Where we are with Quattro-Close and what we're doing is that we're actually using a method that physicians are still relatively familiar with from some of the products that they've used already. So the procedure, we don't dramatically change it. But what we do do is that we change the way on how the device works to increase the reliability of the device and the simplicity of it.

Hey, everyone. In this episode of Medsider, I sat down with Stephen Belcher, co founder and CEO of Secure Closure. Secure Closure is developing Quattro-Close, a device designed for large bore femoral access sites. Trained as a veterinarian, Stephen has spent more than twenty five years in the medical device industry with deep experience in vascular access and closure technologies. He previously held commercial and marketing roles at Abbott Vascular, Edwards Lifesciences and Teleflex, where he was involved in launching key closure devices including ProGlide, StarClose, Sapien 3 and Manta.

Here are a few topics we explored in this conversation. First, how does the transition from a large strategic to a startup change execution? Second, what actually drives physician adoption in high risk procedural categories? Third, how should established clinical workflows influence device design decisions? And last, what does building momentum look like in early stage fundraising?

Before we dive into the full episode, if you're a Medtech Founder or CEO preparing to raise capital, you should check out the Medsider Fundraising Cohort. This four week live workshop combines small group sessions with real time feedback to help you sharpen your investor story, build a targeted investor pipeline, and run a focused fundraising sprint instead of a never ending slog. Over the month, you'll walk away with an investor ready narrative and deck, outreach scripts that actually get responses, a refreshed LinkedIn profile, a simple content plan that keeps you on investors' radar, and a repeatable system for running your raise. You can join the wait list at medsider.com/fundraisingcohort. Again, that's medsider.com/fundraisingcohort. Alright. Let's get to the interview.

Alright, Steve. Welcome to Medsider Radio. Appreciate you coming on.

Thanks very much, Scott. Really looking forward to the conversation today.

Yeah, likewise, likewise. I recorded a very short bio at the outset of this episode, but let's start there. Give us like a one minute, maybe two minute overview of your career leading up to co founding and running Secure Closure.

Yeah, sure. I mean, it's actually probably a little bit more of an unusual one. I actually started my career as a veterinarian. I trained in New Zealand, graduated at Massey. One of the things there about my vet training was that it gave me a very practical way of thinking about biology, anatomy and problem solving, and I've taken that through my career actually.

After I graduated actually from Massey, I ended up in Singapore. I was in private practice there for a couple of years, and then I moved into human medical diagnostics, working for a Singapore US company, and I spent a couple more years doing that. And then after that I eventually ended up with Abbott, primarily with Abbott Diagnostics, that's where I came to Europe. And then I transitioned into Abbott Vascular, where I was involved in the ProGlide and StarClose vascular closure device launches. Then later on with Edwards, with Sapien 3, and even Teleflex with Manta.

What that really gave me was really interesting because I had the experience of launching products at these companies, but I was fortunate enough to have really a front row seat in all the cath labs and really seeing how the products work in real life and how physicians actually use them. One of the things that stood out to me over those years up to now of being in cardiovascular products has been just how much the minimal invasive and structural heart procedures have really taken off, and all of that innovation though has been mostly at the front end of the procedure, the valves, the implants, the delivery systems. But closure, which is absolutely essential for the patient outcomes, has actually barely changed in that time, And I've watched these physicians, excellent physicians out there having incredibly successful cases, but then often struggling at the end of the procedure, not because of their skills or anything, but simply because the tools they were using weren't designed for the anatomy that they were dealing with, and that disconnect stayed with me. And about ten years ago I started asking myself, well, why hasn't this been fixed?' And I started asking, well, why couldn't I build something better?' And that question turned into years of development alongside my day job.

So at some point, I realized that if I believed this strongly in the problem, then I had to actually commit to it. So stepping out and starting the company wasn't about timing necessarily so much or chasing opportunity, it was actually more about finally committing to solve a problem that I'd actually seen physicians trying to deal with for years.

And I'm looking at your LinkedIn profile, which we'll link to in the full write up on Medsider. But it looks like the company officially started in, like, mid 2024 right? So we're you know, we're about roughly a year and a half into its official official beginnings anyway, right? But it sounds like you started tinkering quite some time ago.

Well, yes. I started, like I said, almost ten years ago, started on it and started to develop. So where we are right now, we're not actually in our first generation, we're actually on our third generation product. And you mentioned there that the company was started in mid 2024. I started it with Eric Goslau. He's been a great co founder for me, and really helped me, as someone who has never done this before, to sort of help me with the structure and everything, and guide me through a lot of the processes of actually starting a startup.

If you're listening to this and you haven't checked that interview with Eric, he was on the show maybe like a year ago or so, something like that. That a great conversation. I highly encourage anyone to go back and listen to that one. So I want to rewind the clock, right? And learn a little bit more about kind of the beginnings and we'll cover some other functional topics as well.

But let's start with it, or let's, I should say dig into the technology a little bit more, right? You mentioned closure and kind of the back end of a lot of these structural heart cases. For those that aren't as familiar as you and I with the cardiovascular space, maybe are in ortho or some other specialty, What's done now? What's standard of care and what's different about Quattro-Close, the device that you're working on?

I think before I even dive into that, probably need to even maybe explain what large bore closure is. Many people will know routine cardiac catheterization procedures, putting in cardiac stents, for example. Those are what's called small bore procedures. So, a way to think about it is that those procedures are all done through an arteriotomy, a hole in the artery. It's about the size of the tip of your ballpoint pen.

It's just a few millimetres across, that's all. Large bore, if you can imagine, is not the tip of the pen but actually pushing that whole pen into the femoral artery, and some of those small bore procedures often now done in the radial artery, for example, can be closed just with manual compression, but large bore is on a totally different scale. Much, much bigger. And when you start doing things like structural heart, like TAVR procedures, it's not just the size of the hole that you push into the artery. When you're actually delivering a TAVR valve through the delivery sheath, that sheath acts a little bit like a snake swallowing a rabbit, and you get this bulge that goes through and that actually even stretches the artery even more.

And so you can end up with an arteriotomy hole in the artery that you have to close, being sort of like nine millimetres often and diameter about 26 French, which is quite large. So that's what actually we're dealing with, and plus we're dealing with people who are quite old. Most of these people are in their 70s or 80s, and their arteries don't respond like a young person's artery, where you would make a hole in the artery and it would spring back. You don't have that elasticity in it. The other problem that you have with large bore in particular is that when you make such a hole in an artery, the femoral artery, for example, is under longitudinal tension so that hole isn't even round anymore.

You're actually having to deal with an elliptical shape, so you have to do that as well. So, there's quite a few challenges for that going forward. So, that's a little bit of the background part of it, but like I said earlier on, the closure hadn't developed at the same pace, so that's why I wanted to look at a solution for that. Where we are with Quattro-Close and what we're doing is that we're actually using a method that physicians are still relatively familiar with from some of the products that they've used already, so the procedure, we don't dramatically change it, but what we do do is that we change the way on how the device works to increase the reliability of the device and the simplicity of it. So one of the things we talked about, the elliptical shape, a lot of devices out there use like an X cross sort of closure pattern, and if you do that you can end up with sort of you can get sort of puckering in the vessel on that. So we've developed a purse string type closure, which gives a much more gentle and circumferential closure around the arteriotomy itself.

The other thing is that we've looked very carefully on a lot of these problems that physicians have had, particularly with calcified vessels, and tried to make the system much more reliable by the way that we deliver our needles. So this is a suture system that we're developing because that is still considered the gold standard in the field. So it's a suture system, but we've developed a way of doing it that when we deliver our needles, that a capture mechanism, even if those needles are deviated by calcification, we can still capture them. And the other part is that we want to make it much more easier.

Some of the earlier devices and things like that still relied on things like tying surgical knots, but we don't want to do that. So we have an extravascular clip that is used to gather the sutures together and that's how the closure is secured at the end. So it's sort of a simple thing like that, but one of the things we are focused on is actually on the lifetime management of the femoral artery, because these patients are not going to just be having one procedure. TAVR, for example, is becoming into lower risk and even younger patients, which will mean that many of these patients will have multiple procedures through the same artery. So we want to try and really preserve the integrity of that artery. It's really important to think about what's going to happen in the next ten or twenty years even.

All of that sounds really intriguing. We'll link to the company's website in the full write up on Medsider, which is secure-closure.com. So secure-closure.com, just as it sounds. But we're recording this in early early twenty six here. Give us a sense for kind of where the company's at currently and what's ahead, you know, maybe the rest of this year.

Yeah, sure. I mean, Secure Closure is still in early development at this stage in our third gen. So as I mentioned, we've actually had a couple of generations before, and that's really helped us to de risk the program. We've done some early bench and animal testing through that, but we are still in our development stage. At this point, and particularly since we formed the company in mid 2024, it's allowed me to focus full time on the development of that. And really now we're just trying to finalize everything in our design, lock it in, get our design freeze done, and then for our goal, the next period of time is to get to our OUS first in human. So that's our key milestone that we're targeting at this stage.

And we'll jump into this in a little bit more detail, but give us a sense for kind of that Clin/Reg pathway for a device like this. You mentioned the OUS feasibility study, so I would imagine that then ladders up to some sort of pivotal trial at some point in the future?

Correct. For large bore closure devices, it's a class three category. So for PMA approval, it means that you'll have to go through a clinical trial for that. So that's how the regulatory path will go through. So at this stage, as I mentioned, we're doing our development work, do our OUS first in human, get our first human data together, finalize whatever that we may or may not need to do to the design, and then go into our FDA trial at that point.

Got it. Makes sense. I think that might be surprising to most people that are hearing about this device that in essence closes ideally safely that preserves the artery, right? For future access. You think it sounds relatively simple, straightforward. It's a class three device, right? I mean, that's kind surprising, but I think points to the kind of the critical nature of these devices, right? Kind of on tail end of these structural heart cases. So with that said, Steve, let's spend the next twenty, thirty minutes kind of covering some key functional topics and really kind of diving into kind of like a lot of key lessons, right? That you've picked up on throughout your career and now at Secure Closure.

So with that said though, again, for everyone's reference Secure Closure is the website. We'll link to it in the full write up on Medsider. So first one on the doc I wanted to cover is let's talk about your experiences at some of these large strategics that you mentioned earlier, right? Abbott, Edwards, Teleflex. When you think about kind of all of the, what twenty plus years now, I think what it sounds like you spent at large strategics and then decided to make the jump to the world of startups. Anything particular that you either are carrying with you, right, as you begin to build Secure Closure or maybe flip that on its head and say, what are you specifically trying to avoid, right, as you begin to build a culture at your startup?

Well, I was fortunate enough to work with those companies that you mentioned, and being in those companies, they're all large organizations, and they taught me a tremendous amount. These companies are built around discipline and structure, you know, they have really strong processes and they have really deep expertise across multiple functions, you know, and they have the ability to identify problems and they put large teams on them and they execute at scale. That's what all these companies have done. I learned a lot about commercialisation in those environments. I was fortunate enough to launch quite a few products, particularly a large number of vascular closure devices, And in that environment, I learned how to build sales teams and support physicians clinically, and that's a really important partnership to develop.

I also had really good opportunities, particularly when I was at Abbott, to work very closely with the R and D teams, quality, regulatory, manufacturing, often very early in the development cycle, and that was really incredibly valuable for me. Now, if you take that experience in and you say, well, you're in a startup, what does it give you? I think that part of it gives you perspective, because if you look at each of those functions, companies give you the opportunity to see what good looks like in each of those functions, but you have to then take that and then simplify it, because in a start up you simply don't have that luxury of scale or funding to do things of that size. You have to make those processes work for a much smaller team. And so for me, I think if I take from that those larger organisations, they taught me discipline and cross functional thinking and focusing on the execution, and that's been something to bring into a startup, but again, being aware of the scale that you can apply to a startup.

One of the things that, you know, just hearing you kind of riff on that answer, that reminds me when I first sort of went in house, this was back at Covidian, gosh, I'm dating myself, but gosh, thirteen, fourteen years ago now. But it was such an invaluable experience. One of the keys to making that an invaluable experience was proactively engaging with other functions of the business. So I was in a marketing role at the time. And fortunately, as you know, marketing touches a lot of different functions, but if you're early on in your career, you've gotta be proactive about like reaching out to different even with an R and D as an example, right?

There's like, there's all kinds of, especially at a strategic, there's all kinds of different sort of, I would say departments within our R and D, right? That you can get more familiar with. So if you're listening to this and you're at a strategic and maybe interested in jumping to a startup at some point in your career, take advantage of those opportunities now, you're in that large organization to really learn, not only from other people, but also learn about how certain functions in a business at that scale really operate.

Yeah, I was very lucky, particularly at Abbott Vascular. I moved from Abbott Diagnostics to Abbott Vascular, primarily for the StarClose launch. And at that time Abbott had a very limited amount of information on the product itself. It was a new acquisition. And my role there was to launch the product in the EMEA region.

And to do that, I worked a lot with Global, but also with the R and D teams in Redwood City that were there at the time, the original Perclose team that was there, because then I did the ProGlide launch the following year after that. But you're right, I mean, it was a fantastic experience being able to go there, reach out beyond your own area of expertise. To be able to do a launch like that required me to be able to fully understand the device, what works, what didn't work, how to work with the clinical teams, get all those set up, working with the physicians. We had to even figure out how to use the device correctly. There was a lot of things at the beginning because we had very, very little data before the launch. So, you know, you correctly say this, Scott. You know, if you jump out of your own field and you talk to the other people, it's extremely rewarding.

Yeah. And and sometimes, like, if you're in if you're if you feel like you're in this sort of this point in your career inside a large strategic, sometimes it can feel kind of uncomfortable. Right? Either reaching out to other parts of the business or other people or even trying to like find a way into certain projects. Right? That you maybe didn't get an invite to as well. But like some of that, I think just comes down to being a little bit ambitious, being a little bit proactive and kind of putting yourself out there even if it feels a little bit awkward or a little bit uncomfortable because those of experiences are hard to come by. You may not feel the immediate sort of impact on your career but fast forward five, ten, fifteen years down the road and you'll probably look back and think, wow, that was I'm glad I did that.

So with that said, Steve, let's chat a little bit about sort of this tinkering phase, if you will. Right? I mean, mentioned even though Secure Closure is only about a year and a half old, officially you've tinkering, you've been kind of building and you're already onto your third generation of device. Give us a sense for kind of what you've learned sort of doing this on the side, if you will, right? Because I think there's a lot of folks that listen to this whether a physician or just more entrepreneurial minded that have an idea for a device. And the market seems to be big enough. The clinical needs seems to be there, etcetera, but they don't necessarily know how to get started. And so what have you learned in those earlier development phases when you're not a lot of capital, not a lot of resources to be had, but you've still made some progress on your device. And here we are under the third generation. Touch on that. What are some of the key things that stand out as you look back over the past eight, nine, ten years?

Yeah, I think one of the things is you've got to be persistent and be resilient and be able to take no's a lot of the time when you ask people for funding it, particularly in the early stage. But no, what's helped me tremendously was finding a really good engineer early on that I could work with, and we then put our ideas together and then slowly took it forward. And it's, you know, small increments at a time. I mean, you're not dealing in large amounts of funds, you have to be very careful, very strategic about your thinking about, well, what are you going to spend your money on? And what would those results be at the end of the day?

And learn from each failure, because when you start early on in a medical device program, the bottom line is you will fail multiple times. You're in a field which is difficult. If it wasn't difficult, everyone would do it. So, you've got to be prepared for the fact that you will have failures, and during that time period too, won't there'll be periods if you're doing it on the side like I did, alongside my day job sort of thing, there will be times when you just can't do any more work because you won't have any more funding. You just have to literally park it off the shelf, maybe for a year, until you are back into a position again to where you can take it forward.

So, it's about being resilient, even through the funding process. We're now in the company, now that we've established Secure Closure Incorporated, we're now actually raising funds through a convertible note in our seed round. But before I had that established, the only way to fund it was through my own pay packet, you know. So it's changed a wee bit from there, but you do, you have to think very carefully and you've just got to accept there will be failures and setbacks, and probably times where you just simply, even though you want to move forward, you've got all the ideas, you financially can't do it. You just have to sit on your hands until you can get to the next stage.

Yeah, and sometimes you see stories of like, take Farapulse as an example. Right? You know, everyone looks at at the success Boston Scientific has had with that franchise. But I had Steven Mickelsen on. Gosh. This is a couple years ago on the program. And he he was kinda riffing around, you know, what the early days of of that technology looked like. And it was it was very, very rough. It was very, you know, there's a lot of ebbs and flows early early on. Right?

Because there wasn't a lot of capital to be had. It was in in essence him kind of building building that the very, very early stages of that. And you you fast forward whatever, like a decade now, I can't remember exactly the timeframe, but fast forward like a decade and all of a sudden Boston Scientific does a billion dollars in the first year of commercialization. And it's sometimes it's easy to gloss over like what those early years really looked like. And so they typically don't look pretty and they typically don't look super clean. That's sort of like the nature of how a lot these startups come to be.

Yeah. I mean, we had to learn a lot of new skills to be able to do things in house, even right now. I mean, Peter, for example, is an expert on being able to make the computer animations, for example. He taught himself in house, and so we didn't have to go outside and spend a huge amount of money, because that is often very expensive for a startup if you want to show what your product could potentially do, you need that. But we were able to do that in house and save a lot of money.

Let's chat about some of those devices that you previously launched that were in, that are in the same space, right? Those Closure devices, ProGlide, StarClose, a couple that you referenced previously. When you think about, I mean, I know this maybe sounds like, you're pretty far down the road for a secure closure, but when you think about trying to commercialize into a space, right, where there's a pretty clear gold standard, right, standard of care, maybe it's a mixture, it's a variety of devices per se, but there's a certain way, right? Physicians are going to treat or when it comes to utilization, there's a certain like, there's a pretty clear pattern of behavior. You've been around so many of these commercial launches. Like what do you think is the, I guess, are some of the key lessons, I guess, that you've learned in terms of trying to disrupt that goal standard or really trying to kind of break through the noise with a new novel device?

It's really actually an interesting question, Scott, because when you talk about gold standard, if we go back into vascular closure, of course gold standard originally was an open arteriotomy. It was the physician, a vascular surgeon would close it with sutures. And the field then really evolved with the less invasive techniques and then became percutaneous, as you mentioned, with a number of those products out there. But all of those products that are out there, and they do work quite well in a number of situations, there are always different trade offs. And so I think if you even ask the physicians, is there a really gold standard, we would define a gold standard, I don't think there really is a gold standard yet in large bore closure for devices.

And so I think from that point of view, that field is still open a bit. I think though, you're talking about commercialization and how do you launch a product into a field, I think the physicians, when we go out there, when I've done this with other devices, the first thing that they need to see, and you've got to deliver on these devices, it's got to be a consistent and repeatable outcome for them. It's got to be reliable, because you can launch a product that and I've seen things before in the field over the last twenty years that can sometimes seem to work quite well at the beginning and have had a very big uptake in the first year or something, and then you find that market share changes dramatically after that. It's about having those consistent long term results, and that's what you have to show, and it's not something that's going to be quick. When you do a launch, can normally, when I've launched the Closure devices, we only have pretty good pick up after about a year.

Physicians really want to be able to have that level of time to build up confidence before they will really convert necessarily to a new technology. So I think that is sort of how that market looks like, and it's not something that you sort of go out with all the bells and whistles and you shake around and people come and run and buy the product. People are pretty conservative in this field. It's a pretty big hole that you're dealing with and they want to be sure because one of the biggest problems that you can have with particularly large bore closure is that sometimes things can look good in the cath lab, but if it hasn't closed properly, you get bleeding later on, and that can become quite serious. Fact, if you look out there, and even in the published data at the moment, there's still quite a significant amount of bleeding issues and device failures out there.

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That's really that unmet need, and the device needs to be able to correct those unmet needs, get that bleeding rate, that complication rate, and get the confidence back up, because as we've gone into this minimal invasive field dramatically over the last ten, fifteen years, sites now are looking for people to have, for example, a TAVR, some places will even have that maybe as in the day procedure. You go in the morning and come out in the evening even, there are some. And if you start having complications, that whole model blows. Of course, it's not only for the hospital cost, but it's dramatic for the patients as well, because if you have bleeding in such a large hole, it's not minor. These patients can often end up having to have a blood transfusion, may even have to have the vascular surgeon called back in, and then an extended hospital stay afterwards. So that's the field we're going into. I say, I don't think there is a gold standard established at this point for devices. I think physicians are quite cautious and you need to show persistent and repeatable outcomes for people to really make that change.

Yeah, sometimes it almost seems sort of counterintuitive to a certain extent, but you spend five, six, seven, in some cases ten years, right? Developing a device and you're in the weeds on how it works and why it's different and what it can do better, etcetera. And then you start to think about eventually whether it's commercializing or even just simply getting physicians excited to enroll patients in a trial as an example. And you spent so much time in the weeds but in reality, a lot of cases all they care about is, is it safe for my patients? And then two, is this repeatable, right? To your point, is it durable? Is it repeatable? And as entrepreneurs, right? Sometimes we can gloss over some of those, just those basic sort of things that physicians are expecting. If you're wanting to sort of convert them over to either your device or just a different way to close a hole, right, in this particular example?

It was interesting to see when I was doing a device a number of years ago, it's also important on the feedback from the patients, because when I launched a particular device a number of years ago, we had feedback from patients that they could feel in their leg the closure method, and a lot of them felt very unhappy with that, and that sort of translated back to the doctors as well, because then they didn't want to even though that device might work and could work quite well, you then have patients saying, well, you know, I can feel this thing in my leg and it's really bugging me.' So you have to think about not just from a practical point of view, like you say, with the doctor and their comfort level and everything else, you really have to, when you're designing this, and that's what we've tried to do with QuadraClose, is really think very much about the patient and their comfort, their safety, and long term management of their artery and the access site, because these guys will have not just one of these devices, they're possibly going to have multiple of these procedures and these devices implanted over the next ten or twenty years.

You touched on this earlier, but this concept of preserving the vessel as well, especially important now, right? Because not only are these patients often having repeat interventions for structural heart, right? It's like valve and valve becomes much more common, but a lot of times these same patients are getting PCIs and coronary interventions as well, right? And access is typically done, if not through the wrist, Through the same sort of anatomical locations, right? So becoming that much more important to be using devices that do preserve the arteries as possible.

Correct. I think that's a really important thing. I was talking to someone a little while ago, it's the same sort of topic, and when I was with Edwards even, let's just say ten years ago with the S3 launch, most of the patients that were getting TAVR at that time in the studies and in the cath labs are like mid-80s sort of thing, 80s, 90 year old people, so they were probably only going to have one valve implanted in their lifetime. And so the closure of the vessel itself, it's important to close it, but whether or not you did any deformity to the vessel or left things that made it more difficult to react later on wasn't so critical at that point. When you start to look at it now and we see asymptomatic patients now being approved for TAVR in The US, and I've seen some of the studies coming out I think it was California and think it was New England, where they had a number of patients even being down to as young as 60 in their late 50s for TAVR.

Well, if you look at the average durability time of these valves, let's just say if they're twelve or fifteen years, you can sort of work out they're going to have to at least two or three of these to do that site. And as the patients get younger, the other thing we have to think about, not just the structure and the integrity and how it works, but we want to make sure that the vessel, the actual lumen itself, is kept as open as possible, because these younger patients getting TAVR, for example, they'll want to be much more active than patients ten or fifteen years ago who were twenty years older than them, so they expect when they have a TAVR valve that they can go cycling, they can play with the grandkids, they can go walking or maybe jogging or whatever. If you start closing up the femoral artery each time you deploy something in there to close the arteriotomy hole, you keep deforming it significantly each time, it will degrade their ability to be to be so active because you just won't have the blood flow into the leg. You've to remember these vessels we're dealing with at the beginning are not pristine anyway. They're calcified, torturous and plaque material. So the last thing we want to do is even try and close them up even more.

Yeah. All really good points. I'm looking at the clock and I want to save enough time for the last few questions in the rapid fire portion of the interview. But let's talk a little bit more about the ClinReg pathway, the Class three device, right, which we chatted about a few minutes ago. And you're you're kind of like the the next major sort of ClinReg milestone, you know, in in you know, for for for you and the company is this is this OUS first in human study. So when you think about whether it's building kind of the ClinReg program for Secure Closure or even just specific to kinda your thoughts on how you're going about this this first in human study or how you're how you're approaching it in terms of, you know, site location, geography, etcetera. What would be most helpful for you think for other founders, CEOs that are kind of going through this the first time?

I think as we work towards our OUS, I mean, I probably need to refer more to our regulatory costs and being on this, but we're obviously selecting sites that have done and been involved in OUS studies before, have a good track record, have a good clinical reputation. These sort of things are just the basic things, they're important to do, because whatever data that we generate in our OUS study, we want to be able to take that forward eventually to be able to show FDA, for example, and then to be able to see how we then structure our pathway within The US itself. So the exact sites, where we would do it and that, we're still open to where we would do it. There are several good sites that are out there around the world, multiple countries. A lot of people are very familiar with sites in Paraguay, for example, but there are also the ability to use excellent facilities in places like Georgia and Tbilisi, and even Croatia and other places around the world Australia and New Zealand, for example, as well.

So there is actually quite a wide spectrum of places that you can actually go to to do these studies. You just need to pick the right one that logistically works for you and meets all the criteria that want or need for that study.

I'm looking at your website again, which is secure closure. And you've got what appears to be a pretty strong team around you, right? You mentioned Eric, I see Zach and Thomas in terms of kind of ClinReg advisors, great guys, very experienced. And then obviously a really impressive physician advisory team. How important, whether it's the physicians or even industry folks, right, like Zach and Thomas, how helpful is that, right, in terms of being able to kind of narrow in on certain sites and design a first in human feasibility study like this?

They're absolutely critical. This isn't my area of expertise, Scott, so I rely very heavily on their opinions for this. So, when Zach and Thomas tell me that a study should be done in a certain way, or we should do a certain number of patients, etc, that's the area of expertise. I think as a start up too, and when you're the CEO of a company, you also have to trust your team. If they tell me that, that's the way we'll go. With the Medical Advisory Board, of course, they're critical to us from the clinical point of view as well. As you can see from the locations of where our team is, Medical Advisory Board, we probably wouldn't be using their sites for an OUS trial. But their opinions on how that trial should be done, etc, of course are extremely valuable to guide us on the correct route.

I'm glad you mentioned sort of this reliability on trusted advisors, right, because I think sometimes in CEO role, sometimes you can end up in this spot where you feel like you need to know it all, Right? You need to sort of own all of these different decisions. And the reality is like if you can't get comfortable, right, bringing the right people around you and sort of dedicating that sort of accountability, right, to to a certain function whether it's reg, a reg pathway or whether it's designing a clinical study, etcetera. Like that's really, really key. You don't have to, in essence, I guess the easy way to say is you don't have to know it all, right? That doesn't mean that you get into the weeds of course, right? But that doesn't, you know, it also doesn't mean that you're expected or should know every certain aspect of how a startup should operate.

No, think it's a good point there. I mean, as I mentioned, even earlier on, having Eric as my co founder has been fundamental to me. My side of the business, shall we say, the beginning was the ideas and the development and identifying the need, etc, for a device in this field. I didn't have any experience in how to set up a US company, for example. I had zero experience now, I worked for large strategics and things, but you don't do that when you're working for an Abbott or an Edwards or whatever else.

That's way outside your scope, you're not going to set a company up there. So, to do that, I rely heavily on Eric's expertise there, and then again, one of the things that you learn, I think in the start up, is number one, it's important to have a great product, a great idea, but equally important is having the right people. You've got to have the right people who can execute, who you can trust, and that can also have, as for a startup, a sense of urgency as well. The money that you do raise, you need to get to a particular milestone over a certain period of time, So it's important to have people on board that have that sense of urgency to get things done, but know how to do it the right way. And you've got to trust the people, and if you get the right people, that makes it a lot easier.

I couldn't agree with you more in terms of that being a characteristic to look for, Whether it's bringing advisors by your side or even if you're at a point where you're starting to hire full time employees, is looking for that sense of urgency because it's so, so crucial, especially at your seed, series a, even in series b. You're right. And those kind of those that that early trajectory of a startup, like pace and momentum and knowing that you need to do a lot with, you know, with a a fairly lean lean amount of capital, like so important.

So with that said, speaking of capital, it looks like you were able to get some grant funds back in 2024. But talk to us a little bit about your fundraising journey so far and one of the maybe a couple key things that you know now, right, pitching other investors that you maybe wished you knew five, ten years ago?

I mean, the OED process that you were talking about there, it was valuable for us because first of all, helped validate both the technology and the market because you're talking to people who understood the medical device area. So that was really great to have that from that point of view. Right now, from our fundraising, we're raising a seed round through a convertible note, and and that's very milestone driven. As I mentioned earlier on, you know, that that seed round is to get us to do our OUS first and human, finish our development, and get our OUS first and human. So that milestone is super important for us.

And and then, of course, what we wanna do from that too is be able to, you know, we're we're also looking for a lead investor. That's an important thing for us as well because we need to get from the seed into an a as well. So that that is an important step for us. But I think if you talk about for other people, know, what do I learn about it? I think the first thing is, number one, you you gotta pitch a lot.

You gotta talk to a lot of people. Be prepared for people to take a long time sometimes to make a decision on investment. Fundraising is not easy. It takes time, it takes contacts as well. If you're someone like me who hasn't ever done this before, you you've got to get outside your comfort zone, you've got to really sort of get out there and in front of people.

I'm more of a conservative person, would say, if you want to sort of put it that way. So for me, it's sort of a big step to do that. But, you know, fundraising, you know, it's it's gonna take you longer than what you think. And both to find the people and to raise and even when you get people that are interested, like I said, they they often take quite a bit of time before then the final decision is made.

A lot of lot of good points. And the thing that never never ceased to amaze me is, like, the sheer number of pitches, right, or people that you need to to talk with in order to get sort of that that cap that capital raise. And if you're you're Yep. You're new to that, you're new to this, you're new to fundraising, it it very much is a a full time role in and of itself. Yeah. And and don't underestimate the the number of pitches that you'll have to do, especially at this stage. Right? Because as traditional kind of med tech VC moves later and later, right, and deploys capital into more, I would say, de risked startups, right, that are in maybe a pivotal trial, right, or on the precipice of commercialization, there is this funding gap, right, in seed kind of series A, even I would argue in even into kind of series B stage as well. And so you just gotta talk to a lot of people. I mean, there's money to be had, but it it requires a lot of a lot of a lot of pitches, lot of a lot of conversations.

Yeah. I mean, for our fundraising at the moment, primarily we will raise funds at this point have been through the, shall we say, friends and family. It's not quite that, but sort of like that, but people that myself or Eric have known or through contacts and things like that. So it's having that contact base, particularly at the very beginning, because it's like a snowball something. You start off with next to nothing, you get a little bit more, you get a little bit more, and as you get more, then you often find my experience has been that once you have some people on board, then other people will come on board. So, you know, some people will wait to see who else has joined or who else is investing, so it's like that. And like you say, VCs are looking at later stages, so the way that we're moving ahead now, like I mentioned before, through a convertible note, we're raising funds through those contacts, but of course we're looking for larger investment groups, and I think that for us, I think that VCs and strategics at this point tend to be much later than maybe they were ten years ago or something like that. Now you're having to look through alternative ways of funding, both through private investors and perhaps like family office groups, things like that.

Yeah. Yep. And we don't have time to get into the sort of the mechanics of this in great detail, but you made a point to mention finding a lead investor. Right? It sounds like you're raising on convertible notes right now, but eventually any startup that kinda moves on, right, you know, from a round of round perspective will eventually, you know, need to find a lead investor.

And that's that can be really, really challenging, right, especially if you don't have an existing investor that wants wants to take that lead. So I guess my message to anyone listening to this that's kinda going through this or about to go through a, know, start up start up fundraise is don't underestimate the the amount of time, right, that it takes to to get someone to kinda step out a a firm or an individual or maybe it's an SPV people that are coming together in SPV that will eventually, you know, kinda step up and become that lead investor. So it takes a lot of work, a lot of time for sure. So Steve, get to the rapid fire portion of the interview, but again, for everyone listening secure-closure.com is the website. We'll link to it in the full write up on Medsider.

If you're new to Medsider, if you haven't listened to many of these interviews, we do these longer form write ups that accompany the podcast episodes on the site and you can find a link to Secure Closure there. We'll also link to Stephen's LinkedIn profile as well. So Steve, rapid fire question, feel free to expand a little bit if you want to, or you can answer in rapid fire fashion. But since founding the company officially maybe in kind of mid 2024, what's the most surprising or unexpected thing that you've learned over the past year and a half or so?

Well, it's sort of surprising in a way, I guess, as we touched on it just a moment ago. Funding takes longer than what you think. Development takes longer than what you think. Engineering refinement takes longer than what you think. So it's not necessarily because anything's going badly. It's just because we're involved in a complex medical technology, and it takes time to get it right.

I'm laughing because I have this conversation quite a bit with my business partners, it's this balance where, yes, everything is usually twice as long and twice as expensive, but at the same time as a CEO, you've got to set you know, some ambitious goals. You can't just say, oh, well, it's gonna take longer than expected. Right? I mean, and no one wants to hear that. Right?

So you've got to set some target dates. Right? But know full well that, you know, may you know, you may have to flex on those on those dates, right, as as the technology, evolves. So let's say we're, we just wrapped up maybe dinner and we're having a glass of wine with some other Medtech entrepreneurs. What do you think is like the single most important thing they need to understand if they're gonna experience any success in their venture?

I would say that you really want to try and anchor your decisions on patient outcomes. When you're developing both the product and the company, it's really thinking about the patient. Because when you do that, a lot of the things actually become simpler, particularly if you're talking about your development work, what you may have to trade off later on in the development, for example, and also if you're focused on getting those patient outcomes, that's really what you're out there to try and achieve, then even those fundraising conversations will be easier as well.

Very good lesson to always keep front and center, no doubt. All right, last question I've got for you, Steve. Let's rewind the clock, go back to maybe your late twenties, early thirties. You're at kind of a, maybe a point in your professional career where it's starting to kind of take off. Anything you'd whisper in the ears of the younger version of yourself?

Well, think early on, everyone's focused or at least, at least I was, you're focused on different milestones, you focus on job titles, things like that. But I think what's super important, and you pick this up just as you go, is it's really developing a good judgment on things. You get that feel of what works and what doesn't, and you only really get that through experience. A lot of times those experiences aren't necessarily the positive big wins, they can be sometimes the failures as well, because eventually that experience really just compounds itself quietly over time. So it's not something that you're just going to wake up one morning and that's it.

So it's not like you have to, if you're someone at that age now, and saying, well gee, I don't have this experience or I don't have that. You touched on it earlier on, Scott, when you're in a strategic, reach out to different departments, get experience, find out how things work. And I think that would sit you up well, that's what I keep saying to myself if I was twenty or thirty years old.

Yeah, good way to wrap up the conversation. Again, listening, secureclosure or secure-closure.com is the website. We'll link to it on medsider.com well, where you can find the full write up summary that kind of highlights a lot of the key lessons that Steve shared throughout the course of this discussion. So I definitely encourage you to check that out. Steve, I'll have you hold online, but thanks again for coming on the program. Really appreciate it.

Thanks again, Scott. Really appreciate it too. Thanks.

Yeah. And thanks, Eric, if you made it this far, thanks for the recommendation, right? Steve was a great guest and it'll be fun to kind of watch what you guys do together as you build the company, get into your first in human study here in the not too distant future. But everyone listening, appreciate your attention As always, thanks for, for being a loyal Medsider listener. Until the next episode, 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 medical device and health technology startups. But here's the thing, I'd be super grateful if you could help me reach even more ambitious doers who share our passion.

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