Medsider: Learn from Medtech and Healthtech Founders and CEOs - Using Private Capital to Preserve Control: Interview with SynerFuse CEO Justin Zenanko

Episode Date: February 10, 2026

In this episode of Medsider Radio, we sat down with Justin Zenanko, co-founder & CEO of SynerFuse.SynerFuse is developing the e-TLIF procedure, which combines spinal fusion with neuromodulation by placing leads directly at exposed nerves during surgery.A certified public accountant and serial entrepreneur, Justin previously served as CFO and senior vice president of corporate development at Recombinetics, where he led fundraising efforts totaling $68 million.In this interview, Justin discusses approaching FDA interactions as negotiations, validating procedures with off-the-shelf components before investing in custom devices, and structuring private raises through investment banks to preserve control while delaying institutional venture capital.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 Justin Zenanko.

And a lot of times the clinician will have a lot of things that they see that's in their practice that we need to bring forward into the conversations with the FDA. And you can't be afraid to have pushback on the FDA either because in a lot of times they might ask you to do something that's not necessarily in the best interest for the trial, your product, or for the clinician. You know, you've got to have the wherewithal to be able to push back and not be afraid of push back. Because a lot of times, you know, a lot of people look at government and they're scared of it. Well, don't ask for that. No. You need to ask for it. You need to be willing to take the risk.

Because if you don't, and you're stuck with standards that are coming from big corporations, as a small corporation, you're just not going to have the money to get 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 Justin Zanenko,

co-founder and CEO of Sainterfuse, the company developing a combined spinal fusion and neuromodulation system to address chronic back pain at the point of surgery. A certified public accountant and serial entrepreneur, Justin previously served as CFO, and senior vice president of corporate development at Recombinetics, where he led fundraising efforts totaling $68 million. Here are a few topics we explored in this conversation. First, how do you determine when an FDA request is a requirement versus an opportunity for negotiation? Second, how do you validate your idea before committing millions to custom device development?

Third, what do contract manufacturers need to execute effectively for early stage medtech companies? And last, how to investment banks structure private raises to preserve founder control. 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. Justin, welcome back for round two to MedSider Radio. Appreciate you covering out a little bit of time on this Friday. Yeah, thank you for having me. I'm glad to be here.

It's been a while. Yeah, it has been. I think it's been, gosh, three or four years maybe. And I'm sure Center of Views has made a lot of progress since then, which definitely looking forward to touching on throughout the course of this discussion. And I appreciate you kind of battling through a bug, right, to give us some juice and some key learnings, right, that you guys have picked up along the way, right? In what appears to be, you know, some pretty good milestones that you've accomplished

just the last time we did this. Well, yeah, absolutely. Especially for a class three device that we're building and the procedure, the ET left procedure that we're moving forward with. To see a company of our size with the capital that we've invested over $20 million is kind of unheard of right now that you see in the marketplace. No doubt. I definitely want to touch on that, right, because you mentioned when the class three device, most people would assume you've raised three or four times that amount, right, to get to where you're at, which I think is more the norm. But yeah, certainly interested in touching on that,

as well as kind of the transition you're making, right, from largely what sounds like, you know, angel and individual kind of investors or private investors to maybe more institutional capital. But for folks that either haven't listened to the first interview, which I highly encourage you to go back and check that out if you're interested in learning a little bit more about the early days of interviews. But give us a kind of a one to two minute, you know, elevator style pitch on your background leading up to starting the company. So my background's a little different than most MedDevice CEOs. I was trained as a certified public accountant, serial entrepreneur from commercial furniture to gene editing to, you know, CPA background of taxes and finance.

And, you know, the thing about me is I've, you know, I've always been interested in technology, always interested in kind of what things are missing in the marketplace and how do we actually bring those together. and what was really unique about this opportunity is there's such a large market for people that need back fusions to correct their structural problems, but then there's this neuropathic element that nobody is really talking about. And because the markets are so segmented from fixing the back and then later going for pain, none of those two areas ever got combined until centerfews. And we were really fortunate to, you know, have pain physicians, people from the neuromodulation background, but more importantly, it was getting the spine doctors from the

University of Minnesota at M. Health Fairview together with us to actually take this concept and make it into what it is today, which is, you know, electrifying the spinal fusion surgery, which we call the ET lift, and by doing that, we are now addressing pain at the beginning point of surgery versus waiting years and failing the normal conventional route, which is get your back fix, see if you get better. And we know up to 50% of patients don't get better. Why are we ignoring that under the current continuum? Well, that's because the big companies are the ones that control everything.

And there's no innovation if you're doing something new. Yep. Makes sense. And so let's kind of double click on that for those that are just hearing about center fuse for the for the first time you know i'm looking at your website right right now which is centerfuse.com for those listening s y n-e-r-r-r-fuse dot com so just as it as it kind of sounds s-y-r-n-r-r-fus e-e dot com we'll link to it in the full write-up on medsider but i'm looking just even above the fold on the on the main homepage right you got this graphic of spinal fusion

plus neuromodulation equals centerfuse which you sort of touched on that right and that sort of encompasses this e-tl-f procedure right that that that you've branded so give us a sense you know, kind of maybe like let's go a little bit deeper and talk to us about how neurofuse kind of factors into that equation because I think that's new to sort of the algorithm, if you will, I guess for lack of way of the description since our last conversation. Yeah. So our technology is really based upon the procedure, which is the time and placement of leads directly into the spinal fusion where because those nerves are exposed, you can go and you can directly place the leads or the wires that bring the electrical stimulation.

to disrupt pain signals to the brain, that's never been done before. We did 15 patients here at the University of Minnesota and South Bend Orthopedics. With having all of that done and all of that pulled together, we were able to show A, it's safe, and B, that we have some strong signals towards efficacy, meaning, you know, we've seen upwards of 80% of, in this just small sample size, had pain relief and we're out without opioids. You just don't see that in spinal fusion patients. So where neurofuse comes into place now is we're taking all that perfect concept feasibility data.

We're driving that into neurofuse, which is our state-of-the-art stimulator that we're building that's going to be placed in the next trial, the pivotal trial, at the time of surgery. So you have one incision and you're placing everything into the surgeon's hands that's built for them. Or today, if you were to try to do this, A, you would have questions about reimbursement, but B, more importantly, you'd be trying to convince a surgeon to use a tool that was designed for a pain physician. And surgeons and pain physicians do not talk when it comes to surgeries. Surgeries are done more by the surgeons, and the pain physicians are doing, you know,

they're not doing spinal fusion surgeries. So it's very different, very distinct. Got it. That's very helpful. Because I think the last time, or at least for this initial feasibility study, you were using sort of, you had partnered, I believe, or were using an off-the-shelf or currently available stimulator, correct? Yes. And that's commonly done as a way to, especially when you're going after new IP, that's commonly done in clinical trials for proof of concepts. And then what you do is you take all those learnings and you put that into your new device. so that way, when you're going for the pivotal trial, for the efficacy claims, you have your own device, your own stimulator, and you kind of, you know, you have your own destiny, if you will, established. Got it. That's very helpful. And we're recording this here in the back half of Q4 of 25. So for those listening, then maybe after the fact, right, or three, four or five months down the road, give us a sense for kind of where you're at as it pertains to this pivotal trial. I mean, is it on the kind of the near-term horizon?

So the pivotal trial is probably going to be in 2027 because we're having to finalize the device in the build. And that's going to probably take, you know, 12 to 18 months. These things with medical devices take a long time. You know, for me being from biotech and gene editing world where things go a lot quicker, you need to de-risk it because you don't want to have a bunch of money going into a device that's going to cost you $7,8 million. and you're off on something. So in our way, what we've done is, you know, we just got our feasibility trial data and report fully accepted by the FDA as of August 1st.

And by doing that, we're now taking all of those learnings and putting those into the final elements of our device, design and build. Got it. And you mentioned the number of patients in this feasibility study. Did you say 15? It was 15 patients? Yes. Got it.

15 patients, 10 were single-level fusions and five were two-level fusions, and the safety profile, the safety was the same, which is what we expected, but you never know until you actually get there. Yeah. All right, very good. So looking at 2006, big development year, especially as it pertains to kind of the DB phase leading up to your pivotal trials, it sounds like. Yes, and then it's also finding partners for the multi-center. you know, 150 patient trial and making sure that we have all those ready to go and partners. And in 2026, we should have some major publications coming out on the feasibility study, which will help, I think, convince more surgeons to get on board.

Got it. Go beyond our, you know, our current cohort of medical advisors. Very good. And when you say partners, you're referring to manufacturing partners versus clinical sites, correct, I'm assuming? No, I'm talking about. I'm talking about clinical sites and doctors who would be your trial partners. Got it.

Got it. And also, more importantly, these are going to be the people who will be helping to support the early phases of commercialization because they will have seen it for themselves. And that will become a dogmatic approach for this new technology, this new procedure. And once they get that established with better results that they're seen for their patients and for them, then they'll just start to build more and more support for the growing technology because you need the early adopters. These are the people are going to do the clinical trial,

but then it's going to then expand into, you know, the more of the surgeons who are going to be higher volume and see a lot of patients and a lot of these problems that they can address up front. Yep. That's actually a good segue into kind of the next topic I want to chat about with you is really your kind of your regulatory and how your clinical roadmap ladders up into this regulatory pathway and how you're kind of thinking about that. So let's let's start there.

But again, for everyone listening, it's centerfuse.com is the website. Centerfuse.com, S-Y-N-E-R-F-U-S-E dot com. We'll link to it in the full write-up on MedSider. If you're new to these Med-Sider discussions, these write-ups are longer form articles that accompany the podcast that are meant to kind of really highlight and emphasize certain insights and learnings that are, that our guest share, you know, based on their experiences in the world of MedTech startup. So highly encourage you to check out the write-up,

and we'll link to Centerfuse there as well. So with that said, let's drill into kind of this, you know, a couple of the things that maybe that you've learned along the way kind of going from this initial feasibility study, which is no easy feat, especially for a novel device, right? Like, I think we both know that. Just accomplishing that alone is a high bar, but now you're really gearing up for your, you know, your pivotal trial, which is an even, even bigger lift. So when you take a step back and think about everything that you've learned,

there are a few things that really stand out, you know, that would be especially helpful for other founders, other CEOs that are kind of navigating this, their own Ray Klin kind of roadmap for the first time. Yeah. So one thing that I will say is that, you know, as a CEO, as a co-founder, you have a vision and idea of where you need to get there. You bring in your clinical partner who's going to be the doctor that's going to make your concept a reality. And there are a lot of regulatory and reimbursement support people that you can hire. Do not be afraid of bringing your vision forward and needing to have everything figured out because you'll figure that out as you go through the clinical process, meaning if it works in the clinic, it's building the building blocks

to support the reimbursement and the regulatory pathway. In our case, there's such a large expense to the fusion market that having the pain. and multiple procedures, you know, if you're getting the results of 80% plus of efficacy, and that holds throughout the pivotal trial, it's night and day difference for these patients. And even the patients that failed based on conventional standards, if you ask them, we can do this because it was a feasibility study, if you asked them, do you want the device up because it failed, they would all tell you, no, don't touch my device, keep it in. And so when we're going through the regulatory pathway, we're engaging with the FDA,

we're talking with the FDA, but you have to also remember, you know, they're used to what they're seeing. And a lot of times the clinician will have a lot of things that they see that's in their practice that we need to bring forward into the conversations with the FDA. And you can't be afraid to have pushback on the FDA either, because in a lot of times, they might ask you to do something that's not necessarily in the best interest for the trial, your product, or for the clinician. And it's, you know, you got to have the wherewithal to be able to push back and not be afraid to push back.

Because a lot of times, you know, a lot of people look at government and they're, they're scared of it. Well, don't ask for that. No, you need to ask for it. You need to be willing to take the risk. Because if you don't, and you're stuck with standards that are. coming from big corporations. As a small corporation, you're just not going to have the money to get there. Right. Let's talk about that in a little bit more detail, because it sounds like a lot of folks

in your network as well have the same share the same sort of sentiment, right? Because I 100% agree that it's sort of out of bounds, right, to sort of quote unquote push back on FDA or if FDA issues some sort of like denial letter, whether it's related to an IDE or something else for that matter, that that's sort of the final, you know, the final approval. And there's this hesitation around using that as an opportunity to, I mean, we're calling it pushback, but I mean, a better way to kind of maybe phrase that would be, you know, like educating them in essence, right? Especially if it's warranted.

And so I'm not entirely sure where this sentiment exists, right, this sort of hesitation in pushing back or using these opportunities to help educate people that, for the most part, are not as nearly as familiar, right, with, with your particular domain. I mean, to be fair, they're reviewing a lot of submissions, right, whether it's IDEs or 510Ks, et cetera. So I want to be fair, but at the same time, they're not as experienced, right? They do not have the domain expertise, right, that we do, that our clinicians do, et cetera.

So what have you learned kind of through that process, right, of, I keep saying pushback, but I think you get what I mean, right, of, you know, pushing back in a way of educating, educating a group of reviewers? Well, it comes back to common sense. If you don't ask, you can't get, if you're not willing to put it out there, you can't get feedback. And having open dialogue in frank conversation

is necessary. And if we're not willing to go out there and push on what we need, as a small company, you're just not going to get there because you just don't have the resources, is you don't have the time. And a lot of times, if you do give them reasonable, you know,

and you find compromises, it's a negotiation. It's a conversation. When they say no, okay, what's your counterproposal? And, you know, the one thing I've learned about the FDA is they'll never tell you, they agree, they'll say it's not unreasonable. And, of course, you know, you do these pre-submissions, which we've done now, two of them. and you get these conversations going, but now you have a roadmap of how you're going to get through regulatory, get your clinicals done.

And, you know, for us being a class three device, you know, that's one of the highest hurdles. But now that we have our 15 patient feasibility study done, we know we're going to get to a pivotal trial with our device. There's not a question about that. it's about how is the trial going to be designed and making sure you're not putting yourself in a no-win situation because a lot of times the FDA will want you to have a sham but as we know sham controls can be largely deceiving so the randomized trial and having your efficacy pushed out long enough so you don't have to have a sham is one of the ways around that but if I don't ask those questions, I never get there because I'm taking it from the experts. But one of the things that

I've learned from listening to the experts is they're still giving you a defined response based upon their prior experience. Well, what happens when you bring a whole new technology forward? You know, if you think about this like with Tesla and electric cars and all this other stuff, like what Elon did, if Elon would have asked the current car manufacturers about electric cars you wouldn't have Tesla today. He didn't go there and ask him. He said, this is what we want to do. And he kept pushing and pushing. We owe that to ourselves because, as you know, medical device, things move at glacier speeds. Things don't change quickly. And again, it's built that way to protect people, right? Because we need regulatory to protect people. But a lot of times,

there's all these rules in place that sometimes the safety concerns, as we know, sometimes are not really there because you're using the same materials that are used in all other devices. Why do you need to do another animal study? Right. Yeah. And again, some of these things could potentially be sped up, but you still got to work within the environment you're in, and you need to ask for the things that you want.

want, otherwise you're just not going to get up. Yeah, there's no doubt. The default answer or the easy answer for anyone that's operating in a regulatory context is no, right? That's the safe answer. And if you're listening to this, I can't emphasize that point enough. In startups, urgency and pace really matters, right? Otherwise, you will run out of money. Like, that is, I mean, you will simply run out of money and good luck finding new investors to come in and if you've infused capital into a company that hasn't made progress, right? Definitive progress. And so, So I guess, you know, just to add a little bit of context, I don't want to, you know, get on a soapbox here. But it's like, I think this is an incredible, like, it's an incredibly important point because sometimes these conversations feel uncomfortable.

But if you don't have them with FDA, like you literally won't, like you will be, you will get stuck. I mean, not, not 100% of the time, but a very high percentage of the time, you will get stuck. And it may feel uncomfortable, but this is like sometimes this requires a little bit of salesmanship, you know. You likely have thought through this way more than the regulatory. of you yours. And I almost guarantee that most people in our space, right, are pretty thoughtful about their approach. So it's a matter of, you know, salesmanship and kind of crafting a good response and being willing to kind of, you know, hold your ground in essence, right? And so that's just, I don't know, sometimes that that's looked upon, that sentiment is looked upon is like too

aggressive. But it's like, well, look, I mean, you have to be a bit aggressive, right, in the world of startups, otherwise nothing will get accomplished. Absolutely. And you, and the other thing, is that the big companies can afford to wait. We can act. Yeah. And just to again, kind of circle back around to, you know, trying to be as fair as possible around this, most of the people that I've interacted with FDA are decently reasonable, right? I mean, they're just, they're trying to do their work, but like they probably have a gazillion things going on. They may have run out of time. And so, you know, using these opportunities as truly a way to kind of push through things that are maybe sometimes obvious, but also educate them on the non-obvious things, right? And to, you know,

to tell your story, I just think is really, really important. So anyway, let's transition to another topic here, which is, which I think is really interesting considering where you've been using kind of sort of off-the-shelf components, if you will, to learn about your device in this feasibility study. And now you're shifting up to like, definitely more builds ahead of this, ahead of this, pivotal trial. And then, you know, with a lookout to possibly commercialization. So talk to us a little bit about your thinking kind of through those phases because that is a gap that I see a lot with startups where they may be making really good progress to their credit, but they haven't thought through, what does that technology transfer look like? If you're doing everything in house right now

as an example, can this really scale to a clinical trial or a pivotal trial? Can it really scale into commercialization? So give us a sense for kind of how your team is thinking about that. So fortunately, we don't have the problem that was over a decade ago or two decades ago where you don't have contract manufacturers. Today we have tons of options, tons of contract manufacturers to choose, and it's really finding the right people that can build and then scale it. And fortunately for us, we have a lot of capabilities here in the United States with, you know, everyone from SERTEC to integer, where you take your design once it's built, and for relatively little money, million dollars you can have your transfer file done and they can build your device so scalability

in an interesting way has not been something that i have been too concerned with because a i'm focused on feasibility pivotal and the pivotal is going to be probably about a hundred devices but when we look at the partnership with valentia medical down in katty texas you know we have full confidence in A, the build, but B, more importantly, they're going to be able to provide us the devices for that trial. Got it. Yeah. And so when you think about how you went about evaluating partners, right, that could

effectively scale up, any key learnings or maybe non-obvious things, you know, which, you know, caused you to kind of to land with this particular, you know, CDMO or manufacturing partner? So we were very fortunate in the fact that we have good people that we brought in. you know, product development guys with 30 plus years of experience locally in Minnesota. And Minnesota is unique in the fact that we have all this talent that is based here. And assessing the technical and the engineering risk, and the nice thing about with our device, we're not creating really anything new new. Because of where we are in the ET left and

using very low energy, we're able to miniaturize the device from being, over 30 cc's down to 9 cc's. So you're using smaller, so smaller device, smaller batteries, smaller everything. And yes, there is some engineering, but it's not like creating a whole new chip or a whole new software. You're basically taking everything

and you're making it better and you're making it smaller that's going to actually allow you for the device to work better for patients. And so when you add those capabilities, in, there's a lot of different people that could probably do that. It's just making sure that you have someone in-house or contracted with that can actually help you assess that because I have no engineering background, no engineering experience,

but I don't need it because how many people from the big companies are there that you could get or from freelancers that you can get? And there's a lot of these people available that you can utilize for your manufacturing and device builds. Really good points. And don't be afraid to sort of lean in to the fact that you may not have the technical background to lead those types of discussions. That's fine. As a CEO of a startup, you're not going to be the most experienced in every single topic. And accepting that is I think is pretty important. Yeah, you don't need to. What you need to do is be able to find the people who have the technical background and experience and say, this is the end result, this is what we need to do. And the thing that's nice about our situation is because of the 15 patients that we have

real data on, real energy requirements on, real patient outcomes, data on, efficacy, safety, all these things. I'm able to take all that data and put that into the neurofuse system. I'm not guessing because I know. I've seen it. And the other cool thing is, is that, you know, we have over four different patient stories where these people are living with less pain, less drugs, and those people are, their lives are greatly improved. They're walking around long term, not short term, but long term results. And they're using their phone, the app, to change their power requirements based upon.

the needs that they have. And so when you start adding all that data into everything you're doing, that actually really drives your technical side because it's like, we need to make sure we can do this. And if you're gonna lose that capability, well then okay, then don't go to, I'm making this up. If 15 Cc's to 9 was gonna lose a capability

from our data that we needed, the answer is no. You're gonna have a little bit bigger device. However, the cool part is, is when you have a very capable, partner in Valentia Medical, you can do all of those innovations and bring all that to the table and make sure that you're not losing anything from your feasibility study. Yeah. And it's really important because I'm sure you've heard other comments similar to this where a startup company and maybe it's not even a startup company will complain about their

manufacturing partner, their CMO and say they don't get it, they don't listen, they make all kinds of mistakes, et cetera. And to be fair, some simply aren't the greatest partners. But Sometimes the onus is back on us as whether you're a CEO or leading, you know, leading R&D as an example, to ensure that you're actually giving them precise specs, right? Which you kind of touched on, you know, and that has allowed you to kind of define the specs to a much greater degree now that you have feasibility data, which can be then handed off, you know, which create a clear roadmap for a CDMO. But that seems probably obvious to, I think, most people probably listening. But it is important and sometimes gets glossed over.

Like when you're having issues with the CMO, are you delivering them information that they can actually act on in a decisive way? Because sometimes that's not always the case. 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. Over 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 and 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 Again, that's fastwavemedical.com forward slash invest. Now, let's get back to the conversation.

Right. I would say it's probably most of the time, not the case. Right? Because how often do you actually have feasibility study data that can go into a device? And, you know, when you think about from an investment perspective, the risks of that device not working has been taken off the table because of the study. And again, and this goes to any CEO listening, at the end of the day, it does not matter why it's delayed or why it's not working. That's on you. It's your responsibility to get it done

because you're always going to have a problem in startup world. You're always going to have some roadblock in front of you that you have to get through and are you going to power through it? and if you're not going to power through it, then this is not the career that you should be moving forward on because everybody is going to be against you. That's just the way it is. And our world is very lonely. So that's so true.

And it can seem unfair, right? I mean, you could be in a scenario, this is especially relevant to me as well. You could be in a scenario where literally you are doing everything right, but things sort of the, you know, things are sort of falling in place in a way that's not, that's not going as you would expect it in essence, right? And so at the end of the day, even though you may be doing everything right, and that's, you know, you're still not making the progress. You're not hitting the next milestone. It is ultimately on you, right? Your investors,

I mean, they may care about you personally, but look, I mean, they're making an investment in a company for a reason, right, to get an economic, ideally an economic return. And, you know, if you're looking around for someone else to solve the problem, you likely aren't going to find that person, right? You need to get a mirror and then look at yourself and say, am I going to do I have the gusto, right, to push through this? Because those challenges and those problems are not going to end in your startup. Yeah, no, I agree. I mean, the problem, too, with a lot of med device companies is they are getting investment from VCs or private equity groups. And the problem, too, is a lot of the CEOs don't have their own skin in the game. So,

you know, things go, don't go to plan. You bail and go to your next project. Yep, yep. It's interesting that you say that. I was listening to a podcast. It was actually probably from a couple months ago. And it was not a device podcast. It was actually from a fairly well-known guy that runs an agency actually in the e-commerce world. And I always like kind of listening to like these these conversations that are outside of MedTech because you can often pull some pretty interesting insights. And he was talking about equity, right? Employee. In this case, it was, I think, employee equity. And he said one of the biggest things he learned kind of, because they experimented with a lot of different plans, right, on how to incentivize their team. And he said, the biggest thing that I've learned is I want my people to have skin in the game.

So when he's talking about, like, option grants as an example, right, I want them, I want them to actually exercise those grants immediately because if they don't, there's no skin in the game. They haven't actually injected their own money and kind of felt that in a very tangible real way. And I was like, oh, that's, that's super interesting because it is important, right? I mean, if you don't have, if there's not meaningful, you know, something meaningful, it's so much easier just to bail, right, and go find the next thing. But if you actually have, you know, real skin in the game that matters, it matters in a big way. Yeah, it does. And, you know, in my world, I'm the largest investor in Cinerfews.

I don't have a choice but to make the thing successful. And I have, you know, overcome multiple coup d'etas attempted on me, people that should never have attempted. But, you know, when you raise 90% of the money with your investor base, those people, they didn't invest in, they invested in the concept and the idea, but they also invested in me to make sure that their money was secure. And me being the largest investor also makes me aligned with my investors, which means anything that affects them negatively affects me negatively.

So when your CEO is aligned with your investors, everything is aligned appropriately. But when you get people that have no skin in the game and you have people that have limited skin in the game, they start to take liberties with your vision. And it's like, no. You know what? If you have the same amount of net worth I have into the deal, then let's have a conversation. Until then, there's no point to having the conversation. Right.

On this, this is, I just, I'm glad we're having this, right, this discussion, because it's one of those things that, you know, doesn't, I think doesn't get talked about enough, right? Or maybe if it does, it's behind closed doors, right? So I think it's, it's really, really, really important topic to consider. And on the note of fundraising, you have raised a significant amount and been incredibly capital efficient, considering kind of where, you know, where you're at and, you know, with real clinical data, staring down, you know, eventual pivotal trial, you know, maybe 12 to 18 months from now, talk to us about. this shift, right, from raising mostly private funds to, you know, what's probably going to be institutional capital. How are you thinking about that? What's that, you know, what are, what are some of the learnings or just insights, right, that, you know, for other founders that you can share? Because I think this is a very real issue because the VCs that used to invest in seed series A are getting fewer and fewer by the year. And so there's a real gap at these early, earliest stages. So if you're able to find the money at those earliest stages, that's awesome. But eventually, you'll probably have to make that shift to raising money from venture and from

institutional capital. And so I think, you know, this, you know, it'd be interesting to get kind of get your insights kind of on that transition and how you're thinking about it. So we've been fortunate enough to have individuals, angels, and we've actually got a very different route, which is utilizing broker dealers and the investment banks. And by doing a R-D offering, the nice thing about that is everybody's on the same playing field. You don't have a VC with some interests and different capital stacks. And, you know, for us, as we're looking at the new offerings, because we've done Series A, we've raised over $13 million to date. We're going to be doing an additional $10 million in the Series A to complete our device and get started on that pivotal

trial and going through that process we're working with a well-known investment bank and they're helping guide us of what the market is looking for from a return and you know one of the things that you know in our series a is we used to have it where there was an optional dividend dividend was not guaranteed well now we're going to do an 8% dividend and that gives, could be paying cash or common stock, but that gives the investor who's putting their money to work, they're getting a return while they wait. And that's something that I was unfamiliar with, but I'm also open enough to know that, hey, because I'm the largest Series A holder of stock as well, I would like 8% dividend.

So I like the 8% dividend and that's my thing. Well, then other investors will. And when I've talked to my other friends and people who have invested prior, they're like, man, if you're doing the 8% dividend, sign me up for more. I want more of that. So there's these little things that you learn. But yes, we're going to get more and more institutional investors. But, you know, the problem is when's the timing to go to the institutional investor?

Because if you go too early, they're going to cram you down your value. They're going to take your vision and you're going to be dealing with people that you can't get rid of. Where in my case, you know, we brought in individuals who are largely aligned and when they try to do a different vision than the vision of centrifuge, they had to go. You can't do that if you have a large institutional investor in there because they get them out, the barrier to entry to find someone that will take them out is too high. But once you have your feasibility data, you have these milestones, you have all these things laid out before you. You can start to do these things. And, you know, one big thing that we've done here over the last two years is we've gone from PhDs to MDs. Because the MDs are the ones who are going to utilize your product.

It's not a PhD. If you have a PhD that's in the, you know, in the concept world, an IP world, which is important, but you can't actually put that into practice, you don't get your product off the ground, no matter what you do. So you got to get, you got to get the clinicians and the surgeons utilizing their hands and helping you with the next IP, but also with your commercialization strategies because I can have the greatest product in the world, but if no surgeon wants to utilize it

or doesn't care to utilize it, you can't overcome that because, Surgeons are very dogmatic. The medical industry is very dogmatic. If they perceive something to work, very hard to get them off of it. But if you could show them a better way to do it and to do it correctly, well, now you can bring more of these things together. No doubt. I want to touch on that with a little bit more detail here in a second.

But even going back to your comment around kind of transitioning from largely private investors to more institutional capital, you may. mentioned timing, right? And that's so, so important. I remember a conversation I had with Lloyd Diamond, gosh, this was probably two years ago now, but he had mentioned if you're, I think he was in the context of kind of where they were at, but he said, if you're raising your series B as an example, and not thinking about raising your series C, that's a mistake, right? Because the timing has to matter. And if you're not thinking about the stages and the milestones that you're attempting to fund with your series B and then how that next round would potentially shake out, you need to be, right?

you need to be thinking that that far ahead. And it can seem like, wow, should I be focused on the imminent raise right now? Like, why do I need to think about 24 months from now when I may raise again? Well, all of that lines up, right? And you need to, if you're bringing in institutional investors now, you know, they're investing in underwriting at a certain return. So what does that return look like in the event of a potential exit or liquidity event? Or if you have to raise another round of capital.

So just, you know, really, really good stuff to be kind of, you know, thinking about. And we're also with partnering with the right investment bank, you know, I'm focused on an IPO. Because at the end of the day, if we're doing all the things that allows us to go public, they'll also help force other acquisition strategics to come to the table. And if I have the optionality to not need them, well, guess what? Price goes up. And we all know that, you know that, you know, look at all these acquisitions that are occurring by these dinosaurs, if you will, the big strategics. They don't innovate anymore.

They're not bringing anything to the table. What they're dealing is they're trying to find the right companies that have enough revenues that they can then acquire and bring in. But the problem is, as soon as they bring them into their infrastructure, that whole innovation of that company is gone. Imagine if Inspire Medical got inquired back by Metronic again. Inspire would not be Inspire. And, you know, the same thing with any of these other major innovators or disruptors.

And what I'm looking to do is be a major disruptor in the spinal fusion business because spine care has not been changed in over 30 years. They're doing the same procedures. And, yes, they're utilizing robotics. but we know that there's only so much advances that you can do by placing a pedicle screw in the right area. If you got nerve damage, it doesn't matter what you do. Nothing's going to fix that other than what we know, which is neuromodulation, or opioids, which nobody wants opioids. So, you know, when you bring all this together, it's how do we do this in a manner that's going to give the

greatest return for the investor. And if you're investor focused and your patient focus, which I believe those two are aligned, they're not disaligned, but when you bring those two together and you're thinking what's best for the patient and what's best for the investor, you're going to get to an outcome that's going to create so much value that investors are going to want to participate. Yeah. I'm looking at the clock and I know we don't have a ton of time left. I want to get to the rapid fire portion of the discussion here. But real quick, when, And you've mentioned this a couple times around how you're thinking about this transition from PhDs to MDs.

And I like how you frame that up because I think that's actually really, that's really, you know, applicable. It's a good way to kind of think about this transition as you head into not only a larger scale pivotal trial, but eventual commercialization. If you go there with a novel technology, right, you're creating a category and haven't made, haven't greased the skids, right? haven't developed the type of relationships with, like enrollment is going to be a challenge, undoubtedly, right? Yes. Even if you've got the most phenomenal clinical team and you can, you know, market extremely effectively to patients, you know, for enrolling, if you haven't, if you don't have

that buy-in, that clinical buy-in early, it's going to be a big, a big slog. So I've got to touch on that and kind of what you're, you know, how you're thinking about, that aspect of this transition, you know, as you, as you prepare for that, that eventual pivotal trial. So we're very fortunate in the fact that we had a great medical team from our principal investigator, co-investigator, Dr. Park and Dr. Law. Dr. Law did 11 of the 15 procedures. He's a neurosurgeon focuses on spine. He really carried the ball, really showed other surgeons that this could be done, that you could do a solo procedure yourself. Dr. Park did a really great job with neuromodulation background being the primary inventor, showing how this technology is applicable for spinal fusions.

And having those two surgeons together really laid the groundwork for, okay, what are surgeons going to want to have? And that's how we developed the ETLIF, which was the procedure, which is single incision, and having the neurofewed system within the same pocket as the spinal fusion. Well, if I didn't have Dr. Lal, who now after our study became our chief medical officer and Dr. Park, who was our principal investigator and now he's our chief technology officer, if I didn't have those two guys there, that would have been missed completely, meaning I could have a product that worked, but if it's not working within the way the surgeons want to work, they're not going to be. bring that thing forward. And how Dr. Lal can have a conversation with his other colleagues

throughout the country and say, this is how you do it, this is how easy, this is how you place the leads. And there's these little nuances that, you know, it's surgeon to surgeon, peer to peer. I cannot go in to another surgeon and tell them how to do a surgery. It will never happen. I can't do it. And a lot of times what happens is you have PhDs that think they're clinicians and they're not clinicians. And you want to piss off a surgeon quickly? Have a PhD, tell an MD, a neurosurgeon, how to do a procedure. Never going to happen. So by making sure that you have these guys who are now bringing the gospel of centrifuge to the other surgeons, it's being well received. And now we have Dr. Fulowski, Dr. Reddy. We have all these doctors throughout the country that love,

of the technology and where it's going, but it has to come from the right messenger. And by having your chief medical officer and chief technology officers on board who are the ones who have done the procedure, you know, it's like if you're dealing with a mechanic, do you want the mechanic who worked on the engines of the race cars that win? Or do you want the guy who knows about it in theory? No, I want the mechanic because he knows this is the things that you have to do to make your car work. Same thing goes in surgeries.

These guys perfected these procedures on these 15 patients, and that's what's going to allow for enrollment to go even faster because they're going to know the little tricks in the trade of, hey, when you open that up, you need to open it up more so you can slide the leads in on the nerve. Well, if they don't have that conversation, those other surgeons are going to be more hesitant to doing the procedure. But by hitting all those boxes ahead of time, you're now allowed to force those things through faster because it's very straightforward, very simple.

And that only comes by doing. This can't be taught on a book. No doubt, no doubt. And that point you made about identifying clinicians that are really going to be in a good position to influence other clinicians, right? Find your KOLs of KOLs, if you will, right? that's so so crucial especially with a you know when you're building a category you know like you're doing it at interviews so um also make sure that those kowels don't get ahead of their skis and start talking about things they don't understand like money and trials and you know because

a lot of times what will happen is they'll have a bad experience and they'll try to influence your company and you can't have that either you need to make it where you know like focus on what you know and do it to the tea i'm not coming into tell you how to do your job, don't come in and tell me how to do my job. Yeah. Yeah, if you can find sort of true, true thought leaders that can meaningfully influence in a good way, right, other physician behavior, but yet also also know how to balance that, right? And maybe have been around startups before and kind of know how things work. That's the ideal. Well, and I would also add this too. The best surgeons are loyal to your project and

loyal to the team. If you have surgeons that are disloyal or team members that are disloyal, you do not want those people on your team because they will be like a cancer and destroy the very concept that you're trying to move forward. Yeah. Yeah. I know I want to, we only got five minutes left here, but that's really important because I think most people think about with that, that, that, that, that, this concept of culture, right, within the, within the context of their employees, right? But it, but it's, it's equally applicable to advisors. Right, physician advisors, other, you know, critical consultants, you know, because that, you know, if you should choose to work with the wrong people, regardless of their role, that same effect could happen, right? So I'm glad you kind of, you kind of touched on that. Yeah, you can't have disloyal people. And disloyalty is, what is it, and Dante's Infernal. It's the lowest level of hell.

Yeah. We're laughing about it, but it's a very real thing. So, well, and you know this being in startup, whenever money is involved, people change. People get goofy about things. And if they think they can stab you in the back and take you, they will. Yeah. Unfortunately, money, money does change a lot of behavior. But with all of that said, let's get the rapid fire portion in the interview. But again, everyone listening, centerfews.com, S-Y-N-E-R-F-U-S-E, centerfuse.com.

We'll link to it in the full write-up. We'll also link to Justin's LinkedIn profile as well, so you can follow him on social there. So with that said, first question, if you want to breeze through these real quickly,

just for the sake of time, is since the last time you've been on Med-S-E-Sy, which I think was back, and if I remember, I got to go pull it up, but I think it was like 2000, it was probably at least,

at least over two years ago, right? So, anyway, two to three years ago. It was like 2020. We just had our first patient, I think. Yeah, yeah. It's been a bit. It's been like 22. Yeah, 22. That sounds about right. So I think about the last three years. What's the most, you know, surprising or unexpected thing you've learned? Oh, that's a good, that's a really good question. I'm most surprised by the people who stepped up and performed. And I give a lot of credit to Dr. Loll who forged this new procedure forward on 11 of the 15 patients

and became our chief medical officer and a very, you know, loyal friend, loyal guy who helped bring, foster this thing to the forefront. Those types of people that, like, will hang in the pocket, right? And just are willing to kind of dig in and build along with you in the face of adversity. Those are special people, you know, especially when you kind of get to the other side. So, all right, let's say we're in Minneapolis with a group of, you know, 20, 30 mettech entrepreneurs, which I know we chatted about before this interview, maybe we should do it at some point. But if you've got a room full of startup folks in Minneapolis,

and you want to leave them with like one key lesson they need to learn. What would that be? Don't be afraid to fail. Just start. And if you believe in it strongly enough, put your own money into it and people will follow. Yeah. It's interesting that you say that because that phrase is often, you know, it's easy to gloss over, right? Don't be afraid to fail, et cetera.

but when you're there's always these moments right when especially especially if you if you have you know you know there's going to be differing opinions around the table i'll put it i'll put it that way right but a lot of times i keep coming back to this word of courage you know just having courage to sort of like push through because oftentimes the easiest the easiest path or the right path is not is not the easiest path and so anyway i couldn't i couldn't agree more right of just not being afraid and and uh you know leaning into leaning into courage and so all right uh last question i've got for you Justin here. Take us back to maybe, I don't know, earlier in your career, right, well before interviews, say, call it late 20s, early 30s. What's the one thing maybe you tell you the younger

version of yourself? Don't be disappointed in the people around you because they are going to disappoint you. And it goes back to the whole loyalty thing. You know, you think that you have people that are brothers in arms with you and they're going to be there with you through every step of the phase, but when when shit gets really hard, the people who are with you are going to be very few and you need to understand that most people are going to go by the wayside. And that's okay. It doesn't mean they're bad. Doesn't mean they're evil. It just means that they're just not the ones that are to be with you. And every time I've had a major crisis or major pain point, those people who are really the ones that are of value to you reveal themselves because those people

are going to be there for you. Good way to wrap up the conversation. I like how you phrase that, right? You know, don't be disappointed in people because people are going to disappoint you, right? And just that sounds simple, but that reality is very, is very real. And so I'm excited to watch what centerfews, what you guys are doing, you know, definitely there's not a lot of startups that take on this big of a lift. And so to get this far and then to be staring down a pivotal trial, it's going to be fun to watch your progress over the next year. Great. Well, I really appreciate you having me on. And, you know, it's cool to, you know, the fact that we were three years ago and now we're here, who would have thought that it would

take this long to get a trial? But at the same time, it's really great to have you, you know, hear what you're doing for the community. And I really appreciate it because, you know, we are the lone wolves out there, you know, fighting every day. And I really appreciate what you're doing. No, absolutely. Absolutely. And I always like having these round two conversations, right? Because it's like, it's a unique sort of lens to look through, right? Because you're at a very important point, you know, three years ago. And, you know, I think I would, I would make the argument an even more important point now, you know, stage in the company's lifecycle. So appreciate you carving time. I know things are probably humming on your end. So appreciate your time and sharing a lot of

a lot of really, really good lessons learned kind of over the past handful of years building Cinterfews. So with that said, everyone listening again, centerfuse.com is the website. We'll link to it in the full write-up on MedSider, but definitely encourage you to check out the technology and follow the company, right? Especially if you're local to Minneapolis. So thanks for your attention, as always, until the next episode of MedSater 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

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