#27 - Life-Changing Brain–Computer Interface Technology

What if you could control a computer with a piece of Scotch tape on your brain? For people with paralysis and Parkinson's, this is a game changer. My name is Sam, your guide, and welcome back to The Tech Optimist. We're happy to have you.

It was really always my goal to build companies. We are developing a brain-computer interface that is an implantable medical device that allows people to control computers with only their thoughts. And that sounds like science fiction. We are already starting to see things that have never been seen before.

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There are millions of people who have lost the ability to move and to speak as a result of neurological injuries. Such as stroke, spinal cord injury, and ALS. What would it take to restore their movement, to give them back their voices?

Precision is about building a new technology that will allow us to interface with the brain in ways that have never before been possible.

Brain-computer interfaces, or BCIs, create a direct communication pathway between the electrical activity of the brain and a computer.

The brain is an electrical organ, so when we build a brain-computer interface, it harnesses the electrical nature of the brain to communicate with the outside world.

We have developed the Layer 7 cortical interface, which is the highest bandwidth link between computers and the human brain that's ever been created. This allows people, through thought alone, to operate a computer, to communicate. This is real. This is not science fiction.

The first time we placed that array on and you could just see the electrical activity just washing over the surface of the brain, I thought to myself, gosh, I'm actually watching the brain think.

I was in my junior year and our car got hit by a drunk driver. I came to learn that I actually suffered a spinal cord injury. Having access to a technology like BCI gives me a hope of living a life that is more independent.

Precision is really poised to bring tremendous hope to millions of people. When we started the company, Ben told us his vision has always been to push this into clinical practice.

Ben is the intellectual architect of the system that we're building at Precision. He's a neurosurgeon, so has deep understanding of and respect for for the anatomy that we're dealing with, but he also has an engineer's background, both of which are critical to building a BCI system.

The traditional methods of placing electrodes in and on the brain usually require making a hole in the skull.

This is not an appealing prospect for most people. The microslit insertion technique was invented by Ben, and that enables us to deploy thousands of electrodes in a way that is minimally invasive. When we started Precision, there was a view that you needed to penetrate the brain in order to build a powerful BCI system.

Even the smallest BCI electrodes that are out there do destroy some neurons when they're stuck into the brain.

And Ben's very firm conviction was that that was wrong.

The Layer 7 cortical interface is embedded in thin film that coats the surface of the brain without penetrating the brain. It is a fraction of the diameter of human hair, and that fundamentally allows us to generate a very high-bandwidth interface with the brain without doing any damage, and in a way that could be potentially reversible and even upgraded.

The standard of care in neurosurgical practice is to use 4 or 8 contacts. The Layer 7 device has 1,024 contacts, so over 250 times the spatial resolution, and that's like comparing a movie taken using hand-cranked recorders and bringing it to the world of 4K.

You could literally begin to see the words as the patient was speaking them and form various patterns of electrical activity in the brain.

It's an enormous amount of data that's coming off of these arrays, and it's really artificial intelligence-driven software that makes sense of it.

We're using machine learning architectures and artificial intelligence that were inspired by the brain to decode the brain's own language. And in order to build a highly functional communication channel between the brain and artificial intelligence, you need a lot of data.

Already in our first 5 patients, we started to collect that data, and over the next year, we'll be scaling up that data collection.

We're now in the process of ramping up to 3 sites from 1. In just over 2 years, we went from funding to having a device on the brain of a human patient. Other companies in the space that are 6, 7, 8 years old have yet to do a human implant. We've been able to move really quickly now that our arrays are manufactured in a facility that is owned and controlled by Precision Neuroscience.

Supply chains themselves can be quite fragile, so having the plant here in the United States gives us the greatest degree of control and confidence.

This facility is particularly unique because we have a quality system that's Specifically related to biomedical devices. We need increased control over this process and increased oversight in order to mitigate any safety concerns for patients.

We're really the only people on Earth that can make a device like this.

We've been able to recruit just incredible talent.

The team is now 50 people.

I spent 6 years at Google.

Apple.

I used to work at The New Yorker.

Before Precision, I worked at Neuralink.

Valencia Technologies.

Postdoc at Stanford.

I used to work at Neuralink.

Because our system is reversible, we are able to access the 510 pathway, which is the most rapid pathway to clinical approval through the FDA. This gets us into market, generating revenue, and it starts to generate the high-resolution neural data repository that's really going to drive our algorithms. The initial use case for the Precision System will be to restore function for paralyzed people. Beyond that, the 2 applications that we're very excited about are stroke rehabilitation and refractory depression. In coming decades, we do see the possibility for this to be more of a general-use technology. It's possible that this is a new frontier in how human beings and computers will interact.

Our goal is to help as many people as possible, and we think this technology that we're developing could ultimately have an impact not on tens or hundreds or thousands of patients, But many millions.

Michael, thanks so much for joining us today. Really appreciate you taking the time. We'd like to kick off straight away and jump into a little bit about you. And can you just share a bit of your background, your journey from studying at Harvard and Cambridge to becoming a pioneer in the brain-computer interface field?

Yeah. So, you know, after I graduated from Harvard, I moved to Asia, and joined a hedge fund there called Ward Ferry Management, which is now about a $4 billion hedge fund, investing in companies from India to Australia and everything in between. And that was really my business school. You know, lots of different industries, countries, companies at different stages of development, and really countries at different stages of development. But it was really always my goal to build companies. And I left, In 2012, after becoming a portfolio manager and partner of the firm, I took a year off. I did a master's degree at Cambridge, and then I moved back to New York and really started buying and building companies myself and with a partner. And it was several years into this, after acquiring and growing a number of companies, when I met Ben Rapoport, and that was sort of the genesis of Precision.

Excellent. So maybe in layman's terms, give us an explanation of what your company does and what brain-computer interface space is.

We are developing a brain-computer interface that is an implantable medical device that allows people to control computers with only their thoughts. And that sounds like science fiction, but it has been done now actually for 20 years. The first person implanted with a brain-computer interface in 2004 named Matt Nagle. And he, though he was a tetraplegic, was able to control a computer mouse with his thought alone. And over the course of the past 20 years, around 60 people have been implanted with these devices and have been able to do a number of different things, from play video games to send emails and text messages to create digital art. But all of it has been in the academic setting. So really sort of trapped in academic labs surrounded by technicians. And our job at Precision, the mission that we've undertaken, is to take this technology that we know works and has the potential to change the lives of a large number of people and productize it so that it can scale to millions.

So, so perfect. So maybe let's dig in on that. So what Tell us more about that societal impact. Who's going to benefit from BCI as you go out to serve millions of people?

So the initial use for Precision's device is people who cannot use their arms or their hands as a result of paralysis. And that paralysis can be caused by an injury like a spinal cord injury, a disease like, you know, ALS or other degenerative diseases. And, you know, really, if you can't move your arms or your hands, you can't operate a computer or a smartphone in the way that you or I can. And, you know, in 2024, if you can't operate a computer, it's very hard to have a job. It's very hard to stay sort of in communication with friends and loved ones. It's hard to be connected. And so this fundamentally is the functionality that we are going to deliver to patients. There are about 400,000 people in the United States who, as a result of spinal cord injury and ALS and other diseases, cannot move their arms and hands, and about 30,000 patients that are new every year. And there are many millions globally. We're focused on the US initially, but long-term, we expect and hope that this will be a global business.

So obviously, You kind of alluded a little bit to it before, but, you know, you are touching the soul of the human being with their brain, right? How do you think about the ethical dimensions here? What are the considerations that you need to have?

Well, I think, you know, right now the efforts are pretty straightforward. We are offering therapy to a group of people who today have nothing, and we're giving them a chance at more independence. And over time, you know, we believe that will help people really generate sort of an income for themselves and create safe sort of self-sustainability. I don't think there's a huge amount of debate around the ethics of sort of that first function. Over time, the debate will change. And I think it'll really change as these systems become more powerful. And it'll depend on what they're used for. So as an example, you know, right now all of our functionality is focused on recording from the motor cortex. So the intended movement for people who, because of an injury or an illness, cannot move, but recording the brain activity that's associated with those movements to operate a computer. Our system is capable of not just reading neural activity, but also writing, so stimulating the brain. And the way that that ends up getting used, I think, you know, will likely change sort of the ethical considerations and questions. But it's hard to predict, and I think it'll really be driven based on what we're able to deliver in terms of function and what the systems are used for. The topic that we spend a lot of time thinking about that's connected to this question is really access.

Right.

How can we ensure that this life-changing technology is not, you know, only attainable by a small group of people, but that it is widely accessible. And that's ultimately a question about insurance coverage. And so we're spending a lot of time today preparing for the discussions with, you know, CMS for public insurance and with private insurance companies to ensure that this technology is covered and that the people people who can benefit from it or are able to access.

Understood. So let's go back maybe on a little bit of the history of Precision. So you all started together in about 2021. Tell us about those early days and the vision that brought that team together to make this happen.

Yeah, you know, Precision really was created out of the vision of Ben Rapoport, who who I co-founded the company with in 2020. You know, Ben's vision— to take a step back, Ben is a neurosurgeon. Ben has a PhD in electrical engineering. Ben has spent his whole life preparing to start a BCI company and pioneer this industry. Ben was previously one of the co-founders of Neuralink, which is another company in the space. And, You know, ultimately Ben's vision has been a very consistent one over the course of the past, you know, nearly 2 decades, which is that a brain-computer interface should be high bandwidth. So it should have a large amount of information content that it's able to handle, and it should not damage the brain itself. It should be reversible, and that's really a function of its being non-damaging. And because it's non-damaging, it should be able to be scaled. 10 times, 100 times, even 1,000 times from the first few versions without any incremental damage to the brain or really risk to the patient. Most of our early employees— we now have 65 people across the country, but our initial group of co-founders and early employees, most of them came from Neuralink where Ben had been a co-founder. They knew Ben. And I think they really understood the potential for this technology long-term, and also the drawbacks of some of the approaches that are being pursued by other companies in the space, which do involve some degree of damage to brain tissue.

We will be right back, right after this.

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So I'm curious a little bit more about that relationship with you and Ben and sort of the meeting of the minds there, the synergies of, I guess, having gotten to know both of you now over time. And, you know, it's always interesting to hear the co-founding sort of story. How do you think about all that?

Well, you know, Ben and I met through a mutual friend. He and I went to college together but didn't know each other at the time. And someone who was there at the same time as we both were put us in touch. Really, with the introduction that, you know, Ben is brilliant and has an idea that has the potential to be life-changing, sort of world-changing and enormously impactful, but, you know, needs help developing a business, raising capital, recruiting a team, developing a corporate culture, doing all the things that are required to translate an idea into something that that has widespread impact. You know, Ben is a neurosurgeon. Ben is, you know, a brilliant engineer and innovator. I am none of those things. But what I have is a skill set.

Come on, Michael, you are brilliant.

I mean, let's at least conclude that part.

Maybe not a neurosurgeon.

I have a complementary set of skills that I think has been terrific. You know, he and I, really, I think, respect and trust each other and allow each other to really operate in the domains where we're expert. And, you know, I think that that's from our early days of, you know, having a few people around the table to now 3 offices across the country, and we've raised $53 million and we've done 14 human implants. It's been great. I think we've been able to do that in a short period of time, about 3 years. And it's really been around focusing on exactly what we want to do, how we want to do it, and what sort of people we need to do it, and then just focusing on execution.

As I was doing my Precision Neuroscience research dive here in preparation for this episode of the podcast, I stumbled upon their About page on their website, and it's where they've listed their company milestones. And here, Michael, was talking about how, you know, in just a span of 3 years they've done so much. And I wanted to, you know, help him out and provide some proof that they have done so much in 3 years. And I think it's so fascinating and super cool that they have, you know, their milestones on their website. So I'm going to share a few. So, um, in the year 2021, Precision launched. They raised their first capital. They patented the minimally invasive micro slit technique, which we heard in the video earlier, and they developed and patented the first version of the Layer 7 cortical interface. Now, in 2022, they, they raised their Series B capital. They doubled the channel entry count of microelectrode arrays. They submitted 17 new patent applications. And then in 2023, they launched their clinical partnership with West Virginia University with their first human implantation, which was a huge milestone for them. They acquired and integrated Precision BioMEMS, a microfabrication facility for medical devices. They had their FDA breakthrough designation, and most recently in 2024, they've launched clinical partnerships with Penn Medicine and Mount Sinai. So great stuff, and can't wait to hear what else is on the horizon. Let's get back to the show.

So let's, let's speak a bit about those, those 14 patients. So can you share some of the insight, um, from, from those patients, from those, uh, examples, and some of the initial successes and outcomes from those patients?

Yeah, so, so we've done 14 implants so far, um, with our system across 3 different medical centers. Um, West Virginia University, which came online last year, was our our first site, and earlier this year, Penn Medicine in Philadelphia and Mount Sinai in New York. We are still in the early days. So we are doing temporary implants, really validating the safety of the system, the efficacy of the system, our ability to record and decode large amounts of high-resolution neural data, and also establishing that we are recording ground truth. that we're seeing the same things as the existing standard of care electrodes, which are used in neurosurgery today across the country, but at resolutions that are hundreds of times really what has ever been used in the past. We are already starting to see things that have never been seen before. So patterns of neural activity preceding and then during motor activity that have— you can't find in the academic literature. And, you know, seeing the— I've been lucky enough to be in the operating room when our system is implanted on patients and seeing the reaction from the neurosurgical staff, the intraoperative monitoring staff, the nursing staff for that first time, just that this incredibly high-resolution data start to populate. It's a really exciting time, but we are in early days of Yeah.

Yeah.

And so that your particular technology, the Layer 7 cortical interface, obviously is significant as an innovation in the industry. Can you speak a little bit more to how its design and the surgical techniques involved are different than what's available in other BCI solutions?

Most of the other brain-computer interface systems that are high resolution, i.e., the ones that are able to transmit large amounts of data, are based on paradigms that involve penetrating into the brain. So in one way or another, having electrodes poke holes in the brain that do underlying damage to tissue. And, you know, this is— this has a number of issues associated with it. One is scalability. As I mentioned before, you know, our view is that systems should be able to increase in bandwidth over time, 10, 100, 1,000x. And if you think about other sort of communication devices, and that's really what this is, this is a device that allows the brain to communicate with external computing power. You know, bandwidth has really been key to unlocking additional use cases, but you've really wanted to architect in such a way that bandwidth could increase massively over time. time. A system that is based on incremental bandwidth being achieved by incremental brain damage, we just don't think it can scale in that manner. And so, one of the founding sort of convictions of Precision has been that a proper BCI system should be able to scale without doing brain damage. The way that we accomplish that is an ultra-thin film array. So it's basically— think about a piece of Scotch tape. It's got that sort of consistency that is 20 microns thick. So it's about a 5th of the width of a human hair. And as a result of how thin it is, it conforms to the surface of the brain incredibly well. So it sits on the surface of the brain underneath the skull and underneath the dura and creates a direct interface with brain tissue without harming or disrupting the underlying tissue that it is in contact with. And, that's how we announced just this week that we broke the world record for the number of electrodes on a human brain at once, 4,096 at Mount Sinai. And, whether there are 4 electrode arrays on the brain, in this case that was the case, or 1 or 10, you're not doing any incremental damage to the tissue and you're not posing any incremental risk to the patient. The other key innovation at Precision has been the way that the electrode arrays are deployed. So traditionally, cortical surface arrays, which is what sort of an array that sits on the surface of the brain is called, they've been much, much lower resolution, 1/200th or 1/300th of but also they've required very invasive surgeries to implant them, really craniotomies, which require taking off large amounts of skull. And this is also the way that the penetrating electrode array-based technologies are deployed as well. You know, when you think about having this technology scale to millions of patients, you know, craniotomies pose a number of risks.

Yeah.

And so, you know, we really designed around that. The innovation involves a very thin slit that is drilled into the skull and in the dura. So it's about a millimeter in thickness. And the array is able to pass through the slit sort of like a letter through a letterbox.

Mm-hmm.

And, you know, this doesn't even require shaving your head in order to have a super high bandwidth brain-computer interface implanted. So, you know, I think these are the kind of design considerations that we've really spent a lot of time thinking about and focused on.

Perfect.

Thank you, Michael. And so, you know, what about sort of the regulatory dimensions here, the FDA, sort of where are you in this process and what are the key next steps there?

We expect our first FDA clearance this year. You know, we are able to access the 510 pathway, which is the fastest pathway for a medical device company. And it's really available to Precision and no other BCI company because of the underlying safety profile of our device and the fact that it's reversible. This will allow us to implant for up to 30 days, and we expect additional 510 clearance for some of the electronics that help power our system next year. With that, with the array plus the electronics, we have the opportunity to commercialize our technology for the first time. As we work towards the permanent implant, which is subject to a PMA, which is a longer process and will take another 4 or 5 years, you know, the opportunity to get into business next year, not in 10 years, but next year, I think is a huge competitive advantage for Precision. First of all, it allows us to start generating revenue to help defray our ongoing R&D costs. It helps establish a relationship with all of the stakeholders who are going to be critical for the eventual rollout of the chronic system, whether it's the neurosurgical staff, the nursing staff, the hospital administrators, the payers, all will be aware of the company and we're going to help sort of build the distribution network that will be critical for the long-term implant. And finally, it's data. You know, the amount of data that we're already getting in these first pilot human studies is incredibly important and valuable, and that is just going to increase exponentially with our 510.

Everyone knows the drill at this point. We'll be right back, right after this. Don't go anywhere.

Ever wonder how the ultra-wealthy invest their money? They often back startups before they go public through venture capital. Now, individual investors like you can too with Alumni Ventures. Visit av.vc to get started. Perfect. So, you know, one of the, one of the things I think that sometimes gets glossed over in the startup world is that, you know, even the best companies have moments of difficulty or challenges that they have to overcome that sometimes get lost in the story, if you will. Any examples of that that stick out in the last couple of years that you have all experienced and presumably overcome to be where you are now?

Of course. Absolutely. You know, I think one of the most acute challenges we faced was really over the manufacture of our arrays. So, you know, what we're— what we've developed at Precision is an array that is microfabricated using the same technology as semiconductor chips. You can't make a 1,000-electrode array that has surface area of about, you know, 1.5 square centimeters by hand. And that, by hand, is still the way most medical devices are manufactured today, which is extraordinary.

Wow.

There is no domestic supply chain to manufacture arrays at this level of sophistication and at scale. We looked all across the country, and really we found 2 suppliers that we thought might be able to do it. One was very happy to take our business, but over the course of a year and a half and over $2 million produced 6 arrays in total, which had an average yield. So the number of electrodes that actually worked was about 55%.

Hmm.

The other facility was very professionally able to manufacture our arrays, but owned by a Japanese company a multinational corporation that had a blanket ban on developing anything for human implants. So, we knew the system was manufacturable, but we could only use the high-resolution, high-yield arrays for in vivo work, for animal work. Incredibly frustrating and difficult situation. I think the Japanese company that owned this facility in Texas, had acquired it as part of a larger acquisition. It was sort of a run. And they told us in the spring of last year that they intended to divest it. Actually, they intended to close it down. We had a call, very sort of apologetic. Immediately, we jumped at the opportunity and said, all right, we're going to buy it. We're going to take over your employees and offer them a safe home. And we'll be stewards of this facility going forward. You know, in the whole process from that initial conversation to closing was 6 weeks. It's just an unbelievably frenetic period. And we didn't cut corners. We did all of the sort of, you know, legal due diligence, environmental due diligence, facility due diligence that you'd have to do. We ended up acquiring the facility for what we We believe is a 90% discount to replacement cost, potentially more. And we also inherited a team that we knew was capable of manufacturing these arrays because they had done it before. And I'm happy to say that all of the employees are still at the facility and churning out, you know, several thousand arrays a year at this point with yield of 99% plus. So the story has a very happy ending.

Yeah.

But it was, you know, a critical challenge for the company, and we had a few irons in the fire and were lucky that, you know, one of them hit and we jumped at the opportunity.

Yeah, yeah, definitely turning a potentially very challenging issue into a great, great outcome, great opportunity for the business. That's excellent. All right, excellent. Well, let's get to sort of the last bit of this, Michael, which is, you know, we have a large community, many of which are hopefully joining us today, and We'd love to hear from you what ways in which that community can be useful to you, to Precision. What would be of help?

Well, we're always looking for additional sites to, you know, to use for our clinical studies. So far, we've been fortunate, and all of the demand has been inbound to use our system. And we anticipate going from 3 sites where we're actively implanting to 6 in the next sort of 2 or 3 months. But, you know, we want to scale this up both in the research setting and with our $510K in the commercial setting. And we think that this sort of transition into high-resolution electrophysiology, even, you know, before the BCI functionality, just being able to see the brain during neurosurgical procedures and its activity at resolutions that have never been seen seen before. Already we're seeing potential really meaningful clinical benefit. And so we want to get the word out to as many of the sort of top centers in the country as possible. And I'd say the second major area is talent. As the potential of this industry becomes clearer, and also the fact that you're now actually seeing that transition from the sort of academic lab into the clinic after a long period of waiting, the market's starting to heat up. And, you know, we require a diverse set of skills internally from, you know, microfabrication and material science to ASIC design and microelectronics to, you know, cutting-edge machine learning-based software engineers. And the market for that sort of top-tier talent is just becoming more competitive. And so for folks who want to do something that has the potential to both make a really big impact from a human health perspective, a really positive impact in the world, and also be part of something that I think has the potential to be an enormous business, I think it's a great opportunity. But we're always looking for referrals for great people. And finally, capital. Obviously, that's the genesis our relationship to begin with. You know, we are developing a product that, you know, is significantly hardware in its makeup. And, you know, it will require more capital for us to go from where we are to get to market.

Perfect. Well, Michael, thank you again so much for joining us today. Really, really appreciate your time. And yeah, good luck with the next steps here.

Okay, thanks, Ludwig. Thanks for your support.

Absolutely.

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