Episode Transcript
[00:00:00] Speaker A: Hey, everyone, this is Tom Salemi of Device Talks. Welcome back to the Device Talks weekly podcast. We've got an unusual episode for you today. No FOMO this time around, but we will have Paul grand, the CEO of MedTech Innovator, in the Newmarkers Newsmakers with Chris Newmarker and myself. Then we'll go right to our keynote conversation. I had the great pleasure of speaking with Kelsey Mayo. She's the CEO of Armor Medical.
And Armor Medical walked away with the grand prize from MedTech Innovators contest or program where the winner was selected at AdvaMed. So Kelsey and I talked a bit about that and about the big check, but more just about the entrepreneurial journey and this really amazing technology developed by Armour Medical that could have an enormous impact in healthcare. So, before we begin, I'd like to invite you to join us at Device Talks Minnesota. The agenda is up. Speakers up there as well. Go to minnesota.devicetalks.com to register to check out the agenda. Check out the speakers. Our keynotes include Heather Knight of Sylventum, we'll have Mike Blue of histasonics. And our closing keynote will be the amazing Lisa Earnhardt of Abbott. Looking forward to sitting down and talking with her.
So please do go to minnesota.devicetalks.com to register. All right, without any further delay, let us get this podcast started.
All right, you ready for this?
[00:01:32] Speaker B: Ready.
[00:01:51] Speaker A: Chris Newmarker. How are you, sir?
[00:01:54] Speaker B: Doing well, Tom. Doing well, though, man, you've been, like, digging out out there in New England.
[00:01:59] Speaker A: It's been a sad week.
I was seasonally affected on Monday morning, the storm, really. I've hit my limit. I did make a point of going out on Tuesday for a snowshoe and get some sun on my face.
[00:02:10] Speaker B: I saw that on, like, 10 and
[00:02:12] Speaker A: it did brighten my mood, Chris. But then we snowed again on Wednesday and I was sad again. So I'm.
[00:02:17] Speaker B: You started taking vitamin D, man.
[00:02:19] Speaker A: I probably should. You're right. I absolutely should.
[00:02:21] Speaker B: It's a good Minnesota survival skill. I started taking vitamin D all the time after I moved here.
[00:02:25] Speaker A: Do you have a sun lamp? Kayleen Brown got a sun lamp because she's in the Pacific Northwest.
[00:02:29] Speaker B: I have a neighbor who does, too. He likes to, like, wake up and sun himself and get that vitamin D. There we go.
[00:02:36] Speaker A: Well, speaking of sunshine, we've got a ray of sunshine in the back with us today.
[00:02:40] Speaker B: A blast of sunshine. This is fantastic.
[00:02:42] Speaker A: Paul grand of Medtech Innovator. Paul, you know a little bit about sunshine being where you live.
[00:02:47] Speaker C: I do, I do indeed.
I have to say it was really difficult. I took my sweater out last night and braved, brave the walk around UCLA.
The 65 degree weather was cold. Cold, yeah, you know, but you know, you got to do it sometimes. So.
Yeah, no, I, I, I was in New York three weeks ago and there for, you know, some of the coldest weather I've ever experienced in my,
[00:03:19] Speaker B: I
[00:03:19] Speaker C: have a lot of empathy for you right now, Tom and Chris. So anyways, great to see you, Donnie.
[00:03:25] Speaker B: Good to see you too.
[00:03:26] Speaker A: Yeah, great to have you. You're going to be part of our new Markers newsmakers. But before we roll into the news, Paul, you've got some news from the MedTech Innovator Machine. What's going on with you folks?
[00:03:37] Speaker C: The MedTech Innovator Machine. I like that.
First of all, first of all, apologies for my voice if it's a little, little, little rough this morning. I started losing my voice yesterday. But I've been saving it up entirely for this podcast. I have said I think two words this entire day. So these are all for you.
But hi, Paul Grant, Paul grand here from MedTech Innovator, from the MedTech Innovator machine, which I'm now going to coin after. Tom, thank you for that.
Yeah, we, yeah, MedTech Innovator, for those of you who don't know, is an accelerator for really the best med tech companies on the planet. And this year we, we had 1,830 companies apply for this next cycle.
[00:04:29] Speaker B: Wow.
[00:04:29] Speaker A: Wow.
[00:04:30] Speaker C: Which is astounding even for us. It's another like 23% increase over last year.
So for anybody who thinks innovation is dead, it is not.
There's at least 1,830 companies out there that, that just applied to us.
So no, the news is not that. The news is that we are finalizing selections as we speak for the top 200. It's actually going to be more like 180, but top 200 of those who get invited to pitch at our events that are coming up in the next few months.
And for any of you who've never been at one of our pitch events, um, this is very different. This is not like sitting there and somebody stands in front of the room and they, they present for five minutes and everybody claps and, and then they walk out of the room and then everybody goes, oh, that thing is never going to work.
This is something where we sit around with the leadership of the entire industry. So the strategics, the investors, the clinicians, regulators, well, people from fda, from CMS from AMA will have like everybody who matters is the way I like to put it in the room.
[00:05:42] Speaker B: We'll have hundreds of people. Your board and your judges are who's who of the top companies in the industry.
[00:05:47] Speaker C: Thank you, Chris. I agree. They are the who too. We should, we should coin that too. The who's who of the medtech industry.
[00:05:54] Speaker A: Yeah, let's start giving him free stuff. Chris. Let's start.
[00:05:57] Speaker B: Let's hold back.
[00:06:01] Speaker C: Yeah, I like trade markets. We'll do that.
So, so that who's who of the medtech industry, Tom's like, that's my show.
[00:06:10] Speaker B: That's what we do.
[00:06:11] Speaker C: I like it.
And we'll be bringing all those people together to evaluate the top startups. So we'll have literally hundreds of the who's who, the people who matter in medtech.
Evaluating the top startups in the industry is nothing like it in the world.
And that's going to be April 7th through 9th. We're doing this for the first time as one event.
Usually we do this as three separate events in the west coast, east coast and Ireland. This year we've combined it all into one event.
And the biggest news of all is not that we're going to have all these companies there. The biggest news is not that we're going to have the who's who sitting around the tables evaluating these startups. The biggest news is that Tom Salemi is going to join us.
[00:06:58] Speaker A: Yes, that's right.
I'm not a who's who, but. But I do matter.
[00:07:03] Speaker C: You definitely matter. And you're definitely who's who. Yeah, no, we'll have. As I said, radar form is April 7th through 9th.
It's, it's curated, it's invite only, but we're always looking for new people. So if you're a strategic. If you're somebody from one of the strategics and you're not already planning to be at Radar, we haven't invited you. Reach out to me afterwards. If you're an investor, a clinician, if you're, you know, if you're somebody from one of the specialty societies, we'd love to have you there. We'll have 200 people who are going to be collaboratively evaluating companies. And I'm just going to repeat that again. It's collaborative diligence, which is very different than what you're used to usually. Like people have a one on one meeting with somebody and then, you know, they follow up or they don't. In this case, you're sitting around the table with the experts from the industry. So you've got an investor who's sitting there going, I hate this thing.
I don't like the company. And then somebody sitting there across the table who's the head of the value analysis committee for one of the top medical systems in the country. And they're going like, we would be using this tomorrow if it was available. So I don't know why you hate it and vice versa.
Somebody will say, we love this and someone else will say, we hate it. But it's a debate and it's collaborative and it's feedback and it's amazing. So that's the Radar Forum. It's coming up April 7th through 9th in Manhattan Beach, California, which is a nice warm place to be at this time. It's great. Isn't SoCal SoCal right near the airport? We're like 15 minutes away from the airport.
[00:08:31] Speaker B: Oh, fantastic.
[00:08:32] Speaker C: Yeah. So super convenient. It's a little like. It's actually a really nice kind of resort style hotel that has nine hole golf and pickleball. And we're gonna have an In N Out truck. If anybody has never had In N Out, we're gonna have an In N Out truck there to serve burgers while we play Glow in the Dark Golf. Glow in the Dark golf at night. Had to Glow in the Dark golf.
[00:08:55] Speaker B: That's what.
[00:08:55] Speaker C: Did I mention Glow in the Dark Golf. So if the top.
[00:08:57] Speaker B: I mean, so I would just go for that. I mean, that's great.
[00:09:01] Speaker C: I was going to say if the top 150 startups on the planet and the top 200 people who are literally the decision makers of our industry isn't enough for you, Glow in the Dark Golf might put you over the top.
[00:09:14] Speaker B: We have a new associate editor around la, Skyler Rivera. And I should.
I'm going to introduce you to her, Paul, because, I mean, that sounds like a really great event for her to check out.
[00:09:24] Speaker C: Absolutely, yeah. Love to. Love to have her there. That'd be great.
[00:09:27] Speaker B: Fantastic.
[00:09:28] Speaker C: And make that invite. And in fact, as I said, I'm inviting anybody who's listening to your podcast right now. If you're not a startup, if you're somebody who works with startups in some way or you're a decision maker who might be investing in or acquiring a startup, reach out to me, pauldtechinnovator.org and, and I'll tell you how you might be able to be involved in Radar. And I say might because it's invite only. So I hate rejecting people, but it's invite only anyways. So That's Radar Forum. It's coming up and it is absolutely one of the best experiences anybody has in the medtech industry. And I know that because people tell me that all the time. They say, you know, hey, it's fun to meet with startups, but boy, it's so cool to like, listen to all these other people around the table tell you why they like or don't like these things interactively versus, you know, as I said, more of just kind of the one on one format. So it's something that's really unique to Medtech Innovator and it's in a really fantastic experience.
[00:10:32] Speaker A: Great. Well, we're looking forward to that and we always enjoy the work you've done at Device Talks Boston. You will be there day one at Device Talks Boston this year, but you folks know how to put on a show. I've enjoyed them in Dublin and elsewhere. So looking forward to this experience. So thanks for having me out.
[00:10:51] Speaker C: Yeah, super excited to have you be part of it. It's not something we've had the pleasure of before, so it's going to be great to have you there. Tom.
[00:10:59] Speaker A: Well, that sounds like a great time, Paul, and looking forward to being out there. Chris Newmarker, though, we're here for you, my friend. You are the.
[00:11:05] Speaker B: We're here for the. Exactly.
[00:11:07] Speaker A: The Newmarkers newsmakers, I'm saying it correctly.
So let's roll into number five.
[00:11:15] Speaker B: So I mean number five on the list we've got Ferro Neuro raising $20 million and they've named a former Medtronic executive as their CEO, Amaza Reitmeier, who has like more than two decades of MedTech leadership experience. She most recently was VP of Neuromodulation at Medtronic. So that's just fantastic. Faro is based right here in Minneapolis, where I'm based. And they're technology is a cerebral spinal fluid management system. They also have their mind's eye expandable port for cranial access and minimally invasive neurological procedures. So just some exciting news for this young company here in Minneapolis.
Have you communicated with them before?
[00:12:09] Speaker C: Paul so Faro has not been part of Medtech Innovator, but we've had other companies that are doing similar things like Brainspace in Medtech Innovator. And you know, it's, it's exciting because these companies are taking what was, you know, previously a more like, you know, a drain or something that, you know, doesn't sound very smart and interesting and turning it into like a data machine that can really manage the way patients are cared for and interventions and monitoring things that normally you wouldn't be able to see in other modalities. So super exciting. And you know, and it's great to see somebody coming from Medtronic over to, to lead this company to CEO because, you know, I tell people all the time, every time you're pitching somebody in any meeting, I don't care if it's investor or strategic, it doesn't matter.
What you should be trying to do is achieving two things. One, getting them to want to write you a check, that would be fantastic.
And number two, if they can't do that, maybe they can quit their job and come work for you.
And I'm like, every time I, every time our company's pitch, I said, if the person across the table doesn't say, huh, I wonder if I should quit my job and go work for this company, then you didn't do your best pitch. So clearly they must have done something right at Farrow.
[00:13:30] Speaker B: Yeah, that's fantastic. And moving on to number four on the list. I mean, even. Actually, this is kind of a bit of a Medtronic heavy new markets newsmakers this week. But I mean, they're just making a lot of news recently.
I mean, next up we've got like Medtronic is pricing the IPO for their minimid diabetes unit and they're pricing it at up to $784 million.
I mean, like we've been reporting a lot about, you know, the plans to separate out minimet and it really just seems like an opportunity for MET trying to like really better focus itself on some other technologies at the company.
But man, I mean, so many MedTech IPOs recently. I mean, we were talking about the more IPOs in the Newsmakers like a week ago. I mean, I mean, I'd be interested having you on here, Paul. I mean, I mean, just because you're just following all these potential exits for young medtech companies. I mean, why are we all of a sudden? I mean, gosh, for years and years I almost hardly ever covered a MedTech IPO. And now it seems like we're just seeing a lot of them. I mean, what's going on?
[00:14:37] Speaker C: Yeah, well, I think like everything, it just takes a little bit of time. And then the public markets wake up to where there's and there's absolutely predictable value in the medtech sector.
And for the startup innovation kind of ecosystem in general, there is nothing more important than IPOs.
And not because they all will wind up exiting with an ipo, but because that really drives the flywheel that allows various layers of what they call the capital stack to invest in the medtech sector or any sector. And if you don't have IPOs, it makes it hard for people to get liquidity. And, and so, you know, the medtech sector has been almost entirely M and A in terms of exit for many, many years, as you said. And, and the lack of IPOs makes it hard for venture funds to raise capital. It makes it hard for the startups then to raise capital, and it just goes, you know, all the way downstream. So this is a big deal.
Not just that Medtronic is, you know, got Mini Med coming out as an ipo, but also just in general. It just means we're going to have more people, more retail investors and others who are out there looking at companies and going, oh, that's a medtech company.
What are some other ones that we should be looking at and considering? And I can tell you, we got 800 or so in the MedTech Innovator portfolio alone that would love to have that opportunity. So, you know, it's a good fundraising opportunity, accessing the public markets and great validation for our space. So I'm really happy to see that. Great for diabetes in general to have, you know, strong company out there on its own, focused just on diabetes. There's so many diabetes innovations that are out there. We've had all these Great companies at MedTech Innovator Companies like Nutromics who just published some new, exciting data.
Um, we've got great companies but, you know, they, they need validation that, you know, this space matters. And, and nothing, nothing validates a space either like a big M and a deal or an ipo.
[00:16:48] Speaker B: So, yeah, it's kind of exciting too, that you're going to have the, you know, the maybe, perhaps before, you know, the opportunities to get acquired by, say, Medtronics. Diabetes business was as much because it was part of this larger umbrella. But, you know, you know, once they kind of get all the financing and whatever that comes from out of the way, that comes from getting spun out, you know, this independent company could maybe be more focused on acquiring some innovative technology. So, I mean, that's another potential buyer that's kind of getting a boost, right?
[00:17:16] Speaker C: We have companies like, like companies like Bio Link and others. There's so many great ones out there and, and they're just waiting, you know, they're, they're just waiting for that time when they're either going to, you know, be a dominant player on their own or they're going to merge with somebody else or, you know, whatever that their outcome might be. But having having capital markets that you can access quickly, you know, is something that's really different about the public market.
You know, it's not just the ipo. There's future opportunities to quickly raise capital. Like literally overnight companies can raise capital. And it might be expensive, but you can do, you know, shelf financings and all sorts of creative things where that you, you can do with a public market that you can't do in a private market that, you know, take much longer. So it's exciting. It's great news.
The more MedTech IPOs, the better.
[00:18:08] Speaker B: Yeah, absolutely. Absolutely. So number three on the list, if you.
[00:18:12] Speaker A: Looks like, if you stack up the revenue too, I'm just looking at. Looks like they make about 2, 2.5 billion a year estimated, which puts them above Insulet, but below Dexcom, which is at 4 billion, and Abbott at 5 billion.
So it's immediately a big player.
All right, Chris Newmarker.
[00:18:31] Speaker B: All right, number three on the list, we've got Medtronic winning a CE mark for their next gen software model, like for GI Genius, Colon Pro software. And this is like AI assisted colonoscopy.
Medtronic distributes the GI Genius with Cosmo Pharmaceuticals.
You know, they rolled this out in 2024, so just, just another boost for this platform. And, you know, it's been, it's been really referred to a lot over the years as being like a great example of, that we're already seeing out there of AI being used in medtech in a very constructive way. You know, just the fact that, you know, like someone goes in for a colonoscopy and, you know, the doctor can actually see these little green boxes that say, hey, you might want to look at this like a little more closely. That's, that's fantastic. So, so just, you know, just more advancing of this, of this technology going on.
[00:19:29] Speaker C: Yeah, you know, I think we have, We've got about 80 companies in our portfolio in the GI space, and if you include colorectal, you know, then you've got another, another chunk more.
It's amazing when you look at the difference that AI can bring to these procedures.
It is astounding. And maybe we're seeing that with AI everywhere. But AI and endoscopy is a huge thing. So, you know, again, having, having this be a, you know, a proceed, an entire procedure that includes the AI is, you know, it's, it is something that I think you're going to see everywhere. Procedural AI, operational infrastructure, and not like an add on.
That's really the key. So exciting stuff.
[00:20:20] Speaker A: Absolutely.
[00:20:20] Speaker B: Yeah. We're gonna move on here to number two. We're gonna be talking about mechanical thrombectomy systems.
You know, in this case, this is like new guidelines from the American Heart association and the American College of Cardiology, you know, for pulmonary embolism. And these are like guidelines that are, that analysts say are welcome change from existing qualifications, that these updates are providing a boost to this type of technology. And the really two players we're looking at right now are Stryker after its acquisition of Inari Medical, and Boston Scientific, which is, you know, has a planned acquisition of Penumbra.
[00:21:14] Speaker C: Yeah, I, you know, I can tell you a little bit about, you know, the PE space. You know, we've again, you know, we've got companies like Flow Medical, you know, that are bringing really exciting new innovation to the space.
You know, the guidelines really matter.
And I think that's the real, for me, the crux of this story is having guidelines because it changes the game for everything.
And, you know, and this goes everything from, you know, from on the procedural side up to reimbursement. You know, these guidelines make a difference. And so, you know, having guidelines in place makes everything easier for, you know, reduces friction for the industry. So thrilled to see that, you know, investors like clarity. Everybody likes clarity. So guidelines are a good thing. So I'm excited about that.
[00:22:06] Speaker A: And Sean's article mentions that this is good news for Likely for Imperative Care, Incus Medical and Jupiter Endovascular, which are in the space as well. So guidelines are good. We all agree. Chris Newmarker, what's the big number one this week?
[00:22:20] Speaker B: Hey, number one on the list. I mean, we've been reporting for a while that Johnson Johnson was looking to separate out the Pucenthes, which would be like the largest orthopedic device business in the world. But Sean Hooley, our senior editor over at Mass Device, caught a Bloomberg report, anonymous sources, but they're saying that they're actually eyeing to sell this actually to somebody that this could be a deal worth $20 billion potentially. So, I mean, of course, anonymous sources, these types of Bloomberg stories, I've noticed, don't always pan out, but definitely, definitely intriguing.
And who might buy business.
[00:23:03] Speaker A: Yeah, I know initially I thought maybe given the revenue of about 9 billion or so, it seemed a bit low. But then as we sort of thought about it and I put something out on LinkedIn with the level of the amount of annual growth and sort of just the state of Orthopedics. It seems like a good, I guess, ballpark for the price. And I imagine that we're going to see some private equity folks step in and do what private equity folks do. Paul, how do you see this playing out?
[00:23:31] Speaker C: Yeah, no, I'm right there with you.
The private equity folks, they really know their stuff and it's amazing because the difference between them and the investors who invest early in these companies will often look at something and go, oh, we want to get 3x or 4x or 5x or whatever they're looking for. And in really early stage company. And a lot of times you look at those things and you go, oh, I can't see it being worth much more than that. Say wherever the company is. And then you have these PE guys who come in and look at something for that, a $20 billion deal and they still see the 5x or 10x potential on top of that.
They really have to do their homework. So when you, you know, again, these are all rumors that you're hearing right now. But, but the reality is that this is a really important business and, and this is one of the biggest and, and I think it's going to be a massive player in the future.
I'm thrilled, by the way, as somebody who is there working with all these startups, I'm thrilled to have more acquirers. I want to see more things get divested versus consolidated. So I'm thrilled about this deal.
I hope they get exactly what they deserve in pricing, which is a big number. So it's exciting stuff and it does
[00:24:54] Speaker B: kind of play into this. I mean, if, as you said, rumors, I mean, who knows who it is, but if it's private equity, it kind of goes along with this, this trend that we've been seeing in recent years. I mean, I've been covering this space for well over a dozen years. I mean, I've seen, you know, in, in that whole contract, manufacturing, supplier space, all kinds of private equity. But it really felt like it's only been like in the last few years that in the actual OEMs that we've seen private equity, you know, moving into MedTech and really intriguing if this might be another big private equity play.
[00:25:30] Speaker A: They come and go. I think there's always ways like everything else, private equity will get involved and then it's too expensive. So then the IPO market, well, it's going to be interesting to see how the surging IPO market impacts the valuation for private equity. It may actually cool things down for private equity if things get too Hot and too expensive.
I think if depew had their choice, they probably would do what Medtronic did with Minomet and spin it out and put it on the public markets. But I'm not sure if the growth is there for depew. But intrigued by. I agree with Paul. I think having these sort of streamlined acquirers out there make the likelihood of acquisition or make acquisition more likely. And Paul, I suspect two or three years down the road you'll be seeing some pitches from depew folks who have decided, you know what, now's the time I'd like to start growing my own company and follow my dreams and follow my own ideas. So I think we'll be seeing a shedding of a lot of great talent from depew that's going to really fuel the startup industry.
[00:26:31] Speaker C: I sure hope so.
There's nothing, there's nothing better than from people being able to take some money off the table and go back and join these earlier companies and really level up the leadership.
[00:26:45] Speaker A: Absolutely.
[00:26:46] Speaker C: So, you know, I'm always excited about that opportunity. And you know, when you look at again, you know, you look at leaders, you know, category leaders in a space like it's important when you know, they're focused and having a player that's totally focused on the orthopedic space, that's a big deal. So we like that.
It helps everybody. So again, I'm excited about this and I hope they get the value that they deserve for sure.
[00:27:19] Speaker A: Absolutely. All right, Chris Newmacher. Well, this is a great top five, but folks love five of the biggest news items of the year day.
How can they get that sent to their inboxes?
[00:27:31] Speaker B: Oh my gosh. Just go to Mass Device. Sign up for our daily Plus5 newsletters. You'll get the top five news every day though. Still, come on here and listen to me and Tom and sometimes even Paul here. Come talk about the news.
[00:27:43] Speaker A: It's always great to have a who's who on the. On the newsmakers for sure.
And Paul, you invite folks to reach out to you about the Radar forum, give us the dates again and what's the best way for folks to connect? Just on LinkedIn.
[00:27:55] Speaker C: Yeah. So anybody who wants to find me, you know, the easiest place is medtechinnovator.org, so if you just go to our website www or no www either one, it works just fine. Medtechinnovator.org you can learn about us. There's a link right at the top about the radar form so you can click that to Learn more.
You can email me pauldtechinnovator.org and yes, my favorite place is probably to hang out on LinkedIn because that means people can connect with me directly and quickly and I don't have to read through 700 email messages to find it. So, yeah, so LinkedIn is just fine and it's easy to find me there. Just look for Paul grand on LinkedIn and you should find me pretty quickly at MedTech Innovator. And again, Radar Forum is April 7th through 9th. It's in Manhattan Beach, California. As I said, very close to the airport.
We'll tell you the secret hotel.
If you get invited to join us, then we'll tell you where to go. We don't want to have just a ton of people just hanging out at the hotel, so we'll let you know the location afterwards. But it's very exciting. As I said, there'll be about 400 or so people, 350 to 400 people in total, between the innovators and the who's who of the industry who will be there collaboratively evaluating these companies. And as I said, even if you're not an investor, even if you're not, you know, somebody at a strategic, if you're somebody who has expertise, you really feel like you're part of that who's who, you know more than others about your particular discipline, whatever it is, could be regulatory, could be reimbursement, could be product development, whatever it might be. If you feel you have some value to add, reach out to me. We always want to add people to our ecosystem. We have literally thousands of people in the ecosystem and we're always looking for new people. So reach out to me. We'd love to have you at Radar Forum or just to connect with you in general.
[00:29:57] Speaker A: All right, sounds great. Sounds like a great time. Paul Grant, thanks for joining us on the Newsmakers.
[00:30:03] Speaker C: Thank you, guys. Great being here.
[00:30:05] Speaker B: Fun as always. Hope your voice gets better.
[00:30:08] Speaker C: Hey, me too. It can only get better, right?
[00:30:10] Speaker B: It can only get better from here.
[00:30:11] Speaker C: It can only get better from here.
Yeah, no, thank you, guys. It's great being here. I love being in the booth with you guys.
[00:30:17] Speaker A: All right, thanks. Chris Newmarker and Paul Grant for this week's Neuemarkers Newsmakers, look forward to seeing folks at MedTech Innovators Radar Forum in April. Please go to medtechinnovator.org for more information.
Now, of course, our keynote conversation is with Kelsey Mayo of Armor Medical.
So just to set the scene, Armour Medical is one of four or five Startups MedTech Innovator finalists that presented at AdvaMed back in October at their meeting in San Diego. They all presented on stage and the winner was chosen by the folks in the audience. I was there as well. And Armor Medical walked away with the grand prize of $350,000 to advance their maternal armor, which is a non invasive real time monitoring system to detect early emerging. It's really a clever, clever way of potentially saving a lot of lives. So I really enjoyed this conversation with Kelsey Mayo. We talked a lot about entrepreneurship, about risk, and of course about the importance of medtech. Let's listen.
Well, Kelsey Mayo, welcome to the podcast.
[00:31:32] Speaker D: Thank you so much, Tom. It's good to be here.
[00:31:34] Speaker A: I'm excited to finally have you on. I tried to approach you after you won the MedTech Innovator Award at AdvaMed. You were at the cocktail party that night, but you had a line of people and you had a massive check with you that you were still carrying, which I thought was hysterical. And just a huge flag and a great icebreaker at a cocktail party.
[00:31:55] Speaker D: That was so much fun. Yes.
Honestly, carrying around the big check was a highlight. And later my co founder and I took it because this was in San Diego. And so we took it on a mini bike tour all around all the tourist hotspots. And so it was a blast.
[00:32:11] Speaker A: I did check that folks should go on your LinkedIn page. There's a video of it you posted a few months ago about that. So I'm glad you had a lot of fun with the massive check.
Where does the massive check reside now?
[00:32:23] Speaker D: It's at my office. So right now I'm recording from my home office, but we have space right behind Georgia Tech and Science Square, and so it's proudly displayed there at my office.
[00:32:35] Speaker A: That's fantastic. All right, so how did we get to where we are? How did you find your way into the medtech industry?
[00:32:42] Speaker D: Ooh, excellent question. So it's funny because I started my career as a material scientist, materials engineering, and really have focused in precision medicine for the entire time that I've been fascinated by materials because frankly, something struck me. If you're going to put in a lot of really hard work after hours, especially at this time I was working in the research lab.
I wanted it to have a human impact, a tangible human impact. So I kept getting closer and closer to the medical world.
And when I was getting my doctorate at Vanderbilt, I was building nanoparticle drug delivery systems.
[00:33:25] Speaker A: Very cool.
[00:33:26] Speaker D: Thank you. I think so too. So, you know, it is kind of Fascinating to think, how did somebody who's a material scientist who got a doctorate developing nanoparticle drug delivery systems develop a medtech wearables company in women's health? And you know, looking back on it, it said like that it seems strange, but it was very intuitive to me because I kept trying to build my career where I felt that my passion met the world's needs.
And so there was this really stark moment when I was in grad school and I had my hands. It was way late at night. I was, you know, after a MER marathon of lab work, had my hands in the fume hood and I realized what I was building while I was gonna get the big paper, the publication, track record, you know, thumbs up, looking good.
Nothing that I did felt scalable. I couldn't imagine somebody manufacturing these things. And I asked myself, why? Why at the end of the day am I doing this?
And I started it to help people. And I really wanted to build medicines that made a difference, had a.
And so I call this moment. And folks might have heard me say this before, but it was like I was hand building a supercar and the world just needed a Camry.
And that was striking to me and it was really a pivotal moment when I started shifting more towards entrepreneurship.
[00:35:03] Speaker A: So did you have any kind of family connection to healthcare, any parent who is in healthcare or where do you think that need to have an impact comes from?
[00:35:18] Speaker D: That's a good question. Actually. I come from a fairly blue collar background. My mom, she was a zoologist by training and then a stay at home mom and then later she had to reinvent herself and was in healthcare. Not healthcare, excuse me, in education. It.
[00:35:34] Speaker A: Okay.
[00:35:35] Speaker D: My dad, he's really the canonical entrepreneur. He was a nuclear pharmacist when I was a kid. Built a business in the 80s doing nuclear pharmacy. And he sold his business and the sale of his business got him hooked on the transaction. So he went into commercial real estate. And as a kid I actually, it was fascinating to watch both of my parents navigate their journeys because they both had to reinvent themselves.
It was feast or famine.
We were either fairly wealthy or very not wealthy. And by the time I was going through school, we were in the very not wealthy. And so I was kind of scrapping for everything. I had to put myself through school.
I was the crazy kid. As an undergrad, I went to all my professors at Georgia Tech and I said, I'd love to work in your research lab because I want to build my resume. I think I want to do this science thing for real, but I have to get paid for it. And the shock on their faces. What freshman undergrad, you want to get paid? And I was like, yeah, I've got to buy groceries. So, you know, I'll go bag groceries at the grocery store if I have to, but I'd much prefer to do something, resume building. And I had one guy take a chance on me, and it was Dr. Larry Bottomley. And he was the first and only person willing to give me a paycheck to do work. And he was also one of the biggest mentors that.
It just happened. His lab did biosensors and nanotechnology and biosensors. And it was again, I realized I love this stuff. I love the fact that what I'm building can be used to improve people's health.
[00:37:17] Speaker A: That's amazing. And I mean, it seems as if both your parents were driven by a passion. So it was probably imprinted upon you early on to.
To do what you love, to marry your passion with your career.
Is that accurate or am I podcast reaching with that? No, that's accurate.
[00:37:40] Speaker D: You know, the irony is, after growing up in the feast or famine, I thought, man, I need stability.
So the fact that I took the leap of faith to start a company and the ultimate stretch of uncertainty, I really owe that, frankly, to my husband. So I've been married, I've been together with my husband Trent for 18 years.
And he also comes. His mom was an entrepreneur, a business owner, a crisis counselor, actually. And so he kind of grew up in this environment, but unlike me, he loves risk taking. He's actually a stunt driver as well.
[00:38:18] Speaker A: Oh, no kidding.
[00:38:19] Speaker D: So that, like, is his bread and butter. And so I've always had the.
I really genuinely motivated by helping people I love. I think you should leave the world a better place than when you came into it.
But again, I had the battle my own. I don't really want to, you know, I was risk averse, kind of ironically, and the this is kind of jumping into the real fire in your belly kind of moment. But. But when Trent and I had our first son, he was 18 months old. Trent was doing stunt driving in Atlanta. I was living in Nashville, and I was sitting in my office and nearly died of a hemorrhage.
[00:39:07] Speaker A: Oh, my God.
[00:39:09] Speaker D: And I say that this is a jump in the story, but it's really meaningful to me. Cause you were talking about, like, why take risk? And I would say it started somewhat academically and because of what I would maybe consider my nature. But I knew that hemorrhage was a problem for moms. I knew that this was a solvable problem, a preventable cause of massive amounts of mortality and morbidity. And I'd even talked with my now co founder about, hey, can we use this really cool tech to solve this? I think we can.
But then at that point, you know, where I'm sitting in my office, I don't know what's wrong with me. Enormous amounts of pain in my abdomen wided out from pain and was wheeled into the ER by a coworker, where I was dismissed. I was ignored.
I was told it was in my head, it was gas.
It wasn't. I had had an ovarian cyst rupture and twisted a fallopian tube, and I had been bleeding internally for 10 hours.
And the only reason I was taken seriously and my pain was taken seriously is because I was about to pass out on the floor of the emergency department waiting room, and one of the nurses looked at me, and she was arguing with me, telling me I couldn't lay down. This was not where I wanted to sleep. And I said, ma', am, I can't help it. And then a Lifelight medic saw me and realized I was going into hemorrhagic shock.
[00:40:39] Speaker A: Holy.
[00:40:40] Speaker D: And so I get wheeled back, and he was the first person. And this is a shout out to those folks who are truly heroes in healthcare. He looked at me and said, you're not faking it.
This is real, and we're gonna take care of you.
And, sorry, I still get choked up.
[00:41:02] Speaker A: No, in full disclosure, I read the article you wrote for the Atlanta Business Chronicle. I think it is. And so I came into this interview knowing that you had had an experience with hemorrhaging. I didn't realize it hit you at your office. And my. Oh, my gosh is not at all fake, because I can't believe you're in the er, you're bleeding internally, and they're trying to send you home. I mean, yeah.
[00:41:28] Speaker D: Yep.
[00:41:29] Speaker A: That's just so discouraging.
[00:41:31] Speaker D: You know, when I was PhD, PhD in biomedical field, working for a big healthcare system, and I was being gaslit, and I had no advocate. And by that point, I had lost so much blood, I couldn't think straight.
[00:41:47] Speaker A: Of course.
[00:41:48] Speaker D: And my husband was working in Atlanta. He drove like a bat out of hell, frankly, to get up once he heard that I was in the hospital. Made it. I had an emergency surgery, blood transfusion, and survived.
And that is the moment. Waking up from that experience, knowing that I had almost lost my Life. And the scary thing about that was thinking I would never see my family again.
And I knew it was not long after that moment I just looked at Trent and I was like, well, if this isn't the universe telling you that we need to do something, this is a problem we've talked academically about solving and here's your wake up call that like we need to be doing something. That was it. And from that point on it's almost been a no brainer. You know, if we really have an opportunity to keep any other families for going through this type of experience, how can we not?
[00:42:57] Speaker A: Absolutely that's.
And to go into obstetrics and delivery, I mean that's a setting where I think unfortunately a lot of this goes on as well. The gaslighting, the lack of information, lack of communication, you're in there helpless.
And as try as you are as a soon to be parent to be informed, you just don't know what you don't know and you don't know when to advocate and when to push. So I think it's remarkable to. We'll get into your technology in a moment. But for some reason I did want to come to the conversation unpacking the sort of entrepreneur trip.
And I'm glad you kind of hit upon it early. Do you think this life and death experience kind of reset risk in your mind? Because I think we all have this temptation of starting a company and we all worry about risk, but risk is everywhere. Risk is at a big job, risk is walking down the stairs. Risk is everything and everywhere. How do you see risk now?
[00:44:01] Speaker D: Did it readjust things completely 100% and for a while, I mean it still took a little bit of time for my co founders to invent the device, patent it. Their faculty over at Wash U we kept in contact through this entire period. But you know, it was fascinating that you really get a sense of the veil is removed.
Risk is everywhere. And wouldn't you rather spend the most precious resource that you have your time on something that you care deeply about?
And that was it for me. And still been a journey. I started taking those steps and then as is probably the path of many entrepreneurs, I took the leap of faith. I quit my day job. This was.
We started the company June 2022. I quit my day job in October because it's very difficult to be the mom of two small kids and basically working two jobs.
And I knew I didn't want to give half of my heart to this company. I knew that Armored Medical was something that deserved my All.
And so I took the leap of faith.
[00:45:22] Speaker B: And
[00:45:25] Speaker D: there were definitely periods where we had, you know, I couldn't pay myself because everything had to go into the company.
And you have to be willing to just say, I believe it'll be okay. Like, there's always a way to problem solve in the moment. No matter what hits you, you can figure out how to. We call it pivot over. I mean, it's kind of overused, but you can figure out how to move. Right? Move with it, move around it, over it. Lord, like invent a teleport and go through it.
So it's risk is just problem solving, right? You just. How do you characterize it? And then with the information you have at hand, how do you move it forward? And it's actually. When you start to shift your mindset, it becomes fun.
[00:46:16] Speaker A: Yeah.
[00:46:17] Speaker D: I love problem solving. And if the problem is hard and if it's interesting and if it's a rewarding solution, then, heck, yeah, sign me up.
[00:46:25] Speaker A: I love that. And I love that, the vision that, that, that, that vision of the field. I feel like having done what I. I've done for as long as I've done it, I now feel comfortable whenever I need to make a decision. Let's just do that. Like, we'll do that. We'll figure it out. We'll get there.
Whereas 10 years ago, 20 years ago, I would have fretted about this way or that, now I see the field more clearly. And I may not know the direct path there, but I feel like I can, to your point, get us there and problem solve.
So it's wonderful to have that confidence in view. I'm curious, if you don't mind me asking. Trent had a vision of risk early on. I mean, for his job. And there's an entrepreneurial background as well. Do you find your visions are aligned now, or is he like, whoa, you're like. You've, like, shot past me in terms of.
[00:47:20] Speaker D: No, no. He'll probably laugh when he hears that. No, he.
To this day, I'm still a little bit less of the risk taker than he is, but.
[00:47:30] Speaker A: Okay, well, that's probably healthy.
[00:47:31] Speaker D: He's just, you know, and that's something that I will say is I'm able to do what I'm able to do because I have an amazing support system. I have people around me professionally and personally, who are 100%. They believe in what we're doing. They know me as a person, and so I have that support, and I am very grateful. I'm also surrounded by people who are brilliant in so many different areas. And Trent being one of them too. You know, I joke with him.
He's the best unpaid intern that Armour has ever had.
And when you talk to other entrepreneurs, especially early stage companies, a lot of us have that person have somebody who's the unsung hero, who really without them it couldn't have happened. And so an organization is its people and sometimes those people are both paid by the company and sometimes they're the people in your personal life that allow you to be a human that can do these things.
[00:48:36] Speaker A: That's amazing. Well, I could spend the entire time talking about this, but let's focus a bit on Armor because it's a great story as well.
So how did you mention your horrible experience, the inspiration you had, or the clarity you got from that and then you began talking with your co founders? Walk us through a bit through the co founding of the company and the origin of the technology that you're using.
[00:49:07] Speaker D: Yeah, so this technology is really the brainchild of my colleague and dear friend, Dr. Christine O'. Brien.
She and I met at Vanderbilt in graduate school and her specialty is biomedical optics.
And so she has spent her career building optical devices. And she really applies the lens of global health and women's health. So she is absolutely brilliant. And one of the things that sets her apart as an engineer is she doesn't over complicate things. And she's not forever iterating just to make it an nth degree better.
She actually starts with the problem first and she what is the problem that we are trying to solve? And then she looks at the toolkit available to her and figures out not only what would be excellent at solving the problem, but but there's this practical and applied lens that is rare and I think often undervalued, especially in an academic setting. And that is, is this a fairly inexpensive problem? If you're talking about a global health solution, can this be manufactured at scale inexpensively? Is it, you know, something which has to be housed in a special insulated warehouse or is it something that can withstand the real world?
And she started from her side, you know, I think if you asked her, she would probably say it was the global health lens that really started her thinking about hemorrhage.
She took global health classes at Vanderbilt and was shocked to learn about, you know, the leading causes of maternal mortality.
And when she first told me this was over a decade ago, that we know we can prevent all of these poor outcomes if we just catch it early, but the tools, clinicians have today are primarily visual blood loss estimation or weighing blood soaked pads.
That moment was sobering because we kept thinking, why? Why has nobody looked at this problem and started to build a better tool? There's got to be a better way to measure blood loss.
So she started thinking about, well, what makes it hard? Why hasn't it been solved? And here's the fascinating thing about a maternal hemorrhage specifically.
We know that when we're pregnant, we build up about 50% more blood volume than a non pregnant person.
And so when you have any sort of acute hemorrhage, even if you're not pregnant, the first thing the body does is this autonomic response. We clamp down on blood vessels in our periphery to shunt blood away from areas of the body. We really don't need it in an emergency to your core to protect all of your vital organs.
That is called a compensation response. And now imagine that when you're pregnant, you now have so much extra blood supply in your periphery that you have this extraordinary ability to compensate for blood loss.
So if you go talk to an OB gyn, what they will tell you is when you see a pregnant patient that is suffering from a maternal hemorrhage, she's otherwise typically young, healthy, she looks fine, she looks fine, she looks fine. And then she goes off a cliff and she's not fine.
And that's because she's really good at compensating for blood loss.
So if you're just relying on traditional vitals like heart rate and blood pressure, you're essentially missing this silent early stages of bleeding. And only when that person, in the case of a pregnant patient has lost like 25% of their total blood volume. So we're talking like a liter and a half of blood.
Only then do you often see this hemorrhagic shock. You know, and now we are in an emergency. And so, so that is kind of the crux of one of the reasons this is so hard to see. And it's not like in these patients you're doing invasive monitoring. It's not like we're putting in an A line to understand how their hemodynamics are shifting. That's just not done. We don't do invasive monitoring on pregnant patients. So this is where she started.
And she said, well, if the earliest response to blood loss is this compensation is this peripheral vasoconstriction, what if we look at that, is there a way to really, really accurately measure these subtle changes in peripheral blood perfusion and from that determine Hemorrhage risk in real time and hopefully catch this earlier. So that was really, that was her idea. That was where she started with.
And then she went on to think about the toolbox, you know, of all the possible technologies that could be used to measure this, what fits the bill?
And she landed on a technology called laser speckle imaging.
Laser speckle imaging is like a sister technology, if you will, to pulse oximetry.
[00:54:24] Speaker A: Okay.
[00:54:25] Speaker D: And so what it actually does is it measures the velocity of flowing red blood cells and it does this non invasively. It does this with a laser and a camera.
But it had never been made wearable before. You know, nothing had been done to make this into something that could truly be a wearable tech that would fit the bill for where this technology would need to live in the real world. But it did have a lot of advantages that made it attractive. Things like it was very, very sensitive. So much higher signal to noise ratio, which hugely important when compared with pulse ox is specifically what I'm talking about, hugely important. If you're trying to measure flow in the setting of hemorrhage, where blood flow may already be pretty low to begin with, it also has some benefits when it comes to motion artifact. So higher resistance to motion artifact. Again, good.
[00:55:25] Speaker A: What is motion artifact? What is motion?
[00:55:28] Speaker D: So when you're in the real world, you're moving around, a lot of technologies will interfere with the ability for that device to get good signal needs to
[00:55:39] Speaker A: get recalibrated and kind of reset and kind of.
[00:55:41] Speaker D: You got it, you got it. And so we spent a lot of time in the wearables industry making sure that the device works even if you're moving around.
So you know, just mentally picture right, a setting of a woman in labor.
In some cases, you know, she might be bouncing on a ball. Right. So we know that there's movement involved here. We have to be able to be effective in these settings. And then finally, and this is where my, my second co founder here, Leo, comes in.
Dr. Leo Smojlovich is a brilliant dermatologist. He's an MD, PhD, also works at Washu.
And he and Christine met when they were in their postdoctoral positions because Christine was thinking through this technology. And another thing that she needed to make sure of was that the device worked robustly across all skin tones.
So if you remember, you know, in light based tools like the pulse ox, historically I don't think med device manufacturers have paid enough attention to how robustly devices work for all people who are going to need to wear it.
And so my Hats really go off to my co founders in this because Leo, this is his specialty, like his bread and butter. He's actually kind of like MacGyver. I adore working with Leo.
He's the kind of person that would have like five, like a bay of 3D printers on his kitchen table.
I mean, he's fabulous. But he also comes with this brilliance of how to make light based devices work well across all skin tones. And so when Leo and Christine, together with a brilliant student in Christine's lab, created this technology and really envisioned it, all of those things were baked in from the get go, which is fabulous. And so, you know, she started from the physiology, kind of locked in on this could work, but there were a number of things that have to be done to the tech to actually make it work in the real world. And then she pulled a team of expertise around her to create it. And so that's really. That was the origin story of the technology itself and the original patent on the device.
[00:58:01] Speaker A: So when did Armour Medical come into being? And when did all that you just described become a company?
[00:58:08] Speaker D: Yes. Okay. So they built this thing and they put it on a swine in a controlled model of hemorrhage to see does this actually work.
So this was a swine model and we knew exactly how much blood the swine was losing. And they did a resuscitation. So they put IV fluids basically back.
And I got a call, I was at work and I got a call from Christine and she was beyond excited and she said, I have to show you this data, I have to show you this data. So I think we got on Zoom and she showed me the data and I was floored because this is basically the raw signal we're looking at and the correlation between the change in fluids that her first version of the prototype that she ever built and what we knew was being lost. The hemorrhage event itself was 0.98.
[00:59:07] Speaker A: Wow.
[00:59:08] Speaker D: And I paused and we looked at each other because if, you know science and engineering, nothing ever works the first time around.
And certainly you don't see it in that raw signal.
And I just remember telling Christine, I said, you've got something, you absolutely have something here.
And she said, I think I do. And then she followed up with. And in two weeks, three weeks, somewhere like that, there is this big, I think it was nih, it was the National Technology Accelerator Challenge, ntac, I believe is the acronym, and it was this big Wearables for Maternal Health Challenge. She said, hey, we know the tech works, but we have to do some work to think about how this could actually be a product. And I know that that's your specialty, Kelsey, so could you help me think through, like, for this application, how we take the tech and actually make it a thing? And that technology was a little bit more, again, for, like, global health settings. That was kind of the lens for that application.
So sridharoffice said, absolutely, happy to help, you know, put it together. We, in the span of a couple weeks, threw this thing in and we got honorary mention out of every single entry in the entire country, which was, to me, a huge signal. Right? You know, yes. We didn't take top prize, but dagum, with a couple of weeks of work, we were like, right up there. There is something here. This is real signal.
And so the natural next step was, well, do you want to apply for an sbir?
And I said, yeah, let's do it. And so, because we knew we were going in for an SBIR, we formed the company.
That was June 2023. I think I might be. Might be getting my dates mixed up. It kind of blurs. But that was essentially the impetus. Right. I came into the company, we founded the company because she had such promising data from the first thing she built. And the potential just kept growing, you know, and then it was more about.
For sbir world, you have to do the customer discovery. Is there a market for this thing? Can this really become a product? Is there a real world need?
And what blew me away during that period was the appetite and the interest from the boots on the ground. The clinicians, the nurses, the obs, the ob anesthesiologists were the people who kept looking at what we're doing and going, this is game changing. And that was again, that was just that we kept hearing, good signal. Yeah, it was going to be hard.
Yeah, there was a long way to go, but, like, this could really work.
[01:01:51] Speaker A: That's amazing.
So at that time, just before you were at Vanderbilt University Medical center, were you involved with sort of company creation or spinning out ip? I was circling at your.
Your job at the time. Was that what you were doing at Vanderbilt?
[01:02:06] Speaker D: No, I. Oh, okay. Yeah. I almost went to work with their tech transfer office. There's a good group of folks there. But I was instead recruited to build the data and research center for the next phase of the human Genome Project. It's a big research program called the all of Us research program.
And the reason I loved it was because it was sort of fitting this fascinating need within precision medicine. Because I knew, again, precision medicine was kind of my background, my career.
And if you really want to provide proactive treatment that was tailored to meet the person, then we need better data to do all the science that even makes that possible.
So the all of Us Research program had this really ambitious goal of recruiting a million or more people from across the United States to contribute their health information. And it was more than I'd ever seen done before. It was electronic health records, wearables, data survey data, genomics, other types of omics.
And all of this information would be pulled, harmonized, de identified, and made into a resource to drive forward precision medicine research on a scale that we'd never seen before.
And so I had been involved in a bunch of entrepreneurial activities. I knew kind of a group of folks that were in this space and I was, I think, hire number six for the team that was doing this at Vanderbilt.
And I remember when I was brought on, I was told I was going to be doing one thing, but I had to build everything first.
At some point you're going to be able to do this. But before we do that, here's, you know, go sit in this meeting. And I sketched out on a sheet of paper what essentially was the entire data ecosystem for this massive project.
And then I had the amazing opportunity to go build it. And so the thing that I had in that setting, which I didn't have now as a new founder, is I had money to run with from the very beginning. So we actually were starting from like a $75 million granted, and we had the world class collaborators. I mean, we got to work with people at Columbia University in New York on electronic health record harmonization and utilization. And those guys are brilliant. We got to work with the team essentially from Alphabet and Google, all the Google engineers on our back end, which spoiled me for life. So if David Blazer listens to this podcast, his team and his engineers are brilliant. And then at Vanderbilt, we had bioinformaticists. So people who just are to this day, still on the cutting edge of how do you leverage all this brilliant data and do it in a way that protects privacy?
And then also in this amazing crucible of creation here was this lens of build it with the community. So I loved that the all of Us program had this idea of participants in the study are partners, they are not research subjects, they are participants.
And to build this program correctly, you have to do authentic engagement with these communities to engage people that have never had their voice represented in this type of data set. You have to be smart and you have to Be community engaged. And so, so all of those pieces allowed me to not only essentially get a real world MBA and build up this massive organization and launch products and keep the lights on and all that, but I was also exposed to concepts that are incredibly valuable for the data driven day and age that we are in today for Medtech.
[01:06:02] Speaker A: That's amazing. So this is interesting because you weren't exactly selling paper or copiers when you decided to pursue your dream of starting a company. You had a pretty sweet gig that just hearing you describe it still gets you excited.
You got the news, you got the data, you decided to go forward. The sbir. At what point were you all in? And you're like to your earlier point, you didn't want to love two things. What point did you say? I'm all in an armored medical and I'm going to start a company. And what was that process like?
[01:06:36] Speaker D: Like, so it started with pain because that summer, so gosh, I'm trying to think of what summer this was, but the summer after we formed the company, we were going in for the sbir.
My days look like this. It was wake up before anybody in my house got up. So, you know, 4 or 5am Work for a couple of hours on this grant and on Armor as a company, get the kids up, get them ready to school, get them off to school, then work my day job all day and then finished my day job at Vanderbilt.
I was working remotely at the time, so that did help with things. And then get the kids from school, make dinner, do all the things and then put the kids to bed and then go to work again.
And so I was getting very little sleep and I was doing too much all at once and it was unsustainable and I knew it.
But what I mentioned earlier about the customer discovery being so critical to knowing that this is real signal, I mean that was it, everything I have. So this is interesting and I think it's been part of our success as a company.
We earnestly are going to solve this problem and to do that I think you have to leave your ego on the table a little bit and be willing to throw your ideas out in the world to people who are going to challenge them and be willing for them to take their red pen out and mark all over your ideas and give it back to you bleeding essentially on a sheet of paper, paper and go okay, and we can make it better. And what was fascinating is of course we had these experiences where people were like, yeah, this, this isn't going to work or this isn't going to work, but this is an excellent idea. And what if. And you know, that sort of it, even in spite of all of the obstacles that we even put in front of it to see, like, is it going to hold up? Is this actually going to hold water?
It did.
And so we knew we had something.
But the reality of I had no work life balance and trying to get work life balance was costing me my sleep because I couldn't do all of it.
I just, I talked to my husband, I talked to Trent and said what if and should I? And he said, absolutely.
And if you look at where you're at today and you don't do it, will you always regret it? And I knew the answer was yes. And so that was it. Just like, okay, let's rip the band aid off and go for it.
[01:09:19] Speaker A: That's always the best measure for me. If you imagine yourself looking back and saying, am I gonna regret it? And if the answer is yes, then, then go for it, then you're gonna go for it.
So looking at your website, Armourmedical Us, I love the layout, by the way. I love the problem tab and then the solution tab, like just very clear. I'm a very problem solution guy. So this is wonderful.
Looking at it looks like you've got a. It essentially looks like an Apple watch, a smartwatch that someone would wear.
Talk a bit about where you are with the product development and then we can sort of unpack how you see this playing out once you go commercial, which I think you're hoping to do next year, right? 2027.
[01:10:02] Speaker D: Yeah. So we're essentially hoping to get our FDA authorization next year. And so really looking at commercial early 2028 and this technology, we essentially came up with a product that is a wrist worn Apple watch like device that is connected with a patient monitoring app.
And so the first product in our pipeline is intended to be used in this inpatient setting where we know this is the highest risk window for maternal hemorrhage.
And I am intentionally focusing for this conversation on the obstetric hemorrhage application.
We know we've done some work really showing the extensibility of this technology to, to other cardiovascular monitoring needs, hemorrhage in other areas and other populations. But again, just, just for right now, I want to focus on obstetrics because that is where we're launching. That's the first application.
And the first 24 hours after you deliver your baby is where you're at highest risk. And in the United States, 98% of women are Delivering in a hospital setting.
So we knew that this again, first intended use is in this hospital setting. We've got the device that's monitoring blood flow essentially and then sharing insights with your provider through this patient monitoring app. And essentially that's trying to mimic the way that providers are already getting a lot of other patient vitals.
So you can imagine the way that today we see heart rate, blood pressure, SpO2, all on sort of these inpatient monitoring units.
We are following that same sort of workflow with what we're doing in our first device.
And now remind me, so I just wanted to kind of set the stage with this is what it is. And then. What was the second part of your question?
[01:12:01] Speaker A: The second. Well, let's talk a bit about, about. So commercially you're not, you're not commercial.
What sort of testing are you? And I did not ask this before, what kind of testing are you undergoing right now? You're looking for FDA notification next year. What is that? How do you get there? What will happen between now and then?
[01:12:19] Speaker D: Yeah, so we have already done both animal and human studies at WashU. So this was funded by NIH grants and CDC grants to both my co founders as faculty and to Armour through the SBIR program.
And we have shown in these studies the feasibility of doing real time blood loss measurement in milliliters, you know, predicting blood loss in milliliters in real time, also getting other hemodynamic parameters that inform hemorrhage risk in real time. And so we've done those feasibility studies already.
That is the basis for our work in preparation for commercial launch. Both regulatory and also getting adopted by what is historically a more conservative community of clinicians within obstetric gynecology.
So the work that we're doing is essentially, it's actually pretty complicated because the standard of care in L and D for doing real time blood loss measurements doesn't exist.
We also, because we're doing essentially weighing blood soaked pads, they're in the C section, they're suctioning out blood with a vacutainer and looking at it.
So these are very discontinuous measures and they're very hard to do accurately. So basically imagine us as this medtech startup going, you know, we want to basically vet and validate that our technology does what we say it does in this population. We want to show the accuracy of our blood loss prediction, we want to show the accuracy of our, of our hemodynamic parameter prediction.
And yet the population that we're trying to do this in there is no good gold standard.
Again, like in a healthy mom, you're not going to be doing invasive A lines to get accurate systemic vascular resistance. You're just not. They don't do that unless you're really, really high risk. And we are talking about using our device on every single patient whether or not you're deemed high risk, because we know 40% of people that weren't known as high risk end up having a hemorrhage. So we have to be measuring them.
So that being said, our team has spent a lot of time thinking about the work to gather evidence that really supports both our regulatory plan as well as being adopted into the field of obstetrics by these clinicians who are understandably a little bit risk averse and a little bit more conservative.
And so step one is we had to come up with studies that allow us to go head to head with really accurate gold standards, even if it wasn't in the setting of L and D.
So we've developed, and again, my hat's off to Christine. She was the one that came up with this a blood donor model that really allows us to go and say if we go to the most accurate blood loss measurement we can think of, which is actually weighing in real time the exact amount of blood that's being donated and compare how well our devices predicting that blood loss basis of our signal, like that is how we really understand the accuracy. So we've already done like I think about 13 patients. So she's, I say we, but I want to be clear, like this is work that Christine is leading.
[01:15:45] Speaker A: Sure.
[01:15:47] Speaker D: The next, the next year is really about the company taking the clinical grade unit, so the commercial grade device and replicating that work. Right. And so showing with our system that again, we can accurately measure blood loss, which we've done in our prior studies.
The second piece is this other hemodynamic parameters. So I mentioned systemic vascular resistance. That's a key one for us.
So we also designed another study to go head to head with another gold standard reference, which is really, you can't do it while you're in L and D because there's really again, no way to do this right now in L and D.
So that's the other piece. And then once those two are locked in, we'll be going into L and D and saying, yep, okay, we've validated that we can do accurate blood loss prediction in real time and we can accurately get these other hemodynamic parameters. Then the next challenge is going in and saying, and in the setting of L and D, here's how we compare to the existing standard of care.
And so if you look at when our device sees early signs of hemorrhage, how does that compare with the current standard of care? How much earlier? Essentially, because we believe we can detect it at least five times earlier than the standard of care, which is hugely meaningful from a clinical perspective.
[01:17:08] Speaker A: Sure.
[01:17:09] Speaker D: But then we've just got to do that and more patients to really get that nice body of evidence to support commercialization.
[01:17:18] Speaker A: So are you hearing from Strategics? I mean, I think of Stryker buying a company that uses AI to measure the blood loss by looking at the pads that are absorbing the blood. I mean, there's already a recognition that this is something that needs to be addressed and something needs to be monitored. And you're getting at it a lot earlier than that does because you can track it before the blood exits the body.
I imagine you're getting some attention from larger companies. I mean, this. You're right. Every person who has an operation, really, you could make an argument for them wearing one of these just as a safety check.
[01:17:59] Speaker D: Yeah, that's spot on.
To your point, I most often get outreach immediately from anybody in critical care.
But also, like people who see traumatic hemorrhage in settings outside of obstetrics, we see a lot of interest from anesthesia. So this is from the clinician perspective. Then I'll get to Strategics.
So anesthesiologists are really excited because we're essentially directly measuring peripheral perfusion. And at its core, anesthesia is perfusion and compensation. And right now they use blood pressure as a proxy, oftentimes which is a delayed indicator.
[01:18:36] Speaker A: So.
[01:18:36] Speaker D: So got on a lot of excitement from that community. And then post surgical monitoring. My neighbor next door, he had a hemorrhage scare after a colonoscopy where he'd had a polyp resected.
And in the middle of the night, he's home post surgery. And of course, he didn't realize he was bleeding internally until it was an emergency. And thank God they got him to the hospital and he's okay now.
But, you know, I look at that, and that's another thing. It's like, gosh, if we could send our device home with it, right, and we could pick up on these signals. It's this moment of right now we're guessing, but in the future we'll know because we'll have the data to drive that decision proactively. So we're not going to wait until it's a near miss.
[01:19:21] Speaker A: Right.
[01:19:22] Speaker D: So, yeah, that's the sort of moment where, yes, we see it, we see the potential here in these other places.
Accordingly, we are absolutely getting interest from strategics and, and they fall into a couple of different categories, I'll say. One category is somebody who may already be in this space, this obstetric space, and they perhaps even have devices that are useful in the treatment of early stage hemorrhage. But it's really hard to detect early stage hemorrhage.
And so because our device allows you to do that, we essentially help them deploy more of their product at early stages and improve patient outcomes as a result. So there's that group of folks who we've been talking with for a while and that's really when we think about our job as a startup. We have to do what we say we're going to do, right. And demonstrate a utility in that particular application.
I would say more recently, especially as some of our newer research is ongoing as we'll be publishing more results that kind of show the breadth of things that we can look at that we're seeing folks in the advanced patient monitoring space become interested.
And again, we're essentially the first wearable laser speckle technology. There's a lot of advantages over pulse ox.
We're able to measure different hemodynamic parameters than right now most patient monitoring suites can do. So we're starting some of those conversations, met with some really awesome teams frankly that are interested in where this is going.
So that's kind of the second piece, the second class of strategics, I would say. And then you do have kind of the third piece here, which is right now, my Garmin, my Apple watch can't do what we do. You have to have different hardware than is typically baked into these devices.
But as is the way with all hardware and electronics, right, things are getting smaller, things are getting faster.
So it's very realistic to say in the next couple of years you could take what we do and put it in more consumer like technologies as well.
And in doing so, once again you're opening up a new really rich data stream that is very information rich when it comes to very clinically useful information. And so that's like a third group there that I'd highlight.
[01:22:02] Speaker A: That's remarkable. I mean, just as you're talking, I'm thinking of people on blood thinners. I'm thinking of. There's just, there's a whole, there's something really, I see this as. And it is a version of stroke. It's something very primal about the hemorrhaging it's just the horror of it. I've, you know, I hear your story. I was clearly affected. I've got a very good friend who, while she was delivering her, her son told me her story and I think, I'm sure I turned white just hearing it. It just, there's a, there's just a terror of it. So it's hard to believe that. And then of course, like I said, long term father in law has done blood thinners and they're always checking for bruises and things. I mean, there's just, this seems to be.
I can't imagine they're not. I can't envision a subset of healthcare, be it the patient, the clinicians, the payers. I can't see anybody not thinking this is a great idea and something that isn't made available to people is irresponsible. And I don't typically talk like this about technology, so it's really remarkable.
[01:23:13] Speaker D: Thank you.
[01:23:13] Speaker A: And that's not a question, it's just a statement.
So what's the question? I guess for me, and this has been a great conversation, what's next for you in terms of fundraising and things like that? What are you looking to next to make sure that this vision becomes a reality?
[01:23:30] Speaker D: Oh. Oh my goodness. I'm really excited about this year, frankly, after our MedTech Innovator win. That was amazing. That was such a launch point for us.
I cannot tell you how incredible it was. It was also completely overwhelming as a founder and a small team. The amount of interest and everything that we got after that, I mean, it was just incredible.
But frankly, at the beginning of the year, we dug in as a team and we looked at all of our assumptions on our path to market. What was the product work we have to do, what is the regulatory work we do, what clinical work we have to do.
And I'm so proud of my team because I feel like we have a crystal clear vision of what we're going to achieve with the capital we currently have on hand.
And we are about to open up our next round and that round is essentially gonna get us through our clinical studies in preparation for our FDA submission.
And so that's really the what's next. We've had a lot of fun because I've got part of my team really launching into that clinical unit development. And so we've actually taken the early prototype and made decisions that are, are better for us from a commercial perspective and have yielded a better device. Like the stuff we get to use right now in the commercial grade device.
Is actually causing us to geek out internally on some of the things that we're seeing.
So that's been really cool.
The other thing that we are doing, and I have a brilliant team.
So Amy Smith and Chuck Adams, Jennifer Howard, they're working with me on the commercialization piece and we've done a ton of work on path to payment and how are we going to bridge to reimbursement and who are good customers. And I'm so excited to see that work because essentially we've mapped out who we think would be excellent early adopters, and we're now looking at who are we bringing into these pre FDA studies with the intent of them becoming pilot customers and then early adopters and real advocates for us in the future.
And that work is going beautifully. So I'm really excited. Again, if you haven't been able to tell in this conversation, I'm a total data nerd and I could talk at ad nauseam. I won't. But about the way that we're using real data to drive that commercialization piece, it is so cool. It is so much fun. And I even built, like a widget, a whole website for us to do an entire landscape analysis of every hospital system in the United States. And like, color, I mean, it's just so cool, right? So I love that stuff.
[01:26:35] Speaker A: And then people can see you beaming right now. You just have the.
[01:26:38] Speaker D: I just. I love this. I love when you. I love when data brings insight, when you can really take it and it becomes clarity and vision. And I feel like that's what we've achieved over, you know, the last couple of months. And the other thing that it's been beautiful.
I'm very honored to work with clinicians. So we've got Dr. Keisha Callens, Dr. Ross McQuivy, who have fairly complimentary expertise here. So Ross comes from MedTech, so he used to be CMO at Labori, and he's just got this brilliant. He was an obstetrician, an OB GYN that went into Medtech. So he gets Strategics, he gets that piece of Kesha. Dr. Callens is amazing. She is the boots on the ground when you hear about maternity care deserts where we have, like, people that have to drive hours to go see an ob.
She is the person. She's that OB in the state of Georgia that like, goes out to meet people. Right? She's the one serving all of these underserved communities.
Huge advocate for maternal health. Absolutely brilliant person and a lovely human being. So we've been working together on that clinical strategy. And in my mind, if I can paint a picture of like threads weaving together, that is the way this moment feels for our company.
And so that plan having become tighter and tighter and tighter and really flowing forward, we know what we're going to do with our next capital infusion. We are raising that $5 million round. I can see where it's going to get us and it's positioning us for that commercial inflection point, which is really, I'm just excited about the work we're doing. So I know I'm rambling a bit, but if you can't tell, I think 2026 is going to be a fun year for us.
[01:28:33] Speaker A: That's great. And just circling back to the pain you felt a few years ago when you were putting the business plan together and raising two kids and working a full time job, I'm guessing it was worth it.
[01:28:45] Speaker D: Yes, beyond any doubt. I mean, I love my job. I love my job. It is brutal. It is hard. It is.
I have been, you know, I've had the gut punches along the way. It has been so difficult and infinitely rewarding. And the reason it's rewarding is because of the people I get to work and the impact we're poised to make.
Not a moment that I tell our story goes past that. Somebody doesn't walk up to me and share a deeply personal hey, and this happened to my sister or my wife or.
And yeah, I'm getting chill bumps. Like that is the why. Right? That's why we do this. And that's why I love my job.
[01:29:39] Speaker A: We'll end it right there. This has been a fantastic story. Thank you for being generous with your experiences and for helping to make this technology hopefully become a reality very soon. It feels very important. So thanks so much, Kelsey.
[01:29:54] Speaker D: Thank you so much, Tom. This has been wonderful.
[01:29:59] Speaker A: Well, that is a wrap. Thanks so much for joining us on this episode of Device Talks Weekly. I hope you'll join us at Device Talks Minnesota on May 4th. Go to minnesota.devicetalks.com to register.
Please do subscribe to this Device Talks podcast, Device Talks Weekly podcast, or our Device Talks podcast network so you don't miss a future episode from any of our great podcasts. And of course, as always, we would love you to connect with us on LinkedIn, connect with me, connect with Chris Newmarker, connect with Kayleen Brown, and of course, follow Mass Device and device talks on LinkedIn.
And that's it. That's a wrap. Thanks again. This is Tom Salemi of Device Talks. Thank you for joining us on this episode of the Device Talks weekly podcast.
