Episode Transcript
[00:00:00] Speaker A: Hey, everyone. Tom Salemi here. Welcome back to the Device Talks, a weekly podcast. I had a great time at JPMorgan. Thanks to everyone who said hello and answered my dumb questions. Look forward to asking more dumb questions through 2026.
I'd like you all to join us on February 3rd, 4th and 5th as part of our Device Talks Cardiac Innovations Week. This is one of our Device Talks Tuesday's virtual series. We'll be talking with three great companies in the Cardiac Innovation space in Cardia Field Medical and Val Care Medical. Each of them have very different approaches to treating people with sick hearts and very happy to have them as part of our week. You can join us live and you can ask questions of your own. Kaylene Brown and or I will be leading those discussions. Or you can watch On Demand when it's convenient for you. So go to devicetalks.com to find out more information about Cardiac Innovations. Weekly registration is also open for Device Talks Minnesota and Device Talks Boston. We've got great keynotes lined up for both. You can find them at devicetalks.com or if you want to go directly to minnesota.devicetalks.com for the Minnesota site and boston.devicetalks.com for the Boston site. Very easy to find both. All right, folks, without any further delay, let's get this podcast started.
All right, you ready for this?
[00:01:31] Speaker B: Ready.
[00:01:51] Speaker A: Chris Newmarker. How are you, sir?
[00:01:54] Speaker B: Doing well, Tom. Doing well.
Finally, trash pickup. The other day was the last chance to get the Christmas tree out, so.
[00:02:02] Speaker A: Finally got the Chris Newer CMI to Chris Newmarker. I think we don't.
We didn't clear this in the morning notes about the podcast. What are we going to talk about first? Trash pickup.
I just visited the biggest MedTech Healthcare event of the year and you start up a trash pickup.
[00:02:20] Speaker B: I hold out a lot of garbage.
[00:02:25] Speaker A: Really happy to hear it. Anyway, I was at JP Morgan while you were all, you want to talk about that a little bit?
[00:02:32] Speaker B: Let's talk about that. Yeah, we don't need to talk about it.
I mean, yeah, yeah, J.P. morgan.
[00:02:39] Speaker A: Oh, yeah, that was. That must have been nice, too.
So JP Morgan was great as always.
I'm tired this morning, man. It's like we. I got in late last night.
[00:02:48] Speaker B: Like, come on, man.
[00:02:50] Speaker A: Just like there are some moments where you're, like, looking at your socks and wondering, do I really need to put on socks today?
I don't want to put the effort into putting on these socks. Maybe I'll just go sockless, but.
So I put on the socks but great event, just great meetings, lots of meetings with very interesting, fascinating companies, people who have at device talks. Boston met a lot of Great folks at MedTech Innovators, Innovator Reception on Monday.
So no, great, great overall event and thanks to the fine folks at Isono Health for having me at their next Horizon Summit, which was on Wednesday night. I got to emcee that had Scott Gottlieb and others speaking and presenting. So it was a great, great week and, and a big news week. Chris Newmarker. Tons of news.
[00:03:41] Speaker B: Absolutely. And I mean, and you know, we were covering a lot of the news out of JPM from afar, but a number of our newsmaker based off news that came out of that conference. So I mean, just, I mean I could feel the buzz all the way from Minneapolis, like, you know, what was going on in San Francisco. So it was fantastic.
[00:04:00] Speaker A: Well, I mean, it's no surprise that one of them is going to be Boston Scientific's acquisition of Penumbra. I don't think I'm spoiling anything, but it was just.
[00:04:09] Speaker B: What? Wait, what? Oh my gosh, 14 billion? No way.
[00:04:13] Speaker A: It was interesting to me that it came out on Thursday. I'm like, I wonder why now I'm just in my head because typically you drop that bomb on Monday and that would be like anyone would talk about.
[00:04:22] Speaker B: All week that's wondering this Thursday.
[00:04:24] Speaker A: So you're like, was it strategic? Did they want to kind of mix the formula up a bit or did the papers just not get signed until. I'm guessing it's the latter. I don't think it was. We need to announce this on Thursday and not Monday because that's three days of holding something big like that.
[00:04:40] Speaker B: Was Mahoney having one more. I mean, I totally don't know anything, but was Mahoney maybe having a last minute meeting at the conference perhaps before they sealed the deal finally?
[00:04:49] Speaker A: I don't know.
Yeah, I don't know. Obviously I'm not an investment banker. I imagine everything was all the, everything was in line. They were just dotting I's and crossing T's. Is that right? Yes. Dotting I's and crossing T's.
[00:05:00] Speaker B: I always got that wrong. Crossing T's and yeah, having it out on Thursday with like that like mic drop right at the end.
[00:05:05] Speaker A: But it was. Yeah, but you know what? It was good timing. Like you're kind of like, oh, it's been quiet, been quiet. Then like, boom. It really just kind of as people were leaving.
So anyway, we'll get into that.
[00:05:16] Speaker B: I have More big news from Boston Scientific today that we will get to as well.
[00:05:20] Speaker A: They are.
They're really setting the tone for sure. They did a couple years ago with the Axonics acquisition and they had another acquisition. I don't want to get a newsmaker. All right, let's get into it. There's too much to talk about. Let's get into it.
[00:05:33] Speaker B: The new Markers newsmaker. Right. They don't need to hear us just chatting around.
[00:05:35] Speaker A: Let's get anything else people need to know about your trash pickup, people. You good?
[00:05:40] Speaker B: I'm good, I'm good. Tom, this was the last chance, I think, for people to leave their Christmas trees out. That was why I was.
[00:05:47] Speaker A: Well, I hope people listening to this podcast have put their trees out so they're not realizing that they missed their opportunity.
[00:05:52] Speaker B: Yes, the new market Christmas trees outside the house is Unchristmas now. So we're in the new year, off we go. And all this news.
[00:06:01] Speaker A: That always feels good.
[00:06:02] Speaker B: It does, it does.
But number five on the list, we've got Distal Motion.
You know, they secured funding from Johnson and Johnson that's going to support the rollout of their Dexter surgical robotic system in the ambulatory surgery centers.
[00:06:20] Speaker A: Yeah, I posted about this on LinkedIn. I love. I love JJ using its financial might to kind of place a lot of bets and get a lot and collect a lot of intelligence on the surgical robotics market. I mean, clearly Dexter is not going to conflict with otava and it does give JJ sort of insights in the market.
They did their deal with Renovo, which is a larger kind of modular surgical, larger hospital, hospital focused surgical robotic system.
Again, Distal Motion is more ASC focused. So they're really hedging their bets, I think.
And as Tim Schmidt said@device Dr. West, we're learners. We're doing this to learn.
So great move by JJDC.
[00:07:07] Speaker B: Yeah, ASCs are just like this really fast growing sector of healthcare and not really where you see a lot of really see da Vinci robots. I mean, they're more of a hospital thing because they just have such a large footprint. So, you know, so, yeah, this is. I mean, you know, maybe with the Tava, you know, Johnson Johnson's taking intuitive more like head on. This is like a nice play to kind of like, you know, like grow in a potentially in a peripheral area or at least learn how to grow like, you know, through this investment in distal motion. So, yeah, really interesting story.
[00:07:40] Speaker A: Definitely. Things are starting to formulate on the surgical robotics market. So great. Number five, let's move on to super Exciting space number four, that could have been a number one any week. And I think I'm gonna say that with every episode.
[00:07:50] Speaker B: Yes. I mean, there's so many stories.
Yeah, there's so much going on right now. I mean, next one. I mean, this one could have been a number one in a particular week. We had Edwards Life Sciences, I mean, they've given up on the $1.2 billion genevalve acquisition, especially cause the FTC had a legal win in which a federal jet in D.C.
granted preliminary injunction. And that seems to have been the moment where Edwards decided to give up the fight for this deal.
The FTC saying that there could be antitrust concerns in the TAVR space if Edwards acquired genevalve. But my big question now is what's next?
What's gonna happen next? I've seen some interesting speculation on LinkedIn, including from MedTech, Domus, Joe Mulling's on Joe's Joestre Damas sorry. Yeah, Joe Stradavus had a whole business plan for somebody to potentially acquire. This is why you should acquire Geneva. I was like, this is great.
[00:08:52] Speaker A: Joe's already got it, got it all mapped out. No. And you know, Dene Valve has put it out there that they're for sale. And you have to think that all these other companies that saw the Edwards acquisition saw why it was happening and realized, oh, maybe we should have done that. And now they can. Now they have their second chance. So I suspect who was the one that got away.
[00:09:13] Speaker B: They've got the chance now. And also kind of interesting, since Edwards couldn't acquire genevalver, they gotta make a play somewhere else, like acquire somebody else who's got something innovative that maybe not as worrisome for the ftc. So yeah, we'll keep on following this. I don't think this is the end of this story.
[00:09:31] Speaker A: I am not an attorney in any means and I don't understand these issues at all. But you know, how does Edwards move forward knowing that any sizable acquisition could bring in this sort of regulatory scrutiny?
Certainly, I'm guessing they're kind of going back or already gone back to the drawing board a bit and sort of trying to figure out, well, what, you know, what is this too big a deal? Like, do we only do small tuck ins now?
Maybe one of our listeners has a sense of the what's and whys and they want to comment on our LinkedIn post or something.
[00:10:05] Speaker B: If you're going to do a big deal, do you maybe acquire something else minimally and base that compliments amounts, your portfolio in Some way do you move.
[00:10:13] Speaker A: Away from TAVR into a completely different area instead and build up that. So I don't know. Interesting time.
[00:10:20] Speaker B: Interesting time.
[00:10:21] Speaker A: Couldn't have been a number one any other week.
[00:10:23] Speaker B: This is an awesome time to be covering medtech.
[00:10:25] Speaker A: Yes. So, and let's see, the first article was by Sean Hooley and Sean Hooley. Number four was by Sean Hooley. Number three, Chris Newmarker.
[00:10:35] Speaker B: Well, number three is by a freelancer that we've brought on to help ourselves out, help us on, on Mass Device this week, Skylar Rivera. And Skylar. Yeah, yeah, exactly. She's based outside Los Angeles. And this was just a really, really good story that Skylar wrote off of Intuitive's JP Morgan talk From afar.
This, I mean, it was really interesting that, I mean, you know, they had preliminary results at the same time, I mean, they were saying that, you know, they're, you know, exceeded 25 expectations. You know, looking at, you know, a, you know, at a 21% increase in revenue over the past year, that's just mind, mind boggling. And a lot of this is driven by their next gen DaVinci 5 robot. But I loved how Skyler kind of zeroed in on how CEO Dave Rosa, that was like, like his real excitement seems to have been talking about the Ion robotic, you know, bronchoscopy system and like what, what they could do with that.
[00:11:41] Speaker A: Ion is very cool. Yeah. And it's funny reading Skyler's article now, I see it was a bit jarring for me to read Intuitive CEO Dave Rosa. Like I just was waiting to see Gary Guthard. And I know Dave Rosa has been CEO for a while, but like this, I think this is the first time I've read Intuitive CEO Dave Rosa. So it was interesting to say.
But yeah, no, the Ion is a fascinating piece of architecture. And between that and Monarch and Noah Surgical, I mean, the lung space is just getting such a great deal of attention. I think it's really critical that it does. I mean, this is something that needs to be, it's obviously a critical part of our bodies.
[00:12:21] Speaker B: Rosa said it straight up. He said the North Star that we have with Ion is to improve survivability of lung cancer.
Right now it's used for biopsies, but it could be used for more to perhaps get in there in a blade.
You know, this, this cancer after you find it so very exciting.
[00:12:44] Speaker A: All right, Chris Newmarker, you got any other young, another young buck writing number two in the Newmarkers Newsmakers.
[00:12:50] Speaker B: Oh, yeah. You know, I think this person's really going to go far.
[00:12:53] Speaker C: Chris Newmarker.
[00:12:55] Speaker B: Chris Newmark or Persona.
[00:12:56] Speaker A: That joke never gets old, right folks?
[00:12:58] Speaker D: That's right.
[00:12:59] Speaker B: I'm the cub, cub, cub editor, cub reporter here on the Sting.
You know, I checked out Medtronic's JPM talk from R and the big news that stuck out to me in that talk was Medtronic saying it's really ready to go shopping again. Really ready to step up its tuck in M and A. The company's CFO even saying that they have significant firepower to boost their M and A. So I mean, that's just good news for a lot of young medical device companies that the world's largest medtech is going to be. It's going to be shopping.
[00:13:40] Speaker A: That's great news. Yeah, no, folks have been waiting and wanting Medtronic to get back into the game a bit more with M and A. So I was definitely happy to read that, especially this week at J.P. morgan, which was pretty quiet until the aforementioned Penumbra deal. But even the Penumbra deal, it's more of a merger of giants as opposed to a really kind of Axonics morale boosting acquisition of. Well, even that was publicly traded too. But that was a smaller company. But you know what I mean, people want to see big companies buy small companies.
So yeah, Medtronics news definitely resonated throughout the cocktail receptions at J.P. morgan.
[00:14:15] Speaker B: Yeah, there's only so many big medical device companies out there and I mean we have seen an uptick in IPOs, but I mean for many growing medtech companies, that's their exit. They're going to get acquired by somebody.
[00:14:27] Speaker A: Oh, absolutely.
[00:14:28] Speaker B: Yeah. So this is really good news for those types of companies and it's going to be. Yeah, it's going to be exciting to see who Medtronic acquires.
[00:14:36] Speaker A: Definitely. All right, let's roll into this massive number one. We've got multi part number one.
[00:14:43] Speaker B: Yeah, I mean just a ton of Boston Scientific news this week just to start out. I mean, the Boston Scientific winning an FDA approval for its fair point pulsed field ablation catheter that goes with its extremely popular FariPulse PFA system. So that's a big win for them. I mean, a lot of weeks that might have been the top news, but not this week.
I mean, next up, we got news this week that bias Boston Scientific plans to acquire Valencia Technologies for undisclosed closed amount. I mean this looks like a tuck in acquisition, but they've got solutions for treating bladder dysfunction. So some more big news then. But then you had, you know, the new. Just, you know, not one acquisition this week, but two. And the two is just a whopper.
Boston Scientific, I mean, you know, planning to spend more than $14 billion to acquire Penumbra.
[00:15:47] Speaker A: No huge deal, you know, in just two companies that I really like, two CEOs that I really like seem like a natural fit.
And as a observer of the industry, I'm excited to see Boston Scientific kind of go up against Stryker, which ironically has Boston Scientific's old neurovascular program to battle for leadership in this space. As I said in my LinkedIn post, either of those companies wants to be number two.
So it sure will be a competitive market, which I think is good for patients, I think it's good for investors, I think it's good for entrepreneurs when you have two hungry companies trying to build dominant practices in the neurovascular space. And once again, going back to the patient, we need more help with strokes, with treating people who have had strokes.
So I think this is just fantastic news.
[00:16:43] Speaker B: Yeah, it is fantastic news and just really exciting to see. I mean, Boston Scientific has just been on a real spree, really growing the company, really just expanding their portfolio so much with all these goals. They have to kind of disrupt the whole surgery space with all these minimally invasive procedures. So, I mean, like, just really awesome to see them making this, this next acquisition. But then, you know, just today, Tom, I, I had a, had, had an article today. There was a little old planning commission meeting.
[00:17:18] Speaker A: We gotta go, Chris. Sorry. Let's wrap up the new.
[00:17:20] Speaker B: You know, it's. Yeah, you know, it's just a planning commission story, Tom. That's. It's just a planning commission story.
[00:17:27] Speaker A: Go ahead.
[00:17:28] Speaker B: The Maple Grove, Minnesota Planning Commission, where Boston Scientific is now the Battlestar Galactica of a facility that they recently opened in Maple Grove, Minnesota. Like 400,000 square feet.
They now want to nearly double it. They want to add another 300,000 square feet to this. So just going to be a massive Boston Scientific presence along Interstate 94 in the northwest part of the Twin Cities, Metro.
Not too far from Medtronic headquarters either.
[00:17:56] Speaker A: First of all, I believe it was an Imperial Star Destroyer, not a Battlestar Galactica that we compared it to. But let's not go down too deep down that rabbit hole.
[00:18:05] Speaker B: What about Babylon 5?
[00:18:07] Speaker A: I've never been a big Babylon 5.
[00:18:10] Speaker B: It was like the United nations of space. But anyway, go on, John.
[00:18:14] Speaker A: As long as the name Boston is on the sign of that big building, then I'll take it.
[00:18:18] Speaker C: There you go.
[00:18:20] Speaker A: Boston Scientific's gonna have to put all these businesses somewhere, I guess, right?
[00:18:23] Speaker B: So, yeah, like, have I mentioned that the Boston Scientific has more employees around?
[00:18:28] Speaker A: Yeah.
[00:18:29] Speaker B: You've Twin Cities than Boston.
[00:18:35] Speaker A: All right, Chris Newmark.
[00:18:36] Speaker B: It's a good, I mean, you know, I have to say, I mean, Boston had a big, big win with transmedics. They're going to be like, expanding into a huge new headquarters near the city in Boston. So, so, like, there you go. Boston got a good win and now Minnesota has a good win. So that's, that's good. Rising. A rising tide lifts all ship.
[00:18:57] Speaker A: All the medtech ships are rising and that's all we're trying to do here at Device Talk. So. All right, Chris Newmarker, Great stuff.
[00:19:03] Speaker B: Great as always, man.
[00:19:04] Speaker A: All right, thanks, Chris Neubarker. Now it's time for our FOMO interview. I spoke with Dr. Steven Michelson. He's the founder of Field Medical.
He also was one of the founders of Faripulse, which of course is a pioneer in the pulsed field ablation space. You can find out a little bit more about where Field Medical is headed here in this interview, but I also invite you to join us on our Cardiac Innovations series. Steve and I will be talking on February 4th. You can check it out. It'll be a live conversation. Steve will give a presentation. You can also ask your questions if you're watching live. It will also be available on demand, so go to devicetalks.com to register for that. Once again, we've got three different episodes. We'll be speaking on February 3rd, 4th and 5th. I'll have a conversation with Steve Michelson on February 4th. You can register for one. Register for them all. You can watch them live. You can watch them on demand. All right, now let's hear my conversation with Steve Michelson. We conducted this at Device Talks West.
Hi, everyone. This is Tom Salemi. Welcome to the future of Medtech opportunities. I'm talking with, I think, one of the folks who's going to be shaping that future directly, Dr. Steve Michelstein. He's chief technology officer and founder of Field Medical, of course, founder of Faripulse as well. And we can, we've talked about, I think, PFA a great deal, but now we're talking about the ventricular side of the heart. And I hope I just said that correctly, because as it came out, it didn't sound right. But you've, now you're, you're, you've, you're at Field Medical. You're, you're directing, I think Some of the lessons you learned from, from faripels to the ventricular side of the heart, what is particularly tricky or sort of undiscovered about that side of the heart?
[00:20:55] Speaker D: Well, so the atria is relatively thin, you know, and the, you know, and the big transformation that just happened is treating an arrhythmia called atrial fibrillation. And in order to do that, you create these therapeutic scars that are full thickness in order to kind of shape the way the electricity moves in the heart.
And it's been very successful. The atria doesn't move very much and it's relatively smooth compared to the ventricle, which every time the heart contracts is moving a whole lot centimeters. And so getting stability there is hard.
The ventricle is very complex internal geometry. It's not smooth. It has these things called trabeculation. And so it's got complex shapes inside. And so it's really hard to again get stability or get to the right spot. And most importantly, the ventricle is really thick. And so to get a full thickness ablation when it's needed that depth, almost no technology does it. And so, you know, if you have.
[00:21:54] Speaker A: Something, if you're diagnosed with something on the ventricular side of your heart, I'm sorry, but we really can't do much to help. Yeah, that's the other.
[00:22:02] Speaker D: So open heart surgery used to be the drugs.
A couple of trials just came out that showed the drugs don't work very well. We kind of knew that.
But most people get is an icd, an implantable cardioverted defibrillator that has wires. It can sense when you go into a deadly arrhythmia in the ventricle and shock you out, but it doesn't prevent it from happening.
[00:22:22] Speaker A: Okay.
[00:22:22] Speaker D: And so catheter ablation has been done in the ventricle, but using tools that were really designed for the atria. And so these procedures take four hours or longer and success is good, much better than drugs. But, you know, it's a complex procedure and generally people who get ablation have to go to referral centers where people are willing to take the time. It's very much like afib ablation was a decade ago.
[00:22:48] Speaker A: Okay.
[00:22:49] Speaker D: So I saw that as the frontier and field medical has been focused there. And three years after founding the company, we finally got our first publication showing how well a built for purpose technology can work in that environment.
[00:23:08] Speaker A: So what were the. We're talking about this at device talks west or mid October. You just announced the results. I think Friday, yes, last week. Talk a bit about the results. What did they show? Why you guys were really, really psyched about it.
[00:23:20] Speaker D: Yeah, very exciting. Well, first of all, this is, you know, there's a lot of people working in the ATRIA now with pulse field. But you know, we, this is the first real publication of a, of a, of a prospective trial of a technology in the ventricle.
So it was picked up by circulation, Vivek Reddy and all the physicians who were involved in that are very proud that we were able to show a 98% reduction in VT burden. So if you have an ICD prior to getting the ablation, we would count how many times you're having these deadly arrhythmias and getting therapy and then after the ablation how many arrhythmias we were having. And it was a dramatic drop.
[00:23:58] Speaker A: That's huge.
[00:23:59] Speaker D: Number two, just freedom from, from any VT altogether was an 82% success rate, which is dramatic and it's very good to see small sample, very exciting results, six month results. So all the caveats need to be there. But you know, this is really one of the most important studies I think, you know, showing the next step forward where we can really reduce the period of time that it takes to do a VT ablation from four hours maybe to an hour and turn it into a safer procedure for people who are otherwise very sick.
[00:24:33] Speaker A: And does it also enable interventionalists who were previously able to do that procedure to be able to do that procedure? Was is it less tricky? Less, less.
[00:24:42] Speaker D: Well, the energy, you know, so, you know, there's three steps. What a. EP doctor does they, they diagnose, figure out where the problem is, where the circuit is or where it's coming from. So, you know, they, they map it, they diagnose it, then they localize it and navigate to it with technology, minimally invasively. We do catheters, we put the catheter next to the problem and then we deliver energy. And in the past the delivery of energy has been super problematic, just not effective. And so you spend a lot of time in the chamber trying to get effective energy delivery. And now I think we have successfully found a way to do, to take that step and really compress it. And so yes, I see a future where we can have where general electrophysiologists who currently know how to use focal catheters, which is all of them, will start routinely offering VT ablation.
[00:25:38] Speaker A: And you were saying prior to our recording that with Faripulse, I feel like you had a head start, you had A lot of, a lot of companies followed behind, and now we have a lot of offerings of pfa. Sounds like on the verticular side, the competition, quote, unquote, is lining up more quickly. Others are showing interest in the space. Yeah, who is that? And do you see that as a positive? I would have to think it's positive.
[00:26:01] Speaker D: As a doctor, it's an incredible positive. Like, this means that we're not the only people trying to solve this problem.
As a businessman, it's, you know, other than the frustration of, like, this was my blue ocean and now people are like, jumped in the pool.
[00:26:17] Speaker A: That's right.
Got all these fishing.
[00:26:18] Speaker D: Other than that, like, the reality is it also, you know, it supports the, you know, the business proposition, which is there is value, that is a growth opportunity in the ventricle, and we are all going after it. And so it's not a small market, it's half the size of afib, but it's a very significant market with growth opportunity. And so I think we're not alone anymore. We got Medtronic coming after us. We got Boston doing trials in the ventricle now, and we got Abbott doing trials in Ventricle. Maybe I may be Johnson Johnson, but because, you know, I know a little bit about some of the tools they're playing with.
None of them are as good as ours, obviously.
None of them.
[00:27:01] Speaker A: Fantastic. Well, this sounds like a bright future for medical.
Thanks, Tom. Thanks so much. All right.
All right, once again, go to device talks.com if you want to find out more about field medical and ask questions of your own.
Now it is time for our keynote conversation. I had a chance to speak with Rob Binney. He's the CEO of Shiratronics. And we'll talk about how neuro energy is being used or neurostimulation is being used to help people who suffer from crippling migraines. Let's listen.
Well, Rob Binnie, welcome to the podcast.
[00:27:43] Speaker C: Hey, thanks so much, Tom. Great to be here and thank you for taking the time and allowing us to tell our story a little bit more.
[00:27:49] Speaker A: Oh, my pleasure. No, this is an important area. Migraine is something I fortunately have not had to experience, but I have great sympathies for those who do and love to see medtech step up and try to solve a real problem for folks. Before we get into that potential solution, though, we'd love to learn about your path into medtech.
You have a distinguished medtech career, but it sounds like, looks like from your. Your LinkedIn profile, you had a misstep early on you went into pharma first. Was that, was that your path into, into life sciences?
[00:28:22] Speaker C: Indeed it was.
And candidly, coming out of college, I was a, you know, a typical 24 year old, like, what am I going to do with my life? We were going through a, a bit of a coming out of a recession back in those days. And, and I remember very, you know, very, in a very elementary way going, I need to be involved with an industry that is recession proof.
I landed in healthcare. I was like, the generations are getting older, there's gonna be a need for healthcare. And that's where I ended up making the choice to join a pharmaceutical company back in the 90s.
[00:29:02] Speaker A: And then you turned to the light side and joined Boston Scientific. How'd you make that transition to MedTech?
[00:29:10] Speaker C: Yeah, interestingly, you know, I was on the pharmaceutical career path for the better part of the 90s and I actually, believe it or not, went through three mergers during that time span of around six years. Remember, it was in the 90s, it was a lot of M and A activity going on.
And one of my dear friends ended up leaving my team actually and joined Boston Scientific and just, you know, had been talking to me a little bit about the speed with which technology was transforming patient outcomes. Innovation was happening at a much more rapid clip and I just became enamored with the potential for medical technology in the treatment of patients and improvement of outcomes. And that's how I ultimately followed him into Boston Psi and that began my medical technology career.
[00:30:03] Speaker A: How do you compare and contrast the sales of pharma versus medical devices? Is it the same storyline? Very different.
[00:30:12] Speaker C: Very, very different.
You know, when I think about the business models associated with pharma from a commercial standpoint, and again, remember, my experience is dated, it takes me back to the 90s. But you know, that experience, that business model was very focused on, you know, this idea of repetition. So being out in front of providers with regularity and providing them with, you know, similar sort of messages and you know, VAT features, benefits.
And again, it wasn't as what I would call kind of value selling per se, which is where I believe MedTech really differentiates itself, whereby your presence, hopefully if you're doing your job right, is value creating. Whether that's your ability to support cases or help in the partnering of doing direct to patient types of initiatives or practice building, et cetera. There's just a number of different opportunities to, to bring value.
And I found that to be very refreshing with MedTech. In addition to the fact that the way that your performance is rewarded in Medtech is a lot different than it is in pharmaceuticals.
Your results are very tangible and you're rewarded for them. And subsequently you're performance managed for not performing. And I kind of thrive in that environment.
[00:31:43] Speaker A: That's an interesting point. It's one I've heard of recently, the last couple weeks. So it certainly holds up. And it's a great point about pharma too. Like pharma, you're selling a pill, but you're basically just putting another quarter in an existing machine. Where Medtech you're really saying, no, the machine could work better if you did this or if you use that.
[00:32:00] Speaker C: And the speed with which you are introducing new products, new therapies, et cetera in medtech is just a whole different cadence than the experience in pharma.
[00:32:12] Speaker A: We're glad you found your way over here. You moved over to Access Closure and then spent time at Intersect ENT where you were chief Commercial officer the last couple years, working up through sales.
That's a great company, Great medtech company. How did you come to find your way to Intersect ent?
[00:32:29] Speaker C: Yeah, so I actually spent well, I guess it was around four and a half years at Access Closure. One of my mentors is to this day is Leslie Trigg, Fred Kashravi, and two great ones I had, I that they were really helped me cut my teeth with regard to the sort of Silicon Valley med tech startup experience. I, you know, coming from Boston, it was, it was new, it's a new language, it's, it's a. You talk about pace, it's a whole new pace, you know, a chance to really stretch your skill sets.
But actually I ended up meeting Lisa Earnhardt, another mentor of mine, who's now obviously at Abbott through Lesley, when my time was coming to a close at Access Closure and spent time while I was still at Access Closure, visiting with Lisa, hearing her vision for Intersect D and T and just felt like there was a real match there. Not only because I think Lisa's a phenomenal leader, but I was really impressed by the differentiation, you know, that Intersect had as it relates to the clinical data and clinical evidence.
I love Lisa's leadership and the team she had put together. And I just saw a real opportunity to build, you know, a world renowned team and put together a great growth story of which in retrospect, that, you know, sometimes the intuition's right and I think it was in my case when I chose to Intersect.
[00:34:00] Speaker A: That's great. You just mentioned three of my favorite folks in MedTech really amazing leaders.
And I wonder at this point, when you're at intersect ent again, you're chief commercial officer in 2019, did you see yourself as a CEO? Leslie would move on outset, Lisa would move on to Abbott. Fred Khasravi, of course, is now an imperative and had been at Access Closure.
Did you have that bug at that point?
[00:34:25] Speaker C: You know, it's funny. And it all will come full circle to my mentors.
When I was, I had getting a number of different opportunities come across my desk. You know, Intersect was on everybody's radar. We'd had a successful IPO, we built around $120 million annual revenue line built again, a best in class MedTech team. And so opportunities naturally were coming across my desk.
And I didn't give it a lot of thought as it relates to your point, the president and CEO role until such time as Alidia came across my desk. And I actually, you know, because I don't, I try not to make impulsive decisions. I actually went to Leslie, I went to Lisa and I shared with them the opportunity and why I was, you know, intrigued by the Alidia opportunity.
And I remember having dinner actually at the Stanford Park Hotel with Leslie and she said, why do you want to be a CEO?
And it was the first time anyone had asked me that. And I reflected on my experience at Intersect Access Closure. And I realized that the thing that got me up in the morning was the ability to have influence and the ability to lead people. And I really enjoyed it in my highest points of my career was when I was, for instance, a field sales trainer or when I was a sales director, where people would reach out and ask for advice and would ideate, seek an opportunity to ideate together on solutions. So there was problem and there was solution. I love that aspect of leadership is being able to tackle challenging problems with really talented individuals on your team.
And that was really sort of the, the first moment when I was like, you know, I think at a broader scale I could have some impact and bring some value to an organization.
On top of that, Lisa had done a remarkable job of bringing me into the fold, as she did with all of her senior leaders and helping us as we built Intersect to ensure there was visibility across all functions of the organization. So I really got a great bird's eye view of how and appreciated appreciation of how all the various functions of an organization work together to create success, if you will.
And I think that was a real eye opener for me where I was able to get exposure to regulatory, to R and D to quality, obviously, market, access, clinical.
And I understood how all the pieces kind of work together to execute against a master plan. And so those were sort of the key, I guess, enlightening moments for me that gave me the passion to pursue my first CEO gig at Olidia.
[00:37:42] Speaker A: How much of your learning from that Exposure was you being curious and just sort of wanting to absorb more? And how much was it, do you think, by design, leases, or otherwise, to grow and mature and give experiences to the team? Is it a little bit of both or what do you think?
[00:38:04] Speaker C: I would say it's definitely a combination.
I think some of it. Early on at Access, I didn't know what I didn't know.
I was still earlier in my med tech startup career, but getting exposure to people like Leslie, Mike McKinnon, Frank Khashravi, I think by osmosis, I was absorbing a lot. But then as I approached Intersect entire, I found Lisa to be very intentional in putting me in positions where I can really continue to spread my wings and develop skill sets that have been very applicable in my last job and my one today.
[00:38:41] Speaker A: So just circling in on Olidia, do you remember the moment when you said, I'm going to do it, and what was the switch that was flipped that caused you to make that decision?
[00:38:51] Speaker C: Yeah, I remember very vividly when I really made my decision that this was the right opportunity for me.
And it's probably not as crisp of a revelation that you might expect, because Alydia at the time had just come through their pivotal study, and it was a really challenging study to complete, but they were also running out of money.
And then, as it were, Covid was approaching, and, you know, and at this time, I was kind of like, like, all right, I'm gonna have to immediately get in. I'm gonna have to go fundraise and raise at least a bridge round for us to get to commercial.
Never done any fundraising before, and I was like, yeah, that sounds like a great first CEO gig. I'll do it.
But as it were, I knew that I had a number of talented advisors, mentors that were there urging me on.
And subsequently, I. I assessed that there was nothing that was really broken there. It was just going to be a matter of building a few new muscles and getting out there and problem solving.
The net. Net is those were sort of the external factors that I was navigating and weighing. But at the end of the day, when I looked at the opportunity to apply a very innovative design in a space that historically had only pharmacologic or relatively Few medical intervention types of approaches.
Most of these patients with postpartum hemorrhage were treated pharmacologically.
And I noted that there was no real innovation in labor and delivery at the time.
And then I looked at the data that we had and I saw that we had a real opportunity to introduce a game changing technology. And most importantly, when you tie it to mission to save mom's lives, and when I look at it in retrospect, it was the best decision I could have ever made. It was such a gratifying journey in terms of the ability again to keep families intact, to save moms. And when you, you know, at the end of the day, when you look at sort of your life's work, you hope that you've had impacts.
And you know, from my vantage point, that was the biggest driver was the ability to have a real impact on preserving families, keeping moms alive. And as I look back on it now, you know, we saved a lot, a lot of mom's lives. It was really an awesome and gratifying experience.
[00:41:46] Speaker A: And just a quick what to tell us quickly about Jada, the product that odia.
[00:41:51] Speaker C: Yeah.
So I give the early team a lot of credit. They identified that one of the root causes of postpartum hemorrhage and the rising rates of postpartum hemorrhage in the United States, let alone the developing world, happened to tie back to the the atonic uterus, if you will. And what that means is the uterus will become fatigued over time with a number of factors, comorbidities like hypertension, diabetes, et cetera, and also multiple bursts, it essentially gets fatigued. And the ability for the uterus post delivery to contract is essential in essentially telling the body to shut down the passage of blood to the uterus.
And one of the things that was happening was that many of these patients that were experiencing abnormal uterine bleeding or postpartum hemorrhage had this experience where they just had a tonic uterus, it was not contracting, therefore blood continued to flow and it led to again large rates of blood loss.
And the challenge was that the pharmacological options, while they are effective, it's very difficult to predict who's going to be a non responder.
And so again back to the early engineering team. They identified this opportunity, this need whereby if you could introduce essentially a suction device into the uterus and essentially start to help facilitate the contraction of the uterine walls, that in fact it's almost like doing a cross of which I don't do a lot. But when you do do a curl, the early part of it is hard, but once you get past that 90 degree part it gets much easier. And that's what you're really trying to accomplish with the Jada device is start to facilitate the contraction of the uterus.
And as I believe you know, the data was very compelling.
We were seeing bleeding cessation within approximately three minutes in our early data and that became very compelling.
[00:44:20] Speaker A: And you sold the company or the company was acquired by Organon.
Yep, Organon. Thank you, Oregonon.
So successful outcome and only one year after taking over as CEO. Spending a lot of time in your career. I want to move on to Insuratronics a moment, but I do have one final career question because I'm looking at LinkedIn. You became CEO July 2020. So. So things were just starting to things were already past smoldering at that point. The world was an uncertain place.
Some could say that's a dumb time to take a CEO job because you don't know what's going on. Others could say it's a brilliant time to take a CEO job because you don't know what's going on. I mean, you didn't know what the world would look like.
So I don't think anyone would hold you responsible for a negative outcome. So with those two voices talking to you, an eye of the ear and did you just I have this in mind because I just edited my conversation with Tim Schmidt of Johnson and Johnson and his advice was just always say yes when you're presented with an opportunity. Was this a situation of you just saying yes, that this was an opportunity that you really wanted to do?
[00:45:24] Speaker C: It was really that I just again back to the mission and the innovation that addressed an unmet need. It was just a pull. I just felt like it was an opportunity to do some good. Good and to truly introduce an innovative concept in the treatment of again, a condition that had no real solutions, if you will.
And then I was also intrigued by the fact that there was opportunity to build a lower cost device that could have an effect on women across the globe. And you think about some of the developing nations of Africa where they see abnormal uterine bleeding and postpartum hemorrhage rates that can approach 30%.
Real opportunity there outside of just the U.S. and so I was really compelled again and pulled by this opportunity to be able to leave an impact.
[00:46:31] Speaker A: Fantastic. So let's move on to share a tronics. I've done probably close to over 400 episodes of podcasts over the last five years of various types. I honestly, I cannot recall another one that would, that focused on migraine. And as I said at the top, migraine is a huge problem, but it's not something that you typically see medtech applied to.
So talk to me first a little bit about migraines. What is the market like, what are the challenges?
And then we'll get into your hopeful solutions solution.
[00:47:06] Speaker C: Yeah, absolutely. So I'll try to frame the migraine market for you by a couple of data points. So in the United States alone, there are approximately 40 million episodic migraineurs. So these are patients that struggle with less than 15 headache days per month.
And they experience various ranges of intensity.
You know, headache can be one that, you know, just kind of causes you to have a little bit of, you know, loss of productivity at work, but you're still able to go to work.
And then there's, then there's, you know, the severe headaches. Right. That, that really knock you out for a full day.
And you know, and then there by diagnosis there's another, there's another category of chronic migraine.
These are patients that actually suffer with, if you can believe it, 15 or more headache days per month.
And they need to have those symptoms for three consecutive months just to earn the diagnosis.
Average duration of headaches, about four hours. So when you talk about the level of debilitation, think about it. Every other day you have a headache ache, which is just an extraordinarily lifestyle limiting experience for these patients.
[00:48:33] Speaker A: You don't know when it's coming, you don't know how it's going to hit you.
[00:48:37] Speaker C: And if you go back to the pathogenesis, there's a number of theories about causes of migraines.
What everybody has agreed to is that some trigger stimulates this hyperexcitability within the head that ends up, ends up terminating in the release of these inflammatory mediators that cause head pain.
And some will describe their, I call it stimuli as being red wine or flashing lights.
There are other theories that there's a hormonal component to the triggering of migraines. But the net net is some stimuli ends up taking these patients into a hyperexcitable state, which in turn leads to this release of inflammatory mediators and thus the headache begins.
[00:49:33] Speaker A: And I open this by saying I don't or haven't suffered from a migraine.
Is this something as your body changes, that you could go from a fortunate person who has zero to someone who's suffering from 15 or more events a month?
[00:49:52] Speaker C: Yeah. So really good question. So it Typically tends to be a progressive condition.
Often, oftentimes patients will be diagnosed in their latter teens, early 20s, and many times they will earn the diagnosis of episodic right, where they'll have 2, 3, 6 per month.
And then oftentimes without effective treatment, these patients will move to the diagnosis of chronic. So it typically is, to your point, it is a progression for many of these patients.
And interestingly, I'll point out that there is also a progression, as in the latter years of one's life, when you get over 50 plus years old, sometimes patients actually experience a decrease in headaches.
[00:50:45] Speaker A: Oh, interesting.
[00:50:46] Speaker C: Which is interesting. But the net net is in their prime of their lives, their highest productivity years, the years when they're building families and whatnot, that's typically when they're afflicted by migraine. Another interest data point is approximately 2/3 of the population are premenopausal women.
So it disproportionately affects women, again in their prime of their lives.
[00:51:13] Speaker A: Interesting. So talk to me about the way that the treatments that are available today and the clinical infrastructure that works around and treats migraines. Who are the doctors that are helping patients with this, if there are any?
[00:51:32] Speaker C: Yep. So typically these patients are managed especially early on in their disease process.
They're typically managed by primary care, but when the headaches get to a point of real lifestyle debilitation, they often are referred out to a neurologist.
And a neurologist typically will manage these patients, especially the episodic patients in the severe case.
These patients will be then oftentimes referred out to a headache specialist, which is a branch of neurology, if you will.
So for all intents and purposes, the neurologists really are managing the majority of these patients.
[00:52:20] Speaker A: Okay, what are the treatments that they're offering currently? Is it pharmaceutical? Is it dark room? What are the options for patients?
[00:52:31] Speaker C: Yeah, another good question. So in terms of the treatment algorithm, oftentimes when patients have an episodic diagnosis, they will be treated with the, typically the triptans, the abortive medication. So meaning, you know, reactively, if I have a headache, I take one of these pills and they typically, you know, they typically carry on with that, that form of treatment for a long time.
More and more frequently, patients are actually getting access to the biologics, of which there are a number of them.
And these are obviously the systemic biologics that can be administered via shot form or a pill in the more recent iterations.
And those patients typically are episodics, but then they often will bridge into chronic patient treatment.
Patients also at times are treated with Botox. There's some literature that suggests that, you know, by, by injecting patients in, in you know, select areas of the head that you actually can give them relief.
The literature suggests around a two, two and a half day treatment effect size for those patients that take Botox shots as well. Challenge with that is you end up with a lot of different shots, approximately like 30 plus shots, you know, in one engagement in your head, which is a challenge.
But that, but it is an effective therapy therapy for patients. And then there are some more invasive types of treatments such as nerve block, nerve decompression type treatments. They're not as widely used for more severe patients.
And then there's also external neuromodulation systems that have attempted to be used for patients primarily that are episodic, not the treatment resistant chronic migraine population that looking to serve.
[00:54:35] Speaker A: Interesting. So let's learn about Sharetronics approach.
What's your device and how does it work?
[00:54:44] Speaker C: Yeah, I think what I should probably do is start by articulating the patients that we are focused on.
So our sweet spot, our patient population is really again the patient that has failed all conventional modalities. They failed the triptans, they failed the CGRPs, they failed Botox and they're still left with 15 or more headache days per month and left with no real options.
And to your point, the dark room, shutting down stimuli, locking yourself in a room and just trying to ride it out becomes their primary mode of therapy and treatment.
And so we at Chairtronics actually have been the benefactors of our founders, Dr. Mudit Jain and Lynn Elliott, who had done some extensive interrogation, I'll call it, of some of the off label experience of neuromodulation in treating head pain. And believe it or not, there's a long history of neuromodulation in the treatment of head pain that dates back 20 years.
And in the last, say 15 years, one of available treatment modalities was actually the use of spinal cord stimulators and whereby they would sic the can and the pectoral region and they would tunnel across the neckline all the way up to the target nerve. And at the time the early work was done on the occipital nerve and patients were actually getting some relief.
And so much so that back in the 2010, 10, 11, 12, 13 time frame, many of the big companies, Boston Scientific, Medtronic, St. Jude at the time, all commissioned their own RCTs again using the spinal cord stimulator as their primary mode of stimulation.
And again, at the time they were going after the occipital nerve.
And the interesting thing is that all three of those studies actually failed.
They did not meet their primary endpoint. But there was, and this again goes back to the genius of Mudit and Lyn, who recognized that actually there were some really positive data in the early studies. And they also spent time talking to some of the providers that were doing the off label procedures and they realized that something was working.
And what I mean by that is actually if you look at the secondary endpoint in the St. Jude study, which was mean reduction in monthly headache day, they actually achieved statistical significance.
But as a primary endpoint, which was, you know, using a responder rate, they actually missed.
And the interesting thing is what's happened over the last decade is actually the FDA's come around and agreed that the better measure of efficacy in treating head pain is mean reduction in monthly head headache day, which is actually our primary endpoint. And that thankfully the CGRP companies, the Botox, all got the FDA to agree that that was a better measure of efficacy.
So I think again, to give you some historical context, the endpoints they were using in the early days were the wrong endpoints, which is encouraging for us. And again, our primary endpoint is mean reduction in monthly headache day. The other interesting evolution that has taken place is that that this off label experience persisted over the last 10, 15 years.
And what you find in some of the published literature of the off label experience is that the incorporation of the supraorbital nerve in addition to the occipital nerve actually gives you a doubling of the responder rate, which is our approach.
And so that's another key differentiator, is that we're targeting the supraorbital and the occipital nerve nerve with a neuromodulation platform.
And then the last point I'll make is that in the off label experience, when they were sticking the can again in the pectoral region, they were tunneling across the neckline.
The one confounding factor was there were really high rates of mechanical failure. So the leads were migrating. There would be some lead fracture at times.
And it made sense because you were crossing this neckline with the lead, which the one appendage is moving all the time and applying torque on a lead, for instance, happens to be the head. And that behooved us to believe that a head located head mounted system, one that's tucked in just the subcutaneous tissue of the head, not in the cranium, just in the tissue.
But we believe that that would be a better form factor to be able to address some of the mechanical issues of the early experience.
And I'm pleased to announce again, knock on wood, but in our pilot study done in Australia, we at one year had a zero percent rate of lead migration.
So it tells us that again, small sample size, but it tells us that the original theory that a head located system targeting the superorbital and the occipital nerves was the right way to go.
And so hopefully that gives you a little bit of history of some of our early founder work and also the history of Neuromod in treating head pills.
Sure.
[01:00:27] Speaker A: And looking at the device on your website, I mean it looks like it's about the size of a, maybe a car key fob security thing, but it's obviously slimmer and sleeker.
[01:00:39] Speaker C: It was designed to be a discrete device, one that is imperceptible to the human eye. And so far in, let's call it, we've done roughly, you know, let's call it 150ish implants.
You know, I can confidently tell you that it's virtually imperceptible to the human eye.
[01:01:04] Speaker A: So what kind of effect is it having on patients? Do you have any?
[01:01:08] Speaker C: Yeah, I can't speak to our pilot experience. It is obviously a blinded study, but I can speak to our pilot experience experience.
But our pivotal is again it is a blind study, but in our pilot experience we actually implanted 11 patients and that was done in four centers in Australia.
And we ended up at our primary endpoint of 12 weeks, essentially taking patients from around 19.8 headache days per month to approximately 7 headache days per month. So a very significant drop in monthly headache day. And that is a very meaningful result.
The other thing that we looked at was the ability of our therapy to affect the severity of headaches. And in our pilot work in Australia, we were able to take patients from roughly eight severe headache days to approximately two severe headache days per month. And that's a really, really important point that I'll make because when you talk to neurologists, they will tell you that the mean reduction in monthly headache day is important, it is critical, but it is the combination of mean reduction in monthly headache day plus reductions in the incidence of severe headache days that equals restoration of functionality.
So if you can reduce number of headache days, reduce the number of severe headache days, you actually can give patients the ability to get back to their lives, even if they're having moderate headaches.
That is the difference.
[01:02:52] Speaker A: Cook dinner for the family or pick up the kids.
[01:02:55] Speaker C: That's exactly right. And actually, in our pilot study.
[01:03:01] Speaker A: We.
[01:03:01] Speaker C: Used the migraine specific quality of life scoring, and this is a validated scoring tool that is used in many of the headache studies. And it essentially evaluates the improvements in levels of impairment across three domains, which is emotional outlook, your ability to essentially be present with your family and sort of your personal life, and then also the improvements in your outlook at work. And across all three domains, we saw stepwise improvements from baseline to 12 weeks, indicating that we were reducing levels of impairment for these patients and again, helping them resume normal life, if that makes sense. Sense.
[01:03:48] Speaker A: No, it does. And I was going to ask about that as well, because on the slack channel, you'll often see a coworker, you know, I need to go lie down. I've got a headache. So you see an impact on output.
So going back to your original point about what you liked about Medtech, this is a product that's consistent with your thesis of bringing value, really changing the system.
Assuming you go forward and find clinical success, how do you see this fitting into the clinical setting?
Obviously, this is a procedure of sorts. I'm not sure if a neurologist or a form of neurologist does it. Who do you think would ultimately become the treating physicians?
[01:04:30] Speaker C: Yeah, good question.
So the interesting thing for us is that we're in, I think, a fortunate scenario in that the neurologist who's currently treating these patients today, as I mentioned, don't have a lot of great options. By the way, mentioned that There are about 3 million patients in the United States alone, really, that are deemed treatment resistant, that are chronic migraine patients.
They've tried and failed multiple modalities, and they're just not getting relief.
And so it's a very sizable market. And again, back to the question.
These patients are being managed largely by the neurologist today, and they just don't have an option, you know, other than just continuing to give them biologics and systemic drugs and whatnot.
So what we found in our pivotal study is there, there is a very high degree of willingness to refer these patients out and refer them out to our implanting centers. And our implanters are going to be the neurosurgeons or the interventional pain physicians, at least as a primary focus in our early limited lungs launch.
Our pivotal study has approximately 60, 40 split of neurosurgery and interventional pain physicians.
So the procedure can be done by both Specialties.
And then from there, the implanting physicians really don't have a desire to manage these patients, so they're just simply sent back to the neurologist for ongoing care and maintenance and management.
So we're really trying to create a little bit of an ecosystem with the patient at the center, neurology on one side, interventional pain or neurosurgery on the other.
But again, everybody working together to treat these patients and improve their outcomes.
[01:06:25] Speaker A: That's really interesting. And you had said coming to our centers. You mean your clinical centers. You don't have a plan to build your own treatment centers? No.
[01:06:33] Speaker C: Good clarification. These are our clinical centers, of which There are approximately 27 of them in our pivotal study right now, four of which are in Australia and the rest in the United States. States.
[01:06:43] Speaker A: Interesting.
Are there larger entities out there, larger OEMs that are currently treating migraines in some form or fashion? Or would this, you think, be sort of a, a novel market for, for medtech?
[01:06:58] Speaker C: Yeah. So, I mean, I, well, I will say this.
There's a lot of noise in the channel, you know, and there are a number of different theories on how to treat.
I'm a science guy and a data guy, of which, you know, the modalities that I talked about earlier in terms of, you know, the pharmacologic interventions, the externals, the off label experience, those are the ones that are really backed by, you know, quality science.
[01:07:29] Speaker A: Interesting. All right, final question. Just what kind of response are you getting from the patient community? What is the patient community like?
Are they a community or are they a bunch of 3 million people suffering individually?
What is the patient population like?
[01:07:45] Speaker C: A really good question. And I will point out that more so than most patient populations that I've encountered, they're highly, highly involved with their care.
They know all the different modalities that have been tried on them. They are constantly on, in social media channels, channels and in chat rooms and in support groups trying to, you know, ideate on what's worked, what hasn't worked. They're very active in their care and they're looking for solutions. And so, you know, one example is there's a support group called Migraine Buddy. I think there's, I believe there's about 1.5 million patients that subscribe. And you know, and this is how they're constantly getting notifications, pushed on new modalities, these new treatments.
There's again, support group immunofunction there.
In fact, our study was pushed to a number of patients out there just as a potential option.
So, again, to answer your question, they're just a highly engaged, very sophisticated, intelligent patient population that are looking for new solutions.
And. And again, it's been, I'll say, I guess the right word's not easy, but it's been fairly easy for us to access them throughout our study.
[01:09:16] Speaker A: Interesting. All right, well, it's an important problem. It's a big problem. As I said, it's one I think we all encounter day to day working with folks who suffer from this. So this sounds like an amazing opportunity for MedTech to make a difference. So, Rob, thank you for joining us on the podcast.
[01:09:34] Speaker C: Well, thank you so much. We have some work to do still. Obviously got to get through our pivotal study, I should say. But the early encounters that we've had with patients, especially dating back to our pilot work, are very encouraging.
I'll give you one anecdote and then I'll let you go. But we have in our offices here a watercolor painting hanging up. I call it Hope.
And the reason is one of our patients had previously been a painter 20 years prior to her migraine affliction.
And after a trial course of our therapy, she actually was able to resume pick up the paintbrushes and resume painting for the first time.
And she painted a painting for one of our field clinical engineers whom she had developed a relationship with throughout the process of the study.
And we hang it up there as a reminder that our therapy again, which still has to be proven through science, but our therapy does represent an early opportunity to restore hope and to give patients their lives back.
And that's what it's all about. We only get one turn on this great planet of ours. And my hope is that I can end my career hopefully doing meaningful things like this and really having an impact on patients. And I think at the end of the day, that's what we all want and we'll just have to see. And I appreciate the interest and the opportunity to tell our story and we'll keep you posted along the way.
[01:11:14] Speaker A: That's great. I'm glad you shared that. And it kind of circles back to our pharma versus Medtech comparison. So I don't know if you.
You may get that painting at a pharma company, but to have a medtech professional get to know a patient to that degree and be able to give them a. Be able to be given a gift like that is pretty amazing indeed.
[01:11:32] Speaker C: Yep.
Well, thank you, Tom. I appreciate the time and the interest. And like I said, we'll keep you posted as we keep hitting milestones.
[01:11:44] Speaker A: All right, well, that is a wrap. Thanks so much for joining us on this episode of the Device Talks weekly podcast. Once again, I hope you register for our Cardiac Innovations series. It takes place February 3rd, 4th, and 5th. On February 3rd, we'll speak with the folks at SynCardia. February 4th, once again, I'll talk with Steve Michael Nicholson of Field Medical, and on February 5th will visit with Valcare Medical, which is a company that's redefining structural heart repair. So three great companies tackling three huge issues. And Syncardia, of course, is a pioneer of total artificial heart technology.
Field Medical is looking at ventricular cardiac arrhythmias. And Valcare, as I mentioned, is doing structural heart repair. So lots to learn there. I hope you'll be part of those conversations. Go to devicetalks.com to register.
Also, Device Talks Minnesota and Device Talks Boston are open for registration, so we certainly hope to see you there as well. We'll begin adding to the agenda over the coming weeks, and we really would love to see you at Device Talk Minnesota on May 4th and at Device Talks Boston on May 27th and 28th. All right, well, that's it, folks. Please do subscribe to the Device Talks weekly podcast. You could now subscribe directly to that. Or, of course, as always, you can subscribe to the Device Talks podcast network so you don't miss any of our of our future medtech podcasts. All right, that's a wrap, folks. Thanks again for joining us on this episode of the Device Talks weekly podcast.
