Medsider: Learn from Medtech and Healthtech Founders and CEOs - From Chaos to Order: The Journey of a Medtech CEO with Amplifi CEO Sean Morris

Episode Date: September 6, 2023

In this episode of Medsider Radio, we sat down with Sean Morris, CEO of Amplifi, developers of the groundbreaking Vein Dilation System to improve access sites for dialysis patients.Sean started his professional journey selling medical devices for AngioDynamics. Over his ten-year tenure with the company, Sean rose through the ranks to become the Global Vice President of Marketing and later led the entire Peripheral Vascular Division. After leaving AngioD in 2009, he embarked on various entrepreneurial ventures, including the founding of Veniti, which was acquired by Boston Scientific in 2018. He also spearheaded Euphrates Vascular, an innovative startup in the field of microvascular obstructions.In this interview,  Sean shares the story — from his first job selling medical devices for AngioDynamics to his current role as CEO of Amplifi, how his novel Vein Dilation System is poised to revolutionize dialysis patient care, and the many lessons he’s learned bringing innovative medtech products to market as a startup CEO.Before we dive into the discussion, I wanted to mention a few things:If you’re into learning from proven medtech and health tech leaders and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced life science leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, if you'd much rather read, here's a link to the full interview with Sean Morris.

I think it starts with, you know, the ABC has always be capitalizing, what to say is that, right? The best time to raise money is we don't need it. You're certainly laying the seeds. You got to understand what their goals are. You got to do your homework and understand, you know, what is their mission? You know, what did they, they pitch to their LPs? You know, where are they at in their fund? Is it a new fund?

Is it an aged fund where they want to do later states? You have to understand those things, make sure you're aligned. 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 Sean Morris, who started his professional journey selling medical devices for angiotynamics. Over his 10-year tenure

with the company, Sean rose to the ranks to become the global vice president of marketing and later led the entire peripheral vascular division. After After leaving Angie O'D in 2009, Sean embarked on various entrepreneurial ventures, including the founding of Vinetti, which was acquired by Boston Scientific in 2018. He also spearheaded Euphrates Vascular and now serves as CEO of Amplify. There, Sean and his team are focusing on developing the groundbreaking vein dilation system to improve access sites for dialysis patients. Here are a few of the key things that we discussed in this conversation.

First, the responsibility and a startup ultimately rests on the CEO's shoulders. Nothing is going to get done unless you do it. While this may seem daunting, embracing simplicity can be strategic. strategic to effectively tackle unpredictable events. On top of that, seeking guidance for mentors and not being afraid to ask for help are important virtues for growth. Second, placing human-centric design, clinical data, empathy, and personal relations at the center of a venture is the key to providing true value to end users. Third, engage potential acquires and investors early on.

Not necessarily to sell or raise funds immediately, but to understand if your startup's vision aligns with their long-term goals. Early feedback helps refine your pitch for the future. Before we jump into this episode, I wanted to let you know that we just released the latest edition of Medsider Mentors, Volume 3, which summarizes the key learnings from the most popular Medsider interviews over the last several months, with folks like Jim Persley, CEO of Hinge Health, Carol Burns, CEO of Kajat Vascular, and other leaders of some of the hottest startups of 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. 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. This includes conversations with experts like Nibbiter. Nadim Yared, CEO of CVRX, Renee Ryan, CEO of Kala Health, and so many others.

Learn more by visiting MedsiderRadio.com forward slash mentors. All right, Sean, welcome to MedSider Radio. Appreciate you coming on, man. Thanks for having me. It's good to see you again. Yeah, yeah, this has been a long time coming. You know, I've seen, sort of watched what you've done in the kind of the MedTech startup ecosystem for quite some time.

So it's fun to finally do a finally do one of these interviews together. looking forward a conversation. I've been waiting years and years and years for you'd ask me to do. I wish that was the case, but maybe there's a little bit of truth to that statement. So with that said, I recorded a short bio on your background

at the outset of this interview, but let's hear it from you first. Like give us, without going into the weeds, give us like the elevator pitch for, you know, the Sean Morris, you know, bio leading up to kind of what you're doing with Amplify right now. You bet, yeah. So, you know, my first job out of school,

was lucky enough to be selling medical devices for a very small company at time called angio dynamics. I think we had like $17 million in revenues. I was covering seven states. I took my golf clubs with me. I'd go watch movies by myself. If I was lucky enough, I could take a doctor out to dinner, just covering lots of territory, mainly to interventional radiology. But, you know, watching these doctors do image-guided procedures, you know,

running wires and catheters up arteries and veins was amazing to me. And so it got my attention pretty quickly. Long story short, I spent my first 10 years at Angio, ended up going public and doing some M&A. I got into product development, marketing, training, became the global vice president of marketing over three divisions. And then I got promoted to running the peripheral vascular division at Angio Dynamics, where I really got the opportunity to work with, you know, marketing, sales, operations, R&D, quality, was, you know, reporting to the board and the CEO. Amon Hobbs was the founder. of Angio is still my biggest mentor today. I owe him a lot for just believing in me and always putting me in over my skis. The last three years there was moving to upstate New York where the

company was headquartered. I promised my wife, give me three years of your life. And I will somehow find a way to get us back to St. Louis where she's from. At the time, we had two little girls. We ended up having our third little daughter, Kate, up there. And I learned a lot. You know, just got my face kicked in. He was reading marketing. books, you know, just old school stuff, just, you know, death by a thousand cuts. Had the opportunity to move away from NGO in 2009, started Venety, really a Venus roll-up play, you know, three products, which is where I first learned the hard lesson of trying to do too many things at once. But I worked with some doctors and built a Venus stent.

Funded that. That was acquired by Boston Scientific, 2018. So, you know, really blessed with that experience and not exit. And then I started running another company that is inevitably called Euphrates vascular, which uses iron nanoparticles and rotating magnetic field to address microvascular obstructions deep in the vascular tree where wires and catheters can no longer reach, was able to help the team get an IDE approval for that in a stroke application and wanted to spread some love elsewhere and some risk elsewhere and became the CEO, which I'm currently at a company called Amplify Vascular, which is doing something really amazing. So for me, it's been just a wonderful journey, but it's always been sort of in the image-guided

catheter-based area. And along the way, I've been on boards, and I've made some investment as another place, too. So it's just been a really fun ride. Yeah, and one of the things, I'm glad you kind of lay that out, because one of the things that I mentioned a number of times on this program is that if you've, and this is really more with respect to people who are currently at strategics and maybe looking to, you know, to make a move to a move to a startup or gain broader experience, like it's so helpful if you can make those moves and make those mistakes inside of a larger corporation, even though things move slow and it can be bureaucratic and et cetera, et cetera, there's a lot of things that you just get exposed to, right, that are

undoubtedly going to yield a lot of fruit later on in your career. So it's definitely something that I encourage a lot of people that are looking to, you know, sort of expand the horizons. It's like, well, you don't necessarily have to move, you know, move to a different company. Like just do it within the company you're at, sometimes a lot easier that way. So with that said, and we'll maybe get into that in a little bit more details, we kind of go back in time and learn about your journey leading up to what you're doing with Amplify. But give us a sense for kind of like the core technology and Amplify, maybe how it sort of, you know, came to be. Yeah, so Amplify is very, very interesting because it's really a platform technology, but, you know, right now our main focus is

to give a better access site for for patients that need dialysis, hemodialysis. It's really interesting. So just from a, one of the reasons why I love medical devices is that it's a mechanical solution to, you know, a clinical problem. And in our world of vascular, it's all about plumbing. We're either going to open up a blood bustle or we're going to try to close one. We're going to bypass one. And we're trying to get the water to the, you know, the showerhead so we can, you know, feed these tissues. So, you know, sort of with that backdrop, you know, when a doctor needs to create an access site in the form of a, you know, taking a normal vein and creating an AV fistula, arterial venous fistula.

They're taking an artery and they're connecting to a vein. And over time, that vein starts to believe that it's an artery. It's called arterialization. And there's a lot of interesting discussions about that with like limb flow and deep venous arterialization. But the concept of arterialization has been around a long time. And just with taking an artery and putting blood flow into a vein, the vein really becomes an artery. It can, you know, collateralized, it can do normal things. So by far the best access site for patient eating dialysis is a native fistula.

But the biggest headwind is can that blood vessel enlarge and grow and dilate to the point where it can be stuck with needles, you know, three times a week, four times a week for, you know, as many years you can possibly get out of it. The failure rate, especially in the forearm, is very, very high. In other words, you know, there's good intention to go and increase. this avia fistula, but, you know, especially in the forearm, you know, 70, 80% of the time, you know, they end up failing. And this is even after six to 12 weeks of, you know, dilation or the attempt to arterialize that conduit. And that's really unacceptable. And you're putting, putting a patient through a lot for a low risk of a good outcome. And so, but what we do know is that if the vein itself starts at a larger diameter, the likelihood for success basically

flips. Now you've got like a 70 or 80% success rate. And we know that an artery over time will dilate a vein. What we do is we make that all happen faster and we give it a better chance for success. And what we do is we take an extra corporeal blood pump. So think of an LVAD type blood pump. And we create a venous to venous conduit where we take blood out of the superior venicabirite atrium, like a dialysis catheter would go into that area. And we pull blood out with this pump and then we take another catheter and we basically do an IV stick in the forearm vein and this blood pump dilates his vein rapidly in a couple of days where it would take normally six to 12 weeks and we start you know we get the patient a better larger access site so the doctor

can come in and create that artery to vein conduit or an avie fistula and give it a much better likelihood for success we have human data and of course lots of animal data lots of bench top data some human data that we got out of our partner in Paraguay. And we're on the verge of, you know, working with FDA, or we're working with FDA and on the verge of getting an ID able to do a U.S. study. And I think it's going to be an amazing thing for these dialysis patients. Got it, got it. So still preclinical.

It sounds like a really interesting technology. And we were chatting last week, you know, just because, you know, 10 years plus ago or so, I spent some time in this space with Bard Peripheral, right? before this was before BD acquired BV. And I was asking you as like, bam or balloon, you know, assisted maturation is this still a thing? And you were like, yeah, the problem still exists. Like it hasn't been solved for. You know, and it's like, wow, that's like a 10, 15 years ago now. And this core concept still seems like it's a big, a big issue in this, in this world with, with patients. And so if I understand it from a layman's perspective, you need to create an AV

fistula. That's how patients are going to dialy's best. And the major problem here is that oftentimes it's really hard to create a mature fistula with small vessels. And so Amplifies technology basically dilates these vessels. So a vascular surgeon or an interventional nephrologist can create this, you know, create this fistula faster, basically, right, for for patients. Yeah, that, yeah, that's correct. You know, again, a mechanical solution to, to a clinical problem. Again, not a therapeutic, you know, which would make my head explode, you know, changing

multiple and drugs and everything else too. If I can see it mechanically and I know what it can do and I can demonstrate on the bench and I can demonstrate an animal and I can go into humans, it's a very linear sort of a series of progressive steps. Each de-risks along the way.

We know what the end result needs to be. We know what we can do to get there. But you're exactly right. From a layman's perspective, we're just dilating things. We're making, which by the name, amplify, you know, think bigger, you know, larger sound. You know, we're doing that.

in a more predictable way, in a more controlled way, and I believe it's going to have a big impact. And then, as I mentioned, the platform technology. So you mentioned vascular surgeons. Part of what I did on my diligence venture or journey here prior to jumping on board here was to have lots of conversations with the vascular surgeons. You know, my network of opening up the Rolodex. It's a wise thing to do. As an investor, nowadays, I look at my time spent as an investor. I'm going to invest my time in this night, and I want it to be, you know, a grand slam, you know, for the patient and for our investors and for myself, of course. And so having lots of conversation with these vascular surgeons, I show them the data, and they're immediately intrigued. And so to me, that's like what keeps my

battery charged. You know, they're psyched about it, right? And they'll say, Sean, you know, following them with me. I was in a vascular lab and I'm looking at doing vein mapping. You know, vein mapping is when they look at what veins are candidates for bypass or whether it's a coronary artery bypass graph or cabbage or, you're looking for peripheral archer. bypass or does this patient have a good vein for a v fistula a lot of times they'll look at the forum and they'll say wow that's only two millimeters or two point two millimeters and i'll say forget it let's go up up the arm here when you choose to go you know higher up in the arm you essentially eliminate the ability to go in the forearm so it's a disservice to the patient and once i get it on

their radar the vascular surgeon says i want to be a part of this because i see vein mapping all the time i'm doing vein mapping all the time i see candidates that are not good if we could just amplify that vein, we can get that better avi fistula or Sean. We could do a better cabbage if we do sap in his vein dilation. So I believe that what we're doing is very, very important. But I believe that once we prove that, we are going to have lots of opportunities to help lots of patients and lots of different ways. Got it. And so you're preclinical, we're recording this in kind of mid-Q-3 of 2020, for those listening kind of after the fact or down the road.

the goal right now is IDE for some sort of feasibility study, I would imagine. Do you have a timeline around that right now or kind of a rough approximate timeline? Yeah. So we're working with our friends at the FDA. You know, my interactions just as a plug to FDA is, you know, go as many times as you can, start to build that foundational relationship, you know, given the goods, you know, show them what you've done, you know, identify where you might have some weaknesses, talk about your track and what you want to do. So we are actively engaged with FDA. And my goal is to have an approval before the end of the year so we can start recruiting patients as soon as possible. I think we're ready for it.

You know, we've got good human data elsewhere. We've got a really, really good team. It's all about just satisfying FDA's requirements and then getting that approval. So, I mean, I'm held better getting into humans as soon as possible. Got it. And that, I presume this is a PMA pathway then? Or is it? No, it's a really a low-risk device.

So there isn't a predicate for it. So, you know, we're in the 510K-10-K-Genovo path. Got it. Got it. Profile wouldn't escalate it up, you know, to a PMA. Because at the end of the day, it's on the right side of the heart. So it's all venous to venus. And everything has to filter through the lungs.

So routinely with dialysis patients that already have a graft or a fistula, sometimes they get thrombost. Doctors have to go in. They have to eliminate the clot. lungs are a really, really good filter organ. And as a result, it's, you know, considered a low-risk device. Again, no predicate. So we'll go the Genoopath. Got it. Cool. Sounds good. Well, I think that that serves as a nice kind of like, you know, sort of foundation to kind of go back in time and learn a little bit about your journey kind of leading up to amplify. So let's start first with kind of like the earliest stages of a, you know, a startup, right, a classic startup.

And, you know, maybe, maybe frame this up with kind of like what you've learned, you know, almost a decade, right, at Viniti and then, you know, your experiences with, you know, kind of pivoting to the, to the pivots with pulse therapeutics and now with the Amplify. But what do you think, what do you think are the most critical things that, you know, founders, you know, early stage device company CEOs need to think about as it pertains to, you know, early stage development, right? And being as capital efficient as possible, you know, moving, moving, iterating on different designs, et cetera.

Well, that's a good question. Yeah. So, and I, and I've had the, the opportunity to talk to some early stage people, you know, you know, men and women that are going to, are going to make that leap. You know, I would say the first thing you got to realize is that kind of like the analogy I like to use is, you know, football analogy, you know, when you're a cornerback on the football field, there's really nobody behind you. You might have the safety help, you know, support.

But you're kind of one-on-one with a really, really fast human being and, you know, wide receiver and there's really nobody behind you. So in a startup, you got to do everything. You can't depend on anybody else to do your job for you. Now, eventually you want to align with good people and you want to have really, really good supportive investors and, you know, the smart money, not just the capital, but the people that, you know, want you to be successful to. And, but at the end of the day you have to be so resourceful and know that it's not going to get done unless you do it. And that's touching everything, whether it's reg or regulatory, whether that's clinical, whether that's physician or KOL engagement, you know, marketing, you know, figuring out, you know,

what an eventual commercialization strategy might be five years from now because you only have a back of the napkin concept and you're starting to scratch in your head going, well, why do I need to talk about commercialization right now? Because that ain't happening for five years. you still got to have it on there because it shows you thought you thought it through right and but you know the buck stops with you right that's what you have to realize and the other thing i would say is to uh keep everything as simple as possible you know don't start buying marketing t-shirts you know don't hire a bunch of people to the extent as possible you know find like-minded people that you know maybe find some advisors that are not full-time employees you know you never know when

you're going to run out of money and you're always feeling like you're constantly raising money. And the analogy I use here is you feel like you're trying to fix the car while you're driving it down the road at the same time. I mean, there's only so much of you you can give. So if you keep it simple, it really tends to make, you know, everything go a lot smoother because we are in a very unpredictable, regulated environment. And things are going to happen that you can't anticipate the unknown unknowns. so to keep everything as simple as possible would be the other piece of advice that I would provide. And then last thing is talk to people.

Find your mentor. And mentor defined by me is somebody that will help you but not judge you. Ask those tough questions of somebody and they're not going to say, what a dumb question. Why would you ask me that for? You're going to say,

you know what? I appreciate that question. I didn't know that answer at one point in time either. But here's what I would suggest to you and just to find a good mentor. Yeah. That three really, really great. pieces of advice there. And your second point about keeping things simple, I don't know if you

agree with this, but from my experiences, like a lot of people in med tech have a tendency to just overcomplicate things, right? Whether it's trying to navigate a certain regulatory pathway or whether it's clinical trial design, it's like, it can get complicated really quick. And, you know, the best sort of operators from my experience are really good at just simplifying, right? Like, you know, boiling everything down to like what, like a simple question, like what is the end goal with this thing that we're trying to address, right? So I think your point about really trying to, like, you know, have a straight line, right, have a vector towards, you know, what is the, what is the simple thing we're trying to accomplish here, right? Like, how could we do this?

Like, a friend of mine often, you know, tries to reframe things as like, you just laid out the really hard way to get this done. What, if we could do it the simple way? What's the, what's the easy way to get this done, right? And it just kind of like, it flips the script a little bit. So I think that that's a really important point. And Sean, your first comment around sort of the idea that like the bucks start, you know, stops with the CEO. That's so true. It reminds me of like some, I'm not sure if you know, Lloyd Mincinger, but he spent, I think most of his, you know, the first, whatever, two thirds of his career in various commercial roles and in kind of interventional based startups. But he's now running aqua medical. And he mentioned something

very similar. He was like, you know, when I first got into like a CEO type of role at a startup, You know, he was like, I was just testing this with, I think I'm kind of paraphrasing the conversation, but he was like, I was discussing this with my board. And, you know, he was like, well, you know, I don't, I don't have anyone to, you know, who's going to make this decision on, on this sort of topic? And the response was, well, Lloyd, you know, go over, look, stand in front of the mirror and tell me who you're looking at. And Lloyd was like, well, I'm looking at myself. He's like, well, yeah, that's the person who's going to actually, that's the person who's not only going to make the decision. And that's the person who's actually going to get it done too, right?

So it's like that's the name of the game in the world of startups. It's like you have to wear a lot of hats, right? And not be afraid to kind of put on, put on different hats, right? And approach a problem, a lot of various problems. So yeah, really, really good stuff there. No, yeah, I totally agree. Just a couple things that just is for us in our world, the most important piece of value we can create is clinical data, right?

And human clinical data, even if that is a safety study or a feasibility study, prior to, you know, some randomized controlled pivotal study where you're comparing what you have versus standard of care or something like that. What moves the needle for us because this really, we can do a lot of things that create a lot of value internally, like documentation and quality management and, you know, doing all the, you know, the testing that, you know, FDA requires. That's all just expected, right? It's not going to get a lot of credit for it externally. People are not going to be jumping up and, you know, clicking their heels and saying, oh, my gosh, They went from phase one to phase two.

You know, let's get the valuation by 30% or whatever. It's human data, right? And that's what really moves a needle. So that's what I use is my barometer of like, are we closer to getting a trial started to get human data? Because that's really, really important. And then, you know, the other thing you touched on is, you know, again, the buck stops, you know, with you.

And I've done everything. You know, as a CEO, you sort of imagine about walking down the red carpet and the cameras are flashing and you're famous. You're doing this and that. But that takes a lot of time out of your schedule too. And I've also, I've lived that scenario, been invited on panels and this and that. That's all fun. And it's a way to give back.

But I've also, you know, dumped in a dumpster dove for a piece of a question inadvertently threw away. And I was a volunteer to go in there and find it. I've moved out of facilities. I've downsized. I've had to let people go because we ran out of the money. All these things are tough. situations. Nobody likes to do it, but it's all part of the job. And I would say that, you know, with people, you know, for me, it's a very personal thing. I mean, I'm hiring somebody,

but I'm also hiring their family that they're supporting. So I really, really take, you know, I try to really look at that and say, if I'm going to bring somebody on and make a commitment to them, I want to be sure it's a right person. I'm going to be really honest. We're all going to pull the rope in the same direction because the last thing I'll ever want to do is to have to let that person go because we ran out of money. We didn't, you know, do something we said we were going to do or for whatever, whatever reason. And so that's also, you know, call it the dirty, dirty jobs of a startup when you have eight people working, everybody's doing everything. And so it becomes one of those things where can't hide from it. Right. Yeah. And I, to your point about like the startup world

kind of being glamorous, right? And, you know, you read, it's often, it's very easy to read a story around some, you know, quote-unquote overnight success, right? But the reality is, is most, most of us that have kind of been involved with various startups, don't get me wrong, they're a lot of fun, for sure. But if you're, if you're, like, afraid to kind of roll up your sleeves and, you know, do a lot of dirty work and, like, get into the weeds. And if you have an ego around not, or not being willing, right, to do certain, like, certain aspects of a role, I mean, it's, it's not usually going to work out, right? I mean, that's just, like, part of the game, you know, when you're trying to go from, from zero to one, pushing a bolder,

the hill, you know, so a lot of fun, but you can't be afraid of, afraid of doing a wide variety of things, right? For sure. But with that said, let's transition a little bit to, to kind of just the Klinreg function. You've touched on a little bit already. But when I look at like the companies that you built, right, Vinie, you know, being, you know, almost, almost a decade in and you had a really nice exit to Boston Scientific, no small feat, right? You're doing a Venus Stent, right? That's a kind of a big, a big project. Pulse Therapeutics, now Euphrates, this kind of like novel Bs for, you know, throndectomy. Now with Amplify, I'll go granted, it's a little bit lower risk, but still de novo, right? I mean, these aren't easy projects. And, you know, the whole, the whole Clin-Rae function can be

daunting, just even if it's straightforward. But like you, you seem to, you know, have a bias towards taking on some pretty hefty projects, you know, so walk us through kind of like, you know, for other founders that are kind of in that same boat, they're like, they're staring down, you know, a pretty lengthy process to clearance or approval. What's your, you know, one to two pieces of advice for, you know, for other startup CEOs that are kind of rowing in that same direction. Yeah. So, you know, first of all, you may be scared of what am I doing? I don't know why I'm attracted to the challenge is that I, you know, I'm scrappy for my childhood. But I feel like for to do something, let's do something novel. You know, you can build a better mousetrap and there's

money to be made there and their successes to be had. And that would be really boring for me. Maybe in my future, maybe it's because I'll get more wise or whatever I'll do easier projects. But there's something about a challenge and really they're novel because they're solving really, really tough situations for patients, you know, just taking it stepwise. There wasn't a venous stent out there. And I kept having doctors say we need a venous stent because we're using arterial stents that aren't, they don't have the kind of outward force that are needed in venous stenting. And,

you know, we need to do that. Well, then, well, that's great. But you make a really, really strong outward stent, you know, made a night and all that wants to open up as soon as it has body temperature. And it makes it really, really difficult to crimp that down and do a small enough delivery system that it's palatable to these doctors. So there's always the ying and the yang. With Euphrates, you know, if I say it out loud, hey, we're injecting iron nanoparticles into humans in their blood vessels to open up obstructions that can't be reached with wires and catheters. And we're going to use the magnetic field to get them there. Difficult, right?

But if we can do it correctly, and I believe we will, that'll be hugely impactful for patients that have, you know, bad outcomes in stroke or in stemmy procedures, you know, or in critical limoschemia, you know, opening up blood flow at very, very small blood vessels where that metabolic payload takes place, you know, oxygenation of tissues and delimony. delivering the nutrients and waste products being moved away. Really, really cool and novel. Maybe one day it would be like, Sean Morris is a really, really interesting person

because he did a lot of novel stuff. Amplify, another deal, right? We're using, you know, wall shear stress and blood pump force to rapidly dilate a vein. Again, but they're all answering, you know, you know, really big unmet needs. I would say that they're novel

and from a clinical and a regulatory perspective, my advice is to make sure you have a really, really good roadmap on your regulatory path, because that'll dictate what are the requirements for your clinical study, what are the preclinical requesting. Regulatory people are really, really difficult to find because either they're really, really good at the process of being a regulatory person and talking to FDA, but they're not pragmatic or creative, or they're very creative and pragmatic, but they're missing sort of the blocking and tackling part of it. And you'll need to augment that internally to help manage that process. Now, I found one. I can't even

tell you anybody her name because she's like the horse whisperer. It really, always a really, really, really good balance for my teams who, you know, we're in the, you know, the thick of it, right? I mean, we're in the weeds. Having somebody come out and say, all right, I see what you're saying, but this is a better way to say it. And really what you're trying to accomplish is this. All of a sudden, the light bulb goes off, we're like, oh, my gosh, you know, that's, that's so amazingly helpful. You've really, really helped us to sort of manage the information and the data that we need to put down in these slides without being overly burdensome because the regulatory person on the other side's head might explode because they're reading like 30 pages when it could have been done in two. And so I would say, you know, find your device, understand the regulatory path. what are the clinical requirements and make sure you have a good regulatory support person

that can help you just to calm everybody down and just be very pragmatic and purposeful. 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 Cala Health, Nadim Yared, CEO of CVRX, and so many others. As a premium member, you'll get to join live interviews with these incredible medical

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