Episode Transcript
[00:00:00] Speaker A: You.
Hi, everyone. Tom Salemi here. Welcome back to the Device Talks weekly podcast. This is brought to you by Device Talks Boston. Please join us on May 27th and 28th at Device Talks Boston. Please also join us at Device Talks Minnesota on May 4th. Can't wait to see you at one or both locations. We'd love to see you twice, but once, it's almost as nice can some great events, great agendas, great speakers coming your way. Go to boston.devicetalks.com for more information about that event and minnesota.devicetalks.comfor information about that event. In this episode. Today, we've got a really great conversation I had with Darren Uecker. He's the Chief Technology Officer of Pulse Biosciences, which is a fascinating company that was formed basically to find a useful and of course, productive application for its pulsed technology, pulse field technology. And Darren will get into that story a bit, but his story is quite compelling as well. He has got a great medtech background, starting at the very start with Computer Motion, which of course is now part of Intuitive's story. So I'll talk with Darren about his path in medtech. He's been with many companies.
Most, if not all, have gone on to be acquired. So he's had a successful run in this industry and Pulse Biosciences looks like the next big win.
Before that, you'll get to visit with Ralph Kern. He's the Chief Medical Officer at Cognito Therapeutics. We talked with him at Device Talks West. Cognito is just a fascinating neuro business and I know you'll enjoy that conversation with Ralph. And of course, we'll kick everything off with my conversation with Chris Newmarker. We'll hit the highlights of this week in and we'll of course, talk a little bit of nonsense. But that's to be expected and I hope you enjoy it just a little bit. All right, folks, once again, I hope you joined us at Device Talks Minnesota and Device Talks Boston. Now let's get this podcast started.
All right, you ready for this?
[00:02:11] Speaker B: Ready.
[00:02:28] Speaker C: Christian.
[00:02:29] Speaker A: Mark. How are you, sir?
[00:02:30] Speaker B: Doing well, Tom. Doing well.
So, looks like weather's warming up here in the Twin Cities. Yeah, looks like we're gonna get rid of our ice in more ways than one.
[00:02:42] Speaker A: So, no, I've been reading those headlines and hopeful that there's truth behind that. For sure.
[00:02:50] Speaker B: I will believe it when I see it. But, yes, hopefully it's been a. It's been a tough time and. But yeah, I'm proud of this, proud of these cities. Proud of what we've done.
[00:03:00] Speaker A: Yeah, you very much should be. As I. As I wrote in MDO this week, you know, trying to pinpoint Medtech's hometown. If home is where the heart is and that place is Minnesota, everyone's been very courageous there and very impressive. And I know we have our little fun Boston, Minnesota rivalry banter, but hats off to you folks, so. But no, hopefully, hopefully you'll see some calming down of what's going on over there.
Great news for Minnesota and we're all rooting for you.
[00:03:33] Speaker B: Thanks. Yeah. All getting better. Well, here we are. And there's actually some more. Really? I mean, medtech industry just keeps on buzzing. So much going on.
[00:03:45] Speaker A: Absolutely. No, interesting. You've got an interesting set of newsmakers this week. And of course, we'll be in Minnesota on May 4th at Device Talks. Minnesota. So Star Wars Day, as folks have pointed out, May the fourth, May the.
[00:03:58] Speaker B: Fourth be with you, Tom.
[00:04:00] Speaker A: So I don't know if you've ever seen Star Wars, Chris, but it's pretty good.
[00:04:04] Speaker B: Oh, I've heard it's good. I should check that sometime.
[00:04:08] Speaker A: All right, let us roll into the new markers newsmakers. Chris, what is number five?
[00:04:15] Speaker B: Hey, number five on the list, we've got Carl Storrs and Smith and Nephew announcing a partnership around surgical visualization.
And just as a fun aside, Carl Storrs is also the owner of Ascensus Surgical, which has done a lot of pioneering with surgical robotics and innovating.
But, yeah, this is like this SNN and Carl Storrs partnerships about supporting ors and ambulatory surgery centers.
So, you know, visualization, I mean, this kind of digitization of surgery we've seen over the past decade or two.
Yeah, just. Just sounds like a. Like a cool, cool partnership.
[00:04:57] Speaker A: Absolutely. No, and. And it definitely is.
Again, another indication of Smith and Nephews focus on the asc. I think they started their own surgical network last year, right? Yeah, they started ambulatory Surgical network last year. So the orthopedic industry is getting higher and higher tech, as Yvonne Torto said at Device Talks Boston.
[00:05:22] Speaker B: Yeah, absolutely.
Absolutely.
Yeah, that was. Yeah. And you're right, like Smith and Nephew, like, you know, actually, yeah, they've been working on streamlining their inventory and whatnot for years. So that's also very cool. But, yeah, I mean, this isn't your old, like, oh, here's.
Here's a knee replacement, here's a hip replacement. Here's. I mean, you know, this. Things are getting, like, really high tech. You're seeing a lot of sensors, a lot of digitization, you know, a lot of really neat planning tools around operations to hopefully. I mean, they seem to, like, be doing a really good job, like, reducing, like, errors and giving people better results. So, I mean, yeah, it's. It's exciting. As someone like you who's getting older, you know, and the joints are getting a little more creaky, it's nice to know that, you know, jump up and down, you know, that there might be a little bit of a ache in one of those knees there. It's like, well, I'm glad, Glad they're getting better at how they're doing all.
[00:06:17] Speaker A: That stuff, you know, Someone's got a milestone birthday this year, don't they?
[00:06:21] Speaker B: Chris Newarker. Oh, yeah. Yeah.
[00:06:25] Speaker A: You're not that far behind in this race to the bottom, so. All right, Chris Newmarker, what is number four?
[00:06:31] Speaker B: All right, number four on the list, we've got Next Sense debuting brain activity sensing headphones that can improve sleep. These things are called the smart buds, by the way. The previous article was by senior editor Sean Hooley. This one is by associated Skyler Rivera.
I mean, this is just like, really interesting tech. I mean, uses six EEG sensors to measure electrical activity and detect when users are in light sleep, deep sleep, or drifting away as the user.
As the user falls deeper into sleep.
Yeah, this is just so, basically, they're delivering precisely timed sound frequencies called soft pink noise that nudge the brain's waves into a restorative rhythm, strengthening deep sleep. So.
Wow. So these are smart buds that help you sleep better.
[00:07:32] Speaker A: I'm a gray noise guy. Are you a noise person? Do you have white noise machines or anything going on while you're sleeping?
[00:07:39] Speaker B: You know, I might. I might play something a little. Little mellow, Celtic, New Agey, whatever, you know, like. Like lightly for a bit. While I'm drifting off?
[00:07:49] Speaker A: No, while you're sleeping. You don't have that stuff going on. All nightmares? Good God, no, no.
[00:07:56] Speaker B: Yeah.
[00:07:59] Speaker A: The fan going on her nightstand. But I.
I've got the iPad with some noise. And this is interesting because my kids, one of my kids sleeps with his earbuds in because I think he uses white noise. So this is definitely a way to go about it. It's fascinating that it kind of measures whether or not the quality of your sleep and whether you need the noise or not.
[00:08:21] Speaker B: That's interesting. Yeah.
Is the noise helping or not helping?
[00:08:26] Speaker A: I mean, it definitely.
So if I'm in a hotel, like, if I'm traveling, I, I bring my iPad, I Blare. The gray noise and it just kind of level sets me, just gets me asleep and keeps you asleep too. Which is always the trouble with the hotel.
You wake up at 12:30 in the morning and you're like, oh, it must be time to get up. And then you look at the clock, you're like, oh God, I've got another five hours of this.
So the gray noise really helps me. But this is interesting, having earbuds in which I don't usually do and I'm not sure how I feel about sleeping with those in.
[00:08:59] Speaker B: Yeah, that would be a little interesting. Yeah, yeah.
[00:09:01] Speaker A: But the fact that it kind of comes and goes as you need it, that's a really, really interesting approach. And I'm not sure if that's there Must have some data suggesting that helps because I would think just a steady level of noise would be more steadying and smoothing. But perhaps this counter validation.
[00:09:20] Speaker B: I think it's wild that he uses EEG sensors to sense how you're sleeping.
[00:09:25] Speaker A: Right, Exactly.
[00:09:26] Speaker B: I mean it sounds, it's very sophisticated and by the, this company is based in Mountain View, California. So like right in the, you know, right in the heart of Silicon Valley.
[00:09:34] Speaker A: But all right.
[00:09:35] Speaker B: Yeah, it's exciting. Tech.
[00:09:37] Speaker A: Well, sleep. I have a feeling over the next decade or so it's already, sleep's already seen as important. But I think we're going to, someday we're going to look back and realize we've undervalued the importance of sleep.
[00:09:50] Speaker B: Oh, absolutely.
[00:09:51] Speaker A: To health, to cognitive health, to dementia and things like that. And they're already pointing to sleep as a, as sort of a pre indicator of Alzheimer's or lack of sleep.
So I think this is actually, I mean, we can say it's a lifestyle product, but I believe someday these are going to be healthcare products.
[00:10:09] Speaker B: Health product.
Yeah. I mean my day is so much better when I get a good night's sleep. I mean it's just like kicks it up a notch.
[00:10:15] Speaker A: So I did not get a good night's sleep last night, but that's on me. I was playing Civilization 6 and I just, I just didn't want to go to bed. I was a bad boy. Chris Newmarker if I were my own dad, I would have be able to be myself at a couple hours before I actually went to bed. So.
But that's on me. But, but part of it is also this stupid cough like that just won't.
It just. It's making me very grumbly. So anyway, it's nice to have an escape like, like Civ 6. And it's nice to have these, these noise machines. So let's see where, where this goes.
[00:10:51] Speaker B: We just have little kids over here, so we're dealing with, still dealing with the little kids crawling into the bed sometime. That, that's just like, nothing like waking up and having a kid's foot in your face or something. Yeah, but, oh, well, it'll get better. Everything gets better.
[00:11:04] Speaker A: That goes away.
[00:11:05] Speaker B: Yes, exactly.
[00:11:06] Speaker A: You hope, anyway. All right.
[00:11:09] Speaker B: Better go.
Right.
[00:11:14] Speaker A: What's number three? Chris Newmar.
[00:11:16] Speaker B: Oh, my gosh. Number three on the list. This is from yours truly. I, I noticed a note from a Mike Matson and his colleagues over at Edam company that they were upgrading Medtronic shares to, to buy, you know, which, you know.
You know, I mean, you know, I, I, that, that got my attention. I mean, you know, because, you know, Matson was, you know, just talking about all the products that Medtronic has in its pipeline that could give it a boost.
[00:11:45] Speaker A: Well, that's great news for, for Medtronic for sure. I mean, when I saw the headline and I started listing in my, in my head, what, what's going on, I thought about Hugo. But they, I mean, there's a lot of other, the simplicity news with Medicare is great news. So Medtronic's been on a bit of a roll.
[00:12:05] Speaker B: This Ulta Viva device, I mean, there's a lot of potential in that. I mean, especially because, I mean, stuff that's been out there before has been more like pacemaker like devices. And this is like some tiny thing you put under the skin near the ankle to provide tibial nerve stimulation. And it treats urinary incontinence urge. Urinary incontinen.
So, I mean, if someday I unfortunately had something like that. I mean, yeah, like something like that that they just implant near my ankle. Sounds pretty great.
[00:12:37] Speaker A: All right, Chris Newmarker, let's move on to number two.
[00:12:39] Speaker B: Yeah, number two on the list. This is from Sean and it's Johnson and Johnson reporting some encouraging results around their investigational omnipulse platform for afib. And they also had some more data to back their veripulse system.
So just some, I mean, gosh, this pulse field ablation space is just so dynamic right now.
Just so exciting and offering so much potential. And so it's neat to see JJ moving forward with some more positive data on this investigational system.
[00:13:17] Speaker A: Absolutely. And our keynote guest on the podcast today will be Darren Uecker. He's the chief technology officer at Pulse biosciences And they had some great news last week at the AF symposium here in Boston. There's a smaller trial. I think it was like 150 people, but their success rate for treatment was like 96% after three months. And then I think it was still close to 90 after a longer period of time. And Darren will share it in the interview. But we talked a bit about how this field could shape up and basically how all these different programs can find a successful path. So it's great to have all these options for interventionalists and of course, for patients.
[00:14:02] Speaker B: Yeah. And I love competition. I think the more competition you have, the more innovation that you're going to see.
[00:14:08] Speaker A: Yeah, we actually had a great conversation. He was with Computer Motion at the start. He was chief Technology officer there. And he talked about how they came to be acquired by Intuitive.
It was basically a realization that to your point, competition is great, but they were also like, look, we can keep beating each other up or we can join forces and try to really make an effective change for healthcare.
That's true. That's the path they went. All right, what's the big number one? Chris Newmacher.
[00:14:36] Speaker B: And number one on the list. This is also from Sean. And this is news from Stryker announcing through an SEC filing that all these probes that they have for anti bribery, potential anti bribery law violations have now been dropped.
You know, I mean, a lot of, a lot of medtech companies do a lot of business overseas and, you know, they were, you know, facing some kind of investigation of some kind of like, you know, you know, like, you know, like some kind of like investigation whether potentially some kind of foreign Corrupt practices Act violations occurred. But yeah, they've, they're through it. They, you know, no charges, you know, things have been dropped. So that's investigate. So, you know, those government bodies have ended their investigations. You know, it was the Department of Justice and the securities and Exchange Commission. So good news for Stryker.
[00:15:38] Speaker A: Yeah, good news for Stryker. Good news for the industry. All right.
[00:15:40] Speaker B: Yeah, absolutely.
[00:15:42] Speaker A: Great. Top five, Chris Newmarker. Where can folks get the top five newsmakers every single day? How can they do that?
[00:15:48] Speaker B: Oh, my gosh. You can get the top five newsmakers by just following our daily Plus5e newsletter over at Mass Device. Super easy just to go to the site and you know, right there at the top we got a box to get subscribed for the, for the newsletter. So go over to massdevice.com and you get that daily dose of newsmakers. But of course, always stop by here and listen to Me and Tom chat about the news.
[00:16:10] Speaker A: It's a great newsletter, but it's not as entertaining as you and I are. I mean, we are. It's not just charming as all heck, aren't we?
[00:16:17] Speaker B: Totally. Yeah. We're just the charisma.
I mean, I'm sorry, people. I'm sorry I have to deal with all this charisma.
[00:16:25] Speaker A: Just too much charisma.
[00:16:27] Speaker B: Just too much.
[00:16:28] Speaker A: All right.
[00:16:28] Speaker B: Yeah.
[00:16:29] Speaker A: Chris Newmarker, thanks so much for the.
[00:16:30] Speaker B: Great makes JFK look like a boring person.
[00:16:35] Speaker A: All right, thank you. Chris Newmarker. Now it's time for our Future of Medtech Opportunities interview. Our FOMO interview, this one is led by Jim Hammerand. He's the managing editor of Medical Design and Outsourcing and he spoke with Ralph Kern, Chief Medical Officer at Cognito Therapeutics. They connected at Device Talks West. Let's listen to.
[00:17:06] Speaker C: Hi, I'm Jim Hammerand Managing editor of Medical Design Outsourcing. And we are here live at Device Talks west doing some FOMO interviews for the podcast. I'm here today with Cognito Therapeutics Chief medical and scientific officer, Dr. Ralph Kern. Ralph, thank you. Welcome to the podcast.
[00:17:25] Speaker D: Hey Jim, thanks for having me. Really appreciate it.
[00:17:28] Speaker C: So first of all, let's talk about what drew you into neurotech and neuromods specifically.
[00:17:33] Speaker D: Yeah, my background's in neurology and neuroscience and electricity is the language of the brain. And I spent first part of my career being very much involved in measuring and stimulating nerves.
And it occurred to me that this was a portal that could afford a treatment modality.
And Cognito is really at that intersection of using the language of the brain to bring a treatment to people that are in desperate need of healthcare solution. And that was really the crux of it for me.
[00:18:13] Speaker C: And how exactly does this technology work?
[00:18:16] Speaker D: Our brain uses electricity to maintain its resilience and the resilience is driven by well known biology.
So we're harnessing the brain's own ability to heal itself and maintain a resilient state.
We do that by delivering synchronized light and sound that produce a synchronized electrical activity to drive that same biology. And that's essentially in simple terms what we do. So basically the technology is simple but incredibly impactful because of the native biology that it's able to drive.
[00:19:03] Speaker C: What, from your perspective, are the biggest of the principal challenges right now facing the neurotechnology market?
[00:19:10] Speaker D: Yeah, I think increasing awareness of the capability of neurotechnology, I think understanding particularly for brain disease, that the blood brain barrier is there to keep Most things out, we have privileged access to the brain by using the sensory on ramps. So the synchronized light and sound activates the brain directly without impediment to drive the electrical activity that's important for this biological expression. So we're not limited by the constraints of drugs.
So I think that that awareness is becoming greater and greater, particularly with the brain computer interface, transcutaneous magnetic stimulation, various forms of electrical stimulation, and also the idea that you can activate the brain and change the way the brain functions. So I think that, you know, I think some of the wins are paving the way for us, but I think there's much more work to be done to make people aware that neurotechnology can achieve some outcomes that are not possible with drugs. And there's, they really are complementary, but there's unique attributes of neurotechnology that create huge opportunities to solve difficult problems.
[00:20:41] Speaker C: What about some of the remaining work to be done on the clinical side and the technical side? What are the big challenges?
[00:20:48] Speaker D: Yeah, I think the big challenge for neurotechnology, and we're trying to be on the leading edge of that, is that the evidentiary requirements for regulatory approval and payer access can be very different.
We are developing our technology with a very robust clinical program, which is very data rich, that will try to bridge that gap so that we have a very high level of robust data for regulatory support, but at the same time will translate to payers who want to see, who want to see very meaningful outcomes. And I think that's the approach we've taken. We're in our fifth clinical trial right now.
We have a fully enrolled pivotal trial in mild to moderate Alzheimer's disease in the US at 60 sites. And we're taking a very rigorous approach. That study will read out later next summer and at that point we'll be moving very quickly to a regulatory submission and try to get this into the hands of people who need it as quickly as possible.
[00:22:03] Speaker C: What are some of the big changes happening right now in the neuromod market even beyond your company?
[00:22:09] Speaker D: Yeah, I think neurologists, neurosurgeons, and those who are trying to find solutions for brain disease are increasingly interested in, in neurotechnology options. I think some of the initial wins with deep brain stimulation have fostered that interest.
Really remarkable outcomes. I think we're all standing on the shoulders of giants.
We hope to continue that with our technology and we look to other technologies as brothers in arms to help us move the field forward.
I think one of the big challenges, of course, will be Access and coverage.
And I think health systems will have to play a big part in bringing these solutions to patients.
The way we look at it is that we want to be patient friendly, we want to be provider friendly, we want to be health system friendly and we want to be payer friendly. So we want to provide a solution that really is a win win across the spectrum. So there isn't this divide between health, medical practice and health systems. We want to bring those two together.
[00:23:26] Speaker C: And with regards to your particular market, you know, Neurotech and Neuromod more broadly, paint us a picture of the future. What does this market look like five, 10 years into the future?
[00:23:36] Speaker D: Yeah, I think it's going to move from, from treating very difficult diseases to looking at recovery from injury and then looking at human performance. I think that is the spectrum that we're looking at. You know, obviously starting with disease, a diseased approach, we're looking at, you know, slowing the rate of progression of diseases or hopefully in some cases stabilizing or improving function.
I think the other, the second phase will be looking at things like stroke and traumatic brain injury to look at speeding up and extending the degree of recovery in those individuals.
But there's a very short line to could human performance be improved?
And there's many examples of that in the military and non military use and you know, Formula F1 drivers, competitive sports.
I think that the sky is the limit and I think the lessons we're learning now about building brain resilience will translate across diseases and non disease areas as well.
[00:24:56] Speaker C: I'm always interested in your perspective on what are the technologies that we need to get us there.
[00:25:02] Speaker D: Yeah, I think, you know, one thing that it may not be considered a technology per se, but I think the idea of introducing a disruptive technology and collecting data from patient use real time in the home and integrating that in a platform is going to be incredibly valuable.
In our case, we want to create a platform where the device is customized to the individual.
So in our case we confirm brain activity with our device at the start and we optimize it. We optimize the settings for that. We monitor device adherence real time using the cloud.
We provide adherence reports to the treating physician so they know how the person's using the device real time.
We want to integrate that with the diagnostic step up front so we can treat people earlier.
We also want to integrate it with a monitoring aspect where we monitor the person in their home and we get a sense of whether they're doing better or not.
And I think that bringing all Those things together in a data rich environment will require technology. It'll require different types of analytical techniques to integrate all that data.
It will require different commercial model and it will require a lot of activity at integrated delivery networks.
So the pattern of care in the future will be integrating new technologies, not at the individual patient level only, but at the health system level. So we change care pathways, we monitor performance and we provide real time evidence of impact. I think that's the future.
[00:27:09] Speaker C: Well, the future is bright. I'm very excited to see what you and your team are working on and to follow you in the months and months, years ahead. Thank you so much for not just your time here today, but all the work that you do to advance patient care.
[00:27:21] Speaker D: Really appreciate it, really enjoyed it very much. Thank you, Jim.
[00:27:23] Speaker A: I appreciate it.
All right, once again, it was great to hear from Ralph Kern of Cognito. Now it's time for our keynote conversation. Again, my guest is Darren Uecker. He's the Chief Technology Officer at Pulsa Biosciences. We'll talk a lot of med tech. We'll talk about his, his start at Computer Motion, sort of what went into the decision to combine Computer Motion with intuitive. And he's been with a lot of companies that I know you've heard of because I've heard of them. He's been chief Technology officer, he's been head of R and D, he's been CEO.
So Darren has seen a lot and shares a lot of, I think, tremendous insights on what makes Medtech great. So let's have this conversation with Darren Uecker, the Chief Technology Officer of Pulse Biosciences.
Well, Darren Uecker, welcome to the podcast.
[00:28:21] Speaker E: Thanks, Tom. Thanks a lot for having me.
[00:28:23] Speaker A: It's my pleasure. You had some great news at the AF symposium last week for Pulse Biosciences. I want to unpack, I think, which was some early but I think really dramatic results, and see where you go next. But first, of course, we love to learn about our guests and about their path in medtech. And as I said before, we pushed record, I was going through your path and a lot of familiar names that I want to sort of visit upon and a lot of successful outcomes to the companies you're with as well. So it seems like you're a bit of a lucky charm.
But let's start at the beginning. You were with Computer Motion. Well, actually, my question is always, and let's be consistent, what brought you into the medtech industry?
[00:29:11] Speaker E: Yeah, you know, I feel very fortunate to have, you know, met Some great people and along the way and got into some really fun and exciting companies.
I'm an engineer by background and went to UC Santa Barbara, met some people while I was in graduate school studying robotics and through those kind of relationships ended up at Computer Motion in the, you know, in the early days of that company.
That's what kind of got me into medtech from the get go. And I'm 30 plus years now. I'm sort of a lifer in the development of medical devices.
[00:29:55] Speaker A: So did you self identify as a robotics person first joining Computer Motion? Were you not a medtech person?
[00:30:01] Speaker E: Yeah, honestly, there was a group of people that were at UCSB studying robotics and that company was, was founded by some of those individuals.
But it was really a, you know, it was a robotics background looking for applications and, and then the application of surgical robotics was hit on. So it was really, you know, roboticists that had no real understanding of medical devices, had never been into an operating room and you know, kind of had to take that technology and learn on the fly everything you need to learn when you develop medical devices. I mean it's, it's often the case, I think there isn't, there aren't a lot of programs that sort of teach you the ins and outs of medtech and how to develop devices and you know, the regulatory environment and all those things. And so it really came from a technology base and then met the application and brought in, you know, physicians as KOLs. That helped really connect the technology, you know, to, to the medical field and to the operating room in this case. And that's, you know, that's a theme, right, that I think at least is a through line for me. It's technologies that, you know, you meet up with physicians and magic happens.
[00:31:22] Speaker A: Absolutely. And of course a Computer Motion, it was the system used in the first telesurgery procedure that we've talked about on the podcast before.
Really broke some ground and ultimately was acquired by intuitive.
It looks like you were there for the entire time through the acquisition.
Is your timeline matching up exactly?
[00:31:49] Speaker E: Yeah, yeah. So I was pretty early at Computer Motion and all the way through basically through the acquisition.
So 10 ish years. I mean it was, you know, that's a whole, you know, book in its, in itself. But it was a fascinating experience. I mean it was two companies I think that, you know, had had the same, you know, goal at the end of the day, but took different approaches to sort of the design and the platforms that were being developed and really were battling it out in the early days Trying to figure out, you know, what was going to be the first killer app for robotics and really paving. Pioneering that area.
And I think what happened was there was just a. We were competing fiercely kind of in the market. We were competing fiercely in the patent areas and in some other places. And I think the two sort of management teams got together and said, look, we're going to beat each other up here and slow each other down and maybe coming together and really focusing on, you know, making this market and building this great opportunity and bringing this technology to patients faster and more efficiently and effectively is really the. What we should do. And so that really is what, you know, drove that combination. And I was fortunate to be there. I was fortunate to kind of stay through the integration of it and spent a little time, you know, with intuitive surgical at that time. I have great admiration for, you know, the folks there and what they've done going forward. It was, you know, it was really, I mean, it's an amazing story.
And, you know, I think those early days were foundational in terms of really launching it, and I'm grateful to have played a, you know, a part in it.
So, yeah, it was a fantastic experience.
[00:33:51] Speaker A: That's great. As you sort of describe the decision to join forces, the way you say it, the Tony Hughes, it makes so much sense, but we don't see that happen very often in industry. There seems to be just a slugfest of sorts until there's a declared winner.
Was it just an unusual set of circumstances? What do you think?
Why doesn't that happen more often? Or what was so special about that particular moment that it did happen?
[00:34:17] Speaker E: Yeah, I mean, probably some of the way I described it is the benefit of many years between now and then and, and, and, you know, in, in telling the story, but because, you know, for sure, you know, during a lot of the, that period of time, you know, the competition was fierce between the companies, you know, on the technology side, on the sales and marketing side, you know, in patent litigation, which, you know, is. Is well documented publicly.
And, and so it isn't. It doesn't come about immediately, of course. I think each company thinks they're the ones that are going to win the day.
And, you know, there's, and so, you know, coming to that decision, I think, you know, took a lot of, just a lot of discussion and a lot of, you know, people thinking about what's in the best interest of the future of this technology and, and belief in this technology and the industry.
You know, the CEO of Computer Motion at that time was Bob Duggan, who's, you know, the, the co chairman of the board and has been involved in Pulse for a long time. I've known him for, you know, 30 some odd years now.
And it was just a lot of discussion about thinking through the different paths and, you know, kind of at the end of the day, you know, if your goal is really to see this technology impact as many patients as you can, you know, while being able to build a big successful business, are you better off doing it independently, as you've been doing, or does joining forces make more sense? And so it didn't happen immediately. It wasn't a quick decision by either company.
We had to beat each other up a little bit before maybe figuring out that again, if we keep beating each other up, someone else could enter this market without all the battle scars and, and compete against us. And so why not join forces and really build an impenetrable moat around this technology with the technology itself, the IP and everything else? And so, I don't know. I think people have different, probably ideas about that and how it happened. That's my view.
And I was in favor of it at the time. I mean, I could see how much time and energy we were spending competing, and I could also see how it could just get a lot more efficient and effective if there was one company that was really going after it and applying all their energy to building these systems and everything required to have great outcomes for patients and physicians and everything else. So when I look back, that's kind of how I see it.
[00:37:18] Speaker A: Yeah, sure.
[00:37:19] Speaker E: It was, like I said, it was a pleasure to be involved.
[00:37:22] Speaker A: That's great. And it clearly works. So you were standing at a moment in time when you could, I imagine, continue to focus on robotics or surgical robotics and stay within that world, or go pure medtech. And you went pure medtech. You were CTO at Computer Motion. You took the job as CTO at Reta Medical Systems, which was one of those companies I referenced earlier that I remember, Reta Medical.
What was, what was that? Were you a med tech person at that point? What was there? Was there any tough decision crossroads, anything? Or were you. Were you. Did you see a medtech company as your clear next step?
[00:37:59] Speaker E: Yeah, that's a great question. It's.
It was definitely a difficult decision.
You know, I had been in robotics, you know, surgical robotics. I really believed in the promise of it and the future of it.
And, you know, I think as I kind of stepped back and thought about, okay, what to do next, do I stay a part of intuitive surgical and see that through or do I maybe try, you know, something different? And I got an opportunity at Reta medical systems.
Joe DeVivo, who had been also at Computer Motion, took over Reta Medical Systems as the CEO and he recruited me to come to Reta Medical Systems. And you know, I was just really intrigued by Rita. You know, it was my kind of first step into energy based systems. It was an RF ablation company, one of the early, you know, volumetric RF ablation companies that was treating malignant disease.
So you know, that company was involved in treating cancer in liver, in kidney, bone metastases, a little bit in lung.
And you know, I was, I would say I was, I was drawn to the idea of, you know, devices as sort of therapeutics and treating cancer and treating, you know, diseases that we know to be big problems. Not, not that robotics wasn't doing that, but I think, you know, having spent a good amount of time in robotics, maybe, you know, maybe I was also sort of interested in something a little bit different.
And you know, robotics was a little bit different at the time. It probably still is a little bit different in that at the end of the day it's really a tool and a tool that enhances significantly, you know, surgeons capabilities and you know, getting into energy based systems, it really is more, you know, I viewed it then, I still, I view it now as a little bit more of a therapy type of device. And so I was intrigued by that. I, you know, obviously didn't know a lot about, about radio frequency ablation.
So I, you know, I took the leap. I, I, you know, did my diligence, felt, you know, really excited about it and, and it was, you know, it was a great experience. I learned a ton.
I think we did a lot of great stuff. And as you probably know, it was ultimately acquired by Angio Dynamics.
But it was, you know, which, which was great. I think again, it was, it was, it was the right, right transaction for that company. And that technology, Angiodynamics was kind of building a, you know, what we might call a oncology device platform, which nobody really talked about that kind of thing back then. But now it's a little bit more common. You know, we have interventional oncologists and, and so devices have made their way into oncology and that was kind of an early step into that. But it was, yeah, that was sort of my thinking. And it was again, you know, it was interesting experience.
[00:41:14] Speaker A: That's great. And you held senior technical positions at Conceptus Cyberheart.
And I want to get into your Next move in a moment, but Cyberheart, a Tom Fogarty company. Any.
Any Tom Fogarty stories? I know you joined a couple years after it was started, but what was it like to be.
[00:41:32] Speaker E: Yeah, I don't, I don't. I don't have any. I don't have any great stories. I've just, Just, you know, like most people that were able to meet Dr. Fogarty and spend some time with him, I'm just super grateful that, that I had that opportunity. And, you know, we all know he passed recently, and I just, you know, look back on that time and he was on the board at Pulse. You may not know that for a period of time.
[00:42:00] Speaker A: Oh, I didn't know that. No.
[00:42:01] Speaker E: Yeah. And so I, again, I just. Yeah. My only story is to say that I feel very grate to have had the opportunity to meet him and to get to work with him. He was brilliant, A brilliant in many ways. And just being able to talk to him about the things you're working on and other things was a pleasure. And again, I just felt really grateful for that.
[00:42:29] Speaker A: That's great.
And then in June 2009, you became president and CEO of Gynasonics again. Another company I've heard of, another company that would go on to be acquired. Was being a CEO something you were set out to. You had set out to do early on, or something that you had set a goal for yourself at some point or did. It just. It doesn't ever just come together. But how did you find your way into that role?
[00:42:51] Speaker E: Yeah, yeah, I, you know, I worked mostly at smaller med tech companies, you know, and kind of worked my way up into managing more of the organizations from, you know, early on it was, you know, it was R and D and then it was R and D and operations, and then R and D operations and Clinreg quality.
And I think I was approached initially by a board member at gynasonics to come onto the board at Gynasonics because I had an RF ablation background. Gynasonics, you know, was a company that was developing a very unique.
A device that combined ultrasound imaging with RF ablation for the treatment of uterine fibroids in women's health. And so a board member approached me to come on the board and.
Which I was excited to do. And then pretty quickly after that, the board asked me to come on full time with the company as the president and CEO. And, you know, while I hadn't to your earlier question, and I hadn't really kind of sought that out, but I think you know, in a small company, you know, the role of the president and CEO is obviously much different than in a much larger company. And so I felt like this was an opportunity to, you know, to use my skills on the product development and technology side by, you know, running the company, but then, you know, build some additional skills, you know, around, you know, fundraising and marketing the company and business development activities and things like that. So that's sort of how it came along. And, you know, I was thrilled to at the opportunity. It was very, I thought the application was very exciting and, you know, much needed and the technology was really a good fit for what it was trying to solve.
[00:44:59] Speaker A: So you worked, as I mentioned, a few times at a few startups as CTO and as a CEO, and you've had a lot of success or the companies have gone on to be acquired.
And again, I joke that you were a lucky charm. You obviously had a greater role than that. But were you able to identify common traits in these success stories? Because they are medtech success stories. What does it take to get a, a string of wins like that to lead a company, to be part of a company, to be part of the leadership of a company that would then go on to be part of a larger OEM in a bigger part of healthcare?
[00:45:38] Speaker E: I think that small companies are all about staying focused on the product that you're developing, the data that you need to demonstrate its utility, generate positive outcomes, and in a market that, you know, people are clearly interested in and, and, and is sizable and, and focus on that stuff. You know, I'm not a big fan of, of a strategy which is, you know, managing to exit.
You know, I think that, I think that can be very challenging. It's, it's commonly done and you know, I think some people do it very successfully. And so I, you know, I would, you know, I think, I think if that's the way people want to go, that, that, that works for some people. I think for me, you know, just focusing on, you know, the product and making a great product with good outcomes and continuing to drive as if you can, you know, keep taking it forward is, is the best strategy. And then, you know, you're always in communication with potential acquirers. If you're a small medtech company and, you know, they want to stay kind of in the know with what you're doing and, you know, then, then these things just, you know, can kind of happen. I mean, in my case, they were all very different, very different reasons. And you know, just for clarity, I think at Gynasonics I wasn't there through the hologic acquisition that happened, you know, somewhat recently and I was, you know, already gone. And that company, it took a long time. But I think the, you know, the common thread is, you know, you're just, you're just driving the product development, you're generating great outcomes, you're, you know, demonstrating that physicians can use your device, that it's easy and easy to learn, easy to use in a market that people understand is going to be a good business.
And then the acquisitions, if that's the exit, they come.
So anyway, I think that's the strategy I've tried to hold to and we've done that at Pulse as well. I think it's a common thread.
[00:48:01] Speaker A: That's great. Well, let's get into the Pulse story. I think that's a good, simple strategy though. Good products drive good outcomes.
You joined as President and CEO in 2015.
Talk to us a bit about Pulse and its mission. What problem is it trying to solve?
[00:48:24] Speaker E: So I was recruited to come to Pulse. It was a very unique story.
The company had been kind of pulled together by an investment group or a small kind of investment banking firm called MDB Capital.
They identified the technology, did some research into the technology and its ip, identified a couple of universities and a couple small companies that had IP in what we call now nanosecond Pulse Field Ablation.
[00:49:02] Speaker A: Oh, interesting.
[00:49:03] Speaker E: And realized that this could be a really unique platform technology that could potentially be used in a lot of applications.
And so they secured all of that intellectual property under one company, which is now Pulse Biosciences, in exchange for equity, and then went about hiring a CEO, which was me, to really take this technology which was kind of on the bench, if you will, had come out of universities.
And so the mission was let's take this really unique non thermal technology that has a really unique mechanism of action in terms of its ablation and build a platform and, and explore what are the best applications to, to go after. And you know, I, I had been in ablation throughout my years at, you know, like we just talked about at different places and, and so as I understood the technology, I just believed that, wow, you know, this is a new energy modality.
It's going to have a lot of applications throughout the body.
And so if we build kind of a general purpose platform with this technology and then begin to explore the different applications, I think we're going to hit on a number of them. So unlike a lot of medtech companies that start with a sort of singular application, very Focused, single indication.
And maybe even, as we discussed previously, maybe even with an eye towards strategics that know would be interested in acquiring it and putting it in their channel.
You know, this was much more of a platform kind of opportunity or potential platform opportunity. And, you know, and the field was kind of open in terms of where should we go and what should we do. So that was really the attraction for me. And our vision and mission was really to take this, you know, nanosecond PFA.
[00:51:23] Speaker B: Technology.
[00:51:26] Speaker E: And move it into as many applications as we could for the benefit of patients and physicians and the healthcare system as a whole.
[00:51:35] Speaker A: But the focus was on the heart, or was there opportunities everywhere?
[00:51:40] Speaker E: Yeah, so there were really opportunities everywhere, and we've explored a number of them even through preclinical work and clinical work.
We explored dermatology for a period of time.
We started in on the cardiac ablation side, you know, relatively early, probably a couple years. You know, once we were kind of had our pulse generator platform, which we now call npulse. Once we had that, you know, we then worked with some researchers externally and began our own internal programs to look at cardiac ablation, both on the surgical side and then ultimately, you know, on the electrophysiology side. So it was sort of always one of the top applications, you know. But again, you know, we have. I just mentioned two in the cardiac space, which we currently have ongoing, and then we have another one that's currently in early commercialization, which is a percutaneous ablation device using our nanosecond PFA technology for the treatment of benign thyroid nodules.
So it's very different than treating the heart, but it's a equally compelling application for this technology.
[00:52:58] Speaker A: Essential. I mean, the story isn't identical, but as you're talking about it, it kind of sounded like your computer motion experience too, where you were looking for an application for robotics. And this was clearly more focused than that. But how unusual is this approach?
[00:53:12] Speaker B: This is.
[00:53:13] Speaker A: And I don't mean this in any sort of diminutive way, but this is.
You had a really great hammer and you were kind of looking for the right N. Is that accurate?
[00:53:22] Speaker E: Yeah, yeah, that's. That's right. I mean, you're spot on. And I often, you know, talk to people about the parallels between, you know, robotics and this technology.
It's very, very similar. And, you know, obviously I learned. I lived through the robotics days. I learned a lot in that. In that process, which I think I've, you know, brought to pulse biosciences in terms of, you know, how do you, how do you bring about a platform and then get into, you know, different applications? And one way you start with that is like, is to build the platform so that it has a lot of capability. And so from the very beginning, you know, we built a console which I mentioned called Npulse that you know, is a, if you look at our website, you can see it, it's a very polished, it's a commercial grade system now, but it has all kinds of capability knobs you can turn and it's all software driven.
It has.
Wireless uploading to proprietary cloud infrastructure that we have. So we really started from the beginning and built something that we knew had the capability to allow us to go after a lot of different applications.
So that's sort of point one, right when you're getting into, hey, I think this can be a platform technology. So how do we prioritize our activities from the get go? The second thing I would say in that which I touched on, but I also learned from my robotics days, is you have to really be diligent in the development of your intellectual property along the way.
Because often, and I think this was true in robotics also, you know, the, the early IP is all about the core technology and what it is and those types of things.
But as you develop these systems and you actually, you know, have to move them into the clinic or an operating room, you learn a lot of things along the way that have never been solved because nobody's brought that technology into the operating room before. And you know, we have unique requirements in the operating room around safety and things like that. And so it's very important in those early days to, you know, really make sure you're focused on those things and the IP that you can gain, you know, patents specifically around those different developments, you know, that you're doing. So, you know, I would say the first, you know, third of our history, maybe even the first half, was really focused, you know, kind of on, on those things in particular.
And the last thing I would say quickly about, you know, being able to, to do those things as a platform company is you need, you need board members that have that vision and aren't focused on narrow indications so that you can exit as quickly as possible. And with the good fortune of having Bob Duggan involved with the company from the relatively early days, and he is by all definitions a visionary, someone who really wants to change medicine and change the way things are done in a positive way and is willing to invest in those things. So, you know, those are, you know, those are the Important elements when you're starting out, especially with a platform. I think, you know, robotics was, was very similar and, and we, we're kind of doing those same things here.
[00:57:14] Speaker A: And how did you do all of this as a, as a public company?
You, you went public in 2016. I mean, this is, yeah, just a, a contrarian approach to, to medtech development, I have to say.
[00:57:26] Speaker E: So the, the, the folks that kind of founded and launched the company or brought all the IP together to bring the company together.
Their model was to go early in terms of the company being public. And it was a little bit of a biotech like strategy.
And they were successful in terms of taking us public and we raised money that allowed us to really get going.
And then, you know, subsequently, Bob Duggan got involved and he's, you know, he's really put in a lot of his own money into the company and, and that's, you know, that's been key to us being able to do what I said. You know, I think that you have to, you have to have backing that can see, you know, the vision and can, and can invest for the long term. And you know, as a public company, of course, it's, it is, it can be challenging, but, you know, as a public company, then you're obligated to be reporting on a quarterly basis. And there's a discipline to that that I think is also valuable for companies, even small companies. So, you know, it's, it's, it was the path that we were put on and that we accepted and we've made, I think, the best of it. And I think we find ourselves in a good spot right now as a result of it.
[00:58:55] Speaker A: That's great. Well, I want to unpack a little more about the field, the pulse field ablation field.
But let's just hit upon quickly the news that you had last week released at AF symposium. I know it was a smaller trial, but I think you had like a 96% success rate with your treatments continuing. Can you talk a bit about your recent news and where you are in the clinical development of your PFA system?
[00:59:24] Speaker E: Sure, yeah. So it was very exciting for us.
So our electrophysiology program today consists of a very unique catheter that works with our impulse nanosecond PFA system.
It's a very uniquely designed catheter designed specifically for our nanosecond pulse field technology.
What's unique about it is it's what we would call a circumferential. It creates a circumferential ablation. So a complete 360 degree around ablation. So if you take our catheter, you can place it inside the pulmonary vein and In a single 5 second ablation cycle you completely ablate around the entire circumference of the pulmonary vein.
You can also use it on the posterior wall. And so for the electrophysiologists it's a very simple catheter to use. It requires very few applications to perform pulmonary vein isolation, which is the dominant procedure for treating paroxysmal atrial fibrillation patients.
And you know, last week at the AF Symposium, what we presented was over the last couple years we've been running a feasibility study in Europe at three different centers.
This is our kind of first in human study. And we've been in Prague predominantly at Homolka Hospital with Dr. Vivek Reddy. And he presented the data, you know, from the podium at the meeting. And you know, it was a total of 150 patients were presented it's feasibility data. So during this study we used two different doses. We started with a dose that has been very effective and then we used a lower dose to test that dose as part of the feasibility, ultimately, ultimately going with the dose that we started with. So where we started, we ended and we've also used quite a lot of different mapping and navigation systems through the course of this feasibility study. So we really spent a lot of time doing this study to look at different technologies to combine with our catheter, having different operators with their hands on the catheter, making sure the dose is right.
And we presented all that data, or I should say Dr. Reddy presented all that data at the AF symposium, we're very excited about the data.
While it's feasibility and we need to reproduce this data and we intend to reproduce this data in an IDE study coming up very soon.
You know, as you mentioned, you know, using Holter monitors for procedural success, we had a 96% success rate at one year in 47 patients and 100% success at six months with 75 patients, again with Holter monitoring as the endpoint. So we're thrilled about it. You know, the safety profile is excellent.
And so, you know, we, we've been really, you know, gearing up and working hard on this study as a means to get to our IDE pivotal study.
And again, as I mentioned, that study has now been approved by the FDA. It was approved in December, last December of 2025.
And we expect to be an enrollment on that study here very soon.
[01:03:08] Speaker A: That's great. And just to update folks, you're Now Chief Technology Officer I know Paul Laviolette of SV Life Sciences or formerly SV Life Sciences is CEO.
Let's look broadly at the industry and kind of wrap up with this.
As you were talking, I kind of was thinking back again to Computer Motion, except with the decision, however it came to be, to merge with intuitive the understanding that we're going to, instead of slugging it out with each other, let's combine forces. We're looking at a PFA market now with every major strategic has a program.
We're seeing a number of startups in the area that have their own systems or in some stage of clinical testing.
We've got the founder of Faripulse who's now working at Field Medical. There's a move to the ventricular part of the heart.
So how does this seems like an area where people are going to choose to slug it out.
How do you see this sort of moving forward? How does pulse field. I'm sorry, how does Pulse biosciences fit into this broader field?
[01:04:22] Speaker E: Yeah, so we, I think the way we view this is, you know, we really view ourselves as kind of a second generation PFA technology.
It's a very nanosecond is very different from everything I think that's out there today, which is generally in the microsecond domain.
We think there are significant advantages to nanosecond including, you know, depth of ablation, homogeneity of the ablation, ability to create large ablations quickly.
So we think there are significant advantages.
One thing we have been public about is that we also understand that in order to create a great solution for the electrophysiologist and get great outcomes, it requires the integration of different products, different technologies and so on the ablation side, integrating tightly with a mapping and navigation system, you know, such as the Insight X system from Abbott or the Cardo system from J and J is, you know, can provide the kind of solution that electrophysiologists expect and will help drive great outcomes. And so, you know, we've been public in saying that we, we believe that this business, this electrophysiology business of ours is one where a partnership makes the most sense.
Not just because it can provide the best possible solution, we think, but also because there are some very large companies in this space that have very large footprints and large installed base. And I think strategically we think that just makes the most sense. So we don't know right now, as I'm talking to you, you know, what that looks like for us.
But you know, at the AF symposium we did a live case broadcast.
We showed our catheter with a novel integration from Abbott with the NSIGHT system.
You know, it was very well received. I think it was fantastic.
At the HRS meeting last year, we had an integration with the Cardo system.
And so, you know, we think there's a lot of opportunity out there to partner.
Our goal is to partner because we, again, we think that provides the best solution. And so, you know, I think that's what I would say about, you know, where we're at and, you know, you pointed to, you know, previous in the robotics conversation. It's similar. I think we recognize what we're really good at, what our technology is really good at, but where it makes sense to partner, to leverage what other people are good at and, you know, and drive a really great solution.
[01:07:16] Speaker A: Well, that, that seems like a great sort of sensible possible outcome to, to how things may, may shape up in, in electrophysiology. What about your other two programs? How do you see those playing out in being part of pulsed biosciences futures?
[01:07:32] Speaker E: So we have a cardiac clamp. So we have a, you know, cardiac surgery program where the clamp uses our nanosecond PFA technology. It's, it's very exciting. This is in today and, you know, I think where that heads remains to be seen.
You know, we're fully prepared to take it through the IDE study and to PMA approval and then, you know, continue to move forward and we'll see. I think it depends. But, you know, certainly there are, there are companies that have large cardiac surgery device businesses where they have, you know, reps and others standing in cases where these types of ablations are done. So I think, you know, I think there are opportunities for partnership. There are also opportunities to continue to move it forward, you know, as part of Pulse Biosciences and on the thyroid side, I think, you know, we've made the decision to commercialize.
We're currently in the very early stages of that.
[01:08:39] Speaker A: That.
[01:08:40] Speaker E: But, you know, we think with, you know, a relatively small footprint, you know, we can really, you know, drive in, drive this commercially and, you know, and just, and just continue to build this, this market. It's, it's an untapped market.
It's one we're very excited about and, and I think makes sense, you know, to have our, our own folks in there and, and, and moving this forward for the time being.
And so, yeah, I think they're all kind of different in their own way.
[01:09:12] Speaker A: That's fantastic. Well, Darren, I appreciate the walk down memory lane. You've been getting a lot of medtech success stories and it sounds like you're working on another one, so appreciate sharing your insights and experiences.
[01:09:26] Speaker E: Yeah, Tom, thank you very much. It's been my pleasure. And yeah, that was a lot of fun. Thank you.
[01:09:34] Speaker A: Well, that is a wrap. Thanks so much for joining us on this episode of the Device Talks Weekly Podcast.
Please do subscribe to the Device Talks Podcast Network or the Device Talks Weekly Podcast directly, but if you do the Podcast network, you'll get access to all of our podcasts, including upcoming episodes of Women in MedTech hosted by Kayleen Brown and Avatar, hosted by both Kayleen Brown and myself. So lots of great medtech podcasts coming your way. I hope you will of course, join us at Device Talks boss. And that's happening May 20th, 27th and 28th at the Boston Convention and Exhibition Center. Go to devicetalks.com to find more information or you can go to directly to Boston. Devicetalks.com can also meet us up Meet up with us AT Device Talks Minnesota. As we mentioned, that's happening on May 4th. Go to minnesota.devicetalks.com to register to join us there. It's a great event last year. We're happy to relaunch it and can't wait to be back on Star Wars Day May 4th.
Other than that, please connect with me on LinkedIn, please connect with Kayleen Brown, please connect with Chris Newmarker, and of course, make sure you follow Device Talks and mass device on LinkedIn. That's it, folks. Thanks again for being part of Device Talks and of course for joining us on this episode of the Device Talks Weekly Podcast.
