Medsider: Learn from Medtech and Healthtech Founders and CEOs - Rising to the PMA Challenge as a First-Time Founder: Interview with Corveus CEO Tyler Melton

Episode Date: November 22, 2023

In this episode of Medsider Radio, we had a chat with Tyler Melton, the co-founder and CEO of Corveus Medical, a Houston-based startup on a mission to redefine heart failure treatment. Tyler previously worked at Accenture, consulting for top-tier pharmaceutical companies, and at the J&J Center for Device Innovation, where he honed his skills in strategic planning and financial modeling. He then joined the Texas Medical Center Biodesign Program, where he uncovered his current mission: to treat heart failure with targeted nerve ablation. In this interview, Tyler shares how using off-the-shelf products for early prototypes saved him both time and money and how accelerator programs provided the networking boost his startup needed to tackle the demanding PMA regulatory pathway. 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 recently launched Medsider Mentors Volume IV. 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 Tyler Melton.

Well, I think they think that they know everything, and maybe they do. But even so, your community, your support in the startup world is really, really important to making sure that you're doing everything right because one mistake can cost everything. And I think that is a really solid way to make sure that you're on the right path. 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 Tyler Melton, the co-founder and CEO of Corvius Medical, a Houston-based startup on a mission to redefine heart failure treatment.

Tyler previously worked at Accenture, consulting for top-tier pharmaceutical companies, and at the J&J Center for Device Innovation, where he honed his skills in strategic planning and financial modeling. Here are few of the key things that we discussed in this conversation. First, start out lean. Use off-the-shelf products for prototyping to save money and time. Tap into existing expertise to drive progress rather than trying to solve everything yourself in a silo. Second, accelerator programs provide startups with vital networking opportunities and force them to validate or just. their business assumptions. However, you should carefully evaluate the cost of these programs and equity, time, and other commitments. Third, don't shy away from seemingly difficult challenges.

The PMA route, for example, despite its rigor and scrutiny, can offer a focused approach to proving clinical efficacy. When it comes to fundraising, early planning, and targeted investor engagement can help you efficiently overcome hurdles in your way. Before we jump into this episode, I wanted to let you know that the latest edition of Medsider Mentors is now live. Volume 4. four summarizes the key learnings from the most popular medsider interviews over the last several months with folks like Rob Ball, CEO of Shoulder Innovations, Kate Rumroll, CEO of Abolative Solutions, Dr. Christian Ramdo, CEO of Tempe Health, 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 glean from the founders and CEOs that join our 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. If you're interested in learning more, 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 handpicked collections of the most insightful interviews with the brightest founders and see, Whether you're looking to master capital fundraising, navigate early stage development, tackle regulatory challenges, understand reimbursement, or position your venture for a meaningful exit, Medsider Playbooks have you covered. And last, considering that fundraising can be one of the most daunting tasks for any startup, we created a meticulous database of investors right at your fingertips.

Explore a wealth of 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 make it. us out. Learn more about Medsider Mentors and our premium memberships by visiting Medsiderradio.com forward slash mentors. Again, that's Medsiderradio.com forward slash mentors. All right, without further ado, let's jump right into the interview. All right, Tyler, welcome to Medsider Radio. I appreciate you coming on, man. Happy to be here. Yeah, calling in from Houston, right? Houston, Texas. That's right. You know, that a beautiful weather down here right at this time of year, you know.

I was down there. I was down there, I don't know, a few weeks ago, maybe closer to a month now. it's hot. It was definitely hot for sure. But with that said, yeah, definitely looking forward to the conversation, learning a little bit more about your journey as well as what you're building with Corvius. But let's start there. I recorded a very high level bio on your background at the outset of this interview. But if you can give us kind of an elevator style pitch, maybe add a little bit of color to that and kind of give us, without going too far into the weeds, give us a sense kind of for what you've been doing before or leading up to, I say, to founding Corvius. Sure. So my background originally was in biomedical engineering. I went to the University of Texas at Austin for those who are Austin fans.

And from there, I got involved with startups at the internship level. And so I was able to get my feet a little wet. But then after graduation, I liked to laugh that I went to the dark side of things. I went to the consulting role at Accenture. And so I was working with pharmaceutical companies, really just a lot of project management, implementation, and just really hands on from them. And then after a while, I kind of realized that long term, as an engineer, I'm a person that you're very prideful of your inventions and things that are very tangible. And I really wanted to do something that was my own. And so I decided to go get my MBA and I went to Rice University here in Houston.

And during that time, got involved with working at J&J, other startups and really learned the local Houston medical device community. It was fortunate enough after graduation to go into the Texas Medical Center Biodesign program. And essentially that's what the onset of Corvius was. Okay, got it. Got it. So did Corby's kind of spin out of that your work through that that Bybizan Fellowship? Absolutely. So the whole point of the fellowship is to essentially find an unmet need and essentially launch a company to address that need. And fortunately for us during that time, we really found some really interesting and effective literature showing some, a treatment for cardiovascular disease, specifically heart failure. So we came out of that, supported by TMC originally and then we're able to hit the ground running as well.

And TMC, is that part, is that associated with the Methodist kind of complex down there in Houston? Correct. So the Texas Medical Center essentially owns all the land. They do a, they manage, well, I don't know if they directly manage, but they're definitely directly involved with all the community. Got it. Got it. So this is kind of like the most people that listen to MedSide are somewhat or loosely, I should say familiar with the Stanford Biodesign program. So this is sort of the Texas version of that, right? Exactly. I would presume there's some similarity. So, okay. Cool. So you did that fellowship, TMC, kind of it looks like, based on your LinkedIn profile, 20 to 21 time frame, and then Corvia spun out of that. So you've been working on this for what,

two and a half years-ish, something like that? Is that sound about three, actually. I mean, we were found it about two and a half ago, but the original program started about three years ago. Right smack dad during COVID, so that was always fun. But fortunately, we were able to make us to work out and get really hands-on still at the hospitals. Okay, perfect, perfect. Awesome. That's a super of overview. So yeah, give us a sense for the technology, though. You mentioned heart failure, right? So give us a, if I'm, if I'm, you know, a freshman in high school and I want to kind of learn a little bit more about kind of what you're, what you're doing, give me a, give me a sense for what that, what that looks like. Sure. So we're all familiar with heart attacks and,

you know, the Hollywood heart attack we like to laugh about. But essentially heart failure is a part of that. It's a multifactorial disease that many different things can influence it. But currently, there's really nothing to treat these patients besides pharmacotherapy. So just medication, but over time, that really doesn't work. And so essentially, there's this big gap in care for moderate to severe heart failure. I mean, we're all familiar transplants as well, but there's not enough to go around. And many heart failure patients are so dang sick that they can't even take one. And so during biodesign, we saw specific literature showing a direct correlation between nerve activity and heart failure. A specific nerve was shown to essentially being part of the problem

of heart failure. So we're removing the signal. You offset some of the issues of heart failure and allow the patients to essentially decrease the severity of their disease. And so after finding that, we created a catheter solution to essentially directly address this nerve and give these patients a solution that currently don't have one. Okay, got it. So that's super helpful overview. So it's a catheter based technology that addresses this nerve that seems to be kind of an underlying cause for heart failure. and Hartford, obviously, massive, massive market, not a lot of great solutions, as you mentioned. So give us an idea of kind of where Corvius is at in terms of, you know, development, Clinareg, you know, we're recording this in Q, you know, almost Q4,

late Q3 of 2023. So for those listening after the fact, it's a sense kind of where we got currently. Absolutely. So we have been performed numerous preclinical studies, both on the acute level and the chronic level. So looking for both safety, feasibility, in human factors research. So just directly getting that early on. And we are moving into our first inhuman plan for next year. So the idea would be in next year to be in our first clinicals and essentially utilize that to continue that for FDA approval over the next, you know, or like a handful of years as well.

Okay. Got it. Very helpful overview. And for those listening that don't get to the full summary right up on Medsider, the website is Corvius Medical. So C-O-R-V-E-U-S medical.com. C-O-R-V-E-S medical.com. By the way, Tyler, Corbius, is there kind of some background to the name or sort of the underlying rationale? How you came up with it? And I honestly know. We were looking for, you know, we were looking for one that showed cardiovascular like many of the companies in our space, but also was unique. And so, you know, there are similar name ones, but when we were saying it, it just rolled off the tongue and it felt right. So we went with it.

And fortunately, it's stuck and we're very happy with it. Yeah, yeah, I like it. Corvius Medical. Cool. So let's spend the next 20, 30 minutes kind of talking about some key functional areas, right, that you've learned not only just in your med tech career, but maybe even more specifically over the past two to three years with Corvius. Maybe starting first with early stage development, right, which is where most med tech founders and CEOs, I guess spend the most time trying to be as capital efficient as possible, right, in these early days as you try to address an unmet need, as you mentioned before. So based on kind of your key learnings at other startups as well as kind of what you're doing currently with Corvius, what are like, you know, some of the most, what have you learned the most, I should say, maybe for other and maybe frame that up for other, you know, MedSec founders or CEOs that are kind of new to the startup game. Sure.

So one thing I didn't realize coming in for that really early prototype stage is the utility of using off the shell products. So in order to save money, you could essentially take apart other catheters, other devices, and hold. harvest some of the different components to test out some of your ideas prior to throwing a bunch of capital and time into them. And fortunately, we were able to do that. Since we're supported by the Center for Device Innovation and the Texas Medical Center, they have a robust abundance of different expired parts, expired devices that for the first year or so, we were completely using to make sure that all of our assumptions were correct, that our parameters

were prior to really just throwing any money into the fire. And I'd recommend that across the board because you can do a lot of learning for, very, very little cost at that point in time. Of course, eventually you need to move into your, you know, to your custom made product. But that early stage, it really can utilize that to save money, time and really drive some of your, some of your, I guess, ideas and, and assumptions forward. Yeah, I recently had Angus McLaughlin on the program. He's the founder of Liberate Medical. And he mentioned something very similar. He was like, that's one of the things that, you know, looking back, he felt like they did a good job of, right, based on previous learning.

is just utilizing off-the-shelf gear, right, and not having to kind of build things from scratch. Is that something that you're specifically doing at Corvius based on, you know, learnings at some previous startups then? Well, so actually, no, it was what we're supposed to be doing here, but I didn't learn that before. So after being part of the Texas Medical Center, we have a very robust set of advisors that have a lot of experience and success in the space. And so a lot of those folks as advisors were the ones that kind of planted that in our minds

really drove that forward. But also our head of engineering, Byron Smith, has a robust experience in this as well. And so once we pulled them into the team, he definitely also had that same mentality. It was able to have the experience, to use it as well as successfully did so.

And so it was essentially our network and our team drove that forward. I can't say I can't take full credit for the idea. Yeah, got it. Cool. So maybe the key lesson here is, you know, don't feel like you have to start from scratch, right?

Exactly. to try to steal as much as possible, right, from existing, existing gear products that are tried and true, right, and readily available. With that said, your technology addresses a pretty significant need, right, as we mentioned previously. And I would presume that the Clinton Reg roadmap is PMA, right? That is correct. Got it, got it. So that is, it's no small feat, right, for any, you know, for any CEO founder. In fact, I remember one of the, one of the pieces of advice from that Mike Wallace offered up. He's the found he's kind of a serial med tech entrepreneur most recently sold a

debororo medical to to Boston Scientific is he's like you know he recommends all kind of new ish you know met tech founders and CEOs to really try to prioritize you know 510K you know pathways before they take on a PMA you're obviously taking out a PMA and aren't afraid of that. So give us a sense for kind of how you're approaching it knowing that that's a that's a pretty you know daunting you know mountain that you're going to have to climb. Yeah, yeah, you're not wrong at all. We've had we've heard some more advice. in the past around essentially get your feet wet, learn prior to joining such a robust endeavor. But, you know, the opportunity was too solid, too much there for us to pass it up.

But also one of the things I like about being a PMA is that you essentially are driving toward clinical efficacy and proof. A lot of the, there's not a lot of sales going on. Of course, you have to start working on that toward the latter end of things, but it allows you to really focus on driving the technology, improving out the clinical benefit and safety. instead of just really trying to get a lot of, you know, a lot of different LOIs, a lot of things going forward, you just really need to focus on seeing that endpoint. And fortunately for us, since we did start with pre with literature that we've seen, we are confident

that the benefit is there. And so with the PMA, we can just need to make sure that we drive to the FDA's requirements and get to market. I mean, again, of course, it's a long pathway, but it does allow us to focus directly, which I like a lot. Yeah, yeah, that's a really good point because oftentimes, you know, there's obviously some upside to pursuing kind of sort of lower hurdles, right, you know, through the 15K process or even a de novo.

But, you know, you're also having to manage, right, the commercial implications, right, of those sort of lower barriers to entry where, you know, a PMA process allows you to acutely focus on those, you know, meeting those, you know, various clinical stages. So with that said, you mentioned, you know, you hope to be in first and human next year, generally speaking, knowing that you've got these clear kind of clinical milestones, right, that are going to lead up to your eventual PMA pivotal. Anything that you've learned specifically, kind of as you've thought about that clinical roadmap? Yeah, the more we get into the clinical planning, the more nuance that you can see it is.

And so this is where, as you were saying, maybe first-time founders may struggle because they haven't had that experience. And that's where we're really relying on our advisors or relying on folks that have been there, done that, that have been very pivotal to our success. so far. And because it really does take a trained eye. And fortunately for us, we have access to those folks. And of course, that really affects once you're on market, those trials really affect when you're on market, essentially where you can go at. So we're also a fast follower. And fortunately for us, we can see some of the benefit coming forward and adjust as we do go as well. And so I think

the biggest key is relying on people that have performed these sort of trials and procedures and making sure that you're utilizing their expertise and not assuming you know everything. Yeah, it's definitely, definitely advice that comes up quite, quite often from other founders and CEOs is right. Don't be afraid to ask or seek advice, right, from, from other folks. Dangerous path. If you think you sort of like, you know, know, know it all, right? And are afraid or are concerned about, you know, asking, asking questions. And one thing I want to add is that, you know, while PMAs definitely are more daunting, I find it so much more fascinating for a almost a game-changing product.

There's nothing, you know, I'm not talking any smack around Class 2s or De Novos because they definitely really still have a lot of impact and they can. But I've really enjoyed after working with some Class 2s in the past, the idea of essentially a complete game changer. And it just really drives that passion for it, at least for myself, because you can just see how these patients really need some of these things because there are no solutions, whereas maybe some 510K, it's an improvement. And that's really helped at least our mentality more, or just. just really will help us drive forward without getting any sort of, you know, hit speed bumps along the way, but because we can see how we can help these patients, and we can see the eventual end goal that it's really been a powerful tool. Right. And it sounds like you've been able to kind of curate, you know, a team,

not only of engineers, but, you know, experts in other functional areas. How have you gone about doing that? It sounds like you've got, you know, sort of unique access coming out of the TMC fellowship. But any anything specific that you've done in order to kind of build up? out that team around you? Yeah, we've been fortunate to have a pretty robust network after going up through some of the, you know, the larger accelerators are really helpful ones like by Combinator, MetTech Innovator. And so, and of course, TMC biodesign.

And so by utilizing those, we are already establishing that we are working with experts in the industry from either fundraising, either medical device, cardiovascular. Those itself allowed us to have resources to utilize that many companies don't have the fortune access to. But more importantly, since we did start in a Texas Medical Center, we are working with Baylor College of Medicine and Texas Heart during that time. And many of those physicians are world class and they were able to from day one give us advice going forward. Previous to biodesign, they worked at the Johnson & Johnson Center for Device Innovation here in Houston, which is now the TMC. where I am currently, but Dr. Billy Cohn, a cardiothoric inventor, hundreds of patents, essentially was able to help us from, as I said, day one.

my co-founder, Dr. Eshan Kamat, was a physician at Baylor as well. And we are able to utilize a lot of that really strong network and expertise from some of the top institutions in the world. And Ishawn's actually now at UCSF and is learning from other, just another side of the of the country, a different, but a lot of the cardiovascular experts and just driving that information from subject matter experts is key, I think, in this industry. Yeah, yeah, no doubt. And, you know, I'm looking at your, you mentioned, you know, some of the accelerators and, and, you know, being involved with like MedTech Innovator as an example.

When you think about your experience with some of those programs, right, TMC, we talked a lot about that as well, is that, is that something that you definitely recommend, you know, any new, you know, MedTech founder and entrepreneur to kind of get involved with? Because I'm looking at your background, right? Your time with other startups, Accenture, I'm sure you saw a lot, you know, I can look at your background say, well, you know, is an accelerator really needed, right, for someone like yourself? But, you know, what do you have to say about that? Is that something that you definitely recommend, you know, to other newish founders, MedTech founders or CEOs? Absolutely. I mean,

you know, while experience does help and there's always things you don't know. And the best part of BetTech Innovator specifically was the other companies in the in the cohort. So we learn from each other. And of course, they're also supported by other experts in the industry from either clinical, regulatory manufacturing. A MetTech Innovator has been a tremendous asset to us. Every conference I go to, I see five or 10 different other CEOs of companies that are part of the program. It makes things just so much more comfortable at these as well as a people to ping ideas off of

at the baseline. There's even more than that, I think long term, but I would 100% recommend specifically MedTech Innovator. Some of the other programs went through as well were also extremely beneficial. But the focus on medical device was, really, really helpful for us in that. Hey there, it's Scott, and thanks for listening in so far.

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