Medsider: Learn from Medtech and Healthtech Founders and CEOs - 3 Filters That Separate Breakthrough Devices from Failed Ventures: Interview with Tulavi CEO Josh Vose

Episode Date: September 30, 2025

In this episode of Medsider Radio, we sat down with Josh Vose, CEO of Tulavi Therapeutics.Tulavi is advancing hydrogel-based implants like the allay Hydrogel Cap, which is designed to optimize nerve injury recovery and reduce the risk of neuroma formation.Josh is a physician, engineer, and entrepreneur with more than 20 years of experience in medical devices. He has held leadership roles at Medtronic following its acquisition of PEAK Surgical and drove growth at startups including SIA Health, which he led through commercialization and acquisition by Integra LifeSciences.In this interview, Josh shares why defining the clinical problem with absolute clarity is the foundation of medtech success, and how leaning into the harder regulatory path can create lasting moats.Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You’ll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Josh Vose.

Devices had to do really one of three things for all to be successful. You either had to change fundamentally how some aspect of care is delivered. You had to be more cost efficient or you had to demonstrate some substantial jump in outcomes or safety. And if you didn't do one of those three things, the chances are you were going to enter a funding desert and probably a desert of innovation. refine what innovation means and how you define it and framework it to filter out kind of great ideas from good ideas.

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, it's Scott. In this episode of Medsider, I sat down with Josh Vos, CEO of Tulavi Therapeutics, who is leading development of its hydrogill-based implants to advance peripheral nerve surgery. An engineer, physician, and entrepreneur, Josh has more than 20 years of experience in medical devices, holding leadership roles at Medtronic, following its acquisition of peak surgical and driving growth at startups, including Cia Health,

where he led the company through its commercial ramp and acquisition by Integra Life Sciences. Here, a few of the key things that we discussed in this conversation. First, three-fifference. filters for clarity on whether your device matters. Since the 2008 financial crisis devices that thrive meet at least one of three tests, they fundamentally change how care is delivered, improved cost efficiency, or drive a substantial leap in outcomes or safety. Purpose-built devices designed against those criteria succeed, quote-unquote orphan technologies pulled from university labs rarely do. At Tulaibi, that discipline kept the team focused on neuroma prevention and shaped everything from product design to commercial strategy. Second, lean into the harder

regulatory path when it builds a moat. Shortcuts may get you to market faster, but they rarely create lasting advantages. Tullavi chose the de novo pathway, which meant tougher regulatory requirements, but also positioned the LA Hydrogel cap as the first of its kind. The payoff, FD.E. FD.E. wrote new regulations specifically for their category, forcing future competitors to meet the same evidentiary bar. As Josh puts it, sometimes the more challenging path delivers the strongest protection. Third, match your pitch to the investor in front of you. individuals invest in people. They back entrepreneurs to relationships, warm introductions, and trust. VCs, on the other hand, triangulate price, exit probability, team, and market opportunity with a sharper eye for scalability. The pitch

mechanics may look the same, but the decision-making lens is different. All right, before we dive into this episode, I'm pumped to share that volume 7 of Medsider Mentors is now live. This latest edition highlights key takeaways from recent Medsider interviews with incredible entrepreneurs like Bill Hunter, CEO of Canary Medical, Brian Lord, CEO of Pristine Surgical, Don Crawford, co-founder of Safion and current CEO of Corvista Health, and other proven MedTech founders and CEOs. Look, we get it. Keeping up with every MedSider interview isn't easy. That's why we created Medsider Mentors. These e-book volumes distill the best practices and insider secrets from top founders and CEOs, all in a downloadable, easy-to-digest format. To check the latest

volume out, head over to Medsider Radio.com forward slash mentors. Premium members get free access to all past and future volumes, plus a treasure trove of other resources. If you're not a premium member yet, you should definitely consider signing up. We recently revamped Medsider with swanky new features, especially for our premium members. In addition to every volume of Medsider mentors, you'll get full access to our entire interview library dating back to 2010. You'll also get Medsider Playbooks, curated guides packed with actionable insights and topics like fundraising, regulatory challenges, reimbursement strategies, and more.

And if you're fundraising, don't miss our exclusive investor database, featuring over 750 life science VCs, family offices, and angels. We've even created three custom packages to help you with your next fundraise. Learn more about Medsider Mentors and our premium memberships by visiting MedsiderRadio.com forward slash mentors. All right, without further ado, let's dive in the interview. All right, Josh, welcome to MedSider Radio. Thanks, Scott. It's great to be here. Yeah, I'm really looking forward to this conversation, especially considering your wealth of experience, your wealth of experience at a startup space, I should say. So it should be, should

make for some interesting stories and a lot of learning along the way. So with that said, I recorded a very short bio at the outset of this episode. But let's let's start there. I mean, if you can, I don't expect you to go kind of line by line on your, you know, with your resume per se or your CV. But, you know, give us like a one or two minute overview of kind of your journey leading up to starting to lobby. Yeah, sure. So I grew up in the southeast in a little town in North Georgia, a pretty rural area. Ended up going to Georgia Tech for undergraduate study chemical engineering. and that's literally where my career in medical devices began. For the last two years, my undergraduate,

I worked for a startup on campus, a company called Salumetica, that had been founded by two physician entrepreneurs. They were folks that had left clinical training and clinical practice because they believed that the best way to change health at scale was through merging clinical knowledge and device innovation. I mean, to be honest, it was, I think, one of the most fortunate things it's ever had. happened to me to be in the same room with these people. And that really kind of shaped my,

my early thinking, working for them. And that was, ironically enough, the first generation of products in the nerve space. So I began my career in peripheral nerve and now it's come full circle. I'm here at TILavi. In the intervening years, the 25 intervening years, since I first worked for Salientica, went to medical school. I worked through medical school for two startups. I was very fortunate. One went public. The other was acquired by a big medical device company. Went off to general surgery training in Boston at a big hospital. And during my second year of residency, I was offered a job with a startup in the Bay Area called Peak Surgical Peak, had licensed a technology out of Stanford and built it up. It was called the plasma blade. It was the first low thermal damage dissection device for

bleeding control. And so I joined that company as the medical director. In over three years, we built it to about 20 million in revenue and that was acquired by Medtronic. Spent five and a half years of Metronic and that led to my first CEO job, leading a company in Chicago called SIA, making a resorbable mesh for breast reconstruction that had been founded out of Northwestern and built up. That company went on to be acquired by Integra, and that ultimately led me to lobby through meetings with Fred Kossaravi and the board. Coming out of SIA, I only wanted to work with people I admired and trusted. and I only want to work on things that could scale to improve health,

like what my original mentors had taught me. And Tulavi was right at the intersection of those two things. So with that said, I'm looking at the Tulavi website, right now, which is for everyone listening, T-U-L-A-V-I-T-L-A-V-R-O-L-V-I. We'll link to it in the full write-up on MedSider, but if you don't get there, again, to-L-A-V-I. Give us a sense or maybe help us understand as if maybe I'm a sophomore in high school,

learning about this for the first time. I have no background experience. in what the LA hydrogill cap is and really maybe zoom out and tell us a little bit more about kind of the underlying, you know, major clinical need that you're addressing here. Yeah, let's start with the problem first. So the LA nerve cap was designed to reduce the risk or prevent the formation of neuromas. Neuromas are the leading cause of pain after amputation. And the way they form is what we address directly. So you have two types of nerves in your body. You have central nerves, your brain and spinal cord, then you have peripheral nerves, the nerves that branch out from there,

that control motor and sensory function that handle all your automatic functions like digestion and breathing and things like that. The difference between those two nerves just at a very high level is that if you cut a central nerve, it does not regrow. If you cut a peripheral nerve, it does. The nerve tries to find its counterpart that it was cut off from, and if it doesn't find it, it can turn back on itself and turn into a hypersterectrine. insensitive ball of nerves, and that's a neuroma. And so that's where the pain from neuromas come from. So the way the device works is really quite simple. You deliver it as a liquid. It turns into a solid almost instantly around the nerve in about three to five seconds, and it creates a mechanical barrier that prevents the nerve from regrowing and forming into that hypersensitive ball of neurons called a neuroma. And so we took a hydrogel that had been

developed by this family of companies Incept and applied it to peripheral nerve surgery. And so beyond just simply treating neuromas with our first product, there's a whole other line of products that we can get into that really kind of fundamentally change how nerve surgery is done because it's so easy to apply. You don't need a microscope. You don't need sutures, all the above. But that's how it works. It's literally see one, do one, teach one. Got it. Very interesting. And talk to us a little bit about sort of the patient journey, right? Is this something that is treated, like is there a standard of care, right, for this currently? And then, like, fast forward and let's presume, you know, surgeons across the world, you know, have, have the Alley in their,

in their hands, you know, where is this typically going to be used? Is it, is it with every amputation or is it, you know, is there other kind of use cases that you envision? Just with the nerve cap, the goal eventually is that every amputation, where there's a peripheral nerve involved, which is pretty much every amputation, gets an Alley nerve cap on the end of their nerves. So the number of places where that can be used is pretty wide. There's vascular surgery, general surgery, orthopedics, but it really all begins with the hand surgeons. Hand surgeons are fellowship trained orthopedic or plastic surgeons here in the U.S., and they are the de facto peripheral nerve surgeons in the U.S. There aren't enough hand surgeons to handle the number of amputations that get

done every year in the U.S. Moreover, they're not enough hand surgeons to treat all of the neurons. that have been caused by amputations in the past. So not only do you not have enough peripheral nerve surgeons to take care of the incident population, you don't have enough to even streak the prevalent population that's out there. And so what you need is a scalable technology to be able to do it that works for the hand surgeons, but it's easy enough for everybody else that's not microsurgically trained to be able to use. And that's where we come in.

So our devices is the one that can bridge that gap to true scale. Got it. Super helpful. All right. We're recording this in Q3 of 2025. So someone listening to it, you know, three months, six months down the road. Give us a sense for kind of where the company's at currently in terms of its stage. We're halfway through our third full quarter of commercialization.

So the Alley Hydrogel cap was cleared to market in July of 24. We had our first patient done at the end of August of 24. That was at Kaiser Permanente in the Bay Area. And since then, we've done right around 200 cases, maybe a little bit more. but we're seeing very consistent adoption. And so since first product cleared to market as a de novo, we've been adding accounts and adding commercial representatives, ramping up our marketing work in addition to building out the rest of our product portfolio

to deliver next year. Got it. Very helpful. All right. Let's segue into the next maybe 30 minutes of the conversation, talk a little bit about, a little about, like, you know, touch on some various cross-functional, I guess, topics, right? But also kind of weave in your personal learning, your journey as well.

But again, for everyone listening to lovi.com is the website, t-U-L-A-V-I-com, super cool website. Really interesting technology. Highly encourage everyone to check out the company in more detail there. And again, we'll certainly link to it in the full write-up on MedSiter as well. So, Josh, with that said, first question I've got for you is kind of, you know, kind of an obvious one, considering your background, right, going from physician to entrepreneur. And so there's a lot of, as you can imagine, there's a lot of docs that listen to this podcast and have an idea. in their head, right? And, you know, as you very well know, you guys are closest to the clinical need

in most in most scenarios. And so thinking about like your past, you know, 10, 15 years in the world of startups, any, I mean, are there like a couple things that like really come to mind or maybe words of wisdom that you give to another physician colleague that's, you know, thinking about taking a swing? Yeah, I'm very fortunate because a number of my clinical colleagues, like folks that went on to complete their postgraduate training, they come to me with ideas. You know, they're exposed in the clinical environment every day to the problems that we kind of create, that we didn't create, what solutions can be there? And they asked a similar question, you know, what can I do to kind of take this out? I was fortunate because my career in this space began before I was ever even a

physician, before I even took the MCAD to apply to medical school. And so I had these incredible mentors that influenced me from a very early stage. And that, I was able to kind of leapfrog off of that, and by adding more mentors over time who could evolve on what I learned from the early ones, I think that speaks to what physicians would benefit most from that have been in clinical training and clinical practice for a very long time or even a short time. Physicians, at least the way I was trained, was in a paradigm I think is best described as total ownership. I mean, you are responsible for somebody's care, and the knowledge needed to take care of them is your responsibility. There may be other disciplines that you work with,

like infectious disease or internal medicine or surgery or whatever, that will collaborate with you on the patient, but you're the one that has to be kind of the master of the knowledge, and that's how you've been trained. That creates, I think, kind of a unique blind spot in that if you have been looked to and been responsible as the master of some knowledge that, you may treat developing a device similarly, that you have to be the expert on all domains of development. And that is not the case. You need to surround yourself early and aggressively with people who know more than you do. Your most precious resource in bringing a technology to market is time.

It's not capital. I mean, those two things are interrelated, but it's the time. And the only way to shorten that time period to getting to a minimum viable product or a minimum vital prototype is really by having experts provide input on what you're doing, whether that's your regulatory path, your manufacturing path, materials, whatever. Like, you just simply can't learn it all yourself. So you've got to lean on attorneys to do patent funds. Like, understand the basics of how patents work, but go get an attorney. Don't write the patent yourself.

It just leads to delays. And you'd be surprised a number of physicians that choose to write the patent themselves, and that just waste time. So I think that's the one thing I would pass along. The older I get, the more I realize, you know, the limitations of my own knowledge. and the more it's reinforced every day. You can't keep it all in your head. There's just no way.

Yeah, it's a really, really important point, especially in the world of LLMs, right? You still can't do everything. Even though GPT is pretty powerful or name your, you know, name your LLM of choice. Yeah, but it's really good, it's really, joke it aside, it's really good, really good points. Thinking back to like your own career,

there's a lot of physicians that don't know whether or not they should go full time into this thing, right? They still kind of, you know, sort of ride the fence, if you will, right? They're still practicing, you're still trying to push their thing forward. And maybe they're making even some good progress, right, on the side. One, I guess, do you think that's doable? And at what point do they need to either commit all in or just find a CEO like yourself?

Yeah, that's a great question. I mean, it's the founder's dilemma, right? Do you want to be rich or do you want to be in control? And that, to what you're speaking of, there is a point where you need to hire a CEO to go and build it out for you or even hire somebody younger or just a different training. you that has that early stage expertise because setting aside your own blind spots, physicians over the past, you know, two to three decades are largely employees now of healthcare systems. And healthcare systems don't really want part-time physician employees. They want full-time physician employees. And so by nature, you're going to be burning the

candle at both ends, which means that your day job that, you know, writes your paychecks, you're either going to have to call it in and start putting in less time there, which is going to degrade your clinical care and everything else and how much you're paying attention to things, or you're going to burn kind of your family life in the evenings or your personal time. And more importantly, you're going to be sacrificing that time that goes into the idea and developing that further. So I think it's really a minority of physicians, particularly surgeons, that can do both. I mean, when I think about just the concept of being a part-time surgeon and a part-time

innovator, it sounds like you're really kind of throwing in about 30% into both. Because when you add in life and everything else, you really should kind of choose one or the other or hire somebody that complements your skill set, where you can add value to go and develop the idea alongside you. Yeah, that's really good, really good point. I think it's just helpful to hear that from you specifically, right? You've been there and done that. have made some of those hard decisions. And so maybe the,

uh, the, the, the largest takeaway for physicians that maybe aren't quite ready to go full time, just know that at some point, if, if you're serious, that decision's going to come, right? sooner rather than later. And you should, you should go, you know, head into that eyes, eyes wide open. So, so with that said, let's, let's, let's, let's transition to, um, kind of early stage, uh, design and development, right? I think this is especially interesting considering your, uh, your engineering background. And, and oftentimes I, I consider these are the hardest, sort of the hardest stages of a startup, not a startup, not a lot of capital, not a lot of funding really at that kind of seed, even series A kind of window,

if you will, where most startups are trying to like make serious progress on the next iteration of the device, hit maybe a pre-clinical milestone, maybe even an animal app as some type, but there's just not a lot of money to go around. And so when you think about kind of tips, words of wisdom to other entrepreneurs, other founders or CEOs that are in that period right now, right, where it's hard, you know, funds are, capital is hard to come by, but you need to kind of move, move fast to iterate quickly. What are a few words of advice from yourself? I wish I'd done a lot younger when I first learned this. It had to go all the way until, you know, I was out of residency and through business school. We had a wonderful professor where I went to business school

who had written a paper about the hardest problem in management. And the hardest problem in management is defining the problem you were trying to solve. And I think that's particularly applicable here because that clarity of thought and what I mean by that is defining the clinical problem that you are trying to solve. You know, you see folks try to license technologies out of a university like orphan technologies that they think would be better than something else already in the space, but those weren't designed for purpose. They were designed for something else and then there may be this applicability to that, to a clinical dilemma. But that's pretty rare that orphan technologies turn into successful medical devices. Successful medical devices begin first with

defining the clinical problem that you're trying to solve and then sticking to that definition very specifically to design towards purpose, clinical need, and usability. And that clarity of thought, I think, is something that you can always come back to over and over again. And if you define that perfectly, that carries forward, not just in the design and development of the product, but in the early stage iteration with clinicians in your messaging, ultimately all the way through to your marketing in the future. Our device, for instance, was purpose designed to block the nerve outgrowth from these cut nerves. And we knew the hydro gel could do that. And so everything around the design, the naming, the messaging, the marketing, even our commercial plan is towards solving that one very specific

problem that is of great societal need. So that's what I would focus on, define the client. And problem you're trying to solve. The more time I spend in startups, those frameworks like continue to be more and more important, you know, and they sound, sometimes they can sound cliche when you hear someone say, what's the unmet clinical need? You hear that over and over again in our world, right, in Mettech and in Mettech and, you know, what unmet need are you so, oh, you're talking for, but it's so, so important to nail early on. And if you find yourself kind of wavering, right, or there's just ambiguity there, right? I think it's just a good signal to maybe take a step back and readdress that problem or that question, right?

Is like, what is the true clinical need here that were aimed to fix? It may sound counterintuitive, but, you know, I joined Peak in the fall of 2008. So like literally in the middle of the Great Recession. And that's when you saw the rise of value analysis committees and barriers to entry. You saw capital markets really dry up. And you saw a lot of kind of luxury kind of predicated devices fall to the wayside. devices had to do really one of three things or all to be successful. You either had to change fundamentally how some aspect of care is delivered. You had to be more cost efficient or you had

to demonstrate some substantial jump in outcomes or safety. And if you didn't do one of those three things, the chances are you were going to enter a funding desert and probably a desert of innovation. And so to some degree, ironing out this or creating this crucible in that time period has helped, I think, really refine what innovation means and how you define it and framework it to filter out kind of great ideas from good ideas. Those three points that you mentioned, really valuable to got to go back to, right, consistently, especially as you're working through various challenges or bottlenecks and an early stage kind of iteration and design and development. So with that said, let's move on to kind of to lobby's kind of regulatory bath, right? You mentioned, I think it was last year, right, 24 that you received de novo clearance. And so give us a kind of a sense for like wide de novo versus maybe 510K. And obviously I don't expect you to go into the details there.

But really kind of, I'm sure there's probably some ways to pursue, you know, regulatory clearance, but really more interested in how you think about the difference between the two, right? Like, are you optimizing simply for, you know, to get to market through, you know, through a certain rate pathway? Or are you trying to think about the clinical data as you move through that, that regulatory pathway as well and kind of that overlap? Yeah, it's a good question. You know, we, the systems that we work with and the surgeons they work with, it has been a benefit to us being a de novo because we're in a category by ourselves. We're literally first of a kind. We don't compete head to head with any other

technologies like you would a predicate. But most folks are not familiar with what a de novo is. The simplest way to put is that a de novo sits, it's part of the 510K pathway, but it sits between a traditional predicated device, 510K, which is of generally low risk to patients, and a PMA, a pre-market approval, the highest risk class, so class three devices that are so novel or so different or carry such high risk that they require significantly stronger risk controls in their design and manufacturing usability. So our device sits between those two. as a de novo. It is relatively low risk, the same as a 510K, traditional pathway, but it's so novel in how it's delivered and how it works that it can't be classified based on anything that

came before it. So the products that are in the category where if we had wanted to predicate exist are nothing like our device at all. And so the insight to forming nature that it literally forms in the body when you deliver it. That was so novel that FDA said the best pathway for you is a de novo pathway. That's how the choice was made. It was in agreement with FDA. And it turned out to be strategically very beneficial for the company. Can you touch on that? Because I think that's an interesting topic because it sounds like in your case, this was more of an FDA mandate or requirement, right? But there's other scenarios where, you know, maybe you could have changed something, right, to like, you know, pursue a traditional 510K. You mentioned that this is actually strategic and this may be

allows you to kind of build out a bit of a bit of a moat here. Talk to us a bit about the strategy of kind of, you know, maybe taking on a little bit more work through the de novo and what that can yield, you know, in terms of the benefits for the company. It is a harder pathway, no question than a traditional 510K. FDA, because you're the first of the kind in this category, FDA is literally writing the regulation for your device. Like our category is in situ forming hydrogels for reducing the risk of a symptomatic

neuroma. I mean, that is very specific to us. And so the amount of scrutiny they put into the first of the kind, because other products will predicate off of you for the next 20 or 30 years, that creates a very substantial moat because they have to go meet the same measure of evidence that you do in bringing their device to market. Ardinovo was brought to market using pre-clinical data only. We were very fortunate in that the accepted model for neuroma formation is rats.

And nerve surgeons train on rats. They do neuroma repairs on rats as practice. And so we were fortunate to have a preclinical model where we could go and demonstrate compared to doing nothing how much more efficacious using our device was than doing nothing. And so the star is kind of aligned to both create a strategic mode to get through the preclinical requirements and so on. But we still had a very challenging time with what's called chemical characterization and bio compatibility, any type of chemical product where there is a gray zone between the guidelines

that FDA publishes as their standard and what is kind of internationally recognized as a standard can be widely interpreted. And so the de novo pathway, unfortunately, has like a lot of varying interpretations of how you should get through biocompetability and chemical characterization. I realize that's a little bit in the weeds, but we had enough, I guess if you look back, We had enough things in our favor, pre-clinical novelty, strong efficacy data to choose this path. What was the challenge was getting through a lot of the chemical characterization work because there just simply isn't great guidance. Yeah.

Yeah. I guess maybe just hearing you kind of describe that, maybe the take home here is if you're, if you're staring down what looks like a potential de novo, sometimes the easy response is to try to find the easiest way forward, right? Like the workaround, right? but in often, you know, in a lot of cases, especially in our environment, sometimes it's better just to lean in, right? Lean into that and use it to your advantage. Yeah, it's well said. Actually, there was quite a debate in our board in the early days of whether or not to do a PMA or a de novo

because with a PMA, you would at least come to market with human clinical data in hand. But our founder, and she was right. She believed very firmly in taking the de novo pathway that it would be both strategically faster and commercially better. And so far, that has panned out to be right. It's good stuff. But it's on balance. It's on balance. Yeah, yeah, no doubt. And with the full realization that every, like, people listening to this is like every situation is going to be a little unique, a little bit different, right? But I do think it's a, it's an interesting topic. And I think seemingly comes up more often than the not, right, of whether or not to pursue like the easier the easier rate pathway versus versus maybe leaning into a more challenging hurdle and, you know,

really trying to allocate more resources towards that in the, in the, with the eventual goal of like, you know, a little bit more of a moat or a little bit more, a little bit better foundation for the company moving forward. So with that said, you mentioned something interesting earlier that we touched on is this interplay between time and capital, right? And you've been around a lot of startups now. Every MedTech startup is going to require typically a lot of capital, right? You know, you're usually not talking about, you know, millions. You're talking about tens of millions of dollars, right? So capital, your approach to capital raising is important even in the earliest days. And there's this kind of growing, sort of growing dearth, right?

of early stage companies being able to access, access capital, you know, at that C, series A. And maybe sometimes even in a series B, it's never easy. And so with that said, what are you, what are you, you know, what are a couple of key lessons learned, right, that you picked up on over the years, you know, seeing, seeing not only various startups raise capital, but even at Cia and now at TLAVy. Hey, everyone, let's take a quick break to talk about Fastwave Medical, the company at co-founded and lead as CEO. We're developing next generation intravascular lithotripsy systems, or IVL for short to tackle complex calcific disease. The IVL market is valued at over $10 billion, but there's currently only one major player. In early 2023, we opened up an investment opportunity

to our community and within a month we secured close to $10 million. Then in early 24, we closed and oversubscribed $19 million round in just a few weeks, bringing the total investment into Fastwave to over $40 million. Corporate interest in the IVL space is growing too, the $900 million acquisition of Bolt Medical by Boston Scientific, and then J&J's $13 billion acquisition of Shockwave Medical signals a lot of attention towards emerging IBL startups like FastWave, and we're making some serious progress. FastWave recently received its seventh patent for our differentiated laser IVL platform for coronary applications. On the clinical side, last year we completed the first inhuman study of our advanced electric IVL system

with some pretty compelling results. Next up in 2025, we have IDEE trials plan for both our peripheral and coronary IVL platforms. So if you're interested in investing in the fast-growing IVL market, sign up for our investor waitlist at fastwavemedical.com forward slash invest. Again, that's fastwavemedical.com forward slash invest. Now let's get back to the conversation. I've been very fortunate because I've been able to see both sides of the coin and that with both sides being angel investors, high network, individuals, groups of angels, things of that nature. CIO was financed entirely by folks like that or of that phenotype. I've been very fortunate to be here at Tel Aviv and at Peak and other companies that were more

traditionally venture funding. So you get a great perspective on kind of what it takes to raise from both different types of groups. You know, one, I'd say it's much more relationship heavy. That's with the angels and the high network individuals. You know, they're investing in you. These come through network effects of introductions and the opportunity to venture capital. are really trying to triangulate price, exit probability, and opportunity commercially.

And so even though the mechanisms are similar, they are working from a different set of rules. But I would go back to what I said earlier, which is, one, surround yourself with experts from the early stage because the questions that both the groups ask follow a similar pattern. And you're going to need the expertise from others to iron out that message and your plan and everything that you're doing. That literally like just gets the risk out of what you're trying to do, which is a very important signal to both groups. The other thing is defining the problem you're trying to solve. What we talked about earlier, like that is the hardest thing you will do. And that message needs to be ironclad. At SIA, which had a resorbable mesh for breast

reconstruction, we were replacing biologic meshes, which were really something that grew in kind of the mid-2000s, you know, cadaveric parts and things like that. And it was time for a change because of the safety signals on those products. Here, we're solving the neuroma formation problem, whether it's in symptomatic patients or prophylactic patients. And that literally carries through every line of your deck, every pitch that you do, exactly what your elevator pitch is, all the above. So define the problem, get the expert level risk out using experts. Those are two really good points. And I really like what you mentioned, even as we start talking about this particular topic of knowing the differences between angels and institutional capital, right? And I think you described angels in a very kind of good, pragmatic, accurate description. That's much more of a relationship game, right? They are mostly betting on the entrepreneur. Not to say that VCs or institutional capital is not, right, but it's probably more heavily swayed by angels. So I think it's just really healthy reminder for anyone that's listening to this and, you know, raising. early stage capital really understand kind of your your audience, right? And how they think and how they

are approaching, you know, the potential, the potential of, of investing in your, in your project. Yeah. All right. Let's, let's move on to a couple other topics. One of which is commercialization. And you've kind of established a unique partnership with the VHS, you know, very, very early on. So most, I guess most startups don't have that type of success, right? With the government entity right out, right out of the out of the block. So maybe talk us through like maybe how that came to be. And, you know, is it, is it maybe a sort of an underappreciated kind of channel, right, that other, maybe other startups should, should possibly consider? We have had some really positive early success. But whether it's VHSS or the IDNs we've got

access to, so we've been averaging about 49 days to get through a value analysis committee, which is incredibly fast. I mean, the other technologies have been a part of. of, you know, six to nine months. A fast case would be like three months. But it's because, you know, there are a lot of factors to it. Number one is cost efficiency of our product, efficacy of our product, so on. But really, it is the clarity of the message of what we're trying to solve. So there's not a lot of message drift in what we have.

And that, like, you define that problem well. VHSS as a VA supplier and, you know, the best one out there, they, the VA has, the VA has, has one of the largest captive populations of amputees and long-term amputee care, as well as just chronic condition care in the United States. And so having that continuum of care aligned around the patient with very good medical records and so on, that presents a unique opportunity for us because the surgeons can find the patients wherever they are in the care chain. Oftentimes in the community, what happens to somebody gets treated, they have an amputation,

and then they can end up in the care of a physiatrist down the street, a PT, somewhere else, maybe a prostitist somewhere else, or they can end up in a pain doctor's practice. So they can really end up in different parts of the community. Regardless, like setting aside the wonderful characteristics of the product, addressing the population problem and everything, the real key of why we are successful in getting early wins and continuing this commercial ramp is we hired the best commercial talent. Pay them well.

And if you don't have an outstanding commercial team, you will never realize whatever your mission is. I mean, those folks are the front line. They have to love coming to work every day. They have to believe in what the company does. They have to believe in the future and the clinical need. These are folks that are like you can't, you can't put enough value on your commercial team. Yeah. A really, really killer commercial team often covers up a lot of sins. I like to say, not to say that you want to cover up a lot of sins per se, but they do help you overcome a lot, right? There's no doubt about that. Even certainly back around that that timeline on that Evalu analysis team, that's such a good like metric to think about. I haven't really

thought about that time. What are the things that we can do to reduce a three month, a four month, you know, typical, maybe longer than that, right? Or in the most cases, six month, you know, that process down to what, 40 days you said? That's crazy. Yeah, that's wild, especially considering how novel the therapy is, right? You'd expect a little bit more, not that it would be so fast. I would almost expect maybe kind of on the longer side, because there's going to be more questions, et cetera. But the one kind of like one theme that kind of continues to surface is, is sort of like the clarity around the message, right? And that's kind of like then we've that through really kind of through all stages of the, of two obvious journey here.

So in terms of shortening that, that window, how important was that versus really good clinical efficacy? I mean, I know it's all important, right, but having that tight, that tight message and that type that really strong clarity around like this is a no, basically, this is a no brainer. We should have removed this now. There is no force more powerful in medical device than a surgeon going to the value analysis committee and saying, I have to have this. There is nothing else that can do this. The indispensable nature of our product or any product that has just irreplaceable value in a specific type of case,

forget gravity, forget tractor beams, forget like rage, it is that. That is what gets you through. You have a true believer in telling the powers that be that there is nothing else that fixes what they do and what they see. That's what gets it through. Yeah. And it sounds like you've been able to effectively not only identify those really key champions, but they've been empowered with some pretty clear messaging too. You know what I mean? Because sometimes it gets lost in translation, right?

You could have a surgeon, a cardiologist, name your specialty, right, go to the bat and really, really kind of found the pavement. But unless their message is clear, right, unless they're able to influence other stakeholders. you know, sometimes it can just, you know, the decisions can be prolonged and take a lot of time, but it sounds like you've done a really good, really good job there on that note. Yeah, I appreciate you saying that. We, like I said, we, you know, we came to market with only preclinical data, but our preclinical data, which, you know, we supplied to FDA in order to get this indication, it demonstrated zero percent neuroma formation following transaction.

I mean, it's not too often you have a device that results in zero percent of anything you don't want. And so that on its own is incredibly compelling just to be able to speak with a surgeon, they review the paper, and then they say, yeah, zero percent, it works. That is powerful. Yeah, it's hard to ignore that for sure. The other interesting thing that I heard too that you touched on was this concept of the continuum of care, right? And sort of realizing that the VA very much has a captive audience when it comes to this particular patient. And I think that that really is important because sometimes it's easy.

when you're at like a very exciting stage, right, you're going to start commercializing and just to go too wide, right, to spread yourself too thin. And what you end up in is in a scenario where you're basically chasing down all of these physicians, right, that have an impact on that patient's journey. Whereas with the VA, it's all, it's really tight, right? It's not, you know, you can allocate resources in a very sort of focused, focused manner. So I think that's, you know, I'm sure that was strategic, right? But hearing you describe it, it's like, oh, that's makes a ton of sense. Yeah.

And, you know, aside from the VA, there are a number of systems that work this way now. So Kaiser Permanente works the same way. If you, if you're a Kaiser member, you know, your continuum of care is managed by Kaiser. They may send it to outside experts every once in a while. But for the most part, if you're a routine case or even a mildly complicated case, you will stay in the Kaiser system. And so they have that continuity of care. Freestanding clinics on their own, it's going to be much more fracture.

And so getting into IBMs and carrying that message of unifying, kind of the system of care to optimize for their expense and their costs, that is very important to us. Yeah, because as you mentioned, there's a lot of, like, if someone, if a patient has the, you know, in that situation, right, they're having to have a limb amputated. And they're, you know, they're oftentimes interfacing, right, with a lot of different positions, a lot of different specialists along the way. But if you can kind of tap into a system that allows, that's, sort of closed loop, if you will, right, for lack of better description, you know, it's obviously very, very advantageous. So let's jump to your kind of exits, right? Because there's not a lot of,

I would say, entrepreneurs that come on this program that have been involved in as many exits as you have, right? From peak, you know, you ended up staying at Medtronic for a handful of years and SIA. And now, I would imagine, it sounds like things are going well to lobby. I almost kind of want to invest. Is there going to be a round opening, right, for the lay people here? No, but joking aside, an entrepreneur comes to you and says, Josh, like I'm thinking about, you know, taking investment from a strategic or I've got, you know, two or three strategics that are seemingly interested in my company. You know, what is your, you know, what are a couple tips that you would kind of pass along, you know, as I think about possibly engaging with some of these potential acquires? Yeah, it's a good question. I mean, good businesses are bought, not sold.

And the way you build a good business is focusing on the drivers of success. really first at the patient level and the surgeon and the system so that, you know, a strategic, which is very good at operations and commercialization. So they have the horsepower to manufacture lots of your product and they have lots and lots of horsepower in terms of feet on the street in order to move your product. You want to be able to demonstrate the reproducibility of your business models. So, you know, first, like we talked about earlier, you defined, like what is the problem you're trying to solve. And then you show how that scales in a system time and time again with each commercial representative you put into the field. And then those things add up to a revenue curve over time.

But at the very base level, it's the reproducibility of the commercial model at the rep level. Because when the strategic looks at you and you get into discussions about M&A or an investment or something like that, you know, there are a number of different reasons why people will, why strategics may investing you or to think about acquiring you, setting those aside at the end of the day, they want to get a return on their investment. And that comes down to the reproducibility of the commercial representatives' efforts and the reproducibility of being able to supply it like in an uncomplicated manner to them at will. Obviously gross margins and all those things I'm kind of leaving alone and so on, but it's got to be profitable and it's got to be scalable in their hands. And so that, like,

focus on the fundamentals, you know, what's success at the patient level? Have you generated evidence to show efficacy? Do the systems adopt it? Do they keep using it? Do they grow their business? If you, I think if you execute against those goals in a cost efficient manner to get you to the next round, to keep checking off the milestones, investment and acquisition will come. No, the reproducibility phrase, I really, that really stands out to me because, you know, when we think about strategics, the number of question is oftentimes, you know, will this scale, right? I mean, they're looking for scale, but to your point, how well will it scale, right? Because some things you can scale, but it's really, really hard to, you know, and really, really challenging and super complicated.

But if you're asking yourself, if you're asking yourself the question of, like, yes, does the scale, but how, how straightforward is it to scale, right? I think those are really, really important points. But even going back to, like, you know, the phrase that's often used, and I think it's really, really accurate, right? right? Like in most cases, you know, companies are bought not sold. But everything that ladders up to that is really, really important, those fundamentals, right? And they're easy to kind of say and talk about, right, but are actually executing against those fundamentals to build a really good business. You know, if you can, if you can nail those, you know, in most cases, you'll end up with a lot more opportunity than not for sure. So with that said, anything else you want to talk

about when it comes to when it comes to exits, especially considering you've had a had several on your belt now. I've been very fortunate in my career, and it takes a long time to get to an exit. It begins with early relationships. It begins with cultivating those over time. You can't just go to sell a lot of something and expect somebody to show up and buy it. If to get out and meet the strategics, kind of make that extra effort to get to know them and what their plans are, you've got to read their investor notes and understand where the market's going. Like, you could end up wasting a lot of time talking to people that could never be enlightened. And so it is something that cultivates over years.

It's not something that happens overnight or happens by magic. And I've been very fortunate, you know, at SIA to be surrounded by an incredible team and a great commercial team and a good board that helped us get to that point. You know, it was never, it was never me. I was part of a team effort to get that where we had to go. And at peak, you know, I was early in my career there. We had a wonderful leadership team and they built a great business that we all got to be a part of. And so fundraises in team sport, getting to an exit is a team sport. All of it requires just teamwork kind of at the top of your game.

Everybody's got to bring their best every day. Yeah, yeah. With that said, let's get to the rapid fire portion and interview. Questions of rapid fire in nature. But feel free to expand a little bit on your answers if you want to. But again, for everyone listening to lavi.com is the website, T-U-L-A-V-I-I-T-L-A-V-I-L-I-L-V-I-L-E-L-L-E-I-L-Rawvi. It's really cool, really cool technology. Websites really well done.

branding is there. Everything seems to be like really, really tight, as we've kind of discussed. So really good stuff. So Josh, with that said, first question on the docket, take us out 12 months. Let's call it Q3, late summer of 2006. What are you most excited about at Tulavi? By the end of next year, we will be introducing two new products to the market. You know, knock on wood, everything stays on track. But to be honest, like if I think about scale and over time, every week we get texts from surgeons and we get text from patients. We get people reaching out through the website that have said, you know, I've had a neuroma pain for 10 years. Do you have a doctor near me?

I mean, we are two and a half quarters end of this voyage. And this is happening every week organically. I've never seen anything like it. In 12 months, I can't imagine what it's going to be like, you know, we're going to basically 3x our sales force in that time period, 2x at least. And I mean, just going by the magnitude of it, what are we going to do? what are we going to do with all these testimonials at that point? But it keeps you going every day. Like one comes across the wire in my head of sales and marketing,

she will send to me and send to the team. And, you know, a dozen people reply right away. This is so cool. I can't believe it. This is great. Like you talk about a cultural talisman like that where people see the impact they're making. It makes every day, you know, worth it.

Oh, yeah. Yeah. It reminds me of how cool. is to operate in the space. I mean, it's really hard, right? Doing Megtech, as you know, it's incredibly hard, but it has to be one of the more rewarding kind of verticals to kind of build in, especially considering some of the feedback, the early feedback that you've already started getting it at Chilavi. All right, since taking on the CEO role at the company, has there been anything unsurprising, right? Or I should say surprising

or unexpected that you've learned over the past couple years. Yeah. The most surprising thing is, you know, I mentioned earlier how I began my career in the space, you know, 25 years ago. And the most surprising thing is how little innovation there has been in this space. And that's not disparaging other companies or anything like that. But the only thing that effectively changed between the devices I was working on as an undergraduate, which were non-resorbable polymers that were preformed and implanted in the body, is they switch to biologics. So they move to catavoric tissue, which is harder to regulate, harder to procure,

more expensive to maintain and form and all those things. And it's really been kind of an innovation desert, but that is changing now. I mean, more recently, a company from outside the country got their first, they got a de novo for a sutureless coaptation of nerves. You've seen a number of amputee companies get funding here recently for pain control. Peripheral nerve, you know, really has been dominated by stimulators, but now there's this resurgence and renaissance, I'd say,

of innovation around hard devices that aren't stimulators. And that has been really surprising and encouraging, and it's great to be a part of it. That's cool. Yeah, that is, you'd expect, it's just interesting that you touched on, the lack of innovation, right, in areas that have been a problem for so long.

And it seems like that comes up, you know, more often than maybe, or I continue to be surprised about that, right? And all as it takes is for, you know, a couple of companies to kind of lead the way. It sounds like, sounds like to lobby right there. So let's say we just wrapped up a small, intimate dinner with a group of med tech entrepreneurs and you want to leave them with kind of like one key take-home message.

What would that be? I think the one thing I'd want to impart to them, especially if they're early in the process, like you said, Scott, is how long it takes. But I'd frame it a little bit differently. I'd say it's going to take a lot of work and a lot of resiliency to change health care for the better. You know, health care is like 20% of the American GDP. It's an immense industry. don't eat a pig all in one bite, you know, it takes time, like you start in pieces. Oftentimes, that will feel like an impossible task and you have to stick with it. You have to celebrate the little wins because at the end of the day, what you do is immensely meaningful and important to help. Like, you're not creating a better app to get your laundry done or things like that,

which are important and meaningful things for some folks in the economy. But this is health. You're trying to solve hard problems. Hard problems are not solved overnight. It takes time. The resiliency part of it, you got to keep showing up every day. And that message, I think, is so important to just kind of go back to, right? You know, and that's coming from someone like yourself has had multiple wins, not to say that it's all been easy, right? And oh, you just happen to, you know, luck in to a couple of companies that have exited. But just to go back to that, you know, that framework, right? That these are long journeys, right? And they are hard. So when you're faced with hard decisions, don't be surprised by them, right? And, you know, dig in and know that, to your point,

you know, eat a sandwich bite by bite, not shoving the whole thing in your mouth. A sandwich is much better than a pig. I don't know. I mean, that's easy to understand, too. So, all right, last question on the docket. Take us back to late 20s, early 30s. You know, your device career is kind of accelerating, but, you know, you also did med school along the kind of the same path. It was just quite unique. But anything you tell, you know, the younger version of Josh or whisper in the ears of the younger Josh at that point in time? Yeah, I love that time frame. I mean, when I think back on that time, I think there are two things I reminisce about or I get nostalgic about.

One was like, man, life was so great and uncomplicated. And at the same time, man, life was so aimless in some ways. And I when I think back then that what I would have benefited the most from, and I didn't learn this until kind of my mid to late 30s, I saw a wonderful speaker. Her name is Carla Harris. She's an investment. She's like one of the highest investment bankers in the chain at Goldman Sachs. And she's an incredibly motivational and inspirational leader. She said, you need to find a mentor, a coach, and an advocate if you ever want to get anywhere.

And I thought that was so so poignant. She went on to describe each of them. But you really need all three to evolve into the person you want to become. So the mentor you learn from, you know, you learn their ways. It's like the Jedi Master teaching the student, you know, like how do the best do it? Then you need the coach, the person that is going to tell you like, hey, go over there, get that done. Go, like move that way. Like, go learn this.

This is new. Go do this. Your mentor is not going to do that. Your mentor, like they are practicing their craft. You learn from them. The coach is what pushes you on the field to run harder, to hit harder, to do better, all of it. And then the advocate is the person that pulls you up along the way, whether it's a direct manager, whether it's an adjacent manager somewhere else in the management structure or leadership structure,

somebody that can pull you up and be a champion for you. That's not the coach. The coach pushes you from behind. The advocate pulls you from the front. And that comes down to building relationships with people that have gone through that cycle already. And so between those three, you can. inform your own personal board of directors that you can help bounce decisions off of. And I think that is invaluable no matter what age you are. I mean, if I still have a personal board of directors when I'm

60, I would be so incredibly grateful because you need that push, you need that poll, and you need to learn from the person that's 70 that's seeing what you've done before. Yeah, personal board of directors. I like that a lot. And if you're listening to this at your, you know, maybe a younger point in your career. I think it's just like, you may not have all three, right? But maybe just asking yourself, you know, who is my coach, right? Who is my mentor? Who is my, my advocate? Yeah. Thanks for filling in blank there. But just asking, like, who are those people now and who maybe do I do I want those people to be, right? Like two, three, four years ago or from now, you know? And so, yeah, that's, that's really good stuff. Good way to wrap up the conversation. But, yeah, Josh, I can't think

enough. Really accomplished entrepreneur. Really appreciate you taking out the time. and super fun company. I mean, yeah, you guys are obviously doing something special. If you're seeing value analysis teams, like give you a yes in like a month in essence, right? Yeah, that's pretty strong. Seeing people chime in with testimonials like on through your website. It's really cool. It's really fun to hear about MedTech success stories like this. So yeah, I really appreciate you coming on the show. Thank you, Scott. The pleasure is all mine. And I hope you have a great rest of the weekend. Yeah, yeah. Likewise, I have you all in the line.

But for everyone listening, thanks as always. for your attention. Again, make sure to check out Tulavi, T-U-L-A-V-I-T-L-A-V-I-T-L-A-V-I-T-L-A-V-T-L-A-T-L-A-T-R-A-R-R. We'll link to it the full write-up on MedSider. And if you want to kind of rereadress, a lot of these learnings that Josh shared throughout the conversation. I encourage you to check out the full write-up on MedSider as well. So again, for everyone's listening attention, appreciate it, as always. Until the next episode of MedSider goes live, everyone. Take care. Hey, it's Scott again.

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