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Neurotechnology to Address the Limitations of the Human Body | Fireside Chat at LSI USA ‘24

Kimberly Ha leads the discussion with this panel to explore the frontier of neurotechnology and its transformative role in overcoming the human body's limitations.
Speakers
Kimberly Ha
Kimberly Ha
, KKH Advisors
Andy Rasdal
Andy Rasdal
, Synchron
Tom Oxley
Tom Oxley
, Synchron

Kimberly Ha  0:06  
Great, well excited to kick off this panel. We've got two amazing speakers here. I guess, Tom, if you wanted to kick off with an intro, and then we can go to Andy.

Tom Oxley  0:18  
Oh, good evening, everyone if you're finishing your meal. So my name is Tom Oxley. I'm the CEO of Syncron. I'm an interventional neurologist, by training been working on Syncron for over 10 years, we've raised 130 million in capital to this point, were working towards a PMA, for a first in class of a brain computer interface. It's an interventional technology. And essentially, a brain computer interface is a technology that helps people who can't use their hands to control digital technologies to improve independence.

Andy Rasdal  0:59  
And I'm obviously he's the brains and I'm the brawn up here. This evening, I'm Andy    Rasdal. I spent about 35 years in medical devices, starting with one of the first angioplasty companies in his era, kind of to reference I was the first CEO at ducks calm the lead through building the team, taking the product to the regulatory piece, taking the company public, and then the first few years of commercialization relatively new to BCI. And pleased to be working with Tom.

Kimberly Ha  1:30  
Yeah, I guess first question, what are BCI is right, because it's like a few years ago, no one knew who they were. And then suddenly, with no neural link, and everything had just exploded onto the scene in the last few years, I guess, Tom, there's just been a lot of myths about what BCI is, right? From, you know, God media saying like, are they mind reading technologies? Or like all this augmentation, I guess, could you tell the audience about what BCI is not just to set the stage?

Tom Oxley  2:00  
Yeah, so I think for this for this audience, for med tech audience, neuro, so maybe you're looking at neuro technology neuromodulation or neuro stimulation has been a big growth area within med tech. In fact, I saw last year that neuro tech implantable neuro tech and particularly driven by neuro stimulation had become the biggest back VC area within med tech now overtaking cardiac and orthopedics. So neuros, coming into this kind of heyday, golden period, brain computer interface, I think about it as distinct from neuromodulation. But it's in the domain of neuroprosthetics. So it's primarily a sensing technology. An implant that detects brain activity makes predictions on what the brain is trying to do, and then sends information out of the body to control external devices in a way that's useful for users. And neuro link us and the other brain computer interface. Companies are targeting a similar initial application, which is the large unmet need of not just paralysis, but motor impairment. So essentially, people who can't use their hands to control digital devices. So that comes from a range of range of problems, while your body doesn't work, from spinal cord injury to generic disease, to arthroplasties, to positive movement disorders, like cerebral palsy or Parkinson's disease, where the user is unable to now engage with digital technologies, because you have to engage with touching a screen. So BCI promises to take the signal out of the brain, create a new Bluetooth input into a digital device, and then restored digital device technology control. So really the first wave of BCI Well, this wave of BCI is motor BCI. But actually, the Cochlear device was the first BCI that was a hearing device. So neuroprosthesis is a device that restores a brain function, whereas neuromodulation is a device that provides therapy to restore a symptom of a certain type of disease. So

Kimberly Ha  4:13  
and only I guess, what, how did you get involved with Syncron? And how did that all happen? Yeah, sure.

Andy Rasdal  4:20  
I was fortunate enough to get introduced to Tom and after a couple of conversations on the phone, Tom came to visit me where I live in in Park City. And I tell the story that you wanted to go on a hike and it was late fall, and we started climbing up the the side of a mountain, it started to snow. And Tom never lost his passion about sharing the vision for what BCI could do. And so number one, I was I was attracted to Tom and since I've met the team, I looked at this is obviously BCI for me, unlocks independence for people who otherwise can't live independent Leave it all in not just for them, but for the millions of people who care for them as well. And when I got to know, this is more than just a product, this is a platform technology, I think that has the potential to visit what I saw happen through cardiology, through balloon angioplasty through stents through interventional EP, can serve as a platform to further unlock the whole neural Arena.

Kimberly Ha  5:25  
And kind of where I'm sitting, I see a lot of similarities in terms of obviously, Andy, from your experience, right, just bringing a completely new technology with Dex comm. You know, as former CEO taking the company through a successful IPO to recently I read, you know, I think that it's, it's wild, it hit like over a billion dollars or something like and in sales, right. So how on earth did you actually do that? It's almost like, you know, you're creating a completely new market, which is exactly what same Kron and these other BCI companies are trying to do here? Like, can you tell us a bit about that journey.

Andy Rasdal  6:03  
I mean, in retrospect, everything always looks so linear, and in romantic and, you know, I can tell you, when I started that journey, I was six foot four. And so no matter how you do it, it, it takes its toll. But the truth is, it's it's building a great team that has a common unified vision, and keep solely focused on that. That's the most important thing are the people and that's what attracted me to Tom and Synchron. The next most important piece is you actually have to deliver on something that works and having a really strong foundation of a technology, because anybody who knows that XCOM journey knows that the first product, which was approved in 2006 wasn't adequate to grow the market to what it is today. But having a fundamentally strong platform allowed that technology to evolve into more usable products until today, it's a standalone substitute to manage blood glucose. And so at that point, it became a very large market opportunity, good people, which included very strong and knowledgeable investors, and then navigating the path.

Kimberly Ha  7:08  
And that brings me to my next question, which is on funding right, like, how do you convince investors I know, like, all the attendees, right here, everything, you know, ton of panels on funding VC, the current environment, right. You know, how was that process? Like from, you know, Syncron has been, what, 10 years in the making, right? You know, what was that funding kind of? I read online that you literally cold call to our full rate for funding, you know, walk us through that.

Tom Oxley  7:40  
Well, the funding journey, I guess, yeah, 10 years ago, brain computer interface was a science fiction story. I think my so I was doing neurology and I was watching the advent of interventional neurology, take off in neuro will not take off it was just very early stage. So interventional neurology history was starting with coils. And then over the last five years stroke therapy has started to explode now but the origin story for Syncron i co founded it with Rahul Sharma, who's the Stanford head of the Stanford Cath Lab interventional cardiologist. And the the thesis for Synchron was if interventional cardiology could lead to such an explosion of technologies, not just in the mechanical domain, but in the electrical domain, electrophysiology, mapping, ablation, pacing, defibrillation resynchronisation. Well, the brain is a much bigger electrical organ than the heart. So surely, it seemed to me obvious that that technology will eventually migrate from the heart over to the brain, in which case we're going to see a renaissance revolution of interventional approaches into the brain. So and then, so that idea was in my head and then brain computer interfaces were starting to emerge, the first human clinical report was back in 2006. With the brain gate system, so BCI was in the academic domain for 20 years. And so our approach was or take an interventional approach to solving that and now so you know, the fundraising story has been initially starting with brain computer and the solution for brain computer interface. Now there are several companies chasing brain computer interface, but the ambition for Syncron is is growing because we have an intellectual property position which is interventional implantable neuro technology. And I think as neuro technology is now exploding and the investment is incredible, especially in neurostimulation, but we have a we have a true platform opportunity because the blood vessels get to all areas within the Brain, we've built a full vertical stack platform of technology that can sense or stimulate through the blood vessels. And we're now picking off the areas that we think could be the start of multiple products, starting with brain computer interface and long winded way to get to your question, but it started out with so we had a, we had a technique, we had a surgical approach, we had an intellectual property. And then we had a first product opportunity. And as BCI was getting a lot of excitement, we could attract initial grants. And then it wasn't until I moved to the US. I don't know I think for this audience, it's interesting, because we haven't had traditional med tech investors. And there are other ways to secure funding than just traditional med tech. And I've, you know, I think I've got to say, like, traditional med tech approach is quite a little bit rigid in its thinking, there's very clear views on how a device should be valued and exit, what your acquisition strategies are IPOs in med tech are unusual. So having an IPO strategy or vision is not always kind of like, you know, sought to be very high risk. But there are different ways to go about it. And I think you've got to identify what you're doing differently, what the market opportunity is, and then just do bit by bit, but the visions, the visions got to expand as you go.

Kimberly Ha  11:28  
And now I think the company has raised over $100 million in funding and with the latest round being a 75 million Series C round. I believe 2022. Is that right? Led by arch ventures, even with participation from, you know, some pretty heavy hitters like Bill Gates, and also Jeff Bezos, like how did Honestly, how did you attract? You know, that level of, you know, from from Bill Gates, and that's

Andy Rasdal  11:59  
what we used to hope to raise in an IPO. Right? Let alone in in a series B, or C.

Tom Oxley  12:06  
I think telling the story to different investor bases. So there's a biotech story with what we're doing. So our last, our last investor is more of a biotech. But there's this data enabled biotech is like, is your product infused with AI? And what does that mean? And what does that mean for potential future growth? The tech story is how does your technology converge with consumer technology and for us, like we're using iPads to prove that our technology works, that's what it looks like. It's a medical device that controls an iPad. So there's, you know, Zuckerberg talking about a neural interface being the holy grail of technology control. So there are technology sort of narratives and stories to run with that deliver technology investors into the ground, and then there's actually we're a med tech company, with the same reimbursement and regulatory risks that we have to burn down. So I think, you know, different audiences, different, slightly different talk tracks and different groups giving different valuations for where things might go and just selling the story of where this will go in the future.

Kimberly Ha  13:18  
And, Andy, I think we were having this conversation earlier. I know there's an IPO panel tomorrow. But, you know, how was that process in terms of, you know, taking Dexcom through to successful public, you know, listening?

Andy Rasdal  13:34  
Well, I think it, it was certainly controversial, because we proposed taking ducks calm public in 2005. This was pre FDA approval, obviously, pre any kind of commercialization or revenue, with a device in a category that had never been approved by the FDA before. And again, it really came down to, you know, a strong group of people, I had the fortune of, of, I think, building a very strong board of directors, with some people who had been through not only medical technology, but very high level technology as advisors. We built a good syndicate of advisors with our, with our legal teams, the underwriting team. And then we had very, very strong I think, data and a compelling story, to get out the, you know, get the company out early. And it it was it was a it was a struggle, no doubt, but we did have a successful IPO and raised a lot of money. So

Tom Oxley  14:26  
why is it that there are so many less med tech IPOs than biotech? IPOs?

Andy Rasdal  14:34  
That's a good question. I always almost look at the biotech IPO as being like what we would do in a Series Series, Series D, but it's a very different model, I think, than the med tech. And I've said this publicly a number of times over the many, many years that I think a lot of med tech entrepreneurs and CEOs. Maybe we just were out and we take the early exit, and we take two or three or four or 500 million dollars for a company, rather than take the risk of having to go public having to build a commercial success having to build cash flow and revenue growth and ultimately showing that you're cashflow independent, which is why the values like Dexcom happened if we sold Dexcom, you know, after the series D in the category, you know, it would have been one price, but look at the value. It's created. But not not easy. No question.

Tom Oxley  15:27  
So Dexcom went public, you didn't secure reimbursement, well, Dexcom, didn't secure reimbursement for seven years after the IP owed. And the stock price was, you know, not languishing. But it was at a certain level. But if you look back now, you've we've talked about and I think it's interesting to share the the what was the benefit of getting the PMA early and doing the IPO early that you think contributed to Dexcom success later? And in terms of beating Abbott, or, you know, what, what were the important things that gave Dexcom the edge about taking taking that decision to go out early? Yeah, it

Andy Rasdal  16:09  
always looks so, so much easier in retrospect, when you tried to explain it. But again, I just can't say enough about the fundamental foundation of the technology. This was a real strong platform of a technology, the decision to go public was difficult. And it was controversial, but it accomplished couple things. It got us a large amount of capital, to continue to build the organization at a reasonable cost. And it put all classes of stock into the same level, there was no preferred, there's only common stock. And so besides having an aligned management team, you know how to aligned investment team to be able to go pursue the next step. You know, we were fortunate enough to leapfrog the two other competitors in the market in the regulatory process by yours with a regulatory strategy that allowed that I think we got credit for that. We did a follow on offering upon FDA approval, that was just a little over 100% of the IPO price, we more than doubled. And so I think we picked up some momentum along the way, but it gained US funds gained us independence. And I think more importantly, again, this alignment between the investors and the investors on the board, the management team and the ability to go forward.

Tom Oxley  17:20  
One thing that we've spoken about is heading towards a PMA. So we're viewing if we can, if Syncron can get to a first in class, PMA and brain computer interface. We think that could be a big value generator for the company. So we're making decisions on how can we get to PMA as quickly as possible in our company. If you look back at Dexcom, what was some of the decisions you made around getting to PMA quickly that, say Abbott? You know, compared to Abbott, who you're racing with sort of get first in class approval? What were those decisions? And why were they important? Yeah.

Andy Rasdal  17:58  
So Dexcom, when when I started Dexcom, it was a fully implantable one year device intended to measure glucose like that. And along the way, we figured out that due to human biology and the foreign body response, that it was unlikely we would have a one year implantable device to measure glucose in my lifetime. And we made a decision to switch and from the time we switched to a fully implantable to a sub continuous, again, back to the technology platform. We went into humans successfully then for months at a time. So we had a good platform that enabled us to move very quickly and a good team to move forward with that. And it put us in a position from a technology standpoint of being first the decision to then enter the regulatory Arena. This is a category that had never been approved by the FDA. And the concern with them was people are going to use this new device to measure their their blood glucose levels and Miss administer insulin. And if you take too much insulin, the result is dire at best. And so in moving the FDA along through a number of discussions with very strong data, ultimately, from a randomized crossover study design, we decided to pursue what was called an adjunctive claim for the first continuous glucose monitor that patients could use, meaning that they could use it they could use it for the inflammation but the labeling said before you administer glucose, you should confirm with the finger stick. And I think what that enabled us to do is build a lot of strong trust and credibility with the agency in so we literally move through years ahead of time. And once you're first then you get to set the parameters of competition, as well as the regulatory processes for everybody who follow behind you.

Tom Oxley  19:41  
How do you set the parameters?

Andy Rasdal  19:45  
Well, when you have a when you have a best in class performing device with a strong foundation, in this case, you you show accuracy, reliability. Our display was novel. That was the first time patients had been able to see an actual graph half of their glucose, you know, interestingly enough, I'm sure there's people here that have diabetes, you know, your your glucose isn't changing like this. It's just like the world's slowest game of pong as we used to describe it. But nonetheless, it goes up and down into visually. So we had a visual display that didn't just give people a number, because what is the number matter if you're if your blood glucose is is 130, Meg's per DL, that's great information, if it's going up, at a great rate, for goodness sakes take insulin to bring it down. But what happens if it's 130, and it's on a sharp decline, and you give insulin, then jumped off of hypoglycemia. So we were able to set the standard for reliability, accuracy, and then how that information was conveyed to patients that I think is carry through to this day production. So

Tom Oxley  20:48  
we had, the reason I was chasing Andy to join our board was because I saw a lot of symbols, you could catch me a lot of similarities between brain computer interface and continuous glucose monitoring, sensing technology, lifestyle modification, digital enablement, digital app required to engage with the technology. First, like new new product, new technology, and no obvious reimbursement pathway. So a lot of these things and then chasing a PMA and, you know, having to go down the IPO road. So a lot of similarities for Syncron.

Kimberly Ha  21:30  
And talking about kind of the user experience, Andy, like, we didn't even talk about this. But, Tom, in terms of just how simple Syncron PCI or sentiero Can you talk a bit about just the product design and kind of the thought that went into that? Because I think one key difference between what, what you've built and what neural link and some of these other BCI companies is, is really going through the endovascular approach or, you know, going through the natural highways of the brain, right, your blood vessels?

Tom Oxley  22:05  
Yeah, so the challenge for brain computer interface is that you have to get close to the motor cortex. And traditionally, that would require a craniotomy. And that's what the traditional approach to BCI has been cut open the skull, get to either the surface of the brain or penetrate into the brain, and they both come with challenges. But the I think, we've, our technology looks a lot like a cardiac pacemaker. It sits in a vein. It's, it's, it's got a stent attached to a lead, it gets engulfed or, you know, enveloped into the wall of the blood vessel, and it detects through sensing local voltage changes, changes in you know, the remote region, so, and then it comes down into the chest, and it's got a, it's got what looks like a traditional pacemaker in the chest. So we've actually leveraged a lot of the technology from pacemakers, from stents from neuro stimulators, or pacemakers, and put it all together. In totality. It's a completely novel device, but in its modularity, it's got a lot of predicates, which makes our journey through regulatory and reimbursement more navigable with lots of predicates that we can discuss. And I think that's been very important for the FDA, because we can leverage the safety profile that's known for stents and leads for a long time. And

Kimberly Ha  23:30  
and you've implanted 10 patients in total right now with your BCI device. And I guess, in terms of where you are in the clinic right now, in clinical trials, you know, you're the leading company, kind of, literally, with your early feasibility study, the command study that's ongoing in three clinical sites in the United States right now. Can you tell us a bit about just what's next for Syncron? And just where you are with this?

Tom Oxley  23:57  
Yeah, so we've moved through a first inhuman in Australia, then we did an early feasibility study in the US that's finishing we've completed enrollment, we're getting towards the last follow up for our six patients. So it's 10 patients in total. Now, the FDA is there's been a great conversation with the FDA about what a pathway through to approval looks like and that can conversations continuing to happen. And we're now so we've taken that data set. And we're now and we you know, the manufacturer for that system was at a certain level but we're now getting ready for commercial scale manufacture. So we're moving through completion of manufacturing, design, we're moving into characterization and then it'll validation will happen over the next few months. And then we'll prepare for a later stage clinical trial. With our eyes set on getting a PMA for for a brain computer interface for for motor impairment.

Andy Rasdal  24:56  
And we found a ton we found it's so important that when you're having those forces calm First Nations with with the FDA, if you can set the requirements for safety and efficacy endpoints, and then you can deliver on that data and set threshold, it just makes those following behind, you have to achieve at least what you have achieved. You know, moving forward with that, probably, many people in the audience have gone through developing a device to your first you know, animal work, and you go to your first human use, and was laugh that, you know, when you finally go to humans, you learn what the device really does and doesn't do. And that's the first few humans, when you go to 10, or 20, or 30. Humans, then you actually learn how people use the device. And again, the ability of the team to be able to iterate through that and rapidly change and improve it is important. And again, the advantage of being first

Tom Oxley  25:44  
when, if anyone knows what thrombectomy is, it's the, it's, I'd say the biggest advance in stroke medicine ever, actually. And it basically involves putting a catheter up into the brain grabbing onto a blood clot that's causing an occlusion that leads to a stroke and pulling out the blood clot restoring blood flow 2015, five New England journal papers, overwhelming efficacy nominated to treat of three to get patients with major stroke, back home and independent compared to like, PCI for currently for coronary intervention. numbnuts treatment 26. So huge impact, what that's done is led to a massive increase in neuro interventional resource allocation from local level, like down to community level hospitals. So if you have a stroke, it's likely that the ambulance will take you to down to a secondary level hospital and there'll be an interventionist there on 24 hour seven call ready to pull that blood clot out. So that's, that's led to this maturing of interventional neurology. And so the question now is what technology can we deliver, but as it pertains to endpoint I give. So what happened with stroke was when the first technology came through the way that stroke is now being assessed as using clinical outcomes, Modified Rankin Scale for levels of independence. But when the when the first device came through to show that they could pull out blood clots, the first pivotal trial, it just had to prove that the device itself could pull out the blood clot. And the independent stuff was going to come but the FDA recognized that Well, the first thing we have to do is to prove that the devices work, and that you can restore blood flow. What they didn't know at the time was that you have to restore the blood flow, ideally within six hours. And if you do it at 48 hours, you're probably not going to help that patient even though you've restored the blood flow. It's an interesting predicate, because as a new technology comes to market, the discussion over clinical endpoints with the FDA initially starts with does the device perform as it's intended to perform? And can you have clinical outcomes around that? And then it's like, what is the how do you measure the broader patient health outcome? Because it's not obvious initially. For brain computer interface? How do we measure how you control your iPhone, or how you control your iPad, there's no tool to assess how well how well you text or how well you email or what your level of function is, and then how much of a drop off do you have and your capacity to control your iPhone after a stroke, and then can a BCI restore that level up to a certain function? So we don't know. And we have to develop all these tools. So we're having really interesting conversations with FDA. Now, I think we'll look back in 10 or 15 years, and it'll be more obvious. But smartphones have crept up on us over about a 15 year period, and we take them all for granted. But as soon as you lose your ability to control when you want that back. So figuring out clinical outcome tools to determine clinical efficacy is not an obvious thing right now,

Andy Rasdal  29:03  
with the with thrombectomy. Tom, how much of that has the growth and that's been driven by the evolution of technology making it easier, safer faster has there been so when we went through this in look, the first angioplasty balloons were about that big there was two guiding catheters shape. And if you put it in there for longer than five minutes, it had no support. And so you know, the the Jeffery hearts, there's assignment certs or the Richard milers could do angioplasty, but the people in non tertiary hospitals didn't have a chance as guiding catheter technology became braided as balloons became increasingly miniaturized and smaller. And then the advent of stances where people in the in the community hospital you see a similar path through the the neuro where it's a few people can do it and actually technology enables everybody. So

Tom Oxley  29:51  
in 2010 to 2013 That was the situation. There was some physicians who could get the catheter up, grabbed the blood clot and get it out, even though there weren't perfect tools created for that. And those physicians knew that if you did it quickly the right way the patients come in, unable to talk any priest hemiplegic destined for a nursing home, you get out the blood clot and they wake up like a, like a zombie rising up, then it's unbelievable when you see it. But then the evidence was murky, because some couldn't do it and some could. And then Medtronic made the acquisition of EB three, which was from Chestnut, and they had this device that could grab onto the clot really well. And then the success rates shot up. And then the number needed to treat suddenly was was very high. And now so initially, it was the stent type approach. And then the catheters themselves like a vacuum cleaner, attached to a pump, where the breakthrough had to be in flexibility of catheters with a wide bore that didn't kink. And so that's been the huge breakthrough in catheters now. So now we have really awesome access technology that can get to any region in the brain. And so what our vision has been, okay, now we can get anywhere. How do we now engage with brain tissue through the wall because you've got this huge electrical organ? And, you know, taking lessons from cardiac EP now bringing it into, into interventional neuro technology.

Andy Rasdal  31:20  
You know, it's interesting, the going through that whole, I mean, again, while I was so attracted to Syncron, is, you know, much of my career was watching cabbage, open heart surgery, transition to balloons and then stents surgical ablation to catheter based ablation, in the fact that Syncron doesn't require a craniotomy that we access through through the vessels in the natural passageway seems to be a stronger platform.

Tom Oxley  31:49  
Yeah, and so you've so then I think it was grunt sick. Andreas, Grunt, second 19/81. One

Andy Rasdal  31:56  
first angioplasty? Yeah,

Tom Oxley  31:57  
he put him so he locked himself in the basement. I think he was in Atlanta, I think he was in Atlanta, in Emory. He was at Emory, locked himself in the basement of the hospital, put a catheter into his own heart blew up a balloon. Just did it a week with a nurse there helping him catheterized himself, and then went up to the Christmas party and announced that he just done this. And then the word got around that, oh, you can plasti inside the heart and it doesn't kill the patient. So then plastic took off and then stents and then pacemakers, and there's this huge explosion and I'm looking at neuro right now. You've got DBS for epilepsy for Parkinson's. You've got stereotactic EEG for ablation, you've got monitoring systems. And now brain computer interface, great proof points, if you do it through craniotomy that can be very effective. But, you know, lots of challenges with scaling into market because there's, like, same with cardiothoracic surgery, there's not many sensors that can perform open brain surgery. And so I think, you know, we're at the cusp of this moment in neuro technology, where catheter based therapies are now becoming available, and this explosion of technologies, but the convergence of neurovascular with neuromodulation. And now neuroprosthetics, think intervention is going to be a huge explosion. Now the infrastructure is ready, the resource, the infrastructures, been primed through thrombectomy. But there's so much that can be done because you've because of the electrical side of the brain.

Andy Rasdal  33:31  
And I think when when technology innovation, coincides in the right way with clinical innovation, we see these these, you know, these high growth markets, you know, PTCA, stents, neuro mod some of these as well.

Kimberly Ha  33:45  
And I think that's another unique differentiation with Syncron. And the central right where you don't need to take out, you know, a chunk of your skull and you don't need, you know, you're not basically going through neurosurgeons, you're going through cath labs. So what's your vision, Tom, in terms of scaling BCI, like what, what does the industry still need to do? You know, to enable, you

Tom Oxley  34:08  
know, it's not even that you don't need the craniotomy. It's that even if that was easy and safe and cheap, it's that you can't do more than 10s of 1000s of procedures a year because of the limitation on infrastructure of academic neurosurgical centers. I think there's about 150 places in the US where you can go and have a skull cut open and have technology put into your brain. But there's 10 times that near interventional labs now that with these physicians who are like learn how to do stroke therapy, and they're on 24/7, but they don't have enough to do during the day. So there's actually oversupply of infrastructure in demand like low like a look for demand for interventional technologies and oversupply of the workforce now, because they have to meet 24/7 coverage mandated by government now because they have because it's good for, you know, for for the economy. So, yeah, I think if we can deliver technology that works through catheters scale is built in, it's just a matter of proving that it works well enough.

Kimberly Ha  35:15  
Miss Andy, if you could, if you could redo anything from your decks calm days, what would you redo? And I guess now that you get a different CEO, now that you're kind of, you know, on the board at Syncron, like, what are you telling Tom in terms of what to avoid, basically, as he's building? You

Andy Rasdal  35:33  
know, I think the biggest piece was, was fail fast. And so I'd say fail, fail faster, make sure you make, don't make a decision before you have to make a decision. But it's time to make a decision, for goodness sakes, make the decision, because you need to find out if you're 100%, right, 90% 80%, right, and then be able to flexibly and rapidly adjust the direction. You know, we've had a couple of good companies at EA, which was one of the first coronary stent companies we took a public sold at Medtronic for 4.3 billion back in 1999. And we started as a low cost angioplasty balloon headed for Japan. In ultimately a successful index bomb. We started as a fully implantable, one year glucose monitor and went to a three day patient delivered subcutaneous and so I think it's it's it's fail fast, which we did learn your lessons realized as a CEO, you're either raising money or spending money. And the more successful you are, the more time you get to spend raising money.

Kimberly Ha  36:41  
I guess, Tom, in terms of you know, we're a synchronous today. Well, what would you say is like the tiki technical challenge that you had to overcome, to actually make this product a reality right now?

Tom Oxley  36:56  
I think. So we have a mechanical device, we have a telecommunications component. We have a AI component of prediction of analytics. And then we have a digital component for consumer interaction, I think, putting it all together and building a company building a leadership team, you tend to gravitate towards certain types of focus, and that we're really focused on medtech and PMA approval, but that, you know, so I think managing the areas of, you know, like AI and digital doesn't always go with mechanical and PMA. So I think I think identifying where are the strengths? And where are the weaknesses? And how can we build a team that can execute on all of that, being really pragmatic on manufacturing and design decisions that would give us a break, like just try and simplify things as much as possible, for example, the lead in our system, we've just borrowed from a a cardiac defibrillator lead that is able to you know, we didn't want to reinvent the lead. And the way the head stage works in the in the mechanical component, this stent components, we wanted to try and simplify as much as possible, and then focus on our on our strengths.

Kimberly Ha  38:25  
And I also saw that recently, you acquired a stake in a cuantas. You know, from a manufacturing standpoint, I guess, how far in advance should companies be thinking about manufacturing and kind of controlling the logistics and the supply and everything the supply chain? Yes,

Tom Oxley  38:42  
so our stent is so a stent is usually a tube that's laser cut into whatever shape you want. We have an a circuit electric, like active electrical circuit printed onto a self expanding nitinol stent. So we had to figure out how to build a nitinol stent, put a layer of insulation on it, and we have a ceramic layer. And then on top of that, build an electronic circuit. So we had to do a completely novel manufacturing process using a sputtering technology. And so we've we've made an acquisition, we've made a investment in a partner to shore up that manufacturing line. You know, we wouldn't have I think, identifying I think it's I think what's important is you have to identify where your intellectual property and know how specialization is. If you're building a complex system, and then leveraging other problems that have been solved, don't reinvent the wheel and focus on your strength and your IP and building around that.

Kimberly Ha  39:47  
I want to ask this question, even though you guys don't want me to reimbursement the dirty words. So what's the strategy there right now in terms of reimbursement in terms of bringing a completely novel device that It has never been approved before.

Tom Oxley  40:02  
So it's going to be a journey. The good thing about well, we've we've specifically designed our system to be able to target reimbursement codes that are pre existing. So for example, cardiac pacemaker or a neurostimulator, that sits in the chest that does either receiving or simulating, there are codes that exist for that. So and then, you know, the brain component, and then the software pieces is a bit tricky. I think medic, Medicare and CMS have not traditionally reimbursed digital or software components of systems, it's certainly not an ongoing way. So you're looking for reimbursement upfront. But we've made design decisions that mean that even though it's a new product, we can isolate components of our system and point to predicate reimbursement items. So we've, you know, we've got breakthrough device designation, the T set program that is in front of Congress right now. Well, is it t said I can't remember keeps changing, but it wasn't. You know, we were excited about breakthrough and our investors were excited about breakthrough. But it's not totally obvious to me that tea set and breakthrough is going to be a slam dunk, there's a bunch of reasons why wouldn't be. So even for breakthrough devices, you know, I would recommend that you're looking for avenues of more traditional reimbursement that point to predicates and be very aware of the design decisions you make, should have multiple shots on goal for reimbursement.

Andy Rasdal  41:41  
And I mean, I come in from the outside time, I guess I was impressed with a couple of other things. One, is you've already got a team, and you've already started very early in the reimbursement process. The other that was always very compelling for us as we went through this with, with Dexcom, the power of JDRF, as a patient advocacy group was was just so broad, it's just I think it's the most successful influence group in the world today. But the patients that you're going to treat initially have very, very difficult lives. And just as importantly, all the people who care for them, also have difficult lives without the level of independence. And I think you've already begun to reach out into harness, and it's not hard to do the patient advocacy groups there as well. And so I think starting early patient advocacy, designing the device, to take advantage of codes, and ultimately beginning to deliver on very meaningful outcomes data, that gives people independence will will accelerate that, and there is no substitute. Our challenge was there was still finger sticks, you know, people wanted continuous, but those were the patients payers didn't want it. And so the burden was higher than I think we'll have it Synchron.

Kimberly Ha  42:54  
And Tom, I guess, right now, you know, in terms of patients in the clinical trial, not just patients with ALS, but potentially BCI could be for patients that, you know, have lost mobility through stroke. And I guess what are the other future applications for BCI that you see.

Tom Oxley  43:15  
So the FDA are contemplating BCI as synonymous with neuroprosthesis, as distinct from neuromodulation. neuroprosthesis is a medical device that restores a brain function. So brain function, hearing, seeing, smelling, thinking, planning, feeling. So I think motor BCI is about movement control. And that's relevant, it's critically relevant because so much of brain function is around processing or experiencing I mean, sensory hearing is all input. There's not that much of an output from the brain. So if you think about it, your ability to express your internal state is actually totally dependent on your motor system, carrying fibers out of your brain to express your inner state, I'm using the muscles of my mouth to explain I'm just speculating. So in a way, the output function of the brain that the motor system is in a way, the most impactful loss of brain function because you are not able to express yourself. So I think that's that's a that's what seems to be all the BCI companies are initially targeting but I know neural Link has talked about vision. Next, and there's been there's obviously been a couple of companies that have attempted visual prosthesis yet to sort of break through with a big therapeutic impact. cochlea is a neuroprosthesis hearing device. I know there's a company here that is doing a memory memory prosthesis attempt. Nia, Dad is here somewhere And but I think yeah, so there's there's neuroprosthetics. And then I think interventional will also be an avenue to solve neurostimulation neuromodulation, we'll be able to provide deep brain stimulation options that don't require craniotomy. And then I think there's going to be a whole product line of neuro monitoring, predictive forecasting type devices that with a permanent implant, collecting data over a brain state in certain conditions where predictions of brain states can have a huge impact on lifestyle. Epilepsy as a as an interesting example,

Andy Rasdal  45:39  
I think, Tom Tom probably probably shoot me but you know, the idea of being able to non surgically place a sensor in close proximity to different areas of the brain unlocks so many thing as Tom knows, I live with epilepsy every day in my household, in the impact of improving the quality of life simply has severe epilepsy, just by being able to sense predict, maybe even treat opens up forever. There's, there's, you know, we look at the value we created with with with Dexcom. With 2 million type one diabetics, there's double that amount of people diagnosed with epilepsy in the US today. So there's there's these disease states that are just gigantic that are utterly untreated, except with meds and the ability to place a center unlocks the understanding of the treatment of those diseases.

Kimberly Ha  46:27  
And I guess, would you say that I mean, since you went through, like the whole, you know, Dexcom CGM, like where, where do you see BCI? Right now as as a field and as an industry? Would you say that, you know, we're kind of in the beginning and the middle like heading towards? Where are we right now?

Andy Rasdal  46:47  
I think I think for me to place it temporal is difficult right now. I think we're earlier but the enthusiasm, the momentum, for BCI has captured people's imagination in a way that CGM didn't fry, continuous glucose only captured but really captured the minds or parents of kids with diabetes, who are tired of the fear of hypo. And then adults who are trying to manage their disease. It captured their minds. But that's 1,000,002 million people. If you watch what goes on with BCI. Today, it's captured your imagination far beyond that. And so the momentum and the interest, I think, is going to accelerate it faster than we saw.

Tom Oxley  47:30  
I think it's been hard for people to understand what BCI is, but what what what I've noticed with our patients is, it's hard to imagine what it would be like to lose your ability to move. And what happens when you get when you become paralyzed is you lose your agency in the world, you become dependent on someone else, you lose your privacy, you lose your autonomy, you lose this kind of thing that you take for granted, which is your ability to physically enact your will like your volition. And the feeling that I mean, we're still very early like we've so the system that's working right now can the patients can move a cursor on a screen and make selections and navigate their way we're using iPhone, it's not nearly as fast as what your eye could do with our fingers. But the feeling the patients get when they can make a selection on a screen independently is very powerful. And I think, you know, there's been a big consumer kind of public perception of what BCI is, and, you know, a science fiction overlay of a dystopic outcome here, but the reality is, this is for people who have what has traditionally been considered in medicine and untreatable condition once the nerves are damaged. That's it. And I started neurology and I love the brain. But I quickly realized in medicine oh, we're like the neurologists, to the butt of all the jokes. orthopedic surgeon, why would you do neurology you can't fix anything. Or like you know, you have to do radiology or like dermatology orthopedics, because neurology is you can treat everything but fix nothing. And BCI and neuro technology is now coming up with ways to restore function that was previously considered impossible I am. And in terms of the patient numbers, like we're looking at numbers. It's the number of people who, you know, stroke is a big thing, but then you add in things like ALS, multiple sclerosis, spinal cord injury, severe arthropathy is peripheral nerve disease, brain injury, cerebral palsy, Parkinson's disease, movement disorders, you know, the list is very long. And the technology doesn't solve any of these conditions. It's like a bypass from your brain to digital devices. At restore your agency. So I think I think BCI is going to be massive. I think it could be, it could become one of the largest areas within all med tech.

Kimberly Ha  50:10  
I know, we're, we're getting close to the end of this panel with few minutes left. But do you think that, you know, within my lifetime that, you know, able bodied people would, you know, walk in similar to a LASIK center or something, get a BCI installed? You know, and you know, if that's the future, right now, I completely understand that's for medical use only. But I mean, I don't know, few decades, 50 years time, something like that.

Tom Oxley  50:44  
I think the human body? Well, more is happening in your brain than what you can collect with your mouth express with your words or do with your fingers, you're definitely if you've ever felt like you want to text faster than what you can text like there is a limit on what our body can do. Do I think within 20 years, BCI gets more sophisticated than what the human body can do in terms of digital interactions. I think that's not crazy. I think it's pretty, probably plausible, unlikely. And it's hard to imagine now, looking at how technology is developing what we're going to be doing, or what our children will be doing in 20 years with technology or what that will look like. And will your hands be able to do that? I mean, I think, you know, so there's going to be a Moore's law with brain computer interfaces, if there's a if you can continue to get access to more brain cells in a way, which is sustainable and safe. And it's a procedure that's at the level of a pacemaker. And the technology can do more than what your hands can do, then. Yeah, you can see, there could be a interesting future this way. You know, it's 20 or 30 years away, probably

Kimberly Ha  52:10  
you never know, right? Like, Andy, when you first started Dexcom like did you ever think that the company to grow to like over a billion in revenues with like, I don't even know, like millions of people using CGM right now.

Andy Rasdal  52:22  
Again, it's always easy in retrospect, but but absolutely not never envisioned that it would become as, as important It has has become for people living with diabetes, expanding beyond that and to create the value it has created for all constituencies would have been beyond my my, my wildest dreams. So you

Kimberly Ha  52:43  
never know, Tom, we don't know. We just I mean, the future is out there. Right. Great. Well, any closing comments before we wrap up this panel? I know. You know, maybe we could grab a drink. It's chilly LeBron.

Tom Oxley  53:03  
Thank you. Thank you for coming, Eddie.

Kimberly Ha  53:05  
Thank you, Tom. Thanks, Tom. Sure. Thank you.

 

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