This Company Has a Plan to Beat Neuralink at the Brain-Computer Interface Game

0:00Tim, what do you think is the hottest show on television right now? Well, in my house, it is Severance on Apple TV. What if I told you that the brain tech in Severance exists in real life, but instead of being owned by an evil corporation, it is being pioneered by a benevolent startup, which sees it as the future of helping millions of people who are otherwise unable to interact with the world. That's hopeful, but it sounds expensive. Oh, it will be expensive. We're going to get into it in today's pod. That's next.

0:32Brain implants are going to be hot in 2025. Dozens of people could get a new kind of implant in the next year. That's according to today's guest. And if his company gets its way in the not-too-distant future, you might join them. The array itself is 22 microns thick, so that's a fifth of the width of a human hair. And the system sits conformally on the surface of the brain without penetrating into the brain and creates this incredibly rich picture of neural activity in real time. That's Michael Mager, the co-founder and CEO of Precision Neuroscience, a company that will be installing these things in people's heads.

1:11He has a pretty ambitious goal, giving patients with severe paralysis powers like telepathy and telekinesis, or at least their computer-enabled equivalents. Precision Neuroscience is developing something called a brain-computer interface. And a brain-computer interface enables people to control computers using only their thoughts. They've got plenty of competition, including Elon Musk's startup Neuralink. And Synchron, which is backed by Jeff Bezos and Bill Gates. We reported this week that Synchron is also working with Apple to develop ways for people with brain-computer interfaces to use its devices.

1:50This is easily the most science fiction-y thing we've ever had on this show, but it's real. The U.S. Food and Drug Administration recently approved a core part of Precision's new technology. Welcome to a future we've long been promised, and it's finally here. The commercialization of brain-computer interfaces. From the Wall Street Journal, I'm Tim Higgins. And I'm Christopher Mims. This is Bold Names, where you'll hear from the leaders of the bold-named companies featured in the pages of The Wall Street Journal. Today we ask, is humanity ready for brain implants?

2:30Thank you for joining us in studio in New York City at the heart of The Wall Street Journal. And before we get going, I just want to let the listeners know, we are going to talk about a little thing called brain surgery, but we don't want to get too technical or too gory. This is not a – Speak for yourself, Tim. Well, this is not an episode of The Pit or Severance, but that's what your company does, right? Digging right into the head to insert what is essentially a computer. But before we dig into your business, can you help describe what that's like? We're not talking about sticking a big old MacBook in there, I presume.

3:09Right. So precision neuroscience is developing something called a brain-computer interface. And a brain-computer interface enables people to control computers using only their thoughts. It is a medical implant, as you note. And this sounds like something out of science fiction, but it is very real. Actually, there's been 20 years at this point of validation in some of the leading academic centers in the world where people who are generally paralyzed have been implanted with prototype versions of brain-computer interfaces and they've been able to do amazing things. They've been able to control a computer cursor with their thoughts.

3:50They've been able to play digital video games. They've been able to create digital art. They've been able to send text messages and emails. Again, all using only their thought. But the proofs of concept so far have really been prototype-type devices developed in academia. They can't be manufactured at scale. And so as a result, this technology has up until today touched fewer than 100 people's lives. So in 20 years, fewer than 100 people, it's really very little impact. And so what we are doing at Precision Neuroscience and what a few other companies are doing is taking this technology that we know works, productizing it so that it can – it's robust enough to go through the rigorous FDA regulatory process and so that it can be manufactured at scale and ultimately reach the hundreds of thousands and eventually millions of people who stand to benefit.

4:42So the goal here is to help people who have maybe neurological injuries or diseases. Yeah, the initial target population is people who are severely paralyzed. Severely paralyzed meaning you're going to have them walk again? No. Eventually, we hope. But in the first instance, what we know we can do is give people who are unable to use their arms and hands and as a result can't operate computers or phones or other digital devices in the way that we take for granted. So they're, quote-unquote, locked in. So it's ALS or it's other types of paralysis. Locked-in suggests an inability to speak, and that is a sub-portion of this population.

5:21Some people who are severely paralyzed also are unable to communicate at all. And what this technology is going to enable them to do is to operate digital devices using only their thought and really rejoin sort of a digital ecosystem. The reason that people are severely paralyzed, as you mentioned, is generally spinal cord injury, certain kinds of degenerative diseases like ALS, and then certain kinds of stroke which leave the brain, the cortex intact but disrupt the connection between the brain and the rest of the body. So what's the process like? What's involved in getting this set up? Well, different companies have different approaches.

5:59Your approach. What's your approach? The best approach. Because I will say this. Mims last night was like, dude, you got to watch this video of this thing. It's like brain surgery. And I was like, I had spaghetti for dinner last night and that just was not going to happen. So I didn't see the video. So let's paint a picture, a verbal picture of what this is like. So I co-founded Precision with Ben Rapoport as well as Mark Hedick and Dimitri Papagiorgio. But Ben is really the architect of the system that we're designing at Precision. Ben is a neurosurgeon. He also has a PhD in electrical engineering.

6:36He understands the anatomy that we're dealing with. He understands the electrical nature of the brain. And he's been preparing to start this company his whole life. He was also one of the co-founders of Neuralink. So has seen it being done a different way. And Neuralink is Elon Musk's version of this. We'll get into that. But first, so, okay, how do you set this thing up? It's not as simple as just putting a DVD and a DVD player, right? That's right. So basically, the brain is an electrical organ. And so what we do is measure that electrical activity at a higher resolution than has ever been done before.

7:11There are different approaches to how to get sensors, electrodes to measure the brain's electrical activity into the brain in a safe and stable way. Our system is based on something called a cortical surface array. So it sits on the surface of the brain without damaging the brain. It's a very, very thin film. It's less than the width of a piece of scotch tape. To me, it looks like a fruit roll-up. Sure. It's not how we describe it. Does it taste like one? That's the question. And on the microelectrode array, we have 1 ,024 tiny platinum electrodes that are picking up the electrical activity of the brain.

7:54Most of them are 50 microns in diameter. So just to give you context, that is roughly the size of an individual neuron. And the array itself is 22 microns thick. So that's a fifth of the width of a human hair. And the system sits conformally on the surface of the brain without penetrating into the brain and creates this incredibly rich picture of neural activity in real time. And so this is because there's so much activity visible from the outside of the brain but inside the skull. It's inside the skull and is interfacing directly with neural tissue. And part of the advantage of this approach is it's able to cover large areas of the brain surface without doing any incremental damage to the brain.

8:37Some of the competing approaches to this technology and actually some of the sort of academic work that created this as an industry were based on penetrating electrodes. So microelectrodes that actually sort of puncture the neural tissue and in so doing damage neural tissue in order to create this interface between brains and electrodes. And these are like little hairs that kind of go into the brain. The original version of this is more like wires. And the Neuralink system is based on taking the wire concept and making it softer and more pliable. We just heard how in the past 20 years, fewer than 100 people have had this technology installed in their heads.

9:18But precision neuroscience wants to make it normal for millions of people to get brain implants. How the heck are they going to do it? In order to reach the people who stand to benefit, this is a medical device and should be and will be reimbursed by insurance. Stay with us.

9:44Now that we understand how this works and the mechanics of it, take me into the future. What is the bigger picture here, the long-term vision? What we're focused on today is addressing a very real medical need. Precision is a healthcare company, and we were founded to make a meaningful, positive difference to human health. The way that we're doing that is to allow people who are right now paralyzed, generally homebound, isolated. It has severe implications in terms of mental health, in terms of people's ability to have a job if they choose, and give them back seamless control of computers. The academic prototype versions of this technology have allowed people to control computer cursors, maybe do a click.

10:39Our ambitions are a lot greater than that. When we think about seamless control of a computer, we think about a productivity suite like Google or Microsoft Office or really rich, complex video games and communication systems. So we think by doing that, we have the potential to create a really meaningful business and do something very positive to human health, initially focused on people who are severely paralyzed, who can't use their arms and hands, and in some cases can't speak, but over time extending to people who have some form of motor deficit, but less severe than total paralysis. So think about people who perhaps have had strokes, and so they have partial use of one of their arms and hands.

11:25People who have very severe arthritis and are unable to use a phone or a keyboard in the way that you or I can. This is a population that is at least single-digit millions in the United States alone. And is your goal that eventually insurance will pay for this? I think access is critical and it has to be paid for by insurance. I think there's a really robust model for how this should work. And we're not reinventing the wheel here in terms of reimbursement. But in order to reach the people who stand to benefit, this is a medical device and should be and will be reimbursed by insurance. So this is something that's going to cost hundreds of thousands of dollars to get done?

12:06Well, we estimate that each of these products being developed by separate companies are going to cost somewhere between$250 and$500 million to take from concept to market. For the development, that's not the individual person. Exactly. They're not going to cost$250 million on a unit cost. But to your point, you're absolutely right that unlike, for example, like a pharmaceutical product where the marginal cost is effectively zero, these devices will cost several thousand dollars each. So they have real unit costs. In order to justify all that, in order to justify the capital that's required to develop these systems and then to create a sustainable industry that is able to reinvest profits in additional applications of this technology, we need reimbursement in the six figures.

12:55And I guess I have to imagine getting some form of mobility, perhaps someday being able to walk. The cost of care going forward is probably less for folks. So it's kind of maybe some of that washes out. That's right. I mean we're working on sort of a holistic health economics analysis. But what people don't necessarily know is that when someone is paralyzed, they are generally taken out of the workforce. So people who are severely paralyzed are 60 percent less likely to be employed than people who are able-bodied. But often it will also take a caregiver out of the workforce and usually that is a family member.

13:33And so when you think about the human well-being costs but also just the societal and financial costs of taking two people who are totally sound of mind and it's just – there's been a disruption between the connection – between the brain and the body. Taking two otherwise totally sound of mind people out of the workforce, it's really considerable. So I think that there's like a very strong moral justification for reimbursement for this technology as well as strong financial backing. So how close are we to this really rolling out as a quote-unquote consumer, not a consumer product. You're not going to get it over the counter.

14:14But we've seen some recent FDA approvals for related devices. So what's our timetable? Well, we received our first FDA clearance, which is a really exciting milestone for precision and I think for the industry. This is a major step forward. I think it takes us closer to commercializing the product and to the widespread sort of clinical impact that we seek. The FDA clearance is for a device that is implantable up to 30 days. So it's not the fully implanted permanent implant that we are working on in parallel. But there are some meaningful things that we can do with a temporary impact. How long until the permanent one?

14:56I think in the next five years, you are going to see an explosion in the number of people that this technology touches from precision and from others. I think there's an understandable maybe fatigue among some people who have been following this industry over the past two decades. There have been various false dawns. Part of that is some of the enabling technologies that are really required to turn this into an industry, like the microelectronics, very high performance, very low power, a regulatory regime that's ready, and the FDA has really led the way on this. And then software to decode. We're generating more than a billion data points per patient per minute.

15:38We've done 39 implants so far. And so that is just an enormous amount of data. to think that these systems were able to work even in a rudimentary way 20 years ago without the use of sophisticated software. But today, I think that's obviously a completely different ballgame. And so because of some of these enabling technologies and because of capital availability, we are now at the cusp of really seeing this turn into an industry. So let's just go back to this device that just was approved by the FDA. It can only be in there up to 30 days. So what does that mean? Why the little amount of time and what needs to happen to get to that bigger amount of time, right?

16:16Yeah. So there are two parallel tracks at Precision. One is we are developing the fully implanted permanent implant that we hope people have for many, many years and hopefully forever, just like the other companies in the space. But in parallel to that, precision has the opportunity, and this is unique within the BCI industry. BCI. Sorry, brain-computer interface, excuse me, for the acronym. That allows us to get to market much faster. And that's because of the intrinsic safety of our system, because it doesn't damage the brain, because it is reversible. That idea that the fruit roll-up is just kind of sitting on top of the – That's right.

17:01The fruit roll-up can be removed. Whereas if you're sticking the cords into the brain, that is a much more invasive process. So the precision system has access to what's called the 510k pathway through the FDA for approval. And we have developed a product that is in parallel to the permanent implant, which is effectively the same thing. It's the same fruit roll-up in your analogy, connected to electronics and connected to a computer where an algorithm decodes neural activity. But instead of all being wireless and fully encapsulated in hermetically sealed packages that are biocompatible and in the body forever, the wired system is designed to be explanted within a certain amount of time.

17:46Explanted sounds like a nice way of saying pulled out. Removed. Yanked out. Yank is not a surgical technique. Thank God. Well, so it sounds like you're in those two pathways because some might think, okay, 30 days, that seems pretty incremental like in the grand scheme of things. But it sounds like you're saying this is a big step towards this other thing. And I guess I wonder, okay, how close are you to that other thing, right? How close to not having to get this thing replaced every month or so? So from a functionality standpoint, we're nearly there. Nearly there like next week or? Or what's holding you back from being there?

18:26Let me explain. So I mentioned that we've implanted 39 people so far. And just to take a step back, the company was founded in 2021. So we're almost exactly four years old. In the past two years, we've implanted 39 people. The way that we've been able to implant people is in research settings where they're already undergoing a neurosurgical procedure. For example, they have a tumor that the surgeon is resecting. and our array is placed on their brain. Often these patients are awake during the procedures. And so we can run certain research protocols really to test the safety and the efficacy of the system.

19:03That's the most important thing. Like we want to make sure that what we're doing is working. And also to start training the algorithm to be able to decode neural activity and use it to drive a function. Generally, the duration of these implants has been a matter of hours. And when they're awake, we can ask them to do certain protocols. So for example, they can wear a glove with lots of sensors on it. And we can correlate the movements of their fingers with the neural activity. Or we can ask them to say certain words. And again, we're correlating the movements of their mouth and their tongue to the underlying neural activity that's driving that movement.

19:39But the people in these cases are really only awake for 20 or 30 minutes. And they're anesthetized. They're a little bit out of it. And they're undergoing a surgery. And so the quality of the data is good, but it's not perfect. Even in those settings, we have been able to achieve computer control with 10 minutes of training data. We're going to start releasing demonstrations of what the precision system is doing. But we've also been able to allow people to control robotic hands, again, using only their thought and with only 10 minutes of training data. What the 510K approval allows us to do is implant a lot more people.

20:23So dozens more people, hundreds more people? We'll see, but it's somewhere in between those two numbers. And over what time period? Starting now. So this year you could have a dozen more people with this? I think we're going to have a lot more than that. I mean we did 20 last year, I think, and that was pre-approval. So I think it's going to be a lot more. So there are going to be dozens up to 100 people by 2026 walking around with this literally? No. So this is still a temporary implant. So it still has the requirement that it's removed, not yanked, but removed within 30 days. But what that means is we're going to be able to work with people and train the algorithms not with minutes or hours of data per person, but days and weeks.

21:11Previously, we've reported that Elon Musk has said the surgery to implant Neuralink's brain chip is like replacing a chunk of your skull with a smartwatch, and then sewing threads into brain tissue so they sit close to neurons and directly relay their electrical signals. Also, Synchron has said its stent-like device can pick up signals directly from the brain's motor cortex. It sits in a blood vessel between the two hemispheres of the brain. We just heard about one of the big differences between Precision's approach to brain-computer interfaces and some of its rivals, including Elon Musk's Neuralink.

21:46If Precision's tech is removable, does that also mean it's upgradable, like getting a new iPhone? It's 1 ,024 electrodes on one of the films, but we can place multiple on the brain at once. We've actually set the world record for the highest bandwidth connection. That's next.

22:15So you're talking about a lot of precision. It's right in your name, right? Precision neuroscience. You've described your company as a health company, and I think it's reflected in your background and of your co-founder, who was at Neuralink. And you all have talked publicly about Neuralink as a tech company. What distinction are you trying to make there? Well, I mean, I think if you look at – you said it well. If you look at the founding mission for Neuralink, what they've stated publicly, it is to create some sort of symbiosis between human and artificial intelligence such that we don't get left behind by artificial general intelligence if and when that emerges.

22:57That is a fine mission. Maybe it's the right mission, but it is not our mission. Our mission is really human health oriented. We're a healthcare company. And I think that that's built into the DNA of the company as well as the architecture of the system itself. This concept of a system that is intrinsically safe. It's non-damaging to the brain. It's reversible. But it also provides a really high bandwidth connection. Right. You have a thousand electrodes right on the brain. I picture it like one of those old school, like when you would plug in a printer in the 80s and there's like 200 pins on it or something.

23:33Yeah. I mean – and not only – it's 1 ,024 electrodes on one of the films, but we can place multiple on the brain at once. We've actually set the world record for the highest bandwidth connection ever achieved. Is that a Guinness record? Was that verified? I can't speak to that. Our research of the academic literature suggests that it is a record by several times, but 4 ,096 electrodes. And that just shows you that sort of this is a scalable approach that you can put multiple of these electrode arrays on the brain at once and they're designed to do that without any incremental damage to the underlying null tissue.

24:10I mean I think this is not a field that gets a lot of attention normally, right? And I think one of the things that Elon Musk involvement has done is has made it almost pop culture. I mean people are seeing it on the Twitter. I guess we call it X now. That dates me. But this is old man hour here at the Wall Street Journal. You mean you were born before 2010? Okay, grandpa. It gets attention, right? But that also comes with this perception that he's ahead. He's leading the field. My sense from hearing you is that you feel like perhaps you're ahead or he's not as far ahead as people would think.

24:53Yeah. I mean, I think it really just depends how you define who's in the lead. I think when we look at where we are, we've set the record for the highest resolution system that's ever been tested. I think our team is extraordinary. Yeah, but how many followers do you have on X? Fair point. The approach you're doing is you want to be able to get more out there to see how it is. That's exactly right. And it's also, I think, a design philosophy where, you know, you really want to make sure that the system that you are developing is working in the way that you intend. You want to get feedback from both the patients as well as the clinicians and the surgical staff, the nurses, the administrators.

25:29All of that is critical to building a business and that's ultimately how you have impact. And the sooner you can get that feedback and the more feedback you can get, I think the greater your chances of success. Well, speaking of government efficiencies, the Trump administration has been making a lot of cuts to various agencies. I'm curious how that affects your work in particular with the FDA. I think some other medical companies have suggested they're seeing delays and getting approvals. Approval from the FDA is so key to the gateways of your business plan. What are you seeing? So far, there's been no perceptible impact from our side.

26:09You know, R510K, the FDA has a goal of responding within 90 days for these sort of submissions. I'll also say that, you know, the FDA is a tremendous source of strength. So BCI, it's an industry that is gathering steam not just in the United States but elsewhere as well. It's explicitly called out on China's five-year plan. There is technology that's being developed in Europe as well. But by far the lion's share of the development and the dollars and the talent are in the United States. And a major part of that is the FDA. The FDA has been incredibly forward-thinking. They put out draft guidance for this industry four years ago, so quite a long time ago.