Building the Next Generation of Robotic Surgery with David Fischel, Chairman and CEO of Stereotaxis

[00:00:03] Hello everyone, Saul Marquez here with the Outcomes Rocket reporting live from the Society of Robotic Surgery with none other than the amazing David Fischel. He is the Chairman and CEO of Stereotaxis. David, so glad that you're able to join today. Thank you very much for having me. Yeah, talk to me a little bit about you, your background and Stereotaxis.

[00:00:23] Sure. I entered the surgical robotic field first as a math student, then working in medical device venture capital, medical device hedge fund, and then came across Stereotaxis. It was a very interesting company, had a beautiful, unique technology that was actually working well in the real world, but like many younger technology companies, was struggling operationally and commercially and was almost going out of business.

[00:00:47] And so in 2016, led a group that we invested in the company, paid off its debt, gave it operating capital, joined the board, and very quickly thereafter was asked to start to help run the company. And so that's what got me into the operating role. And it's been nine, nine and a half years now, and we've been building up Stereotaxis ever since.

[00:01:06] There's what you have here at the SRS conference is many surgical robotics is now a huge field, but essentially all of the robots that you see in the conference are either doing laparoscopic surgery or open orthopedic surgery. Yeah, robotically. That's the mix. The biggest field, if you think about how procedures have evolved generally, operating room procedures have evolved over the last several decades, the biggest field of growth has been endovascular surgery, right?

[00:01:34] As you go more and more, less and less invasive, right? Smaller and smaller kind of incisions, less traumatic for the patient. And so across essentially every area of medicine, you've seen this trend towards endovascular surgery, catheters going through the blood vessels. But there's no robots in the endovascular space, essentially. We're the main, we're the leader and the pioneer of robotics in that field. We have 100 hospitals around the world that are working with us, right? Wow. So it's a small drop in the scheme of things.

[00:02:01] But so that's the area that we're looking to pioneer is kind of good robots that allow you to do cardiac, neuro, peripheral procedures well robotically. Man, that's so exciting, David. And that sets the frame for sort of the recent developments for you guys, recent FDA approvals, 10K clearances. Talk to us about the latest. Sure. So if you think about the challenge that Stereotaxis had early on and that I think many companies have is that they think about developing a specific technology.

[00:02:30] And when you work in the robotic field, you have to think about ecosystems. Nothing works. A robot just by itself is useless. It needs to interact with a complicated operating room environment. And it has to interact. You have to have your, you have to have disposables that work with it, right? The catheters themselves, the interventional devices themselves, the robot itself, how that robot integrates from a software perspective with other technologies in the room. So you have to think kind of about the whole, yeah, the whole environment overall.

[00:02:59] In the cath lab, where kind of all interventional procedures are, right, you have to think about the x-ray and you have to think about in electric, let's say in a subset of interventional cardiology where we have most of our community. You have to think about mapping systems and ablating systems. So you have a whole ecosystem around you. And so what we've really been focused on, it's called three, four main drives of innovation. The first one was how do you make the robot more and more accessible so that it doesn't, it's not a construction process.

[00:03:24] It's a robot that can be deployed into any cath lab relatively easily and then taken out relatively easily depending on kind of the needs and desires of the hospital. And so that has been a big process. And we just got, like you mentioned, FDA approval at the end of last year for our newest robot, which took us from a construction world to a placement world. That's awesome, man. So that was ability, mobility, especially ASCs, a lot of stuff moving. I hope that in the, I hope that in the near term, we'll start to be able to describe an ASC strategy.

[00:03:53] You're exactly right, because obviously interventional cardiology has like many areas moved in that direction. The second, third, fourth areas that have been a big focus is how do we take control over our destiny on the catheter side? So historically, we never made the game where is that work with our robots? Now we have, we have our own in-house catheter manufacturing facility and R&D facility. We, we got FDA approval for our own. It's a PMA actually.

[00:04:20] So that was a tough regulatory path, but we got our own ablation catheter for treating patients that have arrhythmia, our own diagnostic catheter. And we're developing a whole suite of other catheters and wires so that the same robot can also be helpful in neural procedures and interventional cardiology procedures. So you expand to become a platform robot across interventional medicine, not just one specific procedure. And then the last one, like probably many of the others you've interviewed, is this whole field of digital surgery.

[00:04:49] How do you add intelligence to your robot? Exactly. Yeah. Well, that's super exciting. No small task. You guys have made a lot of progress. And I think at this point is where things start to pay off. What are you most excited about at this point of the company? I know you're about to go do a talk. So talk to us about what's top of mind for you, what your talk is about.

[00:05:09] So I think kind of the last nine years were to some extent stabilizing a company that was in a challenge, formulating a strategy and then executing kind of that strategy. And that strategy was predominantly in R&D. Invested nearly $100 million in R&D over the last decade, focused on kind of building out this ecosystem and all the infrastructure in order to advance it. And now with multiple regulatory approvals, I'd say we have a dual focus.

[00:05:39] There's the whole initial commercialization focus. How do you demonstrate that these new technologies work well in the real world, are providing real clinical value to patients and physicians and hospitals that rely on us? And how do you ramp manufacturing and all of the practical things that sounds easy, but it's actually a lot of work to do so. And so that's one big area of focus. The other one is how do we continue driving aggressively this second wave of innovation?

[00:06:07] And so kind of this first wave has gone in regulatory approvals, right? We've gotten seven, eight, nine regulatory approvals just over the last year, not a year and a half in the U.S. and Europe. But now the question is, what's the second wave? And so recently we acquired a company called Robocath, which had a very complementary and elegant robotic mechanism of action, also for navigating catheters that can work with our original one. So integrating that, developing that technology, allowing it to also come to market.

[00:06:37] We have a whole additional set of catheters and wires that are being developed and have to go through the regulatory path. And then the digital side is really in its infancy. So we came out very recently. We got FDA approval for kind of this cockpit for the catheter. We have multiple hospitals that have now purchased and even started using that cockpit, both with the robot and even without the robot. But there's a whole that's going to be an innovation pathway to really make digital surgery what it should be. That's going to be a 10 year journey.

[00:07:06] Totally. And at this juncture of the company, I got to ask you, like you've got the approvals, you've got commercial traption, like the strategics have got to be looking at you and opportunities there potentially. Or do you want to be your own company? Rule number one is you always build the best standalone company you can with the capabilities in-house, with the ability to grow significantly, to be kind of self-sufficient and profitable. That's our focus. I love it, man. That's awesome. I love the drive. Well, look, I have really enjoyed this.

[00:07:36] I remember visiting Intuitive Surgical 20 years ago, over 20 years ago. If you look at how the journey of a company like that played out, right, no one would have believed 20 years ago. You visited 20 years ago? Yep, over 20 years ago. So no one would have believed it to how that played out. And so to some extent, if you have that kind of, if you want to transform big fields of medicine in dramatic ways, you have to be willing to play the long game and you have to have that kind of ability to look at that vision. So we have an open hand for collaboration.

[00:08:03] We work with many companies, some of them here, others in our field. You do need to think about collaboration and it's beneficial to collaborate with others because at the end of the day, we're all trying to deliver the best unified solution for patients and physicians. While you have an open hand for collaboration, you also need to be self-sufficient and drive things self-sufficiently. 100%. So what would you say helps fuel your vision and belief? It's obvious. It's obvious.

[00:08:29] You have tens of millions of interventional cardiology, neurointerventional procedures, where essentially a physician is standing in the cath lab right by an x-ray system that's shooting them with radiation. And they're fiddling with devices like this to try to manipulate from the handle. They're trying to manipulate a flexible device where the procedure is taking place a meter away at the other end of that device.

[00:08:56] The precision from trying to fiddle with a flexible device here and trying to move over there. The ability to get where you need to do it safely. The ability to do it focused on the patient and not focus on how do you hold your body in a specific way. All of that, you look at it and it's obvious that over time we are going to evolve to something better. And so it's not a question of if it's going to happen.

[00:09:20] It's a question of how best to do it and who's going to be the group that develops the right ecosystem and creates a good enough solution. We've treated by now 170,000 patients. I see essentially on a weekly basis, I get from some of our users, text messages about patients that are treated with our technology that couldn't be treated without the robot. And that's really where our edge is, right? So most of our use right now is predominantly to treat patients that have arrhythmias, heart arrhythmias.

[00:09:48] And so electrophysiologists, they're the ones using our robot. And they predominantly used us in congenital heart disease. Let's say the catheter that you mentioned, the ablation catheter that we got PMA approval for, we're the first catheter, to dilation catheter to ever get approval specifically for patients with congenital heart disease, right? Because of the mechanism which allows our catheter to move in complex hearts where you can never get a catheter to go otherwise. And so when you look at kind of congenital heart disease, pediatric patients, complex ventricular procedures,

[00:10:18] those are the areas where we shine. And so it's nice to be able to advance medicine in that way. As you make the technology better and better and easier and more accessible and less expensive, that allows it to be used more and more, not just in the most complex patients, but down the complexity curve. And that's also what we're focusing on. Well, that's fantastic, David. I love hearing the story. It takes time to build in medtech. You're certainly doing it. Excited for the next chapter.

[00:10:47] If people wanted to learn more about you, the team, if there's an EP lab listening to this that wants to learn more, where can they find you and the team? We have, we're at stereotaxis.com. We're on all the social media platforms. We are delighted to get a message and we are responsive and move quick. That's awesome. That's awesome. Well, I appreciate the opportunity to connect with you. Thank you very much. And for everybody with us, thanks for tuning in. This opportunity to talk with David Fischel, the chairman and CEO of Stereotaxis.

[00:11:17] Check out the show notes for all the ways to get in touch with him and his team. You're hearing from us live here at SRS. Thanks for tuning in. And until next time, stay on it. Thank you.