Episode Transcript
[00:00:00] Speaker A: Hey, everyone, Tom Salami here. Welcome back to Device Talks Weekly. We've got another great episode for you. A little later in the podcast, I'll Talk with Carl St. Bernard. He's the CEO of Jupiter Endovascular, cool company with a technology that makes a great deal of sense.
And he's got an interesting career, including that one interesting factoid about his time at GE Healthcare. So you'll enjoy that, I'm sure.
Just before that, Kayleen Brown will lead our FOMO conversation with this week's guest comes from Averna. So thank you to Averna for joining us as part of our FOMO series. And then of course, we'll kick things off with my Newmarkers newsmakers. I've had a little trouble saying that throughout the newsmakers. Chris Newmarker from Mass Device will bring the biggest news of the week. Before we let you go, make sure you join us at our Cardiac Innovations Week. It's coming up February 3rd. This is of course digital. This is part of our Device Talks Tuesday series. You can go to devicetalks.com to register. I'll also put a link in the show notes. We've got three great presentations, might be adding a full forth, we'll see, but at least three from the great folks at Synacor, Field Medical and valcare. So we'll be looking at three different areas of cardiac innovation. Obviously, this is a hot space and really looking forward to bringing you those stories. We are fortunate to have some great sponsors, Jubil Healthcare, PSN Labs, Solisis and Confluent. So I hope you join us for our free series where you can participate in my questions in the conversation I'll have with these great companies and you can ask your questions as well. Or if you don't have time to join us at noon Eastern on each day, you can of course watch On Demand at your convenience. So again, really looking forward to speaking with Matt Schuster from Syncardia, with Steve Michelson, Dr. Steve Michelson of Field Medical, and on Thursday we will speak with Steve Sandwig and Dr. David Mirkin there with Valcare. So register now. All right, folks, let's get this podcast started.
All right, you ready for this?
[00:02:14] Speaker B: Ready.
[00:02:31] Speaker A: Chris Newmarker, how are you, sir?
[00:02:34] Speaker B: All right, Tom. Doing all right.
[00:02:36] Speaker A: Got some weather come hitting us both this weekend, huh? What do you got coming? Going? Coming your way in Minnesota.
[00:02:42] Speaker B: Monster weather. I mean, you know. Yeah, just on top of just all the, the craziness still going on in Minneapolis, unfortunately.
[00:02:49] Speaker C: We've.
Yeah.
[00:02:51] Speaker B: Tonight we're talking on Thursday and tonight, it's gonna be a good, good 20 below zero. That fun weather where you, you know, there might be a few. Few pops as nails pop out of the house. Like, when it gets cold enough.
[00:03:03] Speaker A: Does that happen? Nails pop out of the house?
[00:03:05] Speaker B: Nails pop out of the house?
[00:03:07] Speaker A: Really?
[00:03:07] Speaker B: I heard a little pop.
Like, there might have been a nail that just popped out of my house.
[00:03:16] Speaker A: Just walking by someone's house and suddenly get pelted with a nail. It just comes, poof, just shooting away. Wow.
[00:03:20] Speaker B: When it gets that cold, too, there is a slight chance you could have trees explode.
[00:03:27] Speaker D: I mean, not like pieces of wood.
[00:03:30] Speaker B: Flying in the air, but a good, good, good solid crack. Like. Like crack cracking open.
[00:03:38] Speaker A: This is a.
This is an unusual place. Minnesota, where you live. I had no idea it was so, so Narnia. Like, this is fire. Houses shooting nails and trees exploding. This is quite magical.
[00:03:49] Speaker B: That's why we. Well, that's why we're so nice to each other. We've all got to help each other out here.
[00:03:57] Speaker A: Wow. All right, we've got some sub zero attempts coming here this weekend, but just, like, the negative two types, you know, negative 10 with windchill, but not anything you folks.
[00:04:06] Speaker B: Yeah. What would happen if it got negative 20 in Boston? Would it be like, everybody be, like, rushing to the store to get.
[00:04:12] Speaker A: People would still go to Patriots games and take off their shirts. I guarantee it.
[00:04:16] Speaker B: They would. Yeah.
[00:04:18] Speaker A: They were shirtless people at the game last night.
[00:04:19] Speaker B: They would just be very cold.
[00:04:24] Speaker A: I didn't say we were bright, But, yes, we have a big storm coming. Snowstorm coming on Sunday, so I think this is. Is this Canada's retribution? Are they firing all their winter weather at us?
[00:04:39] Speaker D: Yes.
[00:04:40] Speaker B: Yeah, they.
[00:04:41] Speaker D: The.
[00:04:42] Speaker B: Yeah, the angry snow gods.
They didn't tell us they have that ability they can summon.
[00:04:50] Speaker A: I've got the Freezemeister up there firing frozen lightning bolts at us.
[00:04:57] Speaker B: I'm gonna go totally nerd. What was that Stone and Thor like, in the Avengers? The thing that could, like. It's like one of the stones that could, like, bring cold in winter.
[00:05:05] Speaker C: Like, oh, the tesseract.
[00:05:09] Speaker B: But the tesseract. Yeah, Maybe Canada has a tesseract.
That's what's going on.
[00:05:16] Speaker A: Canada is inevitable.
[00:05:18] Speaker B: That's why Canada is inevitable. I love it.
All right, fantastic. All right, now we. Yeah, people are like, what are they doing? Why am I listening to this? We, you know, we're here with MetTech News, so we get into meth tech news. That's why we're here. That's why we're here.
[00:05:33] Speaker A: This isn't one of them pop culture podcasts that we're going to talk about. Our favorite movies of January 2026.
[00:05:39] Speaker B: What's your favorite movie of January 2026?
[00:05:41] Speaker A: The Rip was pretty good. The Rip was pretty good, I have to say.
And his and hers on Netflix was, was very, very entertaining as well. It's a little limited series. Yeah. Yeah, for sure. So check it out. All right, Chris Newmarker Let what's number five on the Newmarkers Newsmakers?
[00:05:56] Speaker B: Hey, number five on the list. We've got OpenAI getting into the, the BCI space.
[00:06:02] Speaker A: This one blew my mind. An AI company investing in a BCI company.
Lot of letters, a lot of letters.
[00:06:09] Speaker B: AI, BCI.
I mean, Sam Altman has co founded a startup called Merge Labs.
Reportedly on some of the news reports out there like Bloomberg TFN, they're saying that Merge Labs had a 252 million dol seed round and OpenAI was one of the major, major investors. So this is, you know, in some ways this is kind of like you. We got Elon Musk, you know, with Neuralink, you know, in the, in the space already. And now this looks like it's another Altman Musk matchup in the brain computer interface space.
[00:06:43] Speaker A: Thank God we don't have bubbles here in Medtech, am I right? I mean, 252 million series seed round, that sounds, that sounds perfectly reasonable.
[00:06:55] Speaker B: I mean, do they get, I mean are they getting, hopefully they're getting all the money right away. I mean, because, you know, before the AI bubble bursts, do we still get the 252 million?
[00:07:11] Speaker A: Lordy, Lordy, lordy. I'm sure they will, I'm sure they will. But. All right, well, the BCI space, obviously we love lots of great BCI companies out there.
[00:07:20] Speaker B: A lot of innovation, very hot space, very hot space, a lot of cool stuff going on.
[00:07:24] Speaker A: Just get a little weird when all these tech folks kind of come roaming in into our territory.
[00:07:30] Speaker B: Yeah, we got Musk here. Now we got Sam Altman and doesn't Synchron. I mean, synchron.
A lot of analysts have kind of pointed at Synchron as being actually the company that's kind of got kind of the neatest edge because they got the stent based bci. But even Synchron has some money from some of these big, they do big tech figures as well.
[00:07:54] Speaker A: I can't remember who exactly and I don't want to just guess. I have it in my head, but I don't want to just throw it out there. Because I'll have to edit this later. But yes, you're right. No, it's a hot space for sure.
[00:08:03] Speaker B: Absolutely. So just another sign of that. So there we go.
[00:08:06] Speaker A: Take us back to pure medtech land. Chris Newmarker, what's number four?
[00:08:10] Speaker B: Yes, back to pure medtech land. We have Abbott picking up a CE mark for their Tectiflex dual energy ablation catheter and their plans to get get FDA approval for this in the future.
So this is, you know, this system like can toggle between pulse field ablation and RF ablation. So it's kind of like, you know, Medtronic has had similar technology with the Farah and this is like Abbott's play with that. So yeah, just another cool entrant into this pulse field ablation space.
[00:08:46] Speaker A: Really amazing how many players are out there in this space and how they're beginning to move into different parts of the heart as well. Field Medical of course, moving into the ventricular side of the heart and I think some of the big players are following. So this pulse field ablation space is just spreading rapidly. It's really remarkable.
[00:09:05] Speaker B: Absolutely. And Abbott as well as with Volt.
Abbott's really trying to get involved with this. I mean it's like Boston Medtronic were kind of the first out of the gate in the United States. But Abbott's looking to get going. You know, also this week, by the way, these are OpenAI is by me.
Abbott is by senior editor Sean Hooley. Sean's actually on vacation this week. Like woohoo Sean. So I, I'm, I've been really cranking out some stuff on, on Mass Device. So thanks to Sean for having that Abbott story run out. But you know, I, I covered Abbott's Q4i4 results. We're talking on Thursday. They, they were this morning and they, it seemed like one of the big things I was hearing from CEO Robert Ford and their earnings call was this was like challenges with their nutrition business that were behind this revenue miss they're trying a new pricing strategy over there. They kind of like, you know, they're trying to do discounts or whatever to try to gain market share but it's hurting their at least for now. Like you say it was going to cause some challenges for, for several quarters. But Medtech, I mean, I mean they were a little bit behind but like what the analysts wanted but grew like 12.3% during the quarter.
[00:10:24] Speaker A: I mean that's, they were behind and they got 12, 12.3%.
[00:10:27] Speaker B: Yeah, they wanted more.
[00:10:31] Speaker D: I Mean, yeah, I mean, that, that's.
[00:10:32] Speaker B: That'S, that's really great performance. And I mean, you know, on top of this, you know, Tactiflex duo, C Markin, we had like, you know, Volt, their pulse field ablation system getting FDA approval recently. I mean, we have them acquiring exact Sciences for $21 billion. We've got this Libra Assist CGM app that's using generative AI to predict how your food's going to affect your blood glucose.
Yeah. So they've a lot of really positive news on the medtech front for Abbott. So here's how they get these nutritional business challenges worked through sooner rather than later.
[00:11:14] Speaker A: No doubt they will. All right, Chris Newmarker, what's number three?
[00:11:18] Speaker B: Number three on the list?
Moving on. We got like Johnson and Johnson, you know, had their earnings report this week as well.
You know, sales up a 7.5. Johnson Johnson MedTech sales were up 7.5% in the, in the fourth quarter though. I mean, JJ sharers were kind of like down when the report came up, you know, maybe because they only matched on their earnings. You know, it's like. It does seem like the markets are especially picky right now with all the unpredictability out there.
[00:11:49] Speaker A: Yeah, I was going to say it's kind of hard really to use the markets as a scorecard right now, isn't it? Between what's going on with the tariffs and the non tariffs and the Greenland and the. Not Greenland exactly. I don't know. You could just have bad timing, I think, and have a quarterly call in the morning when something erupts and then you're negatively affected.
[00:12:07] Speaker B: I know.
I've been very careful with our reporting and earnings season to mention how the S&P 500 is doing because you're absolutely right. It's like something else is said and you know, by somebody and the markets like move, you know, another direction, you know, and you know, was it Greenland or Iceland? Who knows? But you know, we gotta.
[00:12:30] Speaker A: Who knows, who knows.
We had Tim Schmidt at Device Talks west talking about their growth strategy and Jim Amarand was kind enough to let me write an article for Medical Design and Outsourcing talking about their move into higher markets and this is starting to pay off. 7.5% ain't bad.
[00:12:50] Speaker B: If you go to Mass Device to look at the full earnings report article that I put out. I made sure to have a link at the end to your article, Tom, so people can check that out as well. Tim Schmidt had some really great things to say at Device Talks West.
[00:13:04] Speaker A: This is a Chris Newmarker written article linking to a Tom Salemi written article.
[00:13:08] Speaker B: Which is just all the planets are aligned exactly.
Jupiter's in Gemini with Saturn. It's just fantastic. I love it.
[00:13:18] Speaker A: All right, what's number two?
[00:13:19] Speaker B: Chris Newarker, Number two on the list we have Boston Scientific. They've got a.
This is interesting. I've noticed the FDA has gotten really big in this new administration with having these kind of early warnings where they're kind of doing some early flags saying, hey, we think this could be serious. And they were flagging a recall that Boston Scientific was doing with this Axios stent and delivery system.
Like Axios is used for like, you know, these endoscopic ultrasound guided procedures to, you know, drain pancreatic pseudosis. But some of the notices out of, in other countries are kind of saying this, this issue that was being flagged like, was, you know, involved with like, kind of like investigational off label uses of it. They're causing a bunch of cascade of events. And the thing that I think probably caught a lot of people's attention was the FDA was saying that at Boston Scientific, it said there were like 167 serious injuries around this and three deaths. So they're asking health providers to stop using these devices.
Unfortunately, Boston Scientific has their working through a potentially serious recall right now.
[00:14:37] Speaker A: All right, well, it's, you know, as far as the FDA is concerned, I don't think you can be too early with such a thing. So.
[00:14:44] Speaker B: Yeah, no, it's, it's, it, I, it does, yeah. Good for the FDA to try to like, experiment and like, get, get some better ways to get the word out, you know, more quickly because, you know, the sooner health providers know, the sooner we can get stuff taken care of.
[00:14:59] Speaker A: Absolutely. All right, Chris Newmacher, move on to number one interesting number one for sure.
[00:15:03] Speaker B: Yeah, this is a really interesting number one. I mean, just nearly a year ago I interviewed Antares Technologies CEO Wayne Patterson for this podcast.
Really interesting story with that company founded Australia, significant presence outside of Minneapolis and Egan.
But they had, you know, a really cool materials technology and they made a smart pivot with it in the pandemic and started, you know, developing these, you know, biomimetic heart valves, transcatheter heart valves. And you know, they're now like moving forward with like important clinical trials with their Duraver. I hope I pronounced that right, Duraver valve.
You know, it can mimic the performance of a healthy human aortic valve.
And they've attracted the attention of medtronic Wayne was nice enough to do a quick interview with me and he said actually that Medtronic wanted to acquire the company, but he's really. Strategically, they wanted to stay independent and Medtronic, after two and a half years of negotiation, eventually agreed to do this up to $90 million investment in them.
Medtronic gets a 16 to nearly 20% stake in Antares, but Antares gets to keep a great deal of freedom and they also have. They could potentially be doing some kind of co commercialization partnership with Medtronic, potentially manufacturing collaborations around the Twin Cities. I like how that sounds.
[00:16:45] Speaker D: Of course you do.
[00:16:46] Speaker B: Yeah, right.
[00:16:49] Speaker A: You want all the jobs.
[00:16:52] Speaker B: Come on, just bring the medtech shots.
No. Rising tide lifts all ships, Tom. Right, Absolutely.
[00:17:00] Speaker A: No, this, I mean it's. Yeah. Medtronic is staying under the magic 20% mark, so they don't have to do all the additional reporting and everything that goes with that.
In addition to those two things you mentioned, they also get a non voting board seat and I mean it seems like they have an inside track on if they start. If they start talking to another company about or if another company comes to and terrorists looking to acquire Medtronic will.
I don't know if they have a right of first refusal or anything like that, but they certainly will be made aware of it and be allowed to respond to it. But. Interesting. That expires right at FDA approval according to the SEC documents.
[00:17:41] Speaker B: Interesting.
[00:17:42] Speaker A: So I mean, if things are looking good, I think Medtronic has the ability to act and I would pronounce it Duravr. Do you think that's right? Because it's capital avr. D U R Capital avr.
[00:17:54] Speaker B: Same thing in like tavr. Like durr.
[00:17:57] Speaker A: Maybe you're right.
[00:17:58] Speaker B: We'll have to. We are going to have Wayne AT Device Talks, Minnesota, May 4th. So we can get this. We'll get this cleared up with Wayne. We'll get this pronounced. He's probably rolling his eyes at us right now. So he listens to this like he's.
[00:18:11] Speaker A: Thinking on your podcast.
[00:18:13] Speaker B: I talked to you this week, Chris, and you didn't ask me how to pronounce.
[00:18:18] Speaker A: Yeah, sorry. Well, in your defense, you were writing it like it's not a big concern, but when they start talking about it. But we could have gone back and listened to the old podcast. So we'll, we'll. I'll go do that maybe and then I'll pronounce it correctly in the intro. Yeah, yeah, there you go.
[00:18:32] Speaker B: And then people can just laugh at us stumbling on how Stupid.
[00:18:34] Speaker A: We are for sure. Why not? Join the club.
But yeah, no big, big news, I think. Interesting deal by Medtronic, like I said on LinkedIn, looked a lot like the Mazer deal, where it's sort of a investment but plan to acquire. And there's a lot going on in the cardiovascular space for sure.
[00:18:55] Speaker B: You know, and I was excited too about this because I was writing a story about their presentation at Medtronics JP Morgan presentation a week ago. And the big theme in it was they were saying, hey, we're going to go out shopping, we're going to start doing acquisitions again and whatnot. And this looks like it might be like the first salvo of that. So here's to seeking a lot more of these types of deals, like Medtronic going out there and spending some money and like helping to, you know, further some of the innovation in the space. And still interesting too, because, I mean, Edwards genevalve deal got blocked by the ftc. So, you know what's going to happen next? I mean, there's just kind of all kinds of interesting things going on right now in transcatheter heart valves.
[00:19:41] Speaker A: Absolutely. And I just googled it while you're talking. And according to my Google AI, it's DuraVR. So AVR pronounced as the individual letters.
[00:19:56] Speaker B: Wow. Okay.
[00:19:56] Speaker A: For aortic valve replacement.
[00:19:59] Speaker B: There we go. Duravr.
[00:20:01] Speaker A: So we could rerecord this and hide the fact that we're complete morons. Chris. Or I think we should just let our ignorance lay it flat for the world to see. Lay it out for the world to see.
[00:20:11] Speaker B: Do you want to re record this?
[00:20:12] Speaker D: No.
[00:20:14] Speaker A: People know we're dumb. Dumbs. I don't think anyone's going to be shocked.
All right, Chris Demecer. Well, big news for sure.
Great news. You know, happy to see some companies moving forward. Happy to see strong earnings.
[00:20:26] Speaker B: Yeah.
[00:20:26] Speaker A: And always exciting to see a big deal with a big strategic. So great, great new market. Great newsmakers, Chris. Newsmaker. Let me try that again. I'll re record that.
Great newsmakers, Chris, a new marker.
[00:20:40] Speaker B: Thank you, Tom Sale.
[00:20:42] Speaker A: Why did I ever come up with that clever little. It's not newsmakers.
Oh, my God.
[00:20:49] Speaker B: He just came up with a tongue twister, man.
[00:20:52] Speaker A: I thought it was easy enough to say, but no, I still can't do it.
[00:20:55] Speaker B: So great.
[00:20:57] Speaker A: All right, thank you, Chris Newmarker for this week's Newsmakers. There, I said it. Now it's time for our FOMO interview. Kayleen Brown, managing editor of Device Talks, sat down with the Life Sciences Segment.
[00:21:09] Speaker E: Director of Averna, Javier Olea Life Science Segment Director Bora Verna welcome to the future of medtech opportunities. Thanks for being here.
[00:21:19] Speaker D: Thank you, Kaling. Glad to be here.
[00:21:21] Speaker E: So, Javier, there are a lot of reasons why I've asked you to sit down with me today. But the main reason is I have been in the industry for 19 years. I know nothing about test and measurement in medical device manufacturing. So, Javier, I'm hoping that you can educate me and our audience. What does that exactly mean, test and measurement in medical device manufacturing? Why is it important?
[00:21:47] Speaker D: I'll tell you the reasons to test. Number one, design is not perfect. You test because we have imperfect designs. In order to have a perfect design.
Well, perfect designs don't exist, right? So you test for imperfect design. You also test because you have imperfect process.
Processes in the manufacturing line are very complex. They involve automated assembly, manual assembly, manual inspections, thousands of different components being put together, being integrated into sub assemblies, sub assemblies being put together into final devices, and many things can go wrong. So you have a process that is not going to be perfect. So you need to test at the manufacturing light. And also you don't have perfect suppliers, suppliers that provide you with parts to build your product. They may fail or they may supply something that is borderline functional or borderline complying with with requirements. But the combination of that borderline spec with other parts and very complex process, it may cause problems. So we test to make sure that all design is working. We test to make sure that our process didn't have any escapes or any problems. And we test to make sure that the parts that we're getting from our suppliers are appropriate for the product that we're building.
[00:23:09] Speaker E: The actual application of test and measurement in medical device manufacturing, that's had to have been around since the very beginning. So I have to wonder, what are the current challenges when it comes to test and measurement in medical device manufacturing? And what does that look like?
[00:23:28] Speaker D: You know, as devices get more complex and there's more pressure from regulatory agencies, the easy way to go is optimize everything for compliance. So what that means is test more, test every single step of the process. When you make a change, revalidate everything. And that's a lot of overhead, that's a lot of work. It takes resources, it takes time, and it slows down the process. Right? So I think one of the main challenges is how do we leverage existing technology like AI and how do we combine it with a good understanding of the regulatory landscape just to make a more streamlined implementation of test Also, how do we leverage the output of tests or the data the test generates to make a better design to improve our supply chain or to improve our manufacturing process? Right, Because a test generates a lot of data. When you test, you can learn a lot about what's going wrong with your, with your process or with your design or with your suppliers. But most of the time, companies are not set up to leverage that data and feedback that to the other parts of the development process through R and D, or to manufacturing engineering or to supply chain. And we lost that valuable information. So that's another challenge. How do we leverage all the data that is generated by test to improve and make it an asset instead of just like a burden or waste?
That's one of the important things about test, to improve your processes, not just to make sure that you avoid the risk of shipping bad product.
[00:25:14] Speaker E: So we talked through the challenges in this space. If you were to see where we could be in medtech manufacturing in the next five years, what advancements do you hope or do you think will come when it comes to test and measurement?
[00:25:30] Speaker D: I, I would love to see the data that is generated by test systems being used to improve not just the manufacturing process, but the design of a product and also how companies manage their supply chain and even how they make outsourcing decisions. So that's handling that data has been a challenge for a while and in the next five years, I mean, we have more than ever, we have the right, the right tools, the right technologies to be able to leverage that data and it's already being produced.
But if anything, I would like to see test becoming more strategic, using that to feedback the process and improve design of a product, improve turning the data into insights and using it.
I know everybody's talking about AI, but I also think that if we're able to find a way to leverage AI and not impact the validation times and the risk to patients, that could be a significant improvement in time to market and expediting the NPI process. So going from the to commercial production in shorter cycles and as you know, more devices, more and more devices are connected and users demand more data on their devices and being able to configure that on their devices, there are going to be safety risks. So making sure that we build safety into product and how do we use test to make sure that those products are safe, I think it's also a key opportunity for testing that we leverage that infrastructure to ensure safety of patients.
[00:27:22] Speaker E: Excellent. So if you were to think about 10 years, 15 years into the future, and this is a very hopeful, optimistic view and your own personal view. But what would you hope to see in 10 to 15 years in this space?
[00:27:38] Speaker D: 10 to 15 years. Wow. If we can have fully automated linings with minimum operator interaction that generate not just data, but insights that automatically go and feed into other processes for all the way from, from product development to warranties and field repairs and claims, that's. I mean that's the dream. It would take a lot of work, I think. But if, you know, if intend 15 years, we have, we have that and we have fully connected systems that feed the other processes continuously improve. I think that's probably the biggest advantage, leveraging the data that we produce to improve continuously the product and the process and make it always more efficient, safer and with the right features.
You made me think about an example. This is, this example is not so much about tests, but it applies to test. If you think about software as a medical device, and let's say that somebody comes up with a software that analyzes X rays or images taken by a medical imaging device, and this software is able to detect cancer maybe earlier than your average physician. So initially maybe you would want to release a version of that software that helps or augments the physician's capabilities and maybe highlights some areas. Hey, look here, look there. And the physician will make, or the oncologist will make the final call. But this system would augment its capabilities and help him do his job better. But since the beginning, since the get go, maybe you have the vision that the software eventually will be able to make those decisions by itself. It will learn, it will become better, and eventually it'll be able to tell you with certainty before any person can, here's an early sign of cancer and you should treat it.
So that's. If you, if we apply that to test. How do you plan from a software architecture perspective, from a documentation and validation perspective, how do you plan to do those multiple releases from the, from the beginning? If you know that you want to go from point A to point C, but maybe you have B in the way for strategic reasons, both to release something that adds value, but also to learn and continue to improve, then if we can apply the same to test, I think that's also a good vision of the future.
How do we deploy systems that start generating value while continuing to learn without breaking validation and without posing any risk, and then eventually use all of those insights and those learnings to improve the system, make it better and continue the cycle? If in 10 to 15, I think 10 to 15 years is probably Too long. If we can see that in five to 10, I think we would be in a good place.
[00:30:45] Speaker E: That's really encouraging and something to look forward to. Javier, we are very quickly reaching the end of our time unfortunately. But if you would do me a favor, could you help share how Averna works with medical device companies?
[00:31:01] Speaker D: In the last 25 years we have delivered over 10,000 systems for testing our customers products. There are not that many companies out there that have the deep bench, the size, the expertise that Averna has for developing, replicating and supporting test systems.
So the way we engage with our customers is all the way from design VMV to commercial production and then supporting that through the life of the product. And think about Averna as an extension of your team going back to how and when to outsource. We can help with writing requirements or co developing a system, or if you already have a system, we can help replicate that system, deploy it, help with the international logistics and then support that going on.
In my experience, test is usually treated as an afterthought or a distraction from product development or commercial production. Averna brings tests to the front so you can focus on your priorities.
[00:32:08] Speaker E: Excellent. And if our audience wants to learn more, they can visit www.avena.com. that's a V.
And Javier, as I understand it, the Averna team will be at MDM West February 3rd through the 5th, is that correct?
[00:32:23] Speaker D: That's right. In Anaheim, California.
[00:32:25] Speaker E: Excellent. So our audience can meet the team in person. You'll be co located in the NI Emerson booth while Javier Olea, Life Science segment Director of Averna. Thank you so much for joining us on the future of medtech opportunity.
[00:32:41] Speaker D: Thank you, Kayleen.
[00:32:43] Speaker A: Great job. Kayleen Brown, thanks again to Averner for being part of our FOMO series. And now it's time for our keynote conversation. I had the great fortune of talking with Carl St. Bernard, the CEO of Jupiter Endovascular. Let's listen.
Well, Carl St. Bernard, welcome to the podcast.
[00:33:01] Speaker C: Yeah, thank you. Thanks for having me. Tyle.
[00:33:04] Speaker A: I feel like I've been hearing about Jupiter endovascular for a long time and then I realized that you've only been around for about a year or so. So good job to your marketing whoever's getting the word out. So you feel like a medtech fixture.
[00:33:17] Speaker C: They've done a nice job. They've done a nice job.
[00:33:20] Speaker A: We'll get into the story in a moment, but let's first unpack your story. How did you find your way into the medtech industry? You've been Doing this effectively for a good long time.
[00:33:32] Speaker C: Yeah, it's been a while. It's been a while. Yeah. I wish I had a great story about how I kind of prospectively thought about Medtech and got into it, but, but like a lot of stories in my life in the past, it started with a woman.
I had a girlfriend in college who actually got into pharmaceuticals. She was a year older than I was, and I was still in school my senior year, not quite sure what I was going to do with my economics and business degree and another double degree in art history and fine art. So. So, you know, kind of an odd combo. And, you know, she came back to visit campus and, you know, it was. She was selling pharmaceuticals at the time, and I was like, well, that's a good job. And then she got a brand new car, and I go, well, I want a new car. That looks pretty cool. And then she, you know, she was on her way to Jamaica because she just got a bonus from her sales efforts. And I'm like, wow, I want to go to Jamaica. So I, I, I.
A week later, just coincidentally, there was a pharmaceutical job that came on campus, and I interviewed and got that sales job. So I started out selling pharmaceuticals in Long Island, New York.
[00:34:50] Speaker A: That's where I got started. That's interesting. And how did you. I've had a conversation recently about the difference between pharma sales and medtech sales, and I didn't realize that, that the compensation was different and that it was sort of a different entity. I know they obviously are different products, but how did you find your way, your move over to Medtech? And was that a big move for you or was it just a quick step over?
[00:35:15] Speaker C: No, it was pretty quick move.
I had got promoted to a regional manager over time at the company I was at selling pharmaceuticals, and I knew of a number of orthopedic sales reps in the local area and, and I knew they did really well, and it looked really interesting. And a lot of Pharma, you have to follow the same sales script, basically, as you're detailing these various pharmaceutical products to physicians. And it just felt constraining for me in the end.
So I actually went on a couple of sales calls with some of my friends who were in the orthopedic space.
And, you know, I got to go into some procedures, and the first one I was in was a hip replacement procedure.
And. Yeah, and I realized once I was in my scrubs in the room with the physician and the sales rep, I had never seen a procedure ever like that. Before, So I was just, I was. And I was wondering, like, what if I pass out? I could literally faint in here. And I'm sitting down now, but I'm like sitting 6 foot 4 or about £225, so I could, you know, cause my own little emergency in the, in the operating room. And one of the nurses saw me and she goes, look, if you get nervous or just sit here because we don't want to have to pick you up off the floor.
[00:36:43] Speaker A: That's fun.
[00:36:44] Speaker C: All went well. All went well.
[00:36:46] Speaker A: Similar to the story I had recently. The gentleman was like, I just held up the wall. Like I just backed up against the wall and just got. Stayed out of the way. So. So for his first surgery.
So how did you then make the move to GE Healthcare? That seems to be sort of your first MedTech move. I see you went to Cordis and JJ after. We can cover that quickly. But what was that?
[00:37:04] Speaker C: Yeah, at the time, you know, I was getting my MBA and I just like, it seemed like every other case study that we were getting involved in revolved around some GE business. And this is sort of in the early 90s, you know, so. So I always thought it was a great company. Well managed, well run. Obviously they were populating all of the Harvard Business School case studies. So I had an opportunity to join GE Medical Systems at the time. And I came on as a sales rep out in Southern California and became a corporate account manager and then moved to Milwaukee with GE Healthcare, which, you know, people always, I always say, if you don't think I can sell. I convinced my wife from California to move from, from Manhattan Beach, California to Delafield, Wisconsin.
But it was a great, it was a great move for the, for myself, career wise. We had a lot of great people. I mean, Peter Arduini was there at the time.
Omar Ishraq was there.
[00:38:15] Speaker A: Omar Jeff.
Yeah, okay.
[00:38:17] Speaker C: Yeah. Mike Mahoney was there.
[00:38:18] Speaker A: Wow, that's right.
[00:38:20] Speaker C: Yeah. Mike Minogue was there from Abiomed.
So we had, we had quite the mafia.
[00:38:26] Speaker A: Were you ever in the same room at the same time? Like, I feel like there's like this, like something must have happened in that room that just created all these MedTech CEOs.
[00:38:35] Speaker C: We were together a lot back in those days. You know, it was a great experience. I learned a ton. I think the most impactful job I've ever really had was I was the head of sales operations for GE's diagnostic imaging business and for equipment and services and, you know, working for GE and really understanding the business from from that lever, that leverage point really got me ready for every other role I had since then. You know, I was in charge of forecasting for the, for the business, about $3 billion a year, was in charge of operating budgets, commission plans for all the sales forces.
Yeah, it was quite the, quite the task, but it was a lot of fun.
[00:39:20] Speaker A: So what, what led to the move to Cordis and J and J. What, what. How did that happen?
[00:39:27] Speaker C: Yeah, it was a move, it was a tough move. So I really love, loved GE Healthcare at that time, but it had, you know, I had an opportunity to, to join Cordis and, you know, from a JJ standpoint, just the reputation of that organization is just, you know, phenomenal. And my entire career could be in healthcare. And at ge, there was a lot of folks that moved in different businesses from healthcare to, you know, finance to appliances and so on.
I never really wanted to do that. So my career was going to be somewhat limited by not wanting to move into different, different GE businesses. And they're phenomenal businesses at the time, but I just saw myself really loving healthcare and medtech specifically. And an opportunity came up at JJ at Cordis. And, you know, I had sold a lot of the fluoro labs over the years and been involved in those transactions for cardiology and really wanted to kind of get into that side of the device business, so.
[00:40:32] Speaker A: And just again, following the GE posse, Mike Mahoney I'm looking up right now. Did he go over with you around the same time?
[00:40:39] Speaker C: No. It's a good question.
[00:40:41] Speaker A: I mean, it was December 2009, so Omar probably left soon after that, so.
[00:40:47] Speaker C: Yeah, yeah, I think that's right.
I think Mike was at the GHX exchange for a while.
[00:40:56] Speaker A: That's right. Very good point. Yeah. So what, I mean, those are two great training grounds.
GE&J and J.
I imagine you've walked away with some lessons from both and anything you share with people who ask for, I don't know, for wisdom gained.
[00:41:15] Speaker C: Yeah, it's great. I mean, I think both companies are just phenomenal organizations. I mean, the GE really learning how to run a healthcare business, you know, from a operational standpoint, GE really sort of grounded me in those leadership principles.
So I think, you know, from that standpoint, the index on leadership being the number one determinant of success really, you know, kind of learned that at ge. And Jane J. I learned a lot about patients and the impact that we have on patients and, and the impact that our devices have on patients and our decisions.
You know, Alcredo at JJ is really Something that, you know, sits on the wall, but it's also discussed in boardrooms and small conference rooms. It's something that we all took very seriously. And the impact that we would have on our providers, impact we'd have on patients and our shareholders. And, you know, shareholders were last in that. That in that lineup, and they were.
The concept was if we took care of patients and our customers, that. And our employees, that our shareholders would benefit. And that really sort of ordered my priorities.
[00:42:27] Speaker A: So let's talk about your first president and CEO role at Triton. So it's 2017.
I imagine someone came to you with an opportunity. What was.
What was the calculus that led you to leave the big company and join a small one?
[00:42:44] Speaker C: Yeah, I kind of felt like I had learned a lot over the years and that I could better utilize some of my knowledge and experiences in a smaller company where I'd have more control over a lot of the different aspects of the organization, whether it's regulatory, manufacturing, commercial.
And so I've been looking for smaller companies to join and really kind of get into that world. And, you know, and this opportunity came forward and, you know, I knew the technology from years earlier. I had seen it while I was at Cordis. And, you know, bifurcations are really, really tricky procedures for physicians to do in the world of coronary angioplasty and stenting. So this looked like a really, really novel solution to that, you know, to that particular problem, and had the opportunity to join the company at that point.
[00:43:45] Speaker A: And so at some point, there was a box that needed to be checked. You wanted to be president and CEO of a company?
[00:43:51] Speaker C: Well, I. I think, you know, I felt like I had the opportunity to do that. And, you know, it's one of those things where, you know, I could have stayed where I was, but I. I really felt like this was an opportunity for me to. To do more than kind of be the commercial, because I think everyone who's a CEO has some sort of home base of kind of skill sets that they develop, whether they're an engineering person who became a CEO or they're a finance person, then become CEO. You know, that finance is still their core strength, if you will, in their. In their superpowers, if you will. And for me, it's been commercial. And so at some point, I was going to need to move into a bigger, broader general management role. And you.
[00:44:34] Speaker A: And you eventually moved on to. You became the presidency of Alter Biomaterials, which is. Biomaterials, which is a kind of a coding company. How was that? That's not an oem, not a medical device maker. How'd that happen and what was that experience like?
[00:44:48] Speaker C: Well, it's interesting. The pandemic kind of loomed large in this process at the time. It started as Cellanova Biosciences and we had a very special proprietary coating that we had developed, an anti thrombotic coating that we applied at a nanoscale onto different, you know, metal implants. And so our first product was the, the Cobra coronary stent.
And we had developed a product, we were launching it commercially and as we were gaining some momentum, we ran into the pandemic.
So it became really hard to sort of commercialize a brand new coronary stand in a world where nobody could enter the hospital. And it wasn't a priority for anyone to really look at those kind of things.
So as we were looking at our funding levels and trying to determine what to do next, we made a strategic decision to focus on the, on the coding specifically.
[00:45:45] Speaker A: I see.
[00:45:46] Speaker C: And really go after that because we could apply that to existing devices as well and work with other OEMs now.
[00:45:54] Speaker A: You're right, I skipped over that on your profile. So celanova, you went August 2019. If you would share a bit about that experience with the pandemic. I mean, we all think we're going through life and the wind's always going to be there in some form or fashion. You know, things are, certain things are going to be there to help us execute and then they aren't.
What lessons did you take away from that experience?
[00:46:17] Speaker C: Yeah, I mean, it's really a great lesson in just learning to deal with the unknown because it's easy to look back at it now and say, well, we could have done this better or that better. At the time there was a lot of things just not known about the actual coronavirus.
And we didn't know really what the future looked like, like for, from a funding standpoint for companies that were starting up. So a lot of things we didn't control.
The first thing we did is we prioritized the health of all of our employees and, but we wanted to continue to manufacture our product. So we split our team into three different teams and we basically just paid them for full time work, but we only had them manufacturing a third of the time because we didn't want to have that many people in the clean room at a certain time and we wanted to separate folks. So if someone did get sick.
[00:47:14] Speaker A: Gotcha.
[00:47:14] Speaker C: And they, and they infected other people, we'd have the Other shift come in and not infect the entire manufacturing operation.
[00:47:22] Speaker A: It's almost like a space crew during the Apollo missions. Right? I mean, just. Yeah, yeah, yeah, yeah.
[00:47:28] Speaker C: So, like. Like, those kind of things are things you never think about, but those are the types of things we had to make decisions on.
[00:47:34] Speaker A: But as a CEO now, when you're making decisions and you're making plans, do you move forth with the confidence, like, well, we know what the world will be like next year, or do you sort of have a newfound. Well, hold on a second.
We don't know.
Let's plan a little differently.
How does it change you as a CEO?
[00:47:52] Speaker C: Yeah, I think you sort of realize that you can survive a lot of indecision and a lot of unknown, and maybe some things that look like they're showstoppers really aren't showstoppers.
It also helps you kind of keep your focus on True north in terms of the mission of the company.
So I think it helps you build resilience, I would say, into the organization.
[00:48:20] Speaker A: That's great. So let's start moving into Jupyter Endovascular. I want to learn about the company, but first, I'd love to understand the problem you're trying to solve the condition. Talk to me about pulmonary embolisms. What are the challenges of treating. What are they? What are the challenges of treating them that you're trying to help overcome?
[00:48:38] Speaker C: Yeah, that's a great question, Tom. I'll step back, and maybe this will give context to the entire reason that we're in pulmonary embolism.
We look at our technology as fundamentally a platform technology that changes the paradigm for how catheters are being produced today and what they're used for.
[00:48:57] Speaker A: Okay.
[00:48:58] Speaker C: You know, right now, as we know, catheters in endovascular medicine are usually stiff. They're sort of one consistency in terms of stiffness or flexibility. You have to choose many times between a flexible catheter to navigate to where you want to go in the body.
And then once you get there, you need it to be rigid so you can deliver a stent, a balloon, a valve, any kind of therapy. And having all of that into one device is challenging.
So that's why you see it. Any additional interventional procedure, there's all kinds of devices open, and the physicians are always kind of swapping devices, trying to figure out how to move something from one point to another and then give themselves some kind of support to deliver that therapy and this technology. And this is one of the reasons why I really was excited about joining this company it sort of flips that whole paradigm on its head. So the concept is to have a catheter that's as flexible as a guide wire, but then when you want it to be on command, you can make it as rigid as it needs to be in any shape anatomically that you've traveled along. And so what I've done is I brought like just a quick sample here. This is our, our vertex catheter. As you can see it here.
I can bend it, it's very floppy, and I can put it into any shape I want for this demonstration. I'll just put it like this.
And then I use a standard insufflator here that's in every cath lab in America in the world. And I just basically take it up to 6 atmospheres.
And it just stays in that orientation.
[00:50:42] Speaker A: Oh, okay.
[00:50:43] Speaker C: So, you know, this can be done over and over. And then when I'm, when I'm going to move it again after I deliver therapy, I just let it go and it goes back into this flexible. So we call this transforming fixation technology, or tfx.
But in a pulmonary embolism specifically, it's a really challenging pathway to have to get to through the heart. You've got to go into basically one side of the heart, go through two chambers of the heart, two valves of the heart, before you even get to the pulmonary artery where you start to take out that clot.
[00:51:18] Speaker A: So that's how you, that's how you reach the clot. You go through, you go into the heart, through the heart, across the heart, into the lung. That's the, that's the way.
[00:51:25] Speaker C: Yeah, it's, it's a couple of S curves you have to make and you get some kind of position like this. Now I can lock it, it literally in this position.
And current technology, current catheter technology, you have to use very stiff wires to get there. You have to use very stiff catheters, wide bore catheters. This is, you know, a wide bore procedure. So these are relatively large catheters that have to go in there to aspirate the clot.
With my system, we can get in there, we can lock it, and then you don't need the guide wire anymore. The system itself becomes its own support system for going forward. And that's, that changes the whole paradigm of the procedure. Because now the heart, it doesn't get deformed by these stiffer catheters that always want to straighten out when you go through the ca. When you go through the heart. Our catheter, once you get it in place, it becomes its own support mechanism for itself in the anatomy.
[00:52:26] Speaker A: So let's take a step back and talk about the origin of the technology. How did it come to be? I know you're a spin out from Neptune.
Talk a bit about how this came to be.
[00:52:37] Speaker C: Yeah, it's a great question. Essentially this was built in a garage. So it's a quintessential Silicon Valley startup started in Alex Tilson's garage. And. And kind of the same thought process of why do catheters just have to be one thing all the time? Why can't they be flexible when they need to be and then rigid when they need to be? And fundamentally that started it. The initial product was used for gi, kind of an overtube for endoscopy.
But there was always this opportunity to use it for cardiology.
And there's again a lot of procedures that that initially structural heart was some of the things we thought about. We had spoken to a number of physicians and cardiologists, interventionalists, and we landed on pulmonary embolism because again, the pathway to get to the site of care or the site of therapy in pulmonary embolism is so torturous and a challenge to maintain that position in that pulmonary artery that we picked the pe thrombectinum space as our first application. But we totally intend to have a number of other applications for this technology.
So that's where it started. But we see a huge. And then we spun out Jupiter from Neptune to focus on those cardiovascular opportunities.
[00:54:09] Speaker A: So were you with Neptune or did you join Jupiter?
[00:54:13] Speaker C: I joined Neptune for a few months to prepare for the spin out and then I moved over to Jupiter once we finalized it.
[00:54:22] Speaker A: Okay, so we always see Neptune as sort of a. I've always known it as a robotic system.
Is there system similar to what you just showed me with yours or is it a different technology?
[00:54:35] Speaker C: No, it's a similar technology from the tfx, the fixation technology. So it's similar, but we don't use a robot at this point. We're using just standard catheter. The doctors are doing it the old fashioned way.
So that's the big difference. They're developing a robotic GI platform and we don't have the robotic component as part of this platform.
[00:55:01] Speaker A: So that's why the separation was done, because Jupyter could pursue this without the robotics. And I imagine that's a quicker pathway for you and a lot of lower hanging fruit.
[00:55:10] Speaker C: And it's also kind of a clinical breakout. I mean, you know it's tough for a startup to really balance robotics, a GI business, and then this cardiovascular business.
So the investors, the boards of both the companies said we really need to spin this out as a separate entity.
And that happened in July of 2024.
[00:55:31] Speaker A: Talk to me, if you would, a bit about pulmonary embolisms. How.
What's the impact that they have on patients? Where are they treated? Who does that treating? What's the market like?
[00:55:40] Speaker C: Yeah, it's an interesting market. It's the third largest cardiovascular killer behind heart attacks and stroke. And I've heard doctors even say it could be number two, but it's not necessarily diagnosed or recognized many times, and so it could actually be a higher incidence of. Of mortality than we even recognize right now.
The challenging part of this procedure is that the symptoms come in different ways with different patients. It could be short of breath. People could mistake it for asthma. They could mistake it for being out of shape. There's a lot of different ways that people show up. There's micro emboli that come out as well. That could happen over time, and people just recover and just keep going.
So, you know, it's an underdiagnosed phenomena, I would say, in cardiovascular.
And really, a lot of times, by the time they get the diagnosis, they're already, you know, dangerously close to passing away from the embolism.
[00:56:43] Speaker A: Wow.
[00:56:44] Speaker C: You know, so it's a. It's a big, big problem, I think, for the healthcare system from a diagnostic standpoint.
And the treatments right now predominantly are anticoagulation medications.
That's still about half of all the patients that come in receive that as their main therapy.
And mechanical thrombectomy, despite the growth, is only about 20% of eligible patients that would qualify for thrombectomy actually get a mechanical thrombectomy procedure.
So it's, you know, it kind of goes hospital by hospital, doctor by doctor, who may offer this kind of therapy for patients.
[00:57:25] Speaker A: So just so I understand. So we could.
People are. People are walking around with embolisms, and they don't know it at this point.
[00:57:34] Speaker C: In some situations, that's true. Yeah. They might have a chronic, and, you know, it's a blood clot. And so over time, they become fibrotic, and they just become permanent plugs within the pulmonary artery tree. And that just diminishes the capacity of.
From a cardiovascular standpoint. But the one thing I would say, doc, this is definitely a cardiovascular disease. I think, you know, when you look at what's happening to these patients, you know, we've Gotten pretty good at taking out these clots with the current technology, I would say, but we haven't really cracked what happens to these patients if you leave clot behind.
So I've heard one physician tell me that, you know, we figured out how to not have patients die in the ER because of their clot, but ultimately they're passing away due to heart failure.
[00:58:23] Speaker A: Okay, that's what I was gonna ask.
[00:58:25] Speaker C: Yeah. Yeah. The downstream implications of chronic clot typically is an elevated pulmonary artery pressure that puts more strain on the right side of the heart, the right ventricle.
[00:58:37] Speaker A: Okay.
[00:58:38] Speaker C: And then that over time, that right ventricle begins to fail, and the patient unfortunately, can fall into heart failure. So there's about a third of patients who have a PE thrombectomy still have never fully recover from that pulmonary embolism episode.
[00:58:58] Speaker A: Oh, wow.
So you talked about the 20% of folks who are able to get the mechanical thrombectomy.
Why don't the other 80% qualify?
[00:59:12] Speaker C: Yeah, it's a challenging question. I think there's a couple of reasons. One, I think the clinical evidence is being developed right now in terms of level one randomized data.
I think that's coming along like PE Storm and some other trials like Peerless.
Those trials are helping kind of focus the attention in the space.
And the more that that will come along, I believe we'll see guidelines shift.
We did a survey of current users in cardiology, and we found that about half of the doctors said the procedure as it is today is very challenging.
And it's a very high anxiety provoking kind of procedure because they don't normally take these big catheters and kind of bend them through the heart that way, it has absolute cardiac stress on the patients for sure. So, you know, a lot of these procedures are kind of a race. If you will get the clot out, get as much out as you can before the patient decompensates. And, you know, from a. From the cardiac stress of a catheter. And so. So a lot of doctors kind of shy away from that. And if they don't have real strong evidence telling them they should do that, then, you know, they'll take the more conservative approach many times.
[01:00:32] Speaker A: So circling back to your solution, you had your. You now some positive results of a first in human study at TCT 2025. Is it Sperari? Is that how I say it?
[01:00:43] Speaker C: That's correct, yeah.
[01:00:44] Speaker A: Okay, great.
[01:00:45] Speaker C: It's a Latin to basically roughly translates to breathe.
[01:00:49] Speaker A: Okay, well, that works. So sparari. One talk about the trial.
What's the significance of it?
[01:00:57] Speaker E: It.
[01:00:58] Speaker A: And again, help me understand how Jupiter's approach can hopefully help allow for more people to be treated.
[01:01:06] Speaker C: Absolutely. So, you know, it's a first in union trial, so the numbers aren't statistically powered, but we had two sites in Europe, one in Vienna and then another in Poland.
And we had just a phenomenal series of patients in those two sites. The doctors were able to. To easily manipulate our catheter through the heart.
We were able to train them very easily on how to do the procedure. It got to a point where the doctors were actually, because they haven't had that level of flexibility of the catheter where they could literally put it into position in the pulmonary artery and essentially take their hand off the catheter and it would stay right where they left it. Because you can imagine the environment. You've got the lungs going up and down, the patient's breathing, the heart's feeding. You've got this catheter normally kind of flopping around.
[01:01:58] Speaker A: So the heart is beating during this. I assume that.
[01:02:01] Speaker C: Yeah.
[01:02:01] Speaker A: Oh, my gosh. Okay.
[01:02:02] Speaker C: The heart's beating the lung, the patient's breathe. The patient's awake through the entire procedure. Wow. And then the catheter is moving with all of this movement as well. Usually in our catheter, we're able to put it in position, and it just locks in, stays there. So the doctors really hadn't had that kind of flexibility, and we. And they were noticing that the patients were under dramatically less hemodynamic stress due to our conformal nature of our catheter. So they had more time to do a complete thrombectomy and remove all the clot. So the thing that we weren't sure that we'd be able to show, that we showed in our study was that we were able to reduce pulmonary artery pressure from the beginning of the procedure to the end of the procedure by over 30% and fundamentally take patients back to normal hemodynamic status from pulmonary artery pressure standpoint, which has really been unique relative to other devices and other studies in the space.
[01:03:06] Speaker A: So what does that mean? Can you unpack that for me a little more?
[01:03:09] Speaker C: Yeah, I mean. I mean, when you get a blood clot in your pulmonary artery, it's kind of. It's a clogged pipe, basically. So the pressure builds in that pipe behind that clot, so your pulmonary artery pressure shoots up. I mean, a normal pulmonary artery pressure is usually 20 millimeters of mercury or lower. And in a pulmonary embolism, Situation, it can shoot up to 30, 35, 45 millimeters of mercury. So. So being able to take the plug, take the clot out, and reduce that pulmonary artery pressure back to normal is a big goal of the procedure because any amount of pressure over normal puts that patient at higher risk, ultimately of right heart failure.
So our sense was that if we could get them back to normal on a routine basis, that would give the doctors a real clinical endpoint to shoot for in these procedures and then leave the patients in a place where they don't have that residual heart risk, heart failure risk going forward.
[01:04:18] Speaker A: So how is the, how is the clot removed once you get there? Is it pulled back through the catheter, I assume?
[01:04:23] Speaker C: Yeah, we have a smaller catheter, slightly smaller, that fits into our device and that basically aspirates the catheter, the clot out. So. So the nice thing about it, it acts as a bit of an extender. So you can push this catheter even deeper into the pulmonary artery to reach these really hard to reach clots that are more distal in the lung and pull those out.
And so we are just using aspiration because of the nature of our catheter. We can put it right where we want to put it 99% of the time. So we're basically anywhere in the pulmonary artery vessels. We can put the catheter tip, distal tip, right onto the clot, and that allows for really effective and efficient aspiration of the clot.
[01:05:15] Speaker A: And who's performing this procedure? What, specialists?
[01:05:19] Speaker C: Yeah, it's a mix. You know, overall, we have interventional radiologists, we have interventional cardiologists, we have vascular surgeons, some cardiothoracic surgeons. Doctor.
[01:05:30] Speaker A: Same people who perform it with the standard technology today. Same folks.
[01:05:34] Speaker C: Same folks, yeah, same folks. I would say.
I think it's interesting to see the dynamic. It's pretty split. Mostly the majority is done by interventional radiology and interventional cardiology at this point now.
And cardiology is growing as well. I see more and more cardiologists being interested in, in doing this procedure.
So it's hard to say exactly what's going to happen in the future, but it's, you know, right now it's pretty evenly split between IRS and ICs.
[01:06:06] Speaker A: Interesting. And this is. These are, I would imagine, primarily, almost exclusively done in larger clinical hospitals. This isn't an ASC sort of operation. This is a big, big time operation.
[01:06:16] Speaker C: Yeah, yeah. This is usually, I mean, the patients come in through the emergency department compartments. Yeah. So, you know, they come in and the gold standard for diagnostics for this procedure is a CT scan.
[01:06:28] Speaker A: Okay.
[01:06:28] Speaker C: So, you know, that's.
[01:06:29] Speaker A: They've had an event, they've been diagnosed with it and they've been wheeled quickly upstairs for this procedure. That's usually the path.
[01:06:36] Speaker C: That's correct, yeah. And, you know, it's also one of those procedures where people have to be on call. You know, there'll be procedures that'll come in in the middle of the night.
You know, they'll.
Some of them can be staged for the next day, but a lot of them have to be done pretty urgently.
[01:06:51] Speaker A: How do you build a trial around that? I mean, it's not a normal trial where you've got scheduled procedures.
[01:06:58] Speaker C: How does that work? It's been an interesting trial. The other trials I've been part of, we've been able to kind of plot out the cases that we're going to do prospectively and have support for those. This is, we have to have everybody ready to go on their cell phones.
So, you know, a call may come in where there's a patient who looks like they could be a candidate. There's usually a discussion with our head of clinical and the physician that might do the procedure. They talk about the inclusion exclusion criteria of that individual patient and then by then we dispatch one of our field clinical people to support the case.
Sometimes it's a few hour drive and sometimes it's a flight. It depends.
But, you know, many times we screen patients and, you know, they ultimately, you know, fail the screen based upon our inclusion exclusion criteria.
So, yeah, it's been a challenge. It's a, it's a little like, you know, trying to land an airplane at Chicago O' Hare at 5:00'. Clock. You know, you've got, you've got a lot of people coming and going and flying here and flying there and. And we've got European sites that are enrolling in our, you know, the IDE trial here. So we have US sites and European sites. And that makes it even more complicated.
[01:08:16] Speaker A: Do patients need to give any sort of extra consent or is it just.
[01:08:20] Speaker C: No, it's consent. Yeah. So we need to consent patients, which can be a challenge, obviously, depending upon the condition of the patient.
[01:08:27] Speaker A: Yeah, interesting. All right, final question.
You said at the top that this is a platform that you look, looking to build out. Where are some other parts of the body that you're targeting? And you see this unique approach being superior.
[01:08:41] Speaker C: Yeah.
Right. Now, this is a relatively large catheter. It's 26 French and 18 French that we Use for pulmonary embolism. But we can scale this technology all the way down to 10 French, maybe 8 French, and all in between. So, you know, we can address a lot of different areas.
Certainly percol vascular is an area, I think, challenging or complex coronary cases where you're using different types of devices to get through a cto, let's say we think there could be some applicability there. Structural heart is another area where, you know, we've had some early modeling where we've used two of these devices in terms of mitral valve repair.
And just doing some modeling in the lab around that same thing for tricuspid valve repair.
So there's a lot of interesting other beds. Carotid's another area where pretty much anywhere with this tortuous anatomy where you're delivering an advanced therapeutic and you need that stability.
You know, this technology can, you know, can have some value.
[01:09:59] Speaker A: That sounds like the entire human body to me.
[01:10:00] Speaker C: I mean, I know it's a lot.
[01:10:02] Speaker A: I don't think there's many straight highways going from point A to point B.
[01:10:06] Speaker C: Not my body. Not my body.
[01:10:08] Speaker A: Exactly.
I said final question. I lied. I usually do.
You recently raised 40 million. You closed on that in October. So we'll surpass through 40 million targets.
[01:10:19] Speaker C: Target. Yeah.
[01:10:20] Speaker A: What, what are your plans for your next steps, your plans for the capital and, and I don't know, map out your next five years if you can. What. What's your vision as CEO?
[01:10:30] Speaker C: Yeah, I. I think we're just really fortunate for, for raising the amount of money. We did really great, great investors, super convicted with the company, the team itself. A lot of times in small companies, you look at, you know, who gets funded, and I think a lot of it has to do with the team need and the ability to execute. So we've been pretty consistent in hitting milestones in the first year of operation, and we've got plenty more ahead of us. So my sincere thanks to the entire Jupiter endovascular investment consortium that came together for series B, you know, for use of proceeds. Obviously, finish the study and get that submitted to the FDA for approval.
And then we have a couple of enhancements we want to make to the, to the platform before commercial launch. Just ways to enhance the ergonomics of the system.
Some things that we've learned in the, in the clinical trial that we can improve.
Nothing major, just, you know, mostly ergonomics and ease of use types of things. Easy setup, those kinds of improvements and then obviously start a pilot launch after approval in the market.
So you know, that's pretty much what we're focused on. We do have some dollars set aside to develop different form factors of the technology and begin to build smaller French size catheters to be used in different, you know, different procedures.
[01:12:05] Speaker A: And you do have, I see, going back to the round, a strategic corporate investor. You probably won't tell me who it is, but I mean, the old corporate investor rule was you didn't have them in a Series B. I know those have been thrown out the window a long time ago.
Was it part of your plan to have a corporate investor at this point? And what's the strategy for that?
[01:12:24] Speaker C: Yeah, I mean, I think they're a great team. They've done a tremendous amount of diligence before they made the investment and they've really been great partners already. And just advice to the company, I think with the market that we're entering in, pulmonary embolism, there's a number of different entrenched competitors, there's new competitors. So I think having an OEM partnering with us in this round really helped and we wanted to have that support. So we went out and certainly looked for that in this round.
I think also because our platform can do a number of different things, can be effective in, in other device areas like structural, heart or peripheral vascular, potentially neurovascular. We thought having an OEM with a broader perspective on where this might add value would help clarify the direction for us in terms of what we invest in going forward in those new markets.
[01:13:23] Speaker A: Will you tell me who it is?
[01:13:25] Speaker C: I won't tell you. I will not tell you.
[01:13:27] Speaker A: All right, interview is over. That's it.
[01:13:29] Speaker C: I would like to keep them as an investor in my series C, so I can tell you.
[01:13:34] Speaker A: Fair point. Carl, thanks for. This is a great story. Thanks for joining us on the podcast.
[01:13:39] Speaker C: Absolutely. Thanks, Tom. Thanks for having me.
[01:13:42] Speaker A: Well, that is a wrap. Thanks so much for joining us on this episode of Device Talks Weekly. Thanks, of course, to Averna for being part of our FOMO series. If you want to support what we do at Device Talks, there's a few things you can do. Of course, subscribe to the Device Talks podcast network or if you just want the weekly podcast, you can subscribe now to the show individually. Please join us on our Device Talks Tuesday's episodes, including our upcoming Cardiac Innovations Summit our week, which is coming up February 3rd to 5th. And I might have a new edition of that one. We'll see. I'm not quite sure, but stay tuned and of course join us in person at device talks Minnesota on May 4 and device talks Boston and or Device talks Boston on May 27th and 28th. And the least or I was going to say the least you could do, but the next to least thing you could do, the least thing you could do is nothing. The second, the next least thing you think you could do is follow us on LinkedIn, connect with me, connect with Kayleen Brown, connect with Chris Newmarker. And of course, follow Device Talks and Mass Device. Thanks, folks. We'll talk to you next week on Device Talks weekly.
