Could CereVasc Be Boston’s Next Big MedTech Success Story? The Future of Ortho with The Fro

Could CereVasc Be Boston’s Next Big MedTech Success Story? The Future of Ortho with The Fro
DeviceTalks Podcast Network
Could CereVasc Be Boston’s Next Big MedTech Success Story? The Future of Ortho with The Fro

Apr 18 2025 | 01:06:46

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Episode April 18, 2025 01:06:46

Hosted By

Kayleen Brown Tom Salemi

Show Notes

In this episode of the DeviceTalks Weekly Podcast, Tom Salemi talks with seasoned MedTech executive Daniel Levangie about the blood-brain barrier-breaking technology being developed by CereVasc.

The company has developed a less invasive way of treating patients with communicating hydrocephalus, one of the most common neurological conditions affecting both children and adults. But the company’s tech gives physicians access to the brain, creating a potentially huge opportunity for future applications.

Just prior to the keynote interview, Tom talks with orthopedic surgeon and OrthoShow podcast host Scott Sigman, MD, about the Future of Orthopedics, a conversation they’ll resume at the start of DeviceTalks Boston.

Go to Boston.DeviceTalks.com to register to attend the April 30-May 1 conference. Use the code mentioned frequently in the podcast to save 25%.

But we’ll start off with MassDevice Editor Chris Newmarker’s Newsmakers - Abbott, Boston Scientific, Edwards Lifesciences, EBR Systems, and Johnson & Johnson MedTech.

Thanks for listening to the DeviceTalks Weekly Podcast.

Subscribe to the DeviceTalks Podcast Network so you don’t miss a future episode.

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Episode Transcript

[00:00:00] Speaker A: Hey, everybody, this is Tom Salemi. Welcome back to the Device Talks weekly podcast. Busy, busy time here. We'll be meeting up at Device Talks Boss on April 30th and May 1st. Would absolutely love to see you there. We will, in this podcast episode be featuring one of our speakers at Device Talks Boston. It's a new feature we'll be introducing at Device Talks Boston. In fact, our speaker will be kicking off the entire event with me. So looking forward to that conversation. And we'll have lots of other great conversations there as well, including a follow up conversation with Vaughn Tornos of Zimmer Biomet. And of course, I'll be talking the next day with Cecilia Soriano of Baxter. Lots of themes developing. We'll talk lots of talk about medtech resiliency for managing both natural crises and other crises, but also of course, developing new technologies and innovating new ways to help people. So we'll be covering all of that at Device Talks Boston following our invent it, design it, make it and commercialize it pillars and lots there for you to learn from and lean on. And we hope you'll join us there. Again, you can go to boston.devicetalks.com because you're a loyal podcast listener. Please use the code DTWeekly25 and you will save 25% off the cost of registration. And after that, a few weeks after that, it seems probably more. Four or five weeks after that, we'll be at Device Talks Minnesota. Very excited about that. That agenda is coming together with lots of great speakers and conversations centered around cardio, neuro and other principal areas of interest. We'll have a cool AI Surgical Robotics conversation about the future of surgical robotics. So lots going there. You can register for [email protected] that's June 11th at the McNamara Center. And once again, Device Talks Boston is happening April 30th and May 1st at the Boston Convention and Exhibition Center. All right, no Device Talks weeklies until after Device Talks Boston. So we're clear there and I got nothing else to talk to you about. So let's get this podcast started. All right, you ready for this? [00:02:03] Speaker B: Ready. [00:02:20] Speaker A: Chris Newer. How are you, sir? [00:02:22] Speaker B: Doing well, Tom. Doing well. [00:02:24] Speaker A: We're. [00:02:24] Speaker B: We're talking on a Good Friday, right? [00:02:26] Speaker A: It is. It is a Good Friday and is the Good Friday. [00:02:28] Speaker B: So the Good Friday, yes. [00:02:30] Speaker A: Happy Passover and Easter to those who celebrate. Passover's been going on for a bit, I believe. But Easter's this weekend. Do your kids still do the hunty thing? [00:02:40] Speaker B: Oh, there's gonna be a neighborhood Easter egg hunt. [00:02:43] Speaker A: A neighborhood? Oh, wow. [00:02:45] Speaker C: Yeah. [00:02:45] Speaker B: All the neighbors. [00:02:45] Speaker C: We. [00:02:46] Speaker B: All the kids go around, you know, we hide the eggs around the neighborhood. [00:02:49] Speaker A: Or. [00:02:49] Speaker B: No, actually, the Easter bunny hides the eggs around. [00:02:52] Speaker A: Of course, we understood what you meant. [00:02:54] Speaker B: By, it's just so cool. I can wake up on a Saturday morning and get the kids together and go out and this bunny left candy all over the neighborhood. It's pretty. [00:03:01] Speaker A: Pretty cool. Will there be mimosas for the. For the adults to find, do you think? [00:03:06] Speaker B: I hope so. [00:03:09] Speaker A: Have you ever tried a beer mosa, you know? [00:03:13] Speaker B: Yeah, I think I have. Yeah. [00:03:14] Speaker A: The beer Mosa white with orange juice. It's. It's. When I saw it, I'm like, ew. And then I thought about it. I'm like, yes. And I tasted it, and I was like, damn. So beer Moses, everybody. Allagash White, I would say. [00:03:27] Speaker B: Okay, so we, you know, we with. You know, we have a few relatives over usually on Easter, and, you know, we've run really big about doing instead of Easter dinner, do an Easter brunch. Easter brunch. [00:03:38] Speaker A: Just love a brunch. [00:03:39] Speaker B: Fantastic. Yeah. Get a good brunch, you know, so we'll have that Newmarker house. We'll have that good French toast bake. French toast bake. Got the egg bake. [00:03:48] Speaker A: So you won't do anything on Easter Sunday morning because you had the hunt yesterday, tomorrow Saturday, correct? [00:03:55] Speaker C: Or do you do both? [00:03:56] Speaker B: I think we'll probably do both. We got little kids. They're living the dream. So, you know, Easter Bu is so generous. [00:04:03] Speaker A: He just gives and gives. Like he's coming twice to your neighborhood. [00:04:08] Speaker B: Is it? You know, it's. It is interesting. At the bus stop this morning, I heard one of the neighbors saying that his security camera caught a cat dismembering a bunny in his yard. Which. I mean, should he have been saying that in front of our kids, waiting to get on the bus? Oh, no. [00:04:32] Speaker A: Did you have a basket? Was. Now that you mentioned it, did have a basket. [00:04:37] Speaker B: The one kid saying, like, there was a leg. There was a leg lying out on me. [00:04:42] Speaker A: I didn't realize you lived in the Serengeti, Christopher. You got big cats devouring prey. Good golly. [00:04:51] Speaker B: We live near a large regional park. [00:04:55] Speaker A: Hey, the cats. The mountain lions are out there. I saw them. Saw one last year. [00:05:01] Speaker B: You saw a mountain lion in Minneapolis. [00:05:02] Speaker A: That was a mountain lion. Bobcat. Bobcat. Not Minneapolis around here. One of those big cat things. Not a domestic thing. It wasn't close, thank goodness, but it Was definitely like, it was this orange thing coming my way. I'm like, that's not a fox, but oh, yeah, that's a bobcat feline bounce to its stump. [00:05:21] Speaker B: Yeah, you don't go, hey, kitty, kitty. [00:05:24] Speaker A: Just like an elf. Somebody needs a. Huh. All right, we have wasted enough of these fine people's time. [00:05:32] Speaker C: Sorry. Did you, these two guys, did you. [00:05:34] Speaker A: Bring your basket of new markers? Newsmakers? [00:05:37] Speaker B: Yes, brought a nice basket of new markers away. [00:05:40] Speaker A: Chris. Let's hide these, these award winning. [00:05:43] Speaker B: Get hopping, Chris. [00:05:45] Speaker A: There you go. Get hopping on the Newarkers. Chris. Newsmakers. [00:05:48] Speaker B: Chris, number number five, we' EBR Systems winning a FDA approval for a wireless cardiac pacing device for heart failure. Company's based in Sunnyvale, California. This thing is the size of a cooked grain of rice. What it's for is it's working with, it's wireless, it's the size of a grain of rice, and it delivers left ventricular pacing on top of existing pacemakers or defibrillators that are providing right ventricular pacing. So they say that the Medtronic micro already qualifies to work with this thing. [00:06:43] Speaker A: That's fascinating. [00:06:44] Speaker B: And then, yeah, and then they've got it testing underway to get Abbott of Veer. I mean, one of the things with the leadless pacemaking was that, you know, that, you know, like the, like, basically like, you know, like the, you know, the micro would be like in your right chamber, you know, so like doing, you know, pacing on both sides. I mean, Medtronic was, you know, talking about how they plan to, you know, you can get something to get the, the left pacing done, you know, like Abbott, Avere has like two leadless pacemakers that are working. But yeah, this is a really intriguing strategy here and it has FDA approval now. So it could, you know, this company saying that they think this is going to make leadless pacemaking, like, much more widely available. So, yeah, this is going to be really interesting to see how this turns out. [00:07:35] Speaker A: That's fantastic. Kayleen Brown and I spoke with Vish Sharan, who's the divisional vice president of product development at Abbott's CRM business. And actually the interview will be our first Abbott Talks podcast of the year and it's coming out on the 22nd, so it's coming out next week. We talked a lot about Avere and the dual pacemaker and how they, how they chat with each other and what it means to this technology. So it's, I saw the EBR news and I wondered how it or if it synced with others and the fact that it does, I think is pretty remarkable that you can have, yeah, two products from different companies work together. I think that's, that's outstanding. [00:08:16] Speaker C: Yeah, Cool stuff. Very exciting. [00:08:18] Speaker A: Yeah. Medtech is cool. [00:08:19] Speaker B: Chris Newmarker Medtech is so cool. [00:08:21] Speaker A: Medtech is so cool. What's number four? [00:08:22] Speaker B: I felt, I feel so fortunate, Tom. Every day I'm like, wow, we're covering like just really like fascinating technology. So number, number four was, was, was Needham and company analysts are, you know, upgraded Boston Scientific stock ahead of their first quarter results coming out on April 23rd. Upgraded to BI. But the big reason is they're saying that they think, the phrase they use was they thought that the competition for Ferrupul's PFA was actually going to be more benign than had been previously feared. They say they do surveys of electrophysiologists and they say the Ferrupulse is just very popular with them. And at this point, I mean, Paul select for Medtronic is out there, but they're saying the EP community seems to have a preference for Ferro Pulse. They were saying, and Medtronic has a Ferra as well that they've launched in the US but they said at this point that they thought that the supply for afara remains limited. JJ's Verapulse There were the concerns JJ had to work with, you know, out, you know, over, you know, stroke risk concerns, you know, which JJ says that's over but you know, that, that might have been a challenge for them there. So at this point, I mean, they're predicting that Boston Scientific is going to like grow its, its share of the ablation catheter market from 35% to 38.3% over the next 12 months. So, so that's, yeah, Boston Scientific, that's like some, you know, if that pans out that prediction, I mean that's, that's some really good news news for them and you know, success of their PFA technology. [00:10:13] Speaker A: A real tribute to the, the Medtech ecosystem. Of course Boston Scientific was an investor in Firepulse, acquired the Firepulse and its technology and now it's a huge driver for the company. So absolutely, the system works and, and. [00:10:27] Speaker B: It boosts, you know, sales of Watchmen because, you know, hey, you're getting that PFA procedure, you know, might as well get, you know, this, this, this Watchman, you know, in there for, you know, atrial appendage closure to reduce your stroke risk even more. So. So there you go. So that they've got that Going for them, too. [00:10:45] Speaker A: Absolutely. All right, Chris Newmarker, what is number three? Oh, I feel like I need, we need like a new intro music. Tariff talks. What do you think? We need to get like a tariff talks. Maybe need some. But tariff talks. Tariff talks. Time for tariff talks. [00:11:00] Speaker B: No, tariff talk time. [00:11:04] Speaker A: Tariff talk time. [00:11:06] Speaker B: Anyway, yeah, Tariff news. [00:11:08] Speaker A: Chris Newmacher. [00:11:09] Speaker B: Yeah, the tariff news is, I mean, we, you know, heading into earning season again. And so we're, we're actually getting much clearer picture now of how all this trade war, unpredictability, continued high tariffs between the US And China, how this is affecting the finances of major medical device companies. We had JJ and Abbott earnings out this week and each of those companies hundreds of millions of dollars. [00:11:37] Speaker A: J and J said it was taking the charge, but Abbott is not. [00:11:41] Speaker B: Well, the big thing with Abbott is just that they're, you know, Ford was saying that it was going to be a few hundred million dollars. You know, their CEO Robert Ford said it was going to be a few hundred million dollars of cost just for half of the year. So I mean, it's costing them. They stuck by their guidance, though, because they said that like Ford actually said that they were thinking of raising their earnings per share guidance before this happened. So now they're going to stick with it and they think they've got the manufacturing network to handle this going forward, which I think that's very interesting. [00:12:24] Speaker A: I see you wrote this article and you had regarding efforts by AdvaMed and other trade groups to secure a tariff exemption, which we talked about last week for mental devices. Ford said Abbott is actively involved. However, he also said, quote, hope is not a strategy for us. [00:12:41] Speaker B: Yeah. [00:12:43] Speaker A: Sobering words. And yes, you wrote this article and of course you wrote the Boston not, of course you wrote the Boston Scientific Fire Pulse article and Sean Hooley wrote the EBR article. [00:12:53] Speaker B: Yes, exactly. I mean, me and Sean are getting stuff done over on Mass Device. [00:12:59] Speaker A: Sean also wrote the Johnson and Johnson Terrified, so. [00:13:02] Speaker B: Exactly. [00:13:03] Speaker A: Yeah. [00:13:03] Speaker B: And that, you know, that was, yeah, $400 million in tariff costs and really primarily related to the medtech business at J and J and with products being shipped into China. So, I mean, Trump raised tariffs really high on China and China's reciprocated with high tariffs on its side. [00:13:30] Speaker A: We know all that. All right, let's move on to number two. [00:13:32] Speaker B: We know all that. [00:13:33] Speaker A: Let's move on to number two. Sorry, I don't think anyone needs any backstory on. [00:13:39] Speaker B: Sorry. Sorry, everyone. [00:13:40] Speaker A: Sorry. [00:13:42] Speaker B: Didn't want to trigger anybody again there. [00:13:44] Speaker A: The next two of the Two and one are both Hooleys, Sean Hooleys. So what's number two on the list? [00:13:50] Speaker B: Yeah, there we go. Number two on the list. You know, other, we had other news out from J and J, which is that they've completed their first cases with their Autava surgical robot. Yeah. So it's moving forward and, you know, this is, you know, JJ's big play in the soft tissue surgical robotics space that is been dominated by Intuitive for years and years and decades, really. So it's good we got more news that work on Atava is moving forward. [00:14:20] Speaker A: All right, great. We've talked about Intuitive's dominant space or place in this market, but we had some great conversations last week on our Surgical Robotics Week Device talks, including a conversation with SS Innovations, which has developed a large surgical robotic system that is going after Intuitive, both in applications including cardiac surgery and price. So if folks want to sort of see how this market could be upended, you can go to devicetalks.com, you can watch that. And we had presentations by Xcath and EndoQuest and Lupine Dental. [00:14:58] Speaker B: That's fantastic. And then I'm excited too. I mean, my gosh, the amount of Surgical Robotics speakers we're going to have at Device Talks Boston, just Tom, just over a week, I'm saying. [00:15:09] Speaker A: I know Tony Jark from Intuitive, we'll have Maggie Newton from Capstone. So it's going to be great, going to be a great, great couple of days. Hope folks will join us there. But I already told you that at the top of the podcast. All right, let's roll IT to number one, Krishna marker. [00:15:24] Speaker B: And then, you know, number one is we have Edwards Life Science says receiving CE mark approval for the Sapient M3 mitral valve replacement system. You know, so, you know, like Edward says, this is like the first approved transcatheter valve replacement therapy that uses like a transfemoral approach to treat. Mr. So just like a really, really, really interesting innovation out of Edwards and now it's approved for use in Europe. [00:15:57] Speaker A: Fantastic. All right, well, great, great news. Important product by Edwards, they continue to really double down on the structural heart space. And good news, with the approval in Europe, do we know where it is? Is it FDA approved already in the. [00:16:14] Speaker B: U.S. no, right now it's investigational. [00:16:17] Speaker A: So, okay, so interesting that it got Europe approval first. I'm sure there's a reason for it and we're not going to get into the whole big picture of the fda, but just interesting timing. All right, all right, Chris Newmarker. Well, Enjoy the beer, Moses and the Easter Bunny. [00:16:34] Speaker C: Yeah. [00:16:35] Speaker A: And we will talk next week and then of course, we'll see everybody at Device talks, boss. On April 30 and May 1, if you see Chris and I walking in the halls, please stop us and say hello. [00:16:49] Speaker B: Yeah, say hi. That's one of my favorite things about the Boston show is being able to catch up with people and learn about new things. So be awesome. [00:16:58] Speaker A: Chris Newmarker and Sean Hooley will be scouring the exhibit floor, talking to our many great sponsors and reporting live from the floor. So go look for, look for them down there. [00:17:08] Speaker B: Might even rock a little phone video to something like that. There we go. [00:17:13] Speaker A: Get the tripod for you. I'll give you my Bluetooth lapel mics. We're going to go to town. All right, Chris Newmarker, thanks for delivering the Newmarkers newsmakers. Now we're going to feature one of our speakers from Device Talks Boston. We're doing something different this year, creating these future of segments, just short 15 minute presentations about where specific med tech specialties are headed. And Dr. Scott Sigman, who we'll have on today, was kind enough to handle the orthopedic industry and he is the best person to do the job. He's an orthopedic surgeon. He's also a podcaster and he's got some podcast news. He's got a current show called the Ortho Show. That's fantastic. But you can also hear the news in this interview about a new podcast that he's launching. So in addition to podcast talk, we'll also talk about the future of innovation. And Dr. Sigman and and I will be taking stage. We'll be kicking things off at Device Talks Boston with again, short 15 minute conversation about the future of ortho. And then I'll sit down with Ivan Tonos, the CEO of Zimmer Biomet. So it's going to be a great start to do two days of fantastic medtech talk. So now let's hear this interview with Dr. Scott Sigman. Well, Dr. Scott Sigman, welcome to the podcast. [00:18:32] Speaker D: Hey, Tom, Great to be here, brother. [00:18:34] Speaker A: Great to have another podcaster on a podcast. It's always so much easier and, I don't know, more fun because we get each other. [00:18:41] Speaker D: The best podcasts are the ones with great hosts and great guests. No doubt about it. [00:18:46] Speaker A: No doubt about that. Well, I'm really grateful for you taking some time out of your day today. We're talking at 8:15 because you have a busy day, but also on April 30, when you'll be at Device Talks, boss, and opening up the whole damn thing with your state of ortho address, 45 minute oratory exploration into the. No, actually it won't be that at all. It'd be a quick 15 minute opener for the event. And I really wanted to set up this future of series at Device Talks Boston to give a look into where we're headed. And I'm excited to have an actual physician there because that's a blind spot for Device Talks and I think probably for a lot of, a lot of medical devices, it's an area that we're trying to unpack and understand. So before we get into all of that, and I'm talking way too much for a podcast host and not letting my guest talk, talk a bit about you. How did you come to be who you are? How did you choose a field of career in medicine? [00:19:41] Speaker D: Well, I'll get there for a second, but I just want, you know, my listeners to know. It's like I feel like I'm going to be opening up for Taylor Swift. You know, we've got the, the great Yvonne Tornos, the CEO of Zimmer Biomet, who's I guess coming up right after me. So there's a lot of pressure on me here, Tom, I gotta tell you, he'll be watching. [00:20:01] Speaker A: And you're right, he's a superstar on LinkedIn and elsewhere. So it'll be a tough act to have follow you. [00:20:10] Speaker D: Well, it'll be a pleasure to be there. The number one passion in my orthopedic practice, which has evolved over 35 years, is that of innovation and constantly trying to be at the forefront of the newest and greatest things that are gonna be coming down the pipeline for my patients. And so I've been involved with medical device development, professional education. I have all of the CEOs of the largest medtech companies on my speed dial at this point. Now my gray hairs have gotten me to that point. So it'll be awesome to be able to share what I think is coming down the pipeline for orthopedics and med device in the future. It'll be a really great discussion. [00:20:51] Speaker A: I would keep an eye on your phone at Deviceox Boston, because I'm sure a lot of people would like to have, have that information. So keep it in your pocket. [00:20:59] Speaker D: Yeah, no, yeah, that's a good point actually. I've got to make sure that all of that stuff kept. You got to come to the fro your person and maybe you find your Way into my contacts. [00:21:13] Speaker A: So why did you decide to be a surgeon? [00:21:16] Speaker D: Yeah, it's funny, I was like in 10th grade and I was a captain of the lacrosse and football team. I was actively involved, loved sports, was a straight A student. My father was a chemical engineer from mit. And one day I hurt my knee and I went to this really cool sports medicine orthopedic surgeon who had been the captain of the lacrosse team at Johns Hopkins. And I was like, man, this is what I think I can do. I can bring together the intelligence and then I can bring together the sports medicine, bring those things together and I never looked back and here I am. So it was a great choice for me. [00:21:49] Speaker A: That definitely is a marriage, a cultural marriage that's visible to anybody who follows ortho. It's a very team oriented, athletic sort of field. I know those qualities are really necessary in the orthopedics industry. Why is that? What is it about that culture that blends so well with orthopedics? [00:22:08] Speaker D: I think a lot of us actually are paths into orthopedics. If you listen to my podcast, the Ortho show, We've had over 200 guests from around the world or orthopedic surgeons or within industry. And they all, most of them will tell you I had some sort of an injury when I was a kid and I was playing sports and sort of, then it was sort of that crossover. It's interesting. And even in the medical device space, when they're looking to hire for the young listeners that are out there, they love athletes that have been part of a team approach because you're motivated, right? You like to win, you're good around others and communicating with others and being part of a team approach. And I think that that is why a lot of us are drawn to this profession. [00:22:50] Speaker A: That's great. So I know we have only a few minutes with you, but so let's talk a bit about your talk at Device Talks Boston. And we're not going to. You're not going to share your points here, but I was hoping that you could sort of give us again a peek inside of the ortho world from your perspective. I want to ultimately end up understanding what are five things that you'd like to see the medical device industry do to make your job easier and to make patients lives better. But before that, where are we in your. What. What is not jokingly, what is the state of ortho? And I'm asking that because when I started covering medtech, there was an assumption that like ortho's fine. Like, we don't need to innovate. An Ortho, like 90% success rate, yada yada. All the, all the med techs were looking at neuro and all cardio and all these areas where they could stuff tubes into things and make people healthier. But ortho was left alone. Largely. That's not the case anymore. We're talking and Ivan Tornos will cover a lot of that. This has become a tech infused specialty. What's your take on that as an orthopedic surgeon? Are you excited about that? [00:23:56] Speaker D: Yeah, it's long overdue. I mean, you know, like my kids can control NASA satellites with their smartphone and I go in to do arthroscopy and there's like wires. I'm like, wires in life. Right. And so, yeah, I mean, it is long overdue. Artificial intelligence is going to make us better doctors. There's all the new robotics and navig things that are happening as well. So there's a lot of new technology that is long overdue into the orthopedic space. And again, I always hearken back to the ortho show where I have these amazing guests on as well, and we talk about the future. And so I think that there is a really bright future. You know, Yvonne Torno probably does it better than anybody. He's no longer a widget company. Right. That's what medical device was in orthopedics. We built tools, everything was mechanical. But the other thing that's really revolutionized orthopedics now moving forwards is the biologic aspect of how we're trying to biohack the body into creating a healing response. And oftentimes the body stalls. And you quoted 90%. Yeah, we're probably 90% when it comes to metal stuff. But when it came to rotator cuffs and ACL surgeries, we had pretty high failure rates. And so for me, the next great movement in orthopedics is going to be bringing in biology, bringing in technology. We're no longer just operating on mechanics anymore. I'm using my biology degree from tufts University from 40 years ago and we're incorporating that in the stuff that we're doing every day now. [00:25:26] Speaker A: Go Jumbos. Go jumbo. [00:25:29] Speaker B: Exactly. [00:25:30] Speaker A: I'm a BU terrier guy. [00:25:32] Speaker C: All right. I love it. [00:25:33] Speaker A: We can coexist. So final question. I'll let you go. You talked a bit about the ortho show, I'm assuming. Where can folks find the ortho show? Because I love a good podcast. I admire great podcasts. And yours is one. And people always ask, how do you make a good podcast? And you make a good podcast by making a good podcast. It's like, how do you create a good restaurant? It's like, you make good food. That's a good restaurant. What are you looking to accomplish with the Ortho show? And how can folks find listen to the Ortho show if they're not already greatly appreciate it? [00:26:04] Speaker D: They should. We are. We're niche, you know, we're a niche area. Right. We're within the orthopedic industry. But I'm always surprised by the number of doctors and med, device and pharma people that are listening. Plus, you know, everybody knows that listens to my show. You gotta. My mother Judy's always listening too. So you gotta be able to share what you're talking about in a way she can understand. We're on all places at your own podcast, Apple, Spotify, et cetera. I've got some exciting news, Tom, and that is we're about ready to blossom and move on to a larger potential listenership. And there's a new podcast called Smart Medicine powered by veridigm. And I am going to be the host of that podcast moving forward as well. So we're moving into a more general medical space at this point where we'll talk about technology and all the things that matter to patients as to healthcare providers as well as payers, about the things that we can do to make our healthcare in America even better than it is today. So we're excited to be able to share that. That's coming out in May. [00:27:01] Speaker A: What's the name of that again? [00:27:02] Speaker D: Smart Medicine. And it will be in all places. You'll listen to podcasts as well, Spotify, Apple, et cetera. YouTube as well. [00:27:09] Speaker A: All right, well, folks should certainly listen to that and track it down. It's an easy name to remember. Smart Medicine. And they should definitely join us at Device Talks Boston, where they can meet you and ask to take a look at your phone and get some of those phone numbers. [00:27:21] Speaker D: Because the trick is can you get into the contact list? [00:27:25] Speaker C: That's where you want to meet people on the fro. [00:27:28] Speaker D: We got a lot of great stuff going. [00:27:31] Speaker A: Everyone can work toward that. Scott, thanks for joining us today. Go get to work. [00:27:34] Speaker D: Looking forward to seeing you, Tom. Thanks for the opportunity. [00:27:38] Speaker A: All right, well, I certainly hope you'll join us at Device Talks Boston. Now we have another great Boston MedTech story. You're going to hear from Daniel Lavangi. He's the CEO of Sarah Basque, which I think could potentially be one of Boston's next big med tech success stories. Let's listen. Well, Dan Lavangie, welcome to the podcast. [00:28:04] Speaker C: Thanks, Tom. Glad to be here. [00:28:06] Speaker A: Good to connect with another Massachusetts Boston guy. So we can just spend the half hour talking about the Red Sox and all the good things that'll happen over the next five months, or we can focus on your company and your career. So maybe we'll do the latter. Dan, how'd you find your way into medtech? [00:28:26] Speaker C: When I was much younger, I managed to land a job with Abbott Laboratories, and at the time, Abbott was a very highly regarded global diversified healthcare company. I joined as a sales representative in the pharmaceutical division of Abbott and moved through a career progression there into a variety of sales and marketing roles, eventually ending up in the diagnostics business at Abbott. And then. And I spent 17 years there, had a great experience. It was really a terrific training ground for a sales rep to join a company and progress through the ranks at Abbott. [00:29:17] Speaker A: So you were selling pharma the whole time? [00:29:20] Speaker C: No, I was selling pharma and then moved into diagnostics and finished the last portion of my career there in the diagnostics business. [00:29:29] Speaker A: And what got you that job? I'm looking at your LinkedIn profile. You were went to Northeastern for pharmacy, were you? Did you have other career intentions and you just abandoned those for this remarkably rewarding career in medtech? What happened there? [00:29:43] Speaker C: My career intention was to get a job and support my wife and my new baby. And that was as a pharmacist for clarifying. [00:29:53] Speaker A: Yeah, very clarifying for you. [00:29:55] Speaker C: Yeah, that was as a. I practiced pharmacy as a registered pharmacist for a couple of years and then managed to hook on with Abbott. [00:30:05] Speaker A: You ultimately moved into executive roles. Did you always see yourself leading a team, leading a company? [00:30:12] Speaker C: Well, you know, as I said, Abbott was a terrific place to learn. And there was a very clear, clearly defined career pathway from sales position up through marketing, sales training, marketing, into executive management at the company. And that was really one of the great experiences at Abbott is that you could define for yourself if you chose to a career path and if you performed, you were able to progress through the organization and take on more responsibility and eventually make a lot more money and have a lot more responsibility. [00:30:51] Speaker A: Excellent. And you moved over to be president and eventually COO at Scitec Corporation. Scitech was one of those cool companies of 20 years or so ago. You and Hologic were sort of battling it out for market share in the Women's Health special. I don't Know, if you're actually competing for, were you competing for products? Were you sort of competing side by side for products? [00:31:13] Speaker C: They were in a very different business and they were focused on women's health, but theirs was a capital equipment business focused on the mammography segment. And they eventually acquired, you know, Scitech back in, in 2007. But I joined Scitech directly from Abbott. I was recruited there by a fellow that I had met at Abbott who left about a year before I did to join saitech when it was a very early stage venture funded company. He recruited me there and together we basically built that company and had a great run. [00:31:50] Speaker A: Is there we're going to go into your other roles as CEO. You're CEO of Keystone Dental, CEO of Dune Medical Devices. Now obviously you're CEO of Saravask. And we'll get a gap in between where you were a managing partner at Aton. And I'm not sure if I'm saying that right, but we'll get into that. But what are some of the commonalities, the common qualities or the common lessons that you employed as CEO at these various companies? Is there a common approach to being a CEO or is it a very specific application for each company? [00:32:23] Speaker C: Well, I think a lot of it depends upon, you know, the size of the company, the stage of the company. At SciTech we grew from 20 employees when I joined to I think 1600 employees by the time that the company was acquired. And you know, my approach, and again I attribute a lot of this, my experience at Abbott to this. My approach at scitec was I walked the building every day, met with, you know, leaders of each of the functional areas every day that they were in their office. We had customers in the company every week for training. So it was a great experience to be able to meet with customers. And I really, I would say I formed my approach to leadership and management in a company from my experience at Abbott because that was the culture at Abbott. It was very, leadership was very involved in the day to day operation of the company. Knew, knew a lot of the detail. And while they let you make decisions, there was always oversight and accountability. And I think that was really some of the aspects that I took away from Abbott and applied to these other positions that I was in. [00:33:43] Speaker A: What's the best way to hold someone accountable? What do you find works is the best incentive for folks to keep them to their goals? [00:33:51] Speaker C: Well, you know, there's, there are standard approaches to goal setting and updating on a regular basis and holding people accountable. But I think getting to Know the individual and, you know, try to understand some of the challenges that they're facing, help them think through in an open conversation. To me, that's the way that people respond most positively and have an opportunity to really perform and show what they can do. So I think it's an open conversation, a culture that encourages risk taking and doesn't punish when people take a risk and make a mistake, I guess. [00:34:33] Speaker A: No, that sounds great. So the period of time and the firm, is it Aton? I've always wanted. I've spelled it, but I've never said it. Aton or Aton. [00:34:41] Speaker C: Interesting name name. Aton stands for Aids to navigation. [00:34:47] Speaker A: Okay. [00:34:48] Speaker C: And my business partner for many, many years, Pat Sullivan. Pat is a graduate of the United States Naval Academy, and I've been a kind of a lifelong sailor. So the two of us decided that we would name our investment firm Aton Partners. So again, it stands for Aids to navigation. So it's the buoys and the markers that you find in a bay when you go out on the water. [00:35:12] Speaker A: That's great. And Patrick was, of course, he was the CEO of SciTech, correct? Correct, yeah, at the time of the acquisition. So what was Aton set up to do and what were you able to do over those five years? [00:35:25] Speaker C: Yeah, we made small investments, early stage investments. We made an investment as an example in a permanent sterilization technology. We were the lead investors in the seed round. That company was also acquired by Hologic, and we also invested in a company called Constitution Medical. And so Pat and I started that company. [00:35:50] Speaker A: I remember that name. Yeah. [00:35:51] Speaker C: We funded it together with Warburg Pincus. And the objective there was to build and develop an automated system for the hematology laboratory. And it was based upon imaging technology that we had begun to develop at Saitech Corporation. So we licensed IP from Saitech, we hired some of the engineers that work for us at scitech, and we set about to build this very different approach to the complete blood count, which is a very frequently administered test in the hematology lab, performed in the hematology lab based upon old technology. Flow cytometry is really the way it's done. And the technology that we developed involved high speed imaging that would facilitate the evaluation of every sample and do it more accurately and in a much faster way. We spent about four or five years on that project. And that company was acquired by Roche diagnostics back in 2013. [00:37:02] Speaker A: Well, now let's move into the present and talk a bit about your role, or let's talk about the start of Saravask and tell us a bit about Saravask, the company. What's your device and what's your objective? [00:37:16] Speaker C: Yeah, so we're in the interventional neurosurgery segment, and our device is a endovascular treatment for patients with hydrocephalus. I think the story of us starting this is a little bit interesting in that my initial exposure to interventional neuro procedures came when I was the chairman of EV3. And EV3, at the time that I was involved, had a neuro business, primarily treatments for stroke and aneurysm. And so that was my very first exposure to doctors that actually navigated catheters up into people's brains and treated conditions like aneurysm and stroke. And so I became somewhat familiar with the opportunity at the time that we sold Constitution Medical to Roche Diagnostics. Pat and I were looking for our next opportunity for aton, and we met with the neurosurgery team at Tufts Medical center here in Boston, and they had this concept and had actually filed and had been a patent, had been allowed on an endovascular approach to the treatment of patients with hydrocephalus. So we met with the team, we met with the licensing team at Tufts, and we began to do our diligence on the, you know, the condition itself, the current standard of care. And, I mean, we were basically amazed at the fact that this disorder, which affects about a million people in the United States every year, is treated with a technology that's 50 years old and that has a failure rate that's among the highest of. Of any neurosurgical procedure out there. I mean, this is a technology, an old approach, that has a failure rate of somewhere between 40 and 50% within the first two years. And it involves an invasive open surgical procedure, which involves a burl hole in the skull, a catheter passed down through the brain, and a long tunneling procedure that allows the passage of a catheter down into the abdomen so that cerebrospinal fluid flows from the ventricle of the brain through this long catheter system and is reabsorbed into the peritoneum in the abdomen. And that is the standard of care. And again, the failure rate is among the highest in all of neurosurgery. And failures occur as a result of postoperative infection, disconnection of those components because patient's moving or growing, clogging of the catheters, twisting of those catheters. It's a procedure that desperately needs improvement. [00:40:20] Speaker A: People can't see My face. But yeah. No, it sounds medieval. [00:40:26] Speaker C: That's a good description. [00:40:27] Speaker A: Yeah. So let's back way up to the problem. The hydrocephalus. How is that formed? How are a million people, years, and a million people a year impacted from it? What is the cause? Is it a trauma? Is it something else? [00:40:40] Speaker C: Yeah. So you and I, we produce about 400ml of cerebral spinal fluid each day from tissue that lines the ventricles of the brain. And that fluid circulates around the blunt brain and spinal column and provides some cushioning. It also provides a way for metabolites in the brain to be excreted and to be removed from the brain. And because we produce about 400ml and we can only accommodate about half of that, there's a reabsorption of cerebrospinal fluid that takes place constantly. And that excess CSF is reabsorbed through structures that line the venous outflow in the brain called the arachnoid granulations. So in patients with hydrocephalus, there's an impairment of that absorption. And as a result, pressure builds up inside the brain, intracranial pressure rises, and patients begin to experience symptoms that can start with drowsiness and lethargy, can eventually develop into a coma, and patients can die if they're untreated. The cause can be congenital. Patient is born with a malfunction that doesn't allow reabsorption. It can happen as a result of trauma. So patients who have had head trauma or have had a stroke or an aneurysm that's ruptured, or elderly patients who have a disorder that doesn't allow them to reabsorb this excess cerebral spinal fluid. And the total number of cases per year is estimated to be roughly a million patients. [00:42:26] Speaker A: Wow. So now I'm freaking out a bit thinking about all this fluid that's being built, that's being created just as like every day. You don't even know these things are happening in your body. So the treatment that you described, the current gold standard. So is that a permanent fix? That's something that, I mean, this doesn't just. Does this just clear up or. If you've stopped absorbing, you're done absorbing and it's not going to kind of come back. [00:42:54] Speaker C: There are some patients who suffer from hydrocephalus as a result of head trauma in whom long term shunting is not going to be required. Basically, the system by which that excess CSF is reabsorbed, reabsorbed repairs itself over time. But that's a small number of patients. The majority of patients that have this disorder have a lifelong disorder that requires diversion of cerebrospinal fluid for their lifetime. And in children, it's really a very difficult situation in that these kids have frequent failures. They require frequent revision or replacement surgeries. There's an inverse relationship between their cognitive development and the number of shunt revision procedures that they have to undergo. So in kids, it's a major problem. And again, they require lifelong CSF diversion. In the elderly, it's really a neurodegenerative disease in the elderly that if you catch it early enough and you place a shunt and the shunt doesn't fail, those patients have a pretty good outcome. If they're untreated, which the majority are, they go downhill pretty rapidly, and they have a five year mortality rate that's somewhat similar to stage four lung cancer. So it's a disorder that really needs to be treated. Unfortunately, in the elderly, the surgery is in many cases worse than the disease. [00:44:39] Speaker A: Sure. [00:44:39] Speaker C: Yep. And as a result, many of those patients go untreated and they end up in custodial care. They end up being taken care of by their family. But it's a disorder that affects many, many elderly patients, and in many of them, it goes untreated. And that's really one of the attractions of our system. Because our approach is minimally invasive. We leave a very small device behind that allows it functions as the arachnoid granulation functions that I talked about earlier. It allows passage of cerebrospinal fluid through this tiny little device from the subarachnoid space back into the venous system, which is the normal pathway. [00:45:27] Speaker A: One last question about the disease, and then I want to get into your solution and the creation of it, but is there any reason the fluids can't be drained out of the brain into a bag or something like that? Does it need to be kept into the body and reabsorbed in the abdomen? [00:45:42] Speaker C: No. You can put a catheter in the brain and drain it to a bedside bag. Unfortunately, you've got an opening in your head, so you're in the ICU when that happens. [00:45:53] Speaker A: Okay, that's not a solution. Okay, let's move on then. Tom's not going to solve this problem. So what was the process of inventing the solution, of coming up with the eshunt? Was there already when you sat down with those physicians, did they have a solution in mind or did they just present the problem and the solution was something that you needed? To work on? [00:46:15] Speaker C: Well, as I said, they had a patent that had been allowed, so there was a drawing that we had. Unfortunately, I guess, fortunately, the device that we have and we're placing in patients today has very little resemblance to the drawing on the patent filing. It took a lot of our development, effort and refinement to get to the point where we could actually navigate to an appropriate location at the base of the brain, cross from a venous blood vessel across the dura, and leave a device in place that allows passage of. Of cerebral spinal fluid. That design process and all of the testing on the bench in an animal model was a five to six year process that involved not only the development of the device itself, the permanent implant that we leave behind, but a delivery system that would allow us to, in fact, deploy the device successfully. So it took us almost six years to get to a point where we went to fda, actually, we went to the regulators in Argentina and got approval for our first inhuman study, which we conducted there with Dr. Pedro Lillick and his team in Buenos Aires. [00:47:40] Speaker A: So I can't imagine how many iterations you went through of that device. But what was the technology that ultimately allowed you to come up with the ESHUNT system? What are we looking at the video? It looks like a longer kind of implant that you put into the side of the vein and connects, like you said, into the brain area. Sorry, but how many different solutions did you try and not find the success you found with the eshan? How long was that? It was a long process, year wise. But how many different technologies did you try? I'm just curious. [00:48:22] Speaker C: Actually, there were basically two. So first of all, take a step back. The anatomy of the location where we deploy this implant has a favorable structure in that there's. If you navigate from the internal jugular vein into a venous outflow at the base of the brain called the inferior petrosal sinus. There's a turn that occurs at the base of the brain, and so we take advantage of that anatomic structure that allows us to navigate up to the point of that turn and then use that turn to deploy our device across the dura. So that took us a while to understand the anatomy. No one had really mapped the anatomy here very well. We undertook that process with the team at Tufts, where we analyzed 100 MRI studies in patients to basically assess the anatomy, do all the measurements understand specifically the variability from patient to patient. And as a result of that, we were able to design our delivery system to take advantage of the anatomy that we knew and Then the next challenge was to develop a device that would actually respond to the changes in pressure in the subarachnoid space in comparison to the venous outflow. [00:49:53] Speaker A: Interesting. [00:49:54] Speaker C: So the pressure inside your brain is always higher than the pressure in the vein that's nearby. And so we take advantage of that pressure differential. But there's always a range of pressures that occur, whether you're standing or lying down, you're coughing or sneezing. And so we had to develop a device that had a valve that would control the rate of flow of cerebrospinal fluid. And we have achieved that. And it's a valve that basically responds to the differential in pressure between the subarachnoid space and the venous outflow. And we've demonstrated that on the bench in animals and now in humans, showing that the valve mechanism can achieve what we had hoped, which was to respond to pressure differential and to achieve a normal intracranial pressure in patients with this disorder. So I'd say we had a number of iterations of valve design, and. And I think that was probably that contributed to a couple of years of the development to better understand how we would, in fact, develop a catheter with a valve at the end that would control the rate of flow. [00:51:16] Speaker A: Anything unusual in terms of making such a device, in terms of the materials you need, biocompatibility issues, because you're sort of straddling two parts of the body. What were some of the challenges with manufacturing? [00:51:28] Speaker C: Yeah, I think the manufacturing. We use materials that are used in and have been used in other devices. But the biocompatibility assessment required in order to satisfy the regulators was a huge effort by us and was only recently put to bed, frankly, with an approval of our. Our pivotal study. [00:51:57] Speaker A: Fun. So, and how is the device delivered? Is it through? Do you have to go through the groin? Do you go through the neck? How do you get in there? [00:52:04] Speaker C: Yeah, it's a femoral in the groin. Ephemeral venous access that. We then use our delivery catheter to navigate to that location where we want to deploy our device. There's a needle at the end of our catheter that has a shroud over it that protects the needle or protects the vasculature as you navigate to that, to the deployment location. Once you're in that location, that shroud is withdrawn and the needle is exposed. We then advance across the dura, and the device itself is loaded inside the lumen of that needle. And so once we're across the dura with the needle we advance the device. There's a self expanding nitinol anchor that anchors the device on the subarachnoid side of the dura. And then we withdraw the delivery catheter and the device. And the catheter, the outflow catheter is left behind and it's a permanent implant. [00:53:04] Speaker A: Amazing. So let's talk a bit about the clinical trials. You mentioned the work you did in Argentina and now you have the IDE with the fda. What are the plans for testing this and moving forward? [00:53:16] Speaker C: Yeah, so in the first study we did, we selected a very particular patient type because we really had to demonstrate that this new device would act as we had proposed, which would be to reduce elevated intracranial pressure and maintain that pressure in the normal range. And so the patient type is a patient who would have had a ruptured cerebral aneurysm. Their aneurysm would have been repaired. And because they have blood in the CSF from the ruptured aneurysm, they're in the ICU and they have an external ventricular drain. So they actually have a catheter in their head that drains blood and CSF and also has a pressure transducer within it. So you can measure intracranial pressure actively. And in normal care of these patients, that drain is clamped after about a week to 10 days after the blood seems to have cleared from the csf. And if the patient's pressure remains normal, that drain is pulled in. About 20% of the patients, they've developed hydrocephalus. And so when they clamp the drain, the pressure goes back up and that patient is typically taken to the OR and has a conventional shunt procedure. So in our study, we kept that drain clamped and we placed our device. And because we could measure pressure in real time, you could see that the function of the device in lowering pressure and maintaining pressure. We did that in 15 patients in a first in human study. And we demonstrated consistently that we could lower very elevated intracranial pressure almost immediately into the normal range and maintain that pressure in the normal range for the next 48 hours. That was the primary endpoint, at which point that external ventricular drain is removed. So that was really proof of concept that the device in fact would perform as we had proposed. We then took that information, went to FDA and proposed the study. In the elderly patients, these patients that have this disorder that compromises their gait, so they have a very easily recognized stumbling gait, they have cognitive dysfunction, and they typically have urinary symptoms, incontinence and frequency. And so we got approval for a single arm study by FDA in patients with normal pressure hydrocephalus, this elderly variant of hydrocephalus. We also conducted that very same protocol with our team in Argentina. So we've now treated a total of 65 patients. I think 50, roughly 50 of those patients have reached the primary endpoint in that study, which is improvement in those clinical symptoms at 90 days. And we just filed our annual report with FDA and we reported 97% of those patients achieved the primary endpoint. And we had no serious adverse events, which is just remarkable when one compares what you would expect to see from a conventional shunt procedure in the background. We applied with the FDA to approve an IDE study, what we call our pivotal study. And so we've just begun to enroll that study. It's called the Stride clinical trial. It's a randomized trial comparing our device to the conventional shunt. And we will enroll roughly 230 patients in that study. We've got 10 sites in the United States that are activated, are actually enrolling patients, and have begun treating. And our goal is to execute the study in roughly 20 sites in the United States and four to five sites. [00:57:27] Speaker A: Outside the U.S. yeah, I'm sorry, just to recap, the 50 that you mentioned, 50 to 60, you mentioned where you were, saw the improvement. That was in the US So that was in Argentina. [00:57:36] Speaker C: So that's a combination of both. [00:57:38] Speaker A: Of both. Okay, cool. So you did get breakthrough device designation for this, correct? [00:57:47] Speaker C: We did, yep. [00:57:48] Speaker A: So what does that do for you and your abilities to execute on the trials? What kind of latitudes that give you? [00:57:55] Speaker C: The primary benefit, frankly, is a more open conversation process with fda. So as opposed to filing a pre sub request with FDA waiting 75 days, then having the meeting, we can actually pick up the telephone and call the team at FDA and get a meeting on the books in a matter of days. So it really facilitates the interaction between the company and the regulators. [00:58:22] Speaker A: So the problem you described is horrible. The solution you described is horrible. Why hasn't anyone else. Maybe I'll refer. Have others tried to come up with solutions and where have they fallen short? Or have they fallen short? This seems like a problem that someone should have tackled a while ago. [00:58:43] Speaker C: In other words, why are you guys so smart? [00:58:47] Speaker A: Well, I wanted you to say it, but no, I mean, the way you describe it, I'm just like, oh my gosh, this is horrible. [00:58:55] Speaker C: There's a couple of reasons. First of all, there are some very large companies involved in the manufacture of the Current product, the current conventional shunt. And they have spent most of their time, effort, energy, resources on trying to perfect the valve mechanism that controls the rate of flow of cerebrospinal fluid from the brain to the peritoneum. And that's a very complicated physics problem in that there's no relationship between those two cavities and patients. One of the more frequent complications that patients experience is over drainage. So there's too much csf, and as a result, the brain collapses down into the cranium. They can develop subdural hematoma, subdural effusion. And so this valve mechanism that is intended to control the rate of flow has been the source of most of the innovation. In addition, they've spent a lot of those companies, have spent a lot of time and energy in adding antibiotics to their catheters to reduce the rate of infection. And there's really been no change in the performance, unfortunately. And so that's, I think, has diverted a lot of the attention in people focused on treatment of hydrocephalus. They've thought about the current system and how do we make that better? That was. I think that's issue number one. Yeah. So I think another factor that's led to us developing this product is the evolution in imaging technology in the angio suite. You know, much of it has been developed and has evolved in the treatment of stroke and aneurysm. But that technology now allows us to have very precise measurements, the ability to be very precise in what we do in the vasculature in the brain. And that, again, I think, has created a pathway for a technology like ours that we can actually navigate to a precise location, cross the dura from a blood vessel safely, and allow the passage of CSF in a much more natural fashion than the conventional approach. [01:01:19] Speaker A: Interesting. So, I mean, you obviously have a lot on your plate right now focusing on the trials and getting this approved in the U.S. but I'm wondering, do you have some other drawings or other ideas of how this technology might be leveraged to treat other conditions? Is this a potential. Is there a potential platform there for other, I don't know, things that can cross the blood brain barrier? I don't know, are there other opportunities for Saravas? [01:01:45] Speaker C: Thanks for that question. But before I get to that, let me just add one really exciting piece of information that has only recently become available to us, and that is, as I mentioned, the pediatric population really suffers from the failure rate associated with the conventional shunt. And we have spent historically very little time thinking about applying our technology to kids in that we really didn't understand the anatomy in children and so we focused on adults. We've done all of our work in adults. But a group recently came to us from Texas Children's Hospital and they did an evaluation of 100 MRI sequences in patients, pediatric patients, to do the measurements that we do to determine if a patient would be an appropriate candidate for our current technology. And they've just submitted for publication, but they've, they've shown that roughly 2 out of 3 kids have an anatomy over the age of 2 that would be able to accommodate our device. So we're really excited about, and we'll be going back to FDA with a proposal to begin to use our device in the pediatric population. And I think the value there is even greater than in the adult population as a result of the failure rates that these, these poor kids experience. [01:03:18] Speaker A: Yeah. Any parent I'm sure would much would rather hear of this option than the other, I'm sure, yeah. [01:03:24] Speaker C: And in terms of other applications, we've spent some time and effort in thinking about the fact that we cross the dura, we're in the cerebrospinal fluid at the base of the brain, we're across the blood brain barrier. Seems to us that there are a lot of therapeutic agents that have a difficulty in crossing that blood brain barrier. So we see our delivery catheter as a potential method for delivering therapeutic agents to the brain. We've done an animal study, we published this study in sheep, in which we administered a gene therapy in a sheep model using our delivery catheter. And then we, we measured both the distribution of that gene therapy and the transduction of neurons in the brain of that animal and compared it to a more standard approach, which is much more invasive, basically drilling a hole in the skull and administering a gene therapy. And we showed equivalence for our delivery method compared to a more invasive method. Because we're a small company, we're less than 30 employees, we've got a 230 patient clinical trial to execute. We spent almost no time pursuing that. But clearly there's interest in applying our technology to deliver therapies across the blood brain barrier. [01:04:57] Speaker A: Awesome. All right, well, this is a great medtech story and thanks for giving me nightmares. Something else to think about. I haven't discovered a new thing to think about in a health way in a long time. So it's always good to know what's out there. But thanks for the work you're doing and for the success. Grateful that you're having some success and look forward to tracking your future success. Thanks for joining us on the podcast. [01:05:23] Speaker C: Okay, thanks Tom. [01:05:27] Speaker A: Well, that is a wrap. Thanks so much for joining us on this episode of the Device Talks Weekly podcast. I certainly hope you'll subscribe to the Device Talks Weekly Podcast Network or the Device Talks Talks Podcast Network so you can get Device Talks Weekly and our other great podcasts. Also connect with us on LinkedIn. You can follow Device Talks there at Mass Device. There you connect with me, Tom Salemi connect with Kayleen Brown, our Managing editor, and of course Chris Newmarker, the Executive Editor of Mass Device. Please join us at Device talks Boston on April 30th and May 1st. Once again, use the code DTWeekly25 if you want to save 25%. Of course. We will also be at Minnesota on June 11th. It's exciting times to be back in the Minnesota market market and I can't wait to meet our Twin City friends there. Go to minnesota.devicetalks.com to register for that and boston.devicetalks.com to register for Device Talks Boss and can't wait to see you in person. And when we do, please make sure you stop us and say hello. It's a great treat. Chris is right. It's a great treat to meet people who enjoy the podcast. So thanks for listening and we'll have one final pre Device Talks Boston episode for you next week. Take care everybody.

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