Medsider: Learn from Medtech and Healthtech Founders and CEOs - Proof Before Funding: Interview with VenoStent CEO and COO, Tim Boire and Geoffrey Lucks

Episode Date: June 12, 2024

In this episode of Medsider Radio, we had an insightful discussion with Timothy Boire and Geoffrey Lucks, co-founders of VenoStent. The company is developing SelfWrap, a bioabsorbable wrap to improve the success rate of vascular surgeries, starting with dialysis access creation for chronic kidney disease (CKD) patients.    Tim holds a Ph.D. in Biomedical Engineering from Vanderbilt University. He has experience as a Research Associate at Genzyme and was an Entrepreneurial Lead at NSF I-Corps. Geoffrey is a venture partner at Pioneer Fund and has a BA in Economics, Biology, and Zoology from the University of Wisconsin, a Master's in Bioethics from the University of Pennsylvania, and an MBA in Finance from Vanderbilt University. In this interview, they talk about understanding your end user, working collaboratively with FDA, structuring and executing large clinical trials, and staying resourceful to attract funding while developing your concept.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 a curated investor database to 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 VI. 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 Tim Boire and Geoffrey Lucks.

The key to focus, I think, for entrepreneurs is to think about, you know, what is the highest impact thing that I can do? You know, what is a critical milestone that I can achieve to get to the next point where I can raise some additional capital. 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 of the most of the most of. 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 Tim and Jeff, both co-founders of a company called Vino Stint. Tim is the CEO and holds a PhD in biomedical engineering from Vanderbilt. Jeff is the C-O-O and has a BA in economics, biology, and zoology from the University

of Wisconsin, a master's in bioethics from the University of Pennsylvania, and an MBA in finance from Vanderbilt as well. Here are few of the key things that we discussed in this conversation. First, in MedTech, the first task is always to prove your concept. Thoroughly research your space, seek feedback from clinical experts throughout the entire process, and engage with partners who can offer the expertise that you need in your product development. Second, showcase your market savvy by demonstrating a very real problem, a working solution, and a sizable market. Then build early prototypes, even if they're rough around the edges, learn from them and continuously improve. Get your device into the hands of potential users as soon as possible and seek early

feedback. And don't forget to build long-term relationships with investors long before you actually need to approach them for capital. Third, forging a collaborative relationship is the golden rule for navigating regulatory interactions. Understand FDA's perspective, follow their guidance and foster transparency. At the same time, make sure you capitalize on the advantages of your chosen regulatory pathway and position your device accordingly. Before we jump into this episode, I wanted to let you know that the latest edition of Medsider Mentors is now live. We just published Volume 6, which summarizes the key learnings from the most popular interviews over the last several months with incredible entrepreneurs like Dan Rose,

former CEO of Limflow, Dr. Stephen Michelson, founder of Ferrapulse, and current CEO of Field Medical, and other leaders of some of the hottest startups in the space. Look, it's tough to listen or read every Medsider interview that comes out, even the best ones. But there are so many valuable lessons you can pick up from the founders and CEOs that join program. So that's why we decided to create Medsider Mentors. It's the easiest way for you to learn from the world's best medical device and health technology entrepreneurs in one central place. To check out the latest volume, head over to MedsiderRadio.com forward slash mentors. Premium members get free access to all past and future volumes. And if you're not a premium member yet, you should

definitely consider signing up. In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. You'll also be able to see all of our playbooks, which are thematically handpicked collections of the most insightful interviews covering topics like capital fundraising, early stage development, regulatory challenges, reimbursement, M&A, and much more. And last, considering that fundraising could be one of the most daunting tasks for any startup, we curated a database of over 700 VC funds, private equity firms, angel groups, and more, all eager to invest in medical device and health technology startups. Access to this database is a premium member exclusive, so don't miss out. Learn more about MedSider mentors and our premium

memberships by visiting medsiderradio.com forward slash mentors. All right. Without further ado, let's jump right into the interview. All right, Tim and Jeff, welcome to Medsider Radio. Looking forward to a fun conversation and all things Venuscent. So appreciate guys coming on. Thanks for having us. That's real pleasure. Thank you. Yeah. All right, let's get started first. Without getting, you know, I guess going sort of line by line in terms of like your professional backgrounds. Give us maybe a high level kind of elevator style pitch on what you were doing before, you know, co-founding Vienistent. Yeah, so started out of, you know, undergrad chemical and biological engineering and biotechnology, really interested in the biotech space in general. Working

three years at GenZon, I was able to figure out that I was very interested in biomaterials and tissue engineering type of work. So joined a biomaterials tissue engineering lab in 2011 as part of a PhD. And at that point was tasked with developing energy shape Marie Palmer that actually a lot of the underlying chemistry is the same from what I developed back then. And so I was able to spin out my dissertation work into venous stents. And so during the PhD, I did this National Science Foundation ICOR program, and that's where I really got to understand much better the clinical problem that we were planning to address and actually pivoted the technology from its original application from bypass grafting to hemadialysis, because that was a clear, unmet clinical need

and far more acute in nature, and there was no good solution out there. And sort of felt like the marriage of my desires to, like, improve and impact medicine with engineering. So I felt that calling and then from that point on was focused on how do I spin this out of Vanderbilt. And so in 2017, Jeff and I were able to do that. Awesome, awesome. Jeff, how about you? Quick elevator style pitch on your background. Sure, yeah.

So maybe a little bit more circuitous. So I'll try and do this as linearly as possible. But yeah, so immediately preceding Venus status, Tim alluded to we, I was in graduate school. So I was finishing my MBA and he was finishing his PhD when we were. touch with each other by a mutual mentor for whom I was doing essentially like a search fund type work at Vanderbilt. But, you know, prior to that, I, you know, I was, I didn't intend when I went to business school to actually like spin out a company. I knew I went to Vanderbilt because they were a pretty strong healthcare MBA background focus at the university. So that's kind of what

my, you know, like what brought me to Venus stands directly from Vandy. But I, my personal background is essentially I had a brother that had a lot of health issues. He had Spina Bifton growing up and then in 2008 he passed away. So I knew I had a philosophical, moral call into the healthcare space just as a result of that, frankly. And I, you know, kind of oriented my career, my business school path and my brief career before business school to that. So like I said, kind of was a cue in us, but essentially business school, started a company, rest of history. Yeah, awesome. Awesome.

very good. Let's, obviously, we'll learn a little bit more about the journey and kind of what you've been doing over the past several years, you know, building the company. But before, you know, getting too far, I guess, give us a high level overview of your core product, right, the self-wrap device. And maybe frame that up with like, you know, maybe start with AB access. I don't want to go too deep, like on the, on the necessarily like the disease state or the patient's treated. But like, if I'm a freshman or sophomore in high school and I want to just kind of, like, you know, get the basics of understanding where your device kind of operates or fits. Maybe let's start there. And then, Tim, I know you referenced kind of as a follow-up,

you referenced sort of this need to kind of pivot the core technology for for this application. So just curious as to how that, how that came to be, sort of that inflection point of that why now moment that often occurs with most startups. Yeah. So what we are addressing is we are trying to, are intending to improve the outcomes from vascular access creation surgery. So when you connect a vein to an artery in your arm. So these are patients with chronic kidney disease, usually stage four or five. And so they're needing regular dialysis treatments to filter autopsis in their blood

that their kidneys can no longer filter out. Their kidneys are no longer functional enough to perform that critical function for the body. So, humodialysis is the most common means of treatment for end-stage adrenal disease patients. And the issue with the current state of affairs is that, you know, you have a centraline catheter that's used 80% of the time to start access with hemodialysis. and the the art tributaneous fistula which are the vein to artery connections in the arm they have better outcomes but it's still over 50% one-year failure rate so the veins just they either don't grow and mature to support dialysis treatments or they they initially grow to mature and then they they lose their ability to support enough blood flow to to undergo dialysis treatments with through the vein

And so what we do is we have a, we have a bioabsorable wrap that goes around the vein at the time in the vein artery connection, at the time that that artery vein connection surgery is, is done. And that helps with the vein adapting to this new high pressure, high flow environment where it's just not built, the vein's not built strong and elastic like an artery. So you hook it up to this high pressure, high flow environment from the artery. And you get very high failure rates. So with our wrap, we have this.

finely tuned mechanical properties that impacts fluid dynamics. So we're able to have less turbulence essentially and more effective blood flow. We also have an outward remodeling aspect to our device that encourages outward growth of the vein. And so that's the basis of the technology and where we're at from a regulatory perspective. We're currently, we've done several chronic large animal studies, a 20 patient clinical trial OUS outside the United States, and now we're doing a 200 patient randomized controlled trial. Yeah, super helpful. And take us back to, I mean, we're recording this in early 24, Q1 and 24.

You started the company, what it appears to be kind of 2017-ish time frame. Maybe take us back and touch on that real briefly, that moment where you thought this is, you know, this is really cool technology. You have a deep understanding of sort of material science, like the kind of the pivot, to focus on on this particular application? Yeah, so 2014 was really the, during this National Science Foundation I-Corps program, when that Y now moment occurred for the first time where that I was talking to vascular surgeons about applying a rap for bypass grafting surgeries and really just learning more about the surgery itself.

I didn't know much. I'm not a medical doctor. I didn't know much about the clinical application. So just really learning a lot from them, what their needs are. and what their pain points are. And talk to one, I was kind of getting mixed reviews on this because people were saying, oh, you can treat a bypass graph that's failing.

But talk to one vascular surgeon at Vanderbilt who said, why don't you look at hemodialysis axis? Because that's where you have such a high failure rate and there's nothing currently on the market that's really impacting patient care much. I mean, we're looking at, you know, 50% one-year failure rates, and it's just, it's a bad situation. So you could do a clinical trial over the course of a year and potentially show a significant benefit if your technology is

helping. That was sort of the beginning of, you know, having those conversations. Then I started talking to nephrologists, and they, you know, are the sort of the quarterbacks for these patient for these patients. And, you know, there, there's a lot of passion around this from the vascular surgeons and the nephrologist that, you know, this is a real pain of a problem. And it's what they call the Achilles heel of vascular surgery. And so, you know, you felt that passion and then you start talking to, you know, go, going to dialysis centers. And it's like an entirely new world that you're entering where, you know, it's, it's, it's, it's, it's, it's, it's, Honestly, it's just, it's pretty sad.

But, you know, you learn from, you hear from patients, and then you hear from, like, family members of patients where they had a family member pass away, and they come up to you and they encourage you, you know, they encourage me along this path, saying, like, what you're doing, it could really make a difference. And there needs to be something better out there. So it was really, you know, all those things together,

it just became clear that, like, this was the perfect marriage which is my desire to, like, improve and impact patient care with engineering. Yeah, good stuff. And I'm looking at the website right now, vinosdent.com, just as it sounds, V-E-N-O-Stent.com. You can check that out. If you don't get to the full write-up on MedSiter and are just sort of in listening mode, definitely encourages you to go look at the website and learn a little bit more about the technology

and kind of where the company's at. And Tim, you touch on a few kind of recent sort of milestones, but it looks like, and we'll dig into this in a little bit more detail, but just to kind of level set everyone, you're in that, you fully commenced your, your pivotal IDE, it sounds like, here in the U.S. Is that correct? That's right. Yeah. And then recently raised a pretty significant series A, I'm sure to kind of underwrite that effort. Right. Exactly. Cool.

Awesome. Sounds good. And again, Vino St. is the website. Definitely encourage everyone to check it out. We'll spend the next maybe 20 or 30 minutes kind of going back in time a little bit, maybe, and digging into some of the more cross-functional efforts that a lot of, you know, a lot of startups, you know, kind of go through and try to navigate and really curious to get kind of your,

your learnings throughout kind of this next part of the discussion. So first one, first question, I guess, on the doc is related to really to development, right? So I'm sure the venousint that is being used in the pivotal trial now probably, you know, look most likely looks a little bit different. Feels maybe a little bit different, et cetera than the first versions you guys worked on, you know, a handful of years ago, maybe I guess closer to a decade ago, potentially. So, you know, when you think about sort of the evolution of not only your device, yeah, I'm sure you know a lot of other startups too and have worked out of their product. So are there a couple, you know, key tips that come to mind when

you think about your experience is kind of going from alpha to beta and what's allowed you to maybe move, move fast or be capital efficient. And you can frame that up as, you know, things that you guys did right or maybe you know some some lessons learned too yeah i mean just thinking about the first you know prototype you know jeff saw that one 20 2017 what that looked like you know we didn't have a 3d printing process for our prototype at that point and so you know using like a dip casting method and laser ablation it looked it looks you know not definitely very different for what it looks like now and and not as elegant but you know developing a 3d printing print process was critical. So finding a partner here in Houston, you know, we partnered with

Jordan Miller and Gregorian at Rice University, who, you know, they're in the process of spinning out their 3D printing technology and became volumetric. And they partnered with us with, you know, helping to develop the 3D printing process for our novel biomaterial. And then it was, you know, And then looking at the, you know, prototype from that, like first one in a, you know, acute and then a chronic large animal study, you know, there's been several learnings along the way. I would say, like, the key is to, you know, do as much as you can on the front end in terms of like the design, knowing, you know, the vision of what you want. But you got to start somewhere, right? And you can't get it perfectly the first time. So you really, you have to learn in some respects, by. trial is what we've found. And the key to focus, I think, for entrepreneurs is to think about, you know, what is the highest impact thing that I can do? You know, what is the critical milestone that I can achieve to get to the next point where I can raise some additional capital. So getting that first capital in is tough when you have, you know, very little to go on in a way.

I thankfully had the opportunity to incubate the technology in an academic environment. I think that was really beneficial to establish some credibility with the science and some small animal work that I did. But there was a ton of work to be done in a lot of heavy lifting. And so we were able to get some additional funding and some grant support and angel investment. sort of simultaneously to support our first chronic large animal study. And then we were able to show, you know, in a real proof of concept, a reduction in significant reduction in new intimate hyperplasia, which is like the main culprit of these veins failing,

this arterial environment, this high pressure, high-flow environment. And so showing that proof of concept, we could then do additional studies. We could do, you know, continue to do some computational fluid dynamic work and do some bench testing and do additional animal studies. studies and then, you know, eventually get to a point where we are ready for a clinical trial when we've done all the biofantability testing and a lot of other testing to feel confident this could work in humans. So the proof is really in the pudding ultimately to get to that

point of clinical use. That's good stuff. A couple of things that stand out. I'm not sure, Jeff, you want to add anything as well, but this idea of avoiding perfectionism, right? I think sometimes it's hard for all of us that are a bit ambitious and like our idea and want it to be as good as possible, right, but not, I think that's really crucial. And then you're, you know, kind of what you laid out is in terms of that framework of how do I, how do I get this thing to the next major inflection point, right? For one to hopefully raise more capital to kind of fund future initiatives, but also those future initiatives, how can I execute against those, right? So I've got to kind of continue to make this, this progress and really honing in on what are the most,

what's the most impactful things I can do to this idea at this stage to kind of continue that, that progress? Yeah, and I would just add to that. It's all very well said. It's funny because, like, when you juxtapose this to, you know, other tech companies that are out there, you know, call it software companies, you know, one of the principles that so many of these accelerators and really good founders of buy-by is like just ship it, right, ship the product, put in the the user's hands, get them to use it, right?

Because inevitably something's going to break it. it's going to break within the first like 10 seconds of Hady it's it's in the right it's a different beast when it's a it's a medical device company especially especially like for those of us are therapeutic medical device companies right there's a therapeutic that effect that is achieved over time that you can't see within the first you know 10 seconds right so it actually is like it's it implanable takes time so anyway but that that principle of just shipping it and just which is you know just getting in somebody's hands just like people play around it just like the people who are going to be your end user actually have it in their hands and getting it into an animal

model and all the different ways of using that at principle, I think still abide. And that's how you can kind of make it, make these companies like MedTech companies, which are, you know, they're tough. It's tough to raise funding for MedTech, as we all know. I think that's the way that you can, you know, you can mitigate that competitive disadvantage that companies like ours may have, right? Just by getting into people's hands, you know, to mention to that, I don't think you mentioned, was it that, did you mention the I-Corps program itself?

like you did that. Yeah, you know, that customer discovery. That is how you can kind of like hack the system of sorts of the fact that we can actually just like give this product to patients, right? Obviously. So there's just little ways around it and I think can actually discount for a better chance of success. Yeah. No, I'm glad you brought that up because there is like a counter. And I think I see this more so maybe from kind of med tech purists or people that have been around a a fair amount of time and they're like, well, this idea of just shipping or, you know, shipping with a, you know, an MVP, that's not possible in MedSec, right? Silicon Valley, go away, guys. Like, that's not, that's not feasible. But in reality, like, you can look for,

like, sort of incremental ways to do that, right? Maybe you're not necessarily going to be able to ship or sell a product, like the first iteration. No, but there's things that you can do in order to get, you know, the type of feedback, right? Stakeholder feedback that you're looking for. as you kind of make that that sort of that progress in their early development phases and just don't let like bureaucracy stop you you know like you got to find clever ways to you know approach these things and motivate other people's and organizations to definitely yeah get around certain things like leverage your relationships and and you need to be you know focused and driven in that way but not stepping over stepping on too many

right it's a delicate balance right yeah yeah yeah yeah it's like no doubt I just say it's like you know if you're not a somewhat shameless person before you founded or find a company you know before you start a company you end up having to get a certain level of shamelessness but like tip says it's a delicate balance right you have to you know make sure that you know you're not you practice all good practices but that's right you know, you have to, don't let the bureaucracy to trip you up. Yeah. Oh, yeah. I mean, really, I mean, the best entrepreneurs that I always come across are always, always looking to push forward, right? I mean, I think we all understand that momentum is

so, so crucial in a startup. And, you know, that momentum often comes from, you know, the founders, right, that are kind of pushing ahead regardless of how far the mountain. Yeah, yeah. How far the, or how steep the mountain looks, right, as you're kind of pushing that Boulder, Boulder up the, up the hill. But yeah, that's a really,

really good point. Let's shift gears and talk a little bit about regulatory, because you guys received your breakthrough device designation, which is obviously a, like a great sort of achievement in and of itself.

When you think about, kind of your experiences across the board navigating sort of the regulatory maze, especially with a novel, a novel device, right? I mean, this is not like a straightforward, like easy 510K,

you know, 510K layup. I don't know, even know if there would be necessarily a predicate for this, per se. So not, not the, you know, you took on kind of a big, kind of a bit more of a monster here, you know, from a regulatory standpoint. So, you know, are there things that when you think back over the

past handful of years, things that either they work well or, you know, that was a good insight that we kind of picked up on or, you know, in general, any any other pieces of advice that you'd have for other CEOs, founders that are kind of working, working through this landscape currently. Yeah, I mean, we applied for breakthrough the first time in 2019, didn't get it, you know, And as an entrepreneur, you're desperate for, you know, that momentum, that, that additional ambitious milestone, you know. And so what we learn from that process is that, like, it's critical to get FDA's feedback. So we, well, it's easy to get caught up in like this frame of mind where you're just,

what are they thinking? What are they saying? Like, why don't they understand? But you really got to sit in that. and take the time to really break it down, like, point by point to understand where they're coming from and then how to effectively address that and show that progress in the future submission.

So like show that you're taking and incorporating their feedback. So we were able to do that with the pre-sub following that first, you know, failed breakthrough. And that was really critical to defining, for example, like the structure of our first clinical trial, our 20 patient clinical trial, getting FDA's feedback, you know, they had white papers on some of the definitions for certain clinical endpoints.

And no, we need you to see, you know, we need to see this sort of endpoint and exclusion criteria, those types of things. Depending on your review group, that can be really helpful to engage with the agency about the design. And then getting the clinical experts input on that is also critical. wait to the FDA's eyes as well, right, to say, look, I did a scientific advisory board meeting.

It was a four-hour endeavor on a Saturday that took, you know, weeks to prepare and was absolutely humiliating to go through, but it was great feedback and inform the design of the trial to be set up robustly. And so I think once you have like the critical, you know, once you have a good setup for a a design of experiment, a study, you know, clinical study, animal study, whatever it may be, then go out and do it and see what the results are. And like for us, you know, we are just from from the point of that next pre-sub, we were able to show FDA, look, we did this trial that you told us to do, basically. And look, we got these promising results that we were, we talked about.

we get breakthrough designation if we showed this promising data at six months. And so, you know, we are able to do, you know, essentially what the FDA wants us to do and show promising results and then build off of that. And I think one thing that's critical for entrepreneurs is to have transparency with FDA. Hey there, it's Scott. And thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider Premium Members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Renee Ryan, CEO of CalaHealth, Nadine Miarred,

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