the day, you've got to protect what you're making. Right. And so soon as you figure that out, the better, which gets to the prototypes and the models and the, right. Right, right. But all right, we'll get to the rapid fire portion

in this interview, but again, for everyone listening that doesn't make it to the full write-up on Medsiter, excisionmed.com is the website. I encourage you to check out the technology that Greg and his team are building. It's really cool, burgeoning field within the world of cardiovascular, kind of interventional cardiovascular. So with that said, first question on the rapid fire docket

is, and you kind of touched on this already, but take us to Q4 of 26, right? What are you most excited about over the next year at Excision? Oh, yeah, well, we should have, you know, multiple patients with both of our technologies, the lacerator space and in the myotomy space with our Hocom device. And that, I think that'll tell us a ton. That'll really clarify what we're doing in terms of our path forward. Should clarify, yeah, should clarify what we need to do with our next level of funding. So next year is going to be all about that. First and human,

then the next round of funding for the studies following that. And there should be just a ton to learn. so we're looking forward to that. All right. Since co-founded the company, you know, even with your prior, you know, startup kind of experience, is there anything surprising, right, that you've, that kind of stands out over the past four years? Yeah, it's funny how I'm reminded again and again and again. And, you know, maybe I'm just not all that smart so that I need this reminding.

But every different setting, every different project, every different device requires a slightly different approach, right? So if you think the last approach worked, it might not. So you really have to be flexible for, okay, what team do I need right now? What do I need them to do? What's the absolute first thing they should be doing? The thing that I tell the guys every day is like, what's your number one? What do you got to get done today?

Because that's what matters most. And that one's never a surprise to me because that's always the most important. But what I find funny is that you think you have the prescription for it. But the world's always a little different with the next product or the next technology. Wise words. All right, take us to maybe an intimate dinner in Philly in your neck of the woods, maybe with 20, 30 other MedTech entrepreneurs. At the end of the dinner, you know, we're maybe serving, you know, you're drinking a glass, last glass of wine or, you know, dessert. And what's the one lesson that you want to lead everyone with, right?

That you feel like they have to really understand to see success in this space. I would say, you know, I would say the thing that I learned the most is that you really, you have to make decisions. you have to wait, make decisions at the latest possible time that you can. Because the truth is, is that in our world, you're making decisions on 70% of the information. And so you have to be comfortable with that. And then you have to look around and go, it may not work. And if it doesn't, we'll adjust. But we need to make a decision.

When we need to make a decision, we need to be comfortable with the fact that we're not going to know everything. Because you can spend a whole lot of time gyrating trying to figure out, the last little detail and when the decision's really staring you right in the face and you just need to move on. But that is really part of this, you know, entrepreneur stuff, part of the, part of the, we just have to try, give it a go and we'll adjust as we go. But we're not going to know until we get there. And that's kind of the frustrating thing, I think, for corporate, I don't want to say corporate types, but, you know, there's a certain personality that really needs to know the answer before you can tell them the answer. And yeah, that doesn't work in our world. No doubt. All right, last question,

because I know we're up against the clock here. Take us back to like your late 20s, early 30s, right? Your career in MedTech is kind of, you know, starting to take off for some semblance of taking off. Anything you'd whisper in the ears of the younger version of yourself? Three things for sure. Make sure you're curious, right? Don't be in a field where you're not curious about what's going on, right? Because the most important feature for me in a hire, is this is a curious person. They want to know what's going on. They want to see everything. They want to understand everything and they want to make it better. And the next thing that you should really do is make sure that you have a variety of experiences, right? So make sure you get a little bit of marketing experience.

Make sure you get a little bit of patent experience. Make sure you work on different programs. And, you know, I was so lucky that that happened in my career. And I think that the last bit is that you really have to network. So even if you're 20, you should have a network. You should have a mentor. It shouldn't be just that you're showing up at your job. You've got a good job. You like your boss, right? No, you need an external to a company mentor. You need to be going to other programs, other shows. You need experience elsewhere because all of those things will enrich your journey and they will directly steer you into a better journey or a sort of a more satisfying position. And without question, they're going to make you more useful to me. You know, I mean, we, and we have this, you know,

locally we have this Drexel engineering program. So shout out to Drexel's engineering program, but also their co-op program, right? So we get a few Drexel co-ops every, every rotation. And I have to tell you, this, just uniquely, these, these students are just, they're remarkable. They get a great experience with us for six months. They, and then they have, you know, several things to choose from in terms of work experiences. And I just think it makes them so much more in tune with what they want to do and so much capable of doing what I need them to do. Yeah.

Yeah, that's really, really, really good point. Those are three things to, to, to pass me. Yeah. Those are really good. Those are three really good points. And I think they're, they're applicable across a lot of different kind of points in someone's career, whether they're in kind of more of a startup ecosystem now or even if they're at a large corporate, right? That doesn't mean that you can't begin to do those things, right?

Find mentors, begin to build a kind of more cross-functional experience, meet more people. Because a lot of those same folks that you're working with now at a Medtronic, at a Boston Scientific, at Name Your Large Strategic, they're not going to always be there, right? They're going to probably move on and it's good to build those relationships and those will likely, you know, grow over time. So, yeah, it's good stuff. Greg, I know you've gotten a lot of prep work for TCT coming up. A lot of stuff going on in your world. So thanks a ton for coming on the program.

This is a lot of fun. My pleasure. This is fun. Yeah. And for everyone listening, again, Excisionmed.com. We'll link to it in the full write-up on MedSider. I highly encourage you to check out the longer form article that will accompany the podcast

on the website that really highlights a lot of the lessons learned that Greg shared with us throughout the course of this conversation. So thanks everyone for your listening attention until the next episode of MedSider goes 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

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