Medsider: Learn from Medtech and Healthtech Founders and CEOs - What Makes a Medtech Company Investable? Interview with Neuros Medical CEO David Veino

Episode Date: August 3, 2026

In this episode of Medsider Radio, we sat down with David Veino, President and CEO of Neuros Medical.Neuros is commercializing the FDA-approved Altius Direct Electrical Nerve Stimulation System for chronic post-amputation pain.Before Neuros, David held senior commercial leadership roles at Cardiovascular Systems (CSI) and Stryker, and helped grow CSI's coronary and peripheral business from approximately $50 million to more than $250 million in annual revenue while leading key amputation-prevention initiatives. He also serves as a private equity advisor with Sectoral Asset Management. In this interview, David discusses how commercialization begins by mapping the patient journey upstream, what it takes to generate gold-standard clinical evidence for a novel therapy, how investors assess scalable medtech businesses, and how to build an investor pitch that earns the next meeting.  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 David Veino, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:02) - David's 30-year medtech journey from cardiovascular devices to leading Neuros (04:38) - How Neuros is treating chronic post-amputation pain with on-demand neuromodulation (11:08) - Why Neuros completely changed its strategy halfway through the pivotal trial (15:36) - Why commercialization starts with referral pathways, not end-users (18:09) - How prosthetists became one of Neuros' most important referral sources (26:11) - What it takes to generate gold-standard clinical evidence for a first-of-its-kind therapy (37:41) - Building an investor pitch that earns the next meeting (41:42) - What gets David excited enough to invest in a medtech company

So we would look at targeting, we would look at adopters, we would look at utilization of the technology itself. But I think the lesson learned is we would go way upstream to determine what's the referral pathway and where do the patients come from? and how do we educate that part of it as soon as possible to build constituency around the technology so that when patients are looking for affirmation or they're looking for second opinion, there's enough people to say yes, we believe this is the appropriate treatment option for you based on your current condition. 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, we sat down with David Vino, president and CEO of Neuros Medical. Neuros is commercializing the FDA-approved Alteus direct electrical nerve stimulation system for chronic post-amputation pain. Before Neuros, David held senior commercial leadership roles at cardiovascular systems and striker and helped grow CSI's coronary and peripheral business from approximately $50 million to more than $250 million in annual revenue while leading key amputation prevention initiatives. He also serves as a private equity advisor with sectoral asset management. Here are a few topics we explored in this conversation. First, mapping the patient journey upstream, what this actually looks like in practice and how it shapes commercial strategy. Second, what does it take to generate gold standard clinical evidence for a first of its kind technology?

Third, how do investors distinguish a great technology from a scalable medtech business? And last, the anatomy of an investor pitch that earns the next meeting. Before we dive into the full episode, if you're a MedTech founder or CEO preparing to raise capital, you should check out the MedSiter 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 waitlist at medsider.com forward slash fundraising cohort. Again, that's medsider.com forward slash fundraising cohort. All right, let's get to the interview. All right, David, welcome to Medsider Radio. Appreciate you coming on. Hey, thanks for having me. I'm excited to join, so I appreciate it. Yeah, always nice interviewing a fellow Minnesota-based device startup, CEO of a device startup anyway. But with that said, I recorded an abbreviated bio at the outside of this episode. But let's start there. Let's hear like the one to two minute kind of elevator pitch on what you've done throughout the past, you know, several decades in your career

leading up to taking on the CEO role at Neuros. Yeah, it's always hard to talk about yourself. But I think, you know, look, most importantly, I've been in Med Device for 30 years, spanning across cardiovascular, peripheral vascular, a little bit of interventional pain at Stryker, where I built their interventional spine division from the ground up. Spent time in Minneapolis before with CSI, a company that was focused on preferral vascular intervention, saving limbs from amputation. And really the last eight years, almost nine here at Neuros, is building out this organization focused on this pioneering neuromodulation technology for chronic post-amputation pain. So spread the gamut over, over three decades now in different various areas of med device.

and probably the most important part is just having a sickness in a good way for startups and excited to continue to venture through and deliver pioneering technology to the marketplace. It's so funny that you mentioned sickness, right? I mean, this is obviously an audio interview, but we're recording this on video and I'm laughing because it's like earlier on in your careers, it's like startups are the sexy thing and you want to be and then you do a few and you're like, oh, am I insane to do these? Very much so. There's a lot of fun.

They're a lot of fun, but it is not for the, they're not for the faint of heart. I'll put it that way. It is. Not at all. Yeah. So tell us a little bit about Nuros. I'm on the website right now and we'll obviously dig into the company and lessons learned not only through your career, but also over the past, you know, eight years or so at

Neuros and kind of, you know, what you've learned along the way. But Nuros Medical is the website. I'm looking at the technology right now. Maybe explain it as if I've never heard of this. I'm a senior in high school and this kind of sounds interesting to me. Like what is, what is this you guys are building here? Yeah. It's a really cool opportunity, and I think I'll start out with, you know, amputees, right?

There's about two and a half million lower limb amputees in the country, about 230,000 major lower limb amputations every year. 80% of those individuals unfortunately suffer from chronic post-amputation pain, and there really aren't a lot of treatment options for them. You can utilize opioids, and we know the systemic effects of those, unfortunately. And that's really the sort of first line of therapy that most of these patients, you know, are subjected to. Other than that, there aren't a lot of treatment options.

And unfortunately, this patient population really hasn't been studied before. So we were the only company who developed a technology to study these patients directly and get an on-label indicated FDA-approved device specifically for this population for their current condition. So really excited about it. It's a unique technology, one that doesn't exist in the marketplace. It's a high-frequency nerve block. So when you think of neuromodulation technologies for spinal cord stimulation or failback syndrome, very different. Those are therapies that run all the time, kind of run in the background.

And hopefully they will confuse the nervous system enough to say, hey, that stimulus feels better than the pain. This is different. Patients actually can start the device and utilize its ability to provide an on-demand nerve block. So the technology essentially blocks the pain signal from reaching the brain. Very cool. And is it a wearable? Is it like a, is it something that you use, you know, once per day or give me a little better sense for like the kind of the patient experience? It's a fully implantable system.

There's a cuff electrode that actually wraps directly around the patient's severed nerve. And that is what allows the high frequency stimulus to penetrate the nerve and block the signal. And then the battery is actually implanted in the abdominal area. So the patients can actually see when they turn the device on. So it's an on demand as needed. Essentially, if they have pain, they use their control. controller. They start the device. It sends the signal. It blocks the nerve. They get about nine hours of pain relief per session that they use the device. Okay, very good. To a certain extent, kind of set it and forget it,

if you will, right? Is it most of the time, is it implanted at the time of amputation? Is it a post-amputation sort of experience like a procedure? Tell me more about that. Yeah, it's a post-amputation pain procedure. So patients are usually about a year post-amputation when they start developing chronic pain condition. So we're on a large-scale clinical trial. You had to be one-year post-amputation. Most patients were about nine years on average going through numerous types of therapies that have failed and then essentially got our device. So about anywhere a year after amputation is when the device is implanted. Okay, very good. Circling back around to that one of those stats that you mentioned when you're kind of setting up sort of the market, if you will, is 80% of amputees deal with this.

That's incredibly high. Like, I had no idea. Very high. Yeah, I had no idea sort of the prevalence of this sort of experience was that great. So that's always one of the things that's attracted me to the medical device space, right, is these large, like, huge needs. And so it's like not to underappreciate, you know, other startups and other verticals, but that's something, you know, special about the device space.

You're not in your head. So I'm assuming you agree, right? you've been in the game long enough, but it's pretty cool, right, to work on something that, like, solves such a real, pun, unintended, but real pain point here, right, for a lot of, patients. It is. And I think, you know, working in cardiology, working in peripheral vascular disease, working in, you know, interventional spying pain area, you know, you see these large populations, and we certainly know about the number one killer in the U.S. being cardiovascular disease. And I would argue even peripheral vascular disease today. So epidemic of diabetes in

this country, epidemic of amputations, and peripheral vaster disease. Interestingly, when you get into some of these, I would say niche to a certain degree, right? So this niche market, two and a half million patients, another 230,000 every year, and 80% will have chronic post-amputation pain with very little treatment options. Most med-device sectors that we work in have multiple treatment options for a particular disease state, right? It may be different mechanism of actions. It may be different types of therapy, but traditionally there's quite a few different therapeutic opportunities for these patients. This is different. This population of patients really doesn't have anything but a opioid prescription. Interestingly enough, too, 40% of these patients that have a major lower limb

amputation have tried four or more therapeutic interventions that have failed. Most of these patients will have more than one amputation. So between PTSD, depression, anxiety, and worst, this is the worst part of all, over a 60% suicidality ideation rate. So that's probably the worst part. And when we can apply our technology to this population, we can get them off of their opioid dependency. We can restore their quality of life. And most importantly, we can help them from their suicidality ideation by removing their pain. Yeah. Tackling some huge, some huge issues there for sure. So pretty cool technology and pretty cool, pretty cool way to go about solving some of these major issues that these patients suffer with. So with that said, we're reporting this in kind of mid, it's called

mid-2020s. For someone that's listening to this maybe three, six months down the road, where's the company at right now in terms of life cycle? We raised our series D in around and closed it end of July of last year. And then we started commercialization January 1. So we set up the entire team into 25 of last year. So the end of 25 had the team on board at everybody trained and ready to go. got reimbursement. So we got our CPT1 codes last year as well. And that allowed us to really start to venture out into commercial execution, set up the right number of, as you know, territories accounts, targets, measure incredibly well, you know, iterate along the way, change the sales process as needed. So we're in the middle of call it end of month sixth of full

commercialization. Wow. Yeah. So pretty a lot of activity going on right now. And I just think it's always helpful to kind of go to look at kind of the window, right, that you've been with at, at, you know, a CEO that's been at a company, right? And you're almost, you're closer to a decade, right, in terms of time at NEROS. And yet here we are, right, in month six of commercialization. I just think it never sees as amazes me how much, how much time, right, is needed to effectively build these new types of, new types of therapies. It is amazing. When you think about, and we ran an IDE PMA clinical trial, right? So gold standard and clinical trials. There was a uniqueness about this organization that the company was founded in

08 out of Cleveland. It was really a technology out of Case Western Reserve that was in their sort of incubator program. They started really the clinical journey with first in man and the pilot study done in 2012. They kicked off the pivotal study in 2014. Crazy to think 2014 and the trial concluded in 2021. So it usually never takes seven years. years to run a clinical trial. I don't care how hard the trial usually is. This wouldn't pause for about 18 months for financing. So it kind of shut them down for a little bit. Then they restarted. And then we shifted the entire strategy of the clinical trial sort of in mid phase. This is another one of those moments in development of startup companies where you have these moments of, wait a minute,

you change the entire landscape and the trajectory of the company in mid clinical trial phase. How did that happen? Originally, the organization was focused on neurosurgeons and interventional pain physicians. Unfortunately, they don't see post-amputation pain because they don't have a treatment option for them. Vascular surgeons do most of the amputations in any large geographical area. And so we switched our entire sites. So we closed down neurosurgeon sites. We started up vascular surgeon sites. After we did that, COVID hit. And it was probably one of the most interesting things I've ever seen. COVID was a disaster for many, many reasons for many, many people across the globe, including a lot of medical device companies.

For neuros, it was really a silver lining. So patients have chronic pain, which is exacerbated by depression and anxiety. I would argue people that had two good legs like you and I probably had a lot of depression and anxiety during that time, right? So the vaster surgeons kept their ASCs open and running, and the patients flocked to these ASC locations to get the device implanted through the clinical trial. And they accelerated the trial when it was done in record time during the height of COVID. So one of the most interesting things I've ever seen happen. But along the way, look, lots of changes, lots of fundraising,

lots of moments going through the FDA for our PMA approval, our breakthrough device designation. Yeah. To say that it's almost a decade and still here doing it with a smile on my face and excited. Yeah, it takes a lot. Yeah, testament to you and the team, right? I mean, we're both smiling, but it's like, man, these stories never ceased to amaze me. And I think it's more people in device space deserve, deserve even more credit, right? Because these are just, they're challenging companies to build, and the obstacles are, you know, are never ending, you know. So with that said, I'm interested to kind of go back in time and learn a little bit more about some of your experiences, right,

not just with Neuros, but also the other startups that you've been with over the past a couple decades as well. But again, for everyone listening, if you don't get to the full write-up on MedSider, for this particular conversation with David, the website is neurosmedical.com. So just as it sounds, N-E-U-R-O-S-Medical.com, Neurosmedical.com. Highly encourage you to check out the technology. Pretty cool area to be developing solutions in. So the first kind of topic I wanted to discuss was really commercial scale, right?

Because you've done this a number of times at other startups, right? You mentioned CSI as an example that went through some pretty explosive growth during your time there in the peripheral vascular space. When you think about kind of the challenging of taking a technology like this, that although there are a lot of great therapeutic options or very few therapeutic options outside of drugs, it's still novel, right? It's different. And so as you kind of begin to sort of prepare the commercialization skids, if you agree with the skids for commercialization, what would have been some of the more interesting things or lessons learned kind of thinking about those various referral patterns and how those, you know, change and what it takes to, you know, takes for clinicians

to adopt a new type of therapy like this? I think that's the $64,000 question, right? Whenever you start to do this is can you lay out the blueprint? You can get this right, right? And can you get it right early and often versus late and the dollars that you spend and what you invest and you're changing strategies? Those are a killer in any organization, right? Especially venture-backed startup companies. You have so much money and so much time and that's it, right? And if you got to go out and raise more money sooner than you would want to, people get diluted and people get angry, right? So things don't go so well. So can you get it right the first time? The one, area that I would say is probably lessons learned over time is ensure that you have an incredibly

good handle on targeting. And it is not the simple med device. Hey, it's the early adopters and they're sort of this bell curve and we're going to get on the forefront of the early adopters. They're going to go ahead and take us all the way through. Then they're going to hand us off to the next segment and so on and so forth. You really need to understand and know the market. And I think what you have to do is back up and really start to target up front. Who are the diagnosing and referring entities? And what is the patient pathway of getting to a particular area where a disease state is that needs to be treated? So for peripheral vascular back in the day, one of the most important areas for us to target was podiatry. And people would look at that and say, what do you mean?

The majority of patients, where they were first diagnosed for peripheral vascular disease was podiatry. And if you've got a diabetic ulceration, you're about 80% likely, if not intervened, that you're going to get your first amputation. whether it be toes, midfoot, or foot, that's where it's going to start. So we would go all the way up to podiatry and even internal medicine family practice to ensure that we could go there and start the education process because podiatry gets paid on feet. And you probably want two good feet if you're a podiatrist. So how do we ensure that we not only keep your patients as healthy as possible, but how do we intervene at the most appropriate times and have the likelihood of adoption of our technology?

So we would look at targeting. We would look at adopters. We would look at utilization of the technology itself. But I think the lesson learned is we would go way upstream to determine what's the referral pathway and where do the patients come from? And how do we educate that part of it as soon as possible to build constituency around the technology so that when patients are looking for affirmation or they're looking for second opinion, there's enough people to say, yes, we believe this is the appropriate treatment option for you based on your current condition. Maybe draw from your days at CSI doing this, right? Because you mentioned podiatry being a pretty critical kind of starting point, stakeholder in that process. And you've kind of applied a lot of lessons, right, in that sort of that blueprint or that playbook at NEROS. But is that a scenario where you've found it effective to kind of go and collaborate with vascular surgeons who are maybe implanting the technology and then doing sort of educational initiatives alongside, you know, those primary care physicians or, you know, some other key referral stakeholder? What, I guess, in other words, what's working today versus, you know, is that same kind of playbook working today versus

it, you know, maybe, you know, 10 years ago at CSI? It is. And it's interesting because I think what applied here, after many learning lessons at CSI, if you follow the track record at CSI, we had some not so great years for a number of reasons and some explosive growth, right? So not to, you know, sort of replay, you know, those issues, which was, what did we learn from that and how do we implement that in what we're trying to accomplish today? Sort of the same thing.

Amputees, what's interesting. is if you have cardiovascular disease, you go see a cardiologist. If you have a cancer, you see an oncologist. If you're an amputee, there is not an amputeologist, right? So it's very fragmented health care. And so what you have to understand is when a patient receives an amputation, where primarily are they getting their care from? And what's interesting is prosthetist. So a prosthetist who puts on the prosthetic, they're not a health care provider, they're a vendor. but they spend the majority of time with amputees pre-amputation and post-amputation. And so we've spent a lot of our time doing CE education and education in general to the

prosthetist community because they are a gigantic referral source into vascular surgery and reverse the other way. Vascular surgeons send a lot of their patients to prostitists, right? So we took the tact of, hey, vascular surgeons are important to implant our technology, and that's great. But we're going to go way upstream to look at where do we intervene early with education to ensure we have the right patient population getting to the right physician that has the right ecosystem that can adopt our technology. Got it. And was that something that wasn't overly apparent until you, you know, sort of going a little bit deeper with trying

to understand the landscape? Or like, I guess when did that surface? Because it seems like it makes a ton of sense now, right, hearing you describe that. But I got to think it wasn't like, you know, there's maybe a lot of steps to get there, right, to fully understand kind of what that look like. I agree, because I think the traditional focus that a lot of med device companies have is they're looking for the end user first. Hey, who's my end use? Who's my target? Who are we going to spend time with? How are we going to target? Are they early adopters? What targeting information are we going to use to get to those guys? And then who are some of the high level referring entities? I think everybody kind of does that really well. Well, prosthetists are not a, in this case,

you can look at podiatry, who's part of it. You can look at PM and R who is part of it. You can look at even some of the internal medicine family practice that diagnose phantom and residual limb pain. But prosthetists are a vendor. So they don't have NPI numbers. They're not somebody who shows up on an acuity MD targeting list. There's like, not this like, oh yeah, here's this huge list of prostitists, right? You got to really go out and figure out who are those individuals tied to these surgeons? What role do they play? Are they progressive and looking for treatment options for their patients? or they just want to get them in a prosthetic and sell that? Are they tied to therapy?

Do they have relationships with a physical therapist or occupational therapist? So there was a little bit of fact-finding to determine who cares for a lot of these people? Where do they spend most of their time if it's outside the healthcare continuum of MDs? One of those things that I'm just, I'm not sure if this is overly applicable to what you've been through. But one of those things that's like it doesn't really come to light on a PowerPoint, slide deck, right, until you start getting in the mix, right? And going to, you know, getting in the weeds, rolling up your sleeves and really trying to understand kind of the disparate landscape and who really, who really impacts, you know, some of these pathways for a lot of

these patients in various areas of the country. So one other topic kind of on this idea of kind of going all in on a startup and kind of scaling a novel technology, I know you, you're part of the, or at least an advisor, right, to sectoral asset management. So you've seen a lot of, a lot of good ideas come across your desk over the years. But you decide to spend, you know, almost a decade now at Nero's, right? So you kind of understand, kind of like what, you know, where is an area that I sort of want to, I want to double down into? When you think about some of those other technologies that you've seen come and go, that you've sort of, you know, turned away, so to speak, right? Like, is there a difference between, you know, when you decide

to, you know, double down on something and really think it could eventually turn into a sustainable business? Yeah, I think it's a really good question. And I'll give you a couple of examples. One would be cancer therapy treatments, right? I think there's this opportunity for cancer treatments to be much more specific and tailored to individuals, meeting them where their cancer is, versus, hey, we're just going to go ahead and blast this person with whatever therapeutic intervention is sort of the flavor of whatever the oncology treatment community says, right? There's some really specific and awesome things that the cancer community is doing of very specific treatments tailored to patients that preserve healthy tissue and go after cancer tumors. And it's just awesome. And one that

we reviewed not that long ago, which was technology was fascinating. I think it could have had a real market opportunity. But their ability to get that technology to the market, to the masses, to make this a real commercial opportunity that you could see grow and scale and have value creation wasn't there. And the level of heavy lifting that it was going to take and the dollars it was going to require was probably more than what an investment community, especially sectoral, and even some of the other people that passed on it, decided that it was probably worth at the time. So it wasn't quite there yet. I don't think their commercial model was as refined as it needed to be. I think there were some advancements in the technology that still needed to happen. That's probably where

the investment needed to go versus trying to commercialize. I think everybody's looking for that return in X period of time, right? It could be three to four years. It depends on if you're biotech or med tech. But I think everybody's looking for the return window that that particular firm tends to sort of wrap their arms around and say, this is the investment window that we're making. Here's the exit window that we're thinking about in terms of the life cycle of this fund and what we want to invest in. There's a couple of things that are really important. Commercial execution, commercial plan, commercial readiness, and reimbursement. And these are two areas that are major stumbling blocks for a lot of organizations. Sometimes people are really close to their commercial

strategy and probably don't take the time to see it in a 360-degree view. And what holes could other people see in the commercial execution strategy? Second would be reimbursement. We all know that I don't care how great your technology is and they can't get paid for, nobody cares. No doubt. Isn't that the truth? Right. It's like the hard truth, right? Yeah. And understanding kind of what it takes to get there, right, to develop a category, CPT code. And let's transition to talking about kind of what the Clinereg roadmap, not just for NUROS, but kind of what it took to kind of effectively get to a CAT1 CPT code. So I guess first, first question though, before we kind of get to maybe the clinical data that laddered up to that,

like designing for a study, you mentioned one of the challenging early on and the pivot that took that took place at NEROS, right, with kind of, you know, swapping out trial sites for, you know, and heading more in the direction of vascular surgery versus interventional pain, pain medicine. When developing a technology like this with sort of a subject, there's a fair amount, I would imagine a fair amount of subjectivity to pain in general, right? And so do that present other challenges as well as you're thinking about kind of developing or designing, I should say, trials for neuros? Hey, everyone, let's take a quick break to catch you up on Medsider courses.

These 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 the 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. Okay, let's get back to the conversation. Yeah, I would say that's exactly right. And anybody who's ever done a pain study knows there's a lot of subjectivity to pain and to pain

measurement. If you look at a lot of neuromodulation trials that have been done in the past for spinal cord stimulation and we'll just focus on that for a second, they'll measure the baseline level of pain when a patient starts the trial itself. 90 days later, they'll measure their pain. And then they'll get a responder rate. Well, pain is incredibly dynamic. And it doesn't quite happen like that, right? And so we said in order for us to be considered a gold standard of a clinical trial, we better do this against an active sham. So whenever you say an active sham, immediately people start to cringe because there's been a lot of failures of companies that have tried to do an active sham trial and have failed. We said, because our technology is an on-demand therapy, right? So it's not running all the time.

It has a discernible mechanism of action. We need to do a trial against an active sham. right so our trial was randomized one-to-one either the group got full therapy or they got an active sham so they actually got activated therapy that the patients could feel there was a discernible feeling of the therapy itself it was just sub-therapeutic so it didn't have the blocking mechanism that the full therapy did but patients felt it they were randomized one-to-one for 90 days it was double-blinded all the way through crossover and all the way through 12 months Wow. So really challenging for a clinical trial of that nature when you have patients that were in the active sham group cross over and get full therapy. The full therapy group just gets reprogrammed, right, from scratch. To be able to keep those arms completely blinded from everyone, provider, patients, any of the health care providers that were involved in the study, all the way through 12 months, with a very different feeling between active,

full active block therapy versus active sham was an incredible feat. And so for us to do that, it was amazing. The outcomes were even more, I think, mind boggling for people that it was a 50% level of pain reduction in 50% of sessions performed at 30 minutes. Wow. So imagine trying to get a 50% level of pain reduction and 50% of the sessions that the participants utilize the device at 30 minutes when the device shuts off. It's unheard of. Like there's not a chance that's happening, right? And so when I first took over the trial, when we were designing this thing and getting it executed for implementation, I'm like, there's not a chance we're going to pass this. This is our primary efficacy endpoint. This is going to be tough. So we better have some really good,

robust secondaries in case we miss our primary endpoint. We made our primary endpoint, blew the P value away, and then showed a significant pain reduction at two hours. So we measured it at 30 minutes when the device shut off. We measured it again two hours later to demonstrate there was even a greater effect of pain control over time, which there is with the device. And then we had two other things, I think we're critical in the entire outcomes of the study, which I think allowed us to get our CPT-1 codes, which were significant reduction, statistically significant in opioid utilization. So massive reduction in opioid use, 40% of our patients stopped taking opioids altogether. And there was no weaning protocol. So really awesome. So you really know that if a device is working

to reduce acute level pain and they're dropping opioids by that much, clearly that mechanism of action is working. A significant increase in quality of life, more importantly, sleeping, walking, returning to work, critical things for this patient population. And then, you know, one that I love is our ability to demonstrate the long-term pain reduction. So it's one thing to get the 30-minute and the two-hour. We showed a 60% reduction in chronic pain at one year. So that severity and the number of severe episodes that patients were having was reduced by 60% at 12 months. So the results were awesome. We applied for new tech APC. So we thought absolutely with with breakthrough device designation, we should apply for new tech APC. The CMS came back and declined our new tech APC application and gave

us actual CPT1 code. So, wow. Sort of this, you know, we were looking for a new tech APC, which we thought was great, which would have been great for our Medicare patients, would have been challenging for our commercial pay, right? So there was a little bit of a tradeoff there. CPT1 codes were actually great for both, great for our Medicare patients, and then really good for our commercial pay patients as well. So we were lucky. Wow, well, lucky, but I would say there's probably a lot of really good execution along the way, it sounds like, especially running that type of rigorous trial. Kind of on the topic of, you know, sort of being granted a CAT-1 CPT code while you were sort of just asking for the APC, was that, it sounded like that was surprising. Was that

largely driven from just the quality of evidence or the, the, the, the quality of the results from the trial, the Quest study? Yeah, it was two things. One, you know, being completely honest, it was, hey, we didn't meet the new tech APC criteria, which we were all kind of shocked by because it was it was very apparent that when you read the new tech APC application and guidelines, clearly our technology met that. We were a breakthrough device designation. There really is nothing else in this category treating this patient population. And clearly we said, hey, there's not a chance we're not going to get that, right? another fatal flaw of startup organizations when you're so convicted and your consultants who you pay a lot of money to make you even more convicted and what your decision is and then you get surprised right thank god in a good way but we got surprised but i also think it was because of the level of evidence that we had and CMS also said hey look what you're doing is not unfamiliar to us as CMS we're going to slot you into at least one of the two were existing codes right so we're

you got slotted into an existing code for peripheral nerve stimulation. And so the good news is there are organizations that came well before us that did a really good job of laying the groundwork to get peripheral nerve stimulation approved by a lot of the commercial payers. So about 60, almost 70% of commercial payers recognize peripheral nerve stimulation codes, which is great, but still a bit of a surprise to us. Okay. Yeah, well, circling back around to the study in the trial design, I got to think running that

sort of rigorous of a trial with an active sham arm, site selection was even more crucial, right? I mean, it's always, it's always important, right, to any sort of pivotal trial, but especially in this case, talk to us a little bit about that. Like, did you, especially kind of off the pivot, you know, of refocusing on vascular surgery community, how crucial was that to, you know, seeing some of the results that you saw? Incredibly critical. I think it was really important for us to really identify the clinical trial sites that had a lot of experience doing novel clinical studies, even if it wasn't in neuromodulation like this one was, but sites that were very experienced in doing complex clinical studies, right? So that was incredibly important to us.

We also had to spend a lot of time with these clinical sites more than I would have expected, but the patient population and our ability to get people enrolled that had a lot of questions about I've tried four or more treatment options before they failed. Hey, I've got more than one amputation. Hey, I'm a little skeptical of the healthcare system, even though I'm, applying for this clinical trial, it took us a lot of work and more investment than we had originally considered or even budgeted for to put field clinical specialists and education specialists in these targeted clinical trial sites to help the clinical research coordinators get these patients through, educated and into the clinical study. So good side selection,

but great leadership on the clinical side by our team. And I think really, smart investments to make sure that you had the right level of individuals helping to put their arms around these patients and get them in the clinical study. Yeah. Speaks to the, I think, the importance of probably having the right group of investors around the cap table, right, that are willing to continue to inject funds for, you know, maybe not necessarily unbudgeted resources, but maybe just more, you know, more budget needed around certain resources in order to effectively run a trial like this.

I can't say enough good things. And I'm not just saying this just to, you know, in case our investors hear this. I can't say enough good things about our investors and our board members who, you know, thankfully, and I wouldn't say we chose these people the right way. You know how fundraising goes. We don't always get to choose. We get chosen, right? So it's a bit different when you're going through the fundraising hoops.

I would say that some of the board members had really good experience in understanding, challenging technologies like ours. and they invested in other technologies. One, primarily here in the Twin Cities, it's a multi-billion dollar market cap company that hasn't been acquired yet by one of the big companies in sleep apnea. You can probably guess who that is, right?

So a lot of our board members invested in that organization early on and think about their trajectory, right? You're talking about a first-of-its-kind sleep apnea treatment that's an active and planable, right? So patients have to go through a sleep, They've got to go through an endoscopy test. All the different challenges on this referral pathway to get the therapy, our board members had been through that.

They saw it. They understood it. They went through it. They knew it's going to be a little bit more challenging, likely going to take a little bit longer and likely going to take more investment. But I think that investment clearly worked out for them. So we're hoping the same thing happens here. Yeah.

I just want to double click into this for a little bit. Because sometimes, I mean, to your point, a lot of times when we're raising capital, we don't have the optionality that we wish we did, right? And the sort of the choice to kind of pick and choose and be overly selective, right, with investors. But that said, sometimes it's easy to get cut up on valuation and terms, right? And you weigh that maybe or prioritize that more heavily than a group of investors that has been through something similar, right? And so, you know, you choose the right, in a hypothetical scenario, you choose maybe other investors that offered more favorable terms, but then when you encountered a challenge that, you know, where you needed to

throw a little bit more money at a certain at a certain problem right to see a successful outcome. You had investors that were willing to inject and inject more capital or support, you know, further support the company. It's just really, really important because I don't think it's something that I even appreciated as much as I should have five, 10 years ago, right? And so anyway, despite the fact that so many people have always told me, right, like, you know, no one died from dilution and, you know, it shouldn't be, you need to be paid attention to it, of course, right? But the end of the day, the company needs to survive and move forward, right? So, people may not have died from dilution, but it sure as health feels that way at times when that topic

is front of center. Oh, yeah, yeah. It's like, it's like one of the chronic diseases, right, of dilution, right? And so, but we're joking about it. But like, you know, I just, I don't have your list of your list of investors around the, you know, in front of me right now. But certainly, you know, I mean, there's a lot of credit to be, to be said, right, to support a company through, you know, through a lot of hurdles, right, that needed to be crossed to get as far as you have. So with that said, let's chat a little bit more about fundraising, right? Because I mentioned earlier, you advised sectoral. So you've been around a lot of startups. They've seen a lot of ideas,

et cetera, raised a lot of capital. And so when you think about some of the more critical lessons learned, right, and for a new CEO, right, or a founder that's approaching their first seed round or maybe raising their first, you know, series A from institutional investors, you know, what are one or two like things that you definitely think they should understand? Man, get your story right out of the gate, get a great pitch deck. Be very very. very clear in the communication of what it is you're trying to execute. Right. So a lot of people spend a lot of time.

And I've seen pitch decks that are, you know, 30, 40 slides, right? And it is just mayhem. And I think if you can get it down to it, I don't even think it's a, it's the magic number of slides, but I think a very clear, direct understanding of the story and the market opportunity and the problem you're trying to solve and what your unique, you know, technology is, is trying to address. people start to understand that pretty quickly, right? So you got to have a great pitch deck. You've got to make sure that you're targeting the right investors too. So I've seen a lot of people and I've seen it a lot at sectoral and I think we ran into this step early on. Let's just fill the calendar with everybody who will listen to our story, right? And then you give the same exact pitch to every single person. You really need to be methodical and take the time to understand who the individuals are, exactly what category do they fit in? Are they early pre-clinical investors, clinical investors,

the early commercial stage investors, what do they tend to invest in, what's their background, how do you know that, who have they co-invested with? So targeting, understanding, and then delivering a very well-designed, succinct story that people can wrap their arms around where they don't have to sit back and say, hey, can you send me more data

because I'm not exactly sure I understand this, or, hey, let me in your data room so I can really kind of figure out what the hell you're telling me. So be succinct, have a great pitch deck, know the investors inside and out and be able to stratify who they are and how to present each one of them. Yeah, I'm nodding my head in full agreement, especially around the sort of the storytelling aspect, right, and making sure that you have a very clear, succinct, you know, kind of narrative that can be, you know, reasonably understood, right, in a 30-minute, you know,

call with a potential investor. And that takes a while to get to. I mean, it's like, it doesn't come easy to most people, even if you've raised a lot of capital, right? It's like you take some practice and takes a lot of, you know, pitching and refining, et cetera. And I like how you describe, like, the pitch decks that, you know, I both have seen that's like it's like, it's a mayhem, right? It's like, we're all over the place here. You know what I mean? That's what it feels like, you know?

Like, you just went through a hurricane, trying to scroll through the deck. And every word is important. No, we got to keep that. And you're looking at these slides, you're like, people can't make heads your tails of this stuff, right? Like, they have no idea what they're talking about, no idea what they're looking at. So, yeah. Or, hey, let's create an appendix.

and we'll put everything in the appendix we want them to know. So look, if people are interested in, and you can hook the interest of people, you can get more time with them, you can spend more time, you can bring in other subject matter experts, you'll have another bite at the apple, but you want people to say,

hey, I'm really interested and there's something here. Can we schedule another time to talk? Get that, and look for honest feedback, too. As you're a CEO trying to raise capital, you want very direct, open, honest feedback, right? That's what you should be asking to make sure that you can make what it is you're doing better. How can we deliver it better? How can we make it more clear?

What are the changes that we should be making? What additions that should we make? What should we take out? So don't be afraid to ask for feedback. There's a lot of us that think highly of ourselves and think we have the conversational magic, right? We just have it. It's been the best opportunity of my career at Nero's is to ask for a ton of feedback and get as much direct feedback as possible.

so that we can make what we're doing better because the end of the day, that's what we're trying to do. Really well said. Thinking about whether it's your time at neuro specifically or even just, you know, kind of raising capital, I guess, for neuros, or even sitting on sort of the other side of the table at sectoral kind of, you know, assisting in various diligence or even, you know, participating in a lot of calls, trying to vet whether or not an idea is kind of worth, worth taking that follow-up meeting.

What would cause you to kind of lean in and say, this is interesting, right? we should. I mean, we should do another follow-up meeting. Yeah, first of all, I mean, are they addressing a significant unmet need, right? Are they addressing a significant unmet need? Do they have something in this technology that clearly has runway? I'm looking for runway. I'm looking for clear unmet need. I'm looking for maybe platform technology. Are there other applications of this technology I can look at and say, hey, you know, clearly their current indication is X, right? It gives us X amount of runway with additional clinical evidence generation. There may be other indications.

There could be a market expansion opportunities. I'm looking for ease of utilization, right, of the technology. How easy is this to use? I'm looking at cost. We all know cost burden to the health care system. I'm looking for revenue generation reimbursement. So there's critical things I'm looking at. Application of technology, ease of use, commercialization, reimbursement, cost. there's a few factors that if I can check off really quickly and say, wow, this thing meets sort of the first five checkboxes I've got. Hey, let's take another meeting and let's dig in a little bit here and kind of see where this thing is. There are some things that were no-brainers. It was like, yep, we're going to do this.

I mean, it was hard not to just jump out of the chair on the phone and tell people, yep, we're going to go ahead and invest in this thing. Yep, let's take this to another meeting. And then, you know, I look at who's pitching, like who we investing in, who are the people, people were investing it, right? Do they have the passion for this? Do they have the team that can go execute this thing? Yeah, I'm looking for those things too. So there's a lot on the list, but the first four or five are the things that I just nailed, which are, hey, I'm looking for these things. If it has that, then there's a high likelihood. We're taking another meeting. We're going to take another look at this. Yeah. And maybe just hearing you kind of riff on this topic, obviously,

we could probably spend a whole half hour, an hour, right? Kind of going deep on just the single question alone, but maybe the way to frame this up is for, you know, if you're new to kind of the fundraising game, think about those four to five most crucial things that you need to check off that list. If those aren't clear and apparent in a 30-minute, you know, conversation, probably need to go back to the drawing board and make sure it is, right? Or if it's not clear, if you can't answer those questions, you know, maybe taking a step back and kind of rethinking kind of what you're working on altogether, you know what I mean? So like the foundational things need to be, need to be there, right? And then obviously the passion, right, the energy, you need to be bringing that to the

pitch, right? You can't expect the other side who's listening to you to be kind of leaning in without you kind of, you know, being winsome of yourself. You have to. And I would say that, you know, working with a sectoral team who are just amazing, having the experience of working with them made us better in developing our story and developing our pitch, watching others, right? Good or bad, right? I mean, I stole from other people. this is a great idea, man, we should absolutely, you know, position our stuff this way. Hey, that's a great graphic. Graphic utilization of graphical depictions in your slides are critical. I mean, it's so funny because there are times where I'm like, oh, that's exactly telling the story

that we want to tell. And other people are like, you know, the first five or six times are having us explain like, what does this mean? There's a pretty clear indication that, you know, and it's not as clear as you wanted it to be. So when you see other things, you're like, oh man that's really clear yes i'm going to steal that sort of you know graphic it's really important and that made us better at at condensing our deck down and i think we could do our pitch i think as we ended the series d we could probably make it in 20 like a really good pitch in like 22 to 24 minutes that people are like man this is awesome like let's dig in and hey let us get us into the data room we want to sign a non-disclosure hey let's go do that

this. And it was the practicing that we had. It was watching the stuff when I was at sectoral. But it was answering those questions that I would be asking, hey, can we nail these things? If we can, you know, we're going to have a great opportunity to move this thing forward. So we didn't get it right the first, second, third, or sixth time. It took us a while to make sure we got it right. And I think we did a pretty damn good job. Yeah. I'm glad you mentioned the time, too, and I want to get to the rapid fire portion of this interview. But just to touch on that real quick, that's so important, right? Because a lot of times you really only have 30 minutes. And if you're going to allow for any sort of like Q&A towards the end of this 30 minute call,

you really need to nail your pitch in 15, 20 minutes-ish, right? Something like that. Otherwise, you get stuck at a scenario where you only got halfway through it. And those four or five crucial checkboxes that you mentioned earlier, David, you maybe, you didn't even touch on how you're solving for half of them, right? And so you just get in a scenario where it's like you couldn't really effectively tell your whole story or only a parcel, you know, like a certain percentage of it. and that's the early shot, you know?

You could have said it better. I mean, there were moments where early on, and even maybe in Series C, even Series B, probably, early on, there were moments where it's no wonder we didn't get through half of our deck and the other team had to go. I mean, they're busy, right? And, you know, what I had to remember is we had to be incredibly respectful

of the time we were given. Utilize that judiciously. Give them what they're looking for so that we can earn the opportunity for another call. And early on, we didn't do that. We were really full of ourselves, I would say, in this great technology and why wouldn't people want to give us extra time? That sort of transition to our company, where we have put in a policy that you have to

adhere to meeting times, right? So if it's a 30-minute meeting, it's not a 35- or 40-minute meeting. It's a 30-minute meeting. So you better nail what it is you need to in that 30-minute time frame because everybody else is busy. So we've sort of taken that into our company culture. We've learned a lot because of it. Yeah, yeah.

Good little sort of silver lining, right? And lessons learned early on in pitching. But it's good stuff. Again, for everyone listening, Neurosmedical is the website, N-E-U-R-O-S-Medical.com. Neurosmedical.com. We'll link to it in the full write-up on med site. We'll also link to David's LinkedIn profile.

You can check out his background a little bit more detail as well. But let's get to the rapid-fire portion in the interview. You can answer in a rapid-fire fashion if you want, David, or feel free to expand a little bit on your answers. But first one on the docket, take us out to mid-2017. So a year from now, what are you most excited about at neuros? I'm most excited about adoption of our technology in two phases, the vascular surgeons, as well as these limb optimization programs.

So these newly emerging orthoplastic programs that do osseointegration, which is like this guy here. He's got this prosthetic that's bolted into his femur. So these new emerging programs that are doing a lot of crazy work with limb optimization and maximizing the true functional outcomes for amputees. So we're super excited about that program and look to be a standard of care in those institutions. Very good. All right. Let's say we just had a nice intimate dinner in Minneapolis with a bunch of met tech entrepreneurs. What's the one lesson that you want to lead them with that they,

you know, everyone really needs to understand in order to see some semblance of success in their, in their venture? I have a lot of humility, right, which a lot of us sometimes don't have. So I think I have a lot of humility, but also understand that you're trying to deliver technology for these large unmet needs. And it has to be of value not only to the end users, right, but it has to be a value to the healthcare system. We have got to deliver value back to the healthcare system. The days of us bringing high value, high dollar technologies and expecting hospitals and institutions to embrace it and sort of lose money in certain areas is not the case. So we've got to get really effective and efficient and delivering cost-effective technologies to the marketplace for greater

patient adoption and pull through for people that need it. Really well put. I mean, the dynamics and the ever-changing dynamics are certainly make it challenging, right, to take a company as far as you have. So last question I have for you. Take us back to maybe, let's call it your, I don't know, early on in your career, mid-20s, late-20s, et cetera, something like that. Anything you'd whisper in the younger, in the years of the younger version of yourself? A lot. Many things. You know, probably patience, patience, be patient. Be patient. It's excellence, not perfection. And so for me, it was all about, I grew up in this family in this world of high achievers.

And so it was all about perfectionism, right? How to be perfect, how to be way ahead of its time, right? As fast as we could go, as perfect as we could go. And if you didn't, you were a failure. I'd be a little bit more patient. And I'd look for excellence and not perfection. That's what I would tell my younger self. I'm leaning in, right? Oftentimes I need to hear that advice. over and over again, right? Especially in the world of startups. But David, I can't think enough for coming on the program and covering out an hour to tell us a little bit more about

Neuros, obviously, right? But about your, you know, a lot of key lessons learned throughout your journey in the device space. So this has been fun. It's a pleasure. You did a great job. So thanks for having me. I really appreciate it.

I'll have you all in line, David. But thanks everyone for your listening attention. As always, highly encourage you to check out Neuros's website, which will link to in the full write-up at Neurosmedical.com. Until the next episode of MedSider goes live, everyone, take care. Hey, it's Scott again. One quick thing before you go. You see, I love bringing you insightful conversations with the best founders and CEOs of 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. So if you found value in this podcast, if you found yourself nodding your head while listening, or if you simply enjoy what we're doing with MedSider, please take a moment to leave us a review. It's super easy. Just open your Apple Podcasts app or the podcast app of your choice. Search for our show and scroll down to the ratings and review section. Leave your honest thoughts and hit that five. rating if you think we're worthy. Your feedback is incredibly important and so the best way to ensure we keep bringing you awesome discussions with leading founders and CEOs. So take a moment to be a

good friend and leave that review today. As always, thanks for being a part of our journey and for helping MedSider continue to grow and evolve. Your support is greatly appreciated. All right, enough talk about reviews. Stay tuned for another informative episode coming at you soon.