Michael Mager of Precision Neuroscience is featured in this segment of the MedTech Unplugged series, which explores groundbreaking advancements in brain-computer interfaces. The discussion focuses on Precision Neuroscience's pioneering work with their Layer-7 implant technology, representing a new frontier in neuronal communication.
Mager, co-founder and CEO of Precision Neuroscience, examines the transformative potential of brain-computer interfaces in connecting human thought with artificial intelligence (AI). Hosted at theCUBE's New York Stock Exchange studio, the conversation highlights the implementation of Layer-7, a groundbreaking electrode array. This advanced technology offers exceptional precision, operating at a resolution comparable to individual neurons without causing damage, thus enhancing the potential for non-invasive neuro-monitoring and control.
Throughout the discussion, key insights include the importance of designing non-invasive, high-resolution systems capable of seamless integration, the challenges in obtaining Food and Drug Administration clearance, and the monumental role of AI in processing the vast amounts of neural data generated. Mager shares how Precision Neuroscience is establishing a new standard for safety and efficacy in the medical technology field, echoing the sentiments of industry experts and analysts at theCUBE Research.
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Michael Mager, Precision Neuroscience
In this episode from the MedTech Unplugged Series, David West, co-founder and CEO of Proscia, joins theCUBE’s Dave Vellante to explore how AI and digital pathology are transforming medical diagnostics. West shares the origin story behind Proscia and its flagship platform, Concentriq, a cloud-native SaaS solution designed to shift pathology from microscope-based workflows to image and data-driven diagnostics.
The conversation highlights how Proscia is helping pathologists and life sciences organizations handle massive diagnostic image datasets, some exceeding 100GB in size. West discusses the efficiency gains from using AI and agentic systems to streamline lab operations, reduce reporting burden and accelerate access to advanced therapies. With over $130M in funding and growing adoption across pharma and clinical labs, Proscia is well-positioned at the convergence of AI, precision medicine and value-based care.
Additional topics include navigating regulatory hurdles with the FDA and IVDR, Proscia’s dual pricing strategies across diagnostics and life sciences, and how large language models and multimodal AI are enabling new possibilities for patient stratification and workflow automation. West also offers his perspective on the future of AI in healthcare, including the growing role of agents, quality automation and the potential for diagnostics to evolve into a truly data-first discipline.
play_circle_outlineIntroduction to MedTech Unplugged series focusing on brain technology and AI impact.
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play_circle_outlineTransforming Lives: Precision Neuroscience's Brain-Computer Interfaces Empowering Thought-Controlled Communication for Individuals with Paralysis
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play_circle_outlineLayer 7 interface allows instrumentation of the brain with ultra-thin electrode arrays.
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play_circle_outlineRevolutionizing Neuroscience: FDA-Approved Brain-Computer Interfaces Safely Implanted in 56 Patients at Premier Medical Institutions
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play_circle_outlineSurgery uses a thin slit in the skull to minimize invasiveness and damage.
>> Hello, I'm John Furrier with theCUBE. We are here at our New York Stock Exchange CUBE Studios. On the East Coast, of course, we've got our Palo Alto Studio connecting Wall Street and Silicon Valley. This is our MedTech Unplugged series where we look at all the cool technology, and in this segment we're going to look at the brain and how AI is going to be impacting us and some of the work being done to kind of bring that progress and measuring thought. Michael Mager is here, co-founder and CEO of Precision Neuroscience. Michael, thank you for coming on. And we have a prop here. Thank you. Thanks for coming on.
Michael Mager
>> Pleasure to be here.
John Furrier
>> So you guys are doing the brain implant, Layer 7 you call it, a new layer that allows for instrumentation of the brain inside the skull with technology.
Michael Mager
>> That's right.
John Furrier
>> This is one of those topics we've heard brain implants, it's really sci-fi, right? So it's kind of a cool story in the sense of, okay, this is progress. You guys are making it real. So I have to ask the first question. What is going on? Is it a brain implant? Is this the technology? I got a little device here. Explain what you're doing.
Michael Mager
>> Yeah, so I'm the co-founder and CEO of Precision Neuroscience. We are developing a brain computer interface. It's really a communication device that connects human and artificial intelligence. The practical application of the device is to enable people to control computers using only their thoughts. It does sound like science fiction, but in fact this work has been going on in academia for 20 years. People who are paralyzed have been able to control a computer cursor in a cursory way. They've been able to play video games all using their thought, but it's all happened with sort of prototype type devices and in academic lab settings. And so what we're doing at Precision is taking technology, ramping it up in terms of sophistication and the bandwidth of the interface and commercializing so that it reaches the millions of people who stand to benefit.
John Furrier
>> It really is, it's very cool. I love the approach. Explain how it fits in. You guys talk about this Layer 7 interface in the brain. I didn't even know there was seven layers. We had the seven layer stack in tech, the application layer seven. What does Layer 7 mean? Take us through how it connects to the brain.
Michael Mager
>> Yeah, so Layer 7 is a reference to the fact that there are six architectural biological layers to the human cortex. And what we've done is really created sort of a seventh synthetic layer, which is what we have in front of us. So this is an electrode array. It's incredibly thin. So if you can sort of see, it's about a fifth of the width of a human hair, so it's even thinner than a piece of Saran wrap. And we deposit on this incredibly thin array, 1024 micro platinum electrodes, most of which are 50 microns in diameter. So that is roughly the size of an individual neuron. So we're really looking at the brain at the brain's own resolution. The system is implanted onto the surface of the brain without doing damage to the brain itself, and it creates a picture of the awake human brain's activity at a resolution that's never before been possible.
John Furrier
>> All right, so how did you start the company? Were you sitting there saying, "Hey, I want to do an implant," or were you working on some academic side of it? How did you get here? What was the origination story?
Michael Mager
>> My background is in business building and investing. I met Ben Rapoport five years ago. Well, it's been more than that, but we started the company five years ago. Ben is a neurosurgeon, he's also an electrical engineer. He's really dedicated his life to pioneering this technology. He was previously one of the co-founders of Neuralink, which is Elon Musk's company in the brain computer interface space. And he left because he didn't agree with the direction that they were going. Ben doesn't have a background in raising capital, recruiting a team, creating a commercial roadmap. And so that was really the genesis of our partnership. We were actually, he and I were in college at the same time but didn't know each other and we were put in touch by friend.
John Furrier
>> So he obviously picked up the journey, left Neuralink, came here. Where are you guys at now in terms of progress? Can you take us through what do the implants look like? Who's the target? Has it been people who are paralyzed? Is it people who are sick? I mean, who volunteers for this? I mean, sure, my son would probably want to do this, but other than that, who's being worked on? Take us through what the current progress is.
Michael Mager
>> So the company is now four and a half years old. We've raised $156 million over that period. We've now implanted 56 patients across 13 of the world's leading medical institutions. We're active here in New York at Mount Sinai, at Penn Medicine in Philadelphia, at Johns Hopkins, at the Banner's Center in Arizona and many more centers. We received our first FDA clearance earlier this year. So it's a major milestone for us and for the industry. We're the first brain computer interface company that's developing a full stack wireless system that has an FDA clearance so we can actually market and sell. It's for a temporary version of our system. And using that FDA clearance, we have now implanted 56 patients and enabled them in different protocols and different hospitals to do some of the things that I mentioned earlier. So control a computer in order to use productivity software to begin to play video games, even to control external robotics using only their thoughts.
John Furrier
>> And the use cases, you mentioned some of those use cases, is there a hurdle, is there a certain criteria? What's the requirements to participate in this and how do you pipeline customers?
Michael Mager
>> So we actually did our first implant within two years of founding, and that is much more rapid than is typical in MedTech and certainly in the BCI space. Right now we're doing temporary implants. So these are implantations. We started with hours at a time. We're now because of the FDA clearance, allowed to implant up to 30 days, so several weeks at a time. And the reason we're able to do this work so quickly after founding is that the system was designed with certain fundamental characteristics that we think are critical to scaling this technology. One, it's fundamentally safe, so the array does not damage the brain upon implantation. Two is it's reversible. So if people over time want to get a new version of the system, if they just want to be explanted for whatever reason, that's possible to do safely. And three, it's very high resolution. So really this is a communication device, and so the resolution or the bandwidth of the system is core to what it's able to perform in terms of seamless control of a computer. The fact that the system is reversible and fundamentally safe is why we're able to get an FDA clearance within four years of founding the company and implant. At this point, we've implanted more than the rest of the industry combined.
John Furrier
>> That's a huge milestone.
Michael Mager
>> With the constraint that we do explant within-
John Furrier
>> I mean, it's a huge milestone to get the FDA clearance. I'm going to love to discuss how they did that. But my question first is, I mean most people that aren't in the field think of brain surgery as opening up the skull. You said it's reversible. Take us through the mechanics of the surgery or the implant. I mean, it's not over the brain. The skull is inside the skull.
Michael Mager
>> That's right. It's inside the skull and inside the dura. So in order to really drive powerful function, you need high fidelity signals and the skull acts as a physical barrier. And so people who wear sort of EEG hats and other non-invasive modalities really can't accomplish the level of performance that we think is critical to be life-changing technology for people initially who are paralyzed. One of the benefits of having a neurosurgeon as a co-founder is really thinking deeply about how to get electrodes into the brain at scale safely and quickly. So our system is designed to be implanted through a very thin slit in the skull and in the dura, and the array then slides sort of like a letter through a letterbox through the slit and onto the surface of the brain. This is a patented approach from Precision and it obviates the need for a more invasive craniotomy, which is traditionally how this technology has been deployed.
John Furrier
>> And that's why the device being so thin is key. And I can see here, you can't pick it up on the cameras, but you can see, you call this an array. There's like 50 pieces of, what do you call those?
Michael Mager
>> Electrodes.
John Furrier
>> Electrodes. That has to pick up the signals. So where's the software loaded?
Michael Mager
>> So it's actually, you can see the 50 larger electrodes which are optimized to write to the brain. So the system is capable of read and write. What is invisible to the naked eye is the 970 plus electrodes, which are 50 microns in diameter, so, so small that you can't see them. This then connects here. This is the bond pad and it connects to electronics. Those electronics also were developed all in-house, that digitize the signals coming off the brain, amplify them and send them to a chest wall hub that then transmits them wirelessly to a computer. The function, we're collecting, as I mentioned, over a billion data points per patient per minute. In order to make sense of all of that data that's coming off the brain, it's really AI software at the core of the system.
John Furrier
>> I can't help but think of NVIDIA, just on a call with NVIDIA. They got a big event coming up, just getting a briefing. They're talking about a lot of... They do a lot of work in biology. They have basically the ability to build these digital twins. So imagine the data's immense and you said you're getting new data and it's the first time you're doing this. What are you seeing? What's the data look like? I mean, obviously he's got to talk and doing computer gaming and managing other devices, your network together, it's almost like an AI opportunity. How are you using AI in this? And biology is one of the hottest areas right now where AI factories and AI technologies being used. How does AI fit into this?
Michael Mager
>> Yeah, I mean I think the data is absolutely key and we've never before been able to access high-resolution neural data at scale. Initially, we're using the data to train our algorithms to enable seamless intuitive control of computer systems. And what we're seeing is a high degree of transferability from one person to the next, meaning that every implant requires some calibration, but within a matter of often minutes, we're able to calibrate the system and achieve function. But taking a step back, I think this data has the potential to be enormously valuable. We've been approaching in conversation with some of the leading tech and MedTech companies in the world. And I think that there's an intuition that we've been able to make so much progress in other areas of biology by digitizing biology, the genomics revolution, all of the wearables that we have now are examples of that. I think the brain has been very difficult to access. It's in the skull, it's mushy, it's hard to... It has traditionally been hard to create a sort of digitized version of neural data. That's what we're doing. And it is, I think all of the foundational model companies are searching for proprietary data sets. There aren't that many that exist. I think this is one of the most exciting.
John Furrier
>> And you see on these AI factories and these big AI systems, simulation's huge getting that data. So it's really awesome. What's the coolest thing that's come out of this that you can share? Because it's really new. I mean, this is cutting edge. I mean you guys are on the... I mean this is great opportunities, but also it's kind of dangerous too, right? So what's the coolest thing you worked on?
Michael Mager
>> I think part of our jobs as pioneers of new industry and as entrepreneurs is to marry the incredibly exciting long-term potential for this industry with a very practical plan of how to create viable and successful business. And also our founding mission is to advance human health. And so you want to make sure that that's built into everything you do. We're focused initially on people who are paralyzed. So people whose brain-body connection has been either disrupted by a disease like ALS or by an injury like spinal cord injury. And for these people who are often quadriplegic, home-bound, the inability to control a computer or a smartphone or a tablet is incredibly isolating. It means it's very hard to communicate with friends and loved ones. It's very hard to have a job and maintain financial independence. And so what we're giving this group of people is the ability to rejoin the digital ecosystem, massive improvement in quality of life, and also the ability to rejoin the workforce and regain some degree of financial independence. And we think that's going to create a multi-billion dollar business.
John Furrier
>> I mean, MedTech is AI technology in smaller, faster, cheaper devices. They're all getting smarter is really going to be a boom for the MedTech ecosystem. How has your peers and how has the ecosystem around it? I mean research has been one of the big things we're seeing has been part of every leading company and or open source research on robotics. There's a lot of open source work being done. How are you with your peers? I'm sure there's a lot of gravity around this with the tech and the opportunities you guys are innovating on with the brain. What's it like with the peer reviews? What's it like with other researchers? Is there an ecosystem? Can you share your thoughts on how that's developing?
Michael Mager
>> Yeah, I mean I think we're trying to... What we're doing is interfacing with some of the most personal and sensitive biological data that exists, neural data. And we're trying to do that in as transparent a way as possible. So we published our results in a peer review journal in Nature Biomedical Engineering just earlier month. It takes a while for papers to go through the peer review process.
John Furrier
>> It's like the FDA approval.
Michael Mager
>> That's right. So it's basically two-year-old data that was published, but it really shows the safety profile and the efficacy of a system that is ultra-high resolution and also non-damaging, which we think are the two keys to pioneering this industry.
John Furrier
>> And that's a unique approach. That's the key. And you mentioned that got the FDA approval, four years is fast, other companies really have to grind through that. What was that process like? Can you share what was notable and what was unexpected?
Michael Mager
>> Yeah. I mean, I will say we're still in parallel path pursuing an FDA clearance for the permanent or the chronic implant, the version of the system that's intended to be implanted and stay in the body forever. And that is a long process, for good reason. You have to do a lot of bench testing, animal testing. There's just a very rigorous process. I think for us, the biggest challenge with the initial FDA clearance that we received is most medical device companies, even large ones, outsource most of their manufacturing to contract manufacturers who are then responsible for the quality management and have to be FDA audit ready and all that stuff. We actually, we own a FAB and we manufacture this array ourselves. The reason we do that is, there is no supply chain that exists on earth that can make, this is at the beginning-end.
John Furrier
>> You had to vertically integrate.
Michael Mager
>> Exactly. But what that means is that instead of outsourcing some of those core functions, we've done them all in-house. So we have brought our FAB up to ISO 1345. It's human implant grade quality. We're responsible for all the quality systems and we have to be FDA audit ready. And so that's a real burden. It's critical. We're putting devices on human brains, but it's certainly for a company that is trying to do a lot as quickly as possible.
John Furrier
>> Talk about the business model because obviously costs money to do this. You guys raise capital, you're pioneering the area. What's the business model look like? Is it mostly funded, fully funded? Is there revenue coming in and how do you see you guys continuing to grow?
Michael Mager
>> Yeah, I mean any life sciences business that is trying to do something really pioneering has a long regulatory process to go through and during that process, investor capital is what keeps the lights on. And that's the same thing for us. We have a modest amount of revenue from the FAB. We work with a few other cutting edge MedTech companies, but the vast majority of the funding comes from the venture capital community. I think there is a view that this industry and Precision within it are going to create a really, really big business. And Morgan Stanley wrote a report last year that they just updated that estimates a $400 billion TAM for brain computer interfaces. It starts with a focus on people who are totally paralyzed, so unable to use their arms and hands at all. There are about 400,000 people in the United States and several million globally who fit that description, and we think that that's going to create a 2 to $3 billion per annum industry. Beyond that, there are about 12 times the number of people who have partial paralysis that we think are going to be adopters of the technology over time and over 100 million people.
John Furrier
>> And the key is you guys have figured out the safety aspect of the brain insertion, which people aren't in the industry, think it's the classic movie scene where they're doing brain surgery. This is very precise. Talk more about that because I think that's probably one of the misunderstood areas that I would think you hear all the time. Like, what?
Michael Mager
>> I'll say two things. I think the first is that this is not a move fast and break things type of industry. We are very-
John Furrier
>> We're talking about the brain. It's like no one... Can't get that wrong.
Michael Mager
>> Exactly. We're highly regulated for good reason. With the FDA we have stringent data privacy and security regulations as a result of HIPAA, and this is a long process that companies have to go through to get to market to be able to sell a device. I'd say the second thing is a little bit more philosophical, which is Precision was founded by a neurosurgeon. So we are a physician-led company and safety is built in to the DNA of the company in a way that is not necessarily true for all BCI companies or all MedTech companies. We believe that in order to achieve the promise of this technology and the scale of this technology, a system just has to be fundamentally safe and non-damaging. But that comes from our sort of founding DNA.
John Furrier
>> And the opportunities to discover more things. I mean, once you get data... I mean right now data, there's no real data. You talking about no FABs, of course you have to do that, but now you're going to open up new data sources. Who knows what can come from that?
Michael Mager
>> I think that's exactly right. I mean, there's so much in neurological illness that is diagnosed by subjective descriptions. I have a headache, I feel sad, I feel anxious. How do you convert these subjective descriptions into something that is quantifiable and something that you can measure over time and something that you can compute on? It's been very difficult slash impossible to do that up until now. And I think the reason is we've lacked an ability to collect high fidelity data over time. I think this industry is going to change that.
John Furrier
>> And the AI will help you when you start getting more supercomputing power with AI factories. You can look at it and say, wow, let's take some base data, give you some synthetic data and start doing some modeling. Kind of figure things out.
Michael Mager
>> I think we're in the early days in terms of the data collection. Again, we've implanted 56 people. That's more than the rest of the industry combined. We're excited about that. It's been temporary implants, but still a wide diversity, but 56 is a drop-
John Furrier
>> On those 56 implants and customers obviously paralyzed. Someone say, "Hey, I want to communicate." What's been the results? Playing video games? What are some of the things that come out of that?
Michael Mager
>> So the people that we've implanted so far have actually been undergoing a neurosurgical procedure for another reason, and they have elected to participate in a study where our array goes on their brain during the surgery, and starting this year after our FDA clearance, they've kept the array on their brain for days and weeks at a time. This is not the group of people that we hope to help with the permanent implant. What this does though is it enables us to prove the efficacy of the system and work through the data collection and algorithm training now, not in a few years when we're going through sort of the pivotal trial and permanently implanting-
John Furrier
>> So there's no use case yet for those. Those are to test the procedure, efficacy of the data collection.
Michael Mager
>> And we've enabled them to begin to control computers with their mind. I mean, so the core function, so part of the benefit-
John Furrier
>> So the question, have they done that?
Michael Mager
>> Yeah, no, absolutely.
John Furrier
>> Okay, so that's what I was getting at.
Michael Mager
>> We're going to be releasing demo videos over the course of the next few months of the system in action to answer exactly that question because it's like what does it do and how does it look? We have film crews now coming into some of the implantations. And I think that there's something profound also about the fact that people are able to go into the hospital, walk into the hospital, have a procedure, they become superhuman for a fixed amount of time. They can do something that no other or very few other people on earth are able to do. And then they get explanted and they walk away and they talk about the experience and-
John Furrier
>> All right, Michael, what's next? What are you working on? Give a plug for what the work is doing. Are you hiring? How do people engage with you if they want to collaborate? Give a plug.
Michael Mager
>> Yeah, I mean, we're growing. The team is based in... We have three hubs, New York, Santa Clara, and then we manufacture in Dallas and Addison, Texas and North Dallas. So if you're interested, we require cutting edge expertise in a number of different disciplines, from mechanical engineering to electrical engineering to software engineering, to firmware to chip design, to clinical support. It takes a really interdisciplinary team to make this all work at the highest degree of safety and efficacy. Please visit our website at precisionneuro.io. I think we're going to... The demo videos over the course of the next several months, I think are going to be a really exciting moment for-
John Furrier
>> It's such a real world example of what people talk about and kind of like the sci-fi. I always joke on the CUBE, if I had a neural implant, I could get all the CUBE AI in my brain and be smarter or put in robots as you get more data collection. So very cool things. Thanks for coming on and sharing. Congratulations. Great technology. Very thin. You're nailing the procedure. FDA approval, which is very difficult. That's a huge accomplishment. Congratulations.
Michael Mager
>> Thanks so much. Thanks for having me.
John Furrier
>> All right. I'm John Furrier with theCUBE. We're at the NYSE. Again, MedTech series where the innovation is coming and it's going to change the world. Of course, from a healthcare perspective and helping society, you're starting to see that the hardware and the software of AI is coming and get ready for it. We're doing our part by bringing this to you. Thanks for watching.
>> Hello, I'm John Furrier with theCUBE. We are here at our New York Stock Exchange CUBE Studios. On the East Coast, of course, we've got our Palo Alto Studio connecting Wall Street and Silicon Valley. This is our MedTech Unplugged series where we look at all the cool technology, and in this segment we're going to look at the brain and how AI is going to be impacting us and some of the work being done to kind of bring that progress and measuring thought. Michael Mager is here, co-founder and CEO of Precision Neuroscience. Michael, thank you for coming on. And we have a prop here. Thank you. Thanks for coming on.
Michael Mager
>> Pleasure to be here.
John Furrier
>> So you guys are doing the brain implant, Layer 7 you call it, a new layer that allows for instrumentation of the brain inside the skull with technology.
Michael Mager
>> That's right.
John Furrier
>> This is one of those topics we've heard brain implants, it's really sci-fi, right? So it's kind of a cool story in the sense of, okay, this is progress. You guys are making it real. So I have to ask the first question. What is going on? Is it a brain implant? Is this the technology? I got a little device here. Explain what you're doing.
Michael Mager
>> Yeah, so I'm the co-founder and CEO of Precision Neuroscience. We are developing a brain computer interface. It's really a communication device that connects human and artificial intelligence. The practical application of the device is to enable people to control computers using only their thoughts. It does sound like science fiction, but in fact this work has been going on in academia for 20 years. People who are paralyzed have been able to control a computer cursor in a cursory way. They've been able to play video games all using their thought, but it's all happened with sort of prototype type devices and in academic lab settings. And so what we're doing at Precision is taking technology, ramping it up in terms of sophistication and the bandwidth of the interface and commercializing so that it reaches the millions of people who stand to benefit.
John Furrier
>> It really is, it's very cool. I love the approach. Explain how it fits in. You guys talk about this Layer 7 interface in the brain. I didn't even know there was seven layers. We had the seven layer stack in tech, the application layer seven. What does Layer 7 mean? Take us through how it connects to the brain.
Michael Mager
>> Yeah, so Layer 7 is a reference to the fact that there are six architectural biological layers to the human cortex. And what we've done is really created sort of a seventh synthetic layer, which is what we have in front of us. So this is an electrode array. It's incredibly thin. So if you can sort of see, it's about a fifth of the width of a human hair, so it's even thinner than a piece of Saran wrap. And we deposit on this incredibly thin array, 1024 micro platinum electrodes, most of which are 50 microns in diameter. So that is roughly the size of an individual neuron. So we're really looking at the brain at the brain's own resolution. The system is implanted onto the surface of the brain without doing damage to the brain itself, and it creates a picture of the awake human brain's activity at a resolution that's never before been possible.
John Furrier
>> All right, so how did you start the company? Were you sitting there saying, "Hey, I want to do an implant," or were you working on some academic side of it? How did you get here? What was the origination story?
Michael Mager
>> My background is in business building and investing. I met Ben Rapoport five years ago. Well, it's been more than that, but we started the company five years ago. Ben is a neurosurgeon, he's also an electrical engineer. He's really dedicated his life to pioneering this technology. He was previously one of the co-founders of Neuralink, which is Elon Musk's company in the brain computer interface space. And he left because he didn't agree with the direction that they were going. Ben doesn't have a background in raising capital, recruiting a team, creating a commercial roadmap. And so that was really the genesis of our partnership. We were actually, he and I were in college at the same time but didn't know each other and we were put in touch by friend.
John Furrier
>> So he obviously picked up the journey, left Neuralink, came here. Where are you guys at now in terms of progress? Can you take us through what do the implants look like? Who's the target? Has it been people who are paralyzed? Is it people who are sick? I mean, who volunteers for this? I mean, sure, my son would probably want to do this, but other than that, who's being worked on? Take us through what the current progress is.
Michael Mager
>> So the company is now four and a half years old. We've raised $156 million over that period. We've now implanted 56 patients across 13 of the world's leading medical institutions. We're active here in New York at Mount Sinai, at Penn Medicine in Philadelphia, at Johns Hopkins, at the Banner's Center in Arizona and many more centers. We received our first FDA clearance earlier this year. So it's a major milestone for us and for the industry. We're the first brain computer interface company that's developing a full stack wireless system that has an FDA clearance so we can actually market and sell. It's for a temporary version of our system. And using that FDA clearance, we have now implanted 56 patients and enabled them in different protocols and different hospitals to do some of the things that I mentioned earlier. So control a computer in order to use productivity software to begin to play video games, even to control external robotics using only their thoughts.
John Furrier
>> And the use cases, you mentioned some of those use cases, is there a hurdle, is there a certain criteria? What's the requirements to participate in this and how do you pipeline customers?
Michael Mager
>> So we actually did our first implant within two years of founding, and that is much more rapid than is typical in MedTech and certainly in the BCI space. Right now we're doing temporary implants. So these are implantations. We started with hours at a time. We're now because of the FDA clearance, allowed to implant up to 30 days, so several weeks at a time. And the reason we're able to do this work so quickly after founding is that the system was designed with certain fundamental characteristics that we think are critical to scaling this technology. One, it's fundamentally safe, so the array does not damage the brain upon implantation. Two is it's reversible. So if people over time want to get a new version of the system, if they just want to be explanted for whatever reason, that's possible to do safely. And three, it's very high resolution. So really this is a communication device, and so the resolution or the bandwidth of the system is core to what it's able to perform in terms of seamless control of a computer. The fact that the system is reversible and fundamentally safe is why we're able to get an FDA clearance within four years of founding the company and implant. At this point, we've implanted more than the rest of the industry combined.
John Furrier
>> That's a huge milestone.
Michael Mager
>> With the constraint that we do explant within-
John Furrier
>> I mean, it's a huge milestone to get the FDA clearance. I'm going to love to discuss how they did that. But my question first is, I mean most people that aren't in the field think of brain surgery as opening up the skull. You said it's reversible. Take us through the mechanics of the surgery or the implant. I mean, it's not over the brain. The skull is inside the skull.
Michael Mager
>> That's right. It's inside the skull and inside the dura. So in order to really drive powerful function, you need high fidelity signals and the skull acts as a physical barrier. And so people who wear sort of EEG hats and other non-invasive modalities really can't accomplish the level of performance that we think is critical to be life-changing technology for people initially who are paralyzed. One of the benefits of having a neurosurgeon as a co-founder is really thinking deeply about how to get electrodes into the brain at scale safely and quickly. So our system is designed to be implanted through a very thin slit in the skull and in the dura, and the array then slides sort of like a letter through a letterbox through the slit and onto the surface of the brain. This is a patented approach from Precision and it obviates the need for a more invasive craniotomy, which is traditionally how this technology has been deployed.
John Furrier
>> And that's why the device being so thin is key. And I can see here, you can't pick it up on the cameras, but you can see, you call this an array. There's like 50 pieces of, what do you call those?
Michael Mager
>> Electrodes.
John Furrier
>> Electrodes. That has to pick up the signals. So where's the software loaded?
Michael Mager
>> So it's actually, you can see the 50 larger electrodes which are optimized to write to the brain. So the system is capable of read and write. What is invisible to the naked eye is the 970 plus electrodes, which are 50 microns in diameter, so, so small that you can't see them. This then connects here. This is the bond pad and it connects to electronics. Those electronics also were developed all in-house, that digitize the signals coming off the brain, amplify them and send them to a chest wall hub that then transmits them wirelessly to a computer. The function, we're collecting, as I mentioned, over a billion data points per patient per minute. In order to make sense of all of that data that's coming off the brain, it's really AI software at the core of the system.
John Furrier
>> I can't help but think of NVIDIA, just on a call with NVIDIA. They got a big event coming up, just getting a briefing. They're talking about a lot of... They do a lot of work in biology. They have basically the ability to build these digital twins. So imagine the data's immense and you said you're getting new data and it's the first time you're doing this. What are you seeing? What's the data look like? I mean, obviously he's got to talk and doing computer gaming and managing other devices, your network together, it's almost like an AI opportunity. How are you using AI in this? And biology is one of the hottest areas right now where AI factories and AI technologies being used. How does AI fit into this?
Michael Mager
>> Yeah, I mean I think the data is absolutely key and we've never before been able to access high-resolution neural data at scale. Initially, we're using the data to train our algorithms to enable seamless intuitive control of computer systems. And what we're seeing is a high degree of transferability from one person to the next, meaning that every implant requires some calibration, but within a matter of often minutes, we're able to calibrate the system and achieve function. But taking a step back, I think this data has the potential to be enormously valuable. We've been approaching in conversation with some of the leading tech and MedTech companies in the world. And I think that there's an intuition that we've been able to make so much progress in other areas of biology by digitizing biology, the genomics revolution, all of the wearables that we have now are examples of that. I think the brain has been very difficult to access. It's in the skull, it's mushy, it's hard to... It has traditionally been hard to create a sort of digitized version of neural data. That's what we're doing. And it is, I think all of the foundational model companies are searching for proprietary data sets. There aren't that many that exist. I think this is one of the most exciting.
John Furrier
>> And you see on these AI factories and these big AI systems, simulation's huge getting that data. So it's really awesome. What's the coolest thing that's come out of this that you can share? Because it's really new. I mean, this is cutting edge. I mean you guys are on the... I mean this is great opportunities, but also it's kind of dangerous too, right? So what's the coolest thing you worked on?
Michael Mager
>> I think part of our jobs as pioneers of new industry and as entrepreneurs is to marry the incredibly exciting long-term potential for this industry with a very practical plan of how to create viable and successful business. And also our founding mission is to advance human health. And so you want to make sure that that's built into everything you do. We're focused initially on people who are paralyzed. So people whose brain-body connection has been either disrupted by a disease like ALS or by an injury like spinal cord injury. And for these people who are often quadriplegic, home-bound, the inability to control a computer or a smartphone or a tablet is incredibly isolating. It means it's very hard to communicate with friends and loved ones. It's very hard to have a job and maintain financial independence. And so what we're giving this group of people is the ability to rejoin the digital ecosystem, massive improvement in quality of life, and also the ability to rejoin the workforce and regain some degree of financial independence. And we think that's going to create a multi-billion dollar business.
John Furrier
>> I mean, MedTech is AI technology in smaller, faster, cheaper devices. They're all getting smarter is really going to be a boom for the MedTech ecosystem. How has your peers and how has the ecosystem around it? I mean research has been one of the big things we're seeing has been part of every leading company and or open source research on robotics. There's a lot of open source work being done. How are you with your peers? I'm sure there's a lot of gravity around this with the tech and the opportunities you guys are innovating on with the brain. What's it like with the peer reviews? What's it like with other researchers? Is there an ecosystem? Can you share your thoughts on how that's developing?
Michael Mager
>> Yeah, I mean I think we're trying to... What we're doing is interfacing with some of the most personal and sensitive biological data that exists, neural data. And we're trying to do that in as transparent a way as possible. So we published our results in a peer review journal in Nature Biomedical Engineering just earlier month. It takes a while for papers to go through the peer review process.
John Furrier
>> It's like the FDA approval.
Michael Mager
>> That's right. So it's basically two-year-old data that was published, but it really shows the safety profile and the efficacy of a system that is ultra-high resolution and also non-damaging, which we think are the two keys to pioneering this industry.
John Furrier
>> And that's a unique approach. That's the key. And you mentioned that got the FDA approval, four years is fast, other companies really have to grind through that. What was that process like? Can you share what was notable and what was unexpected?
Michael Mager
>> Yeah. I mean, I will say we're still in parallel path pursuing an FDA clearance for the permanent or the chronic implant, the version of the system that's intended to be implanted and stay in the body forever. And that is a long process, for good reason. You have to do a lot of bench testing, animal testing. There's just a very rigorous process. I think for us, the biggest challenge with the initial FDA clearance that we received is most medical device companies, even large ones, outsource most of their manufacturing to contract manufacturers who are then responsible for the quality management and have to be FDA audit ready and all that stuff. We actually, we own a FAB and we manufacture this array ourselves. The reason we do that is, there is no supply chain that exists on earth that can make, this is at the beginning-end.
John Furrier
>> You had to vertically integrate.
Michael Mager
>> Exactly. But what that means is that instead of outsourcing some of those core functions, we've done them all in-house. So we have brought our FAB up to ISO 1345. It's human implant grade quality. We're responsible for all the quality systems and we have to be FDA audit ready. And so that's a real burden. It's critical. We're putting devices on human brains, but it's certainly for a company that is trying to do a lot as quickly as possible.
John Furrier
>> Talk about the business model because obviously costs money to do this. You guys raise capital, you're pioneering the area. What's the business model look like? Is it mostly funded, fully funded? Is there revenue coming in and how do you see you guys continuing to grow?
Michael Mager
>> Yeah, I mean any life sciences business that is trying to do something really pioneering has a long regulatory process to go through and during that process, investor capital is what keeps the lights on. And that's the same thing for us. We have a modest amount of revenue from the FAB. We work with a few other cutting edge MedTech companies, but the vast majority of the funding comes from the venture capital community. I think there is a view that this industry and Precision within it are going to create a really, really big business. And Morgan Stanley wrote a report last year that they just updated that estimates a $400 billion TAM for brain computer interfaces. It starts with a focus on people who are totally paralyzed, so unable to use their arms and hands at all. There are about 400,000 people in the United States and several million globally who fit that description, and we think that that's going to create a 2 to $3 billion per annum industry. Beyond that, there are about 12 times the number of people who have partial paralysis that we think are going to be adopters of the technology over time and over 100 million people.
John Furrier
>> And the key is you guys have figured out the safety aspect of the brain insertion, which people aren't in the industry, think it's the classic movie scene where they're doing brain surgery. This is very precise. Talk more about that because I think that's probably one of the misunderstood areas that I would think you hear all the time. Like, what?
Michael Mager
>> I'll say two things. I think the first is that this is not a move fast and break things type of industry. We are very-
John Furrier
>> We're talking about the brain. It's like no one... Can't get that wrong.
Michael Mager
>> Exactly. We're highly regulated for good reason. With the FDA we have stringent data privacy and security regulations as a result of HIPAA, and this is a long process that companies have to go through to get to market to be able to sell a device. I'd say the second thing is a little bit more philosophical, which is Precision was founded by a neurosurgeon. So we are a physician-led company and safety is built in to the DNA of the company in a way that is not necessarily true for all BCI companies or all MedTech companies. We believe that in order to achieve the promise of this technology and the scale of this technology, a system just has to be fundamentally safe and non-damaging. But that comes from our sort of founding DNA.
John Furrier
>> And the opportunities to discover more things. I mean, once you get data... I mean right now data, there's no real data. You talking about no FABs, of course you have to do that, but now you're going to open up new data sources. Who knows what can come from that?
Michael Mager
>> I think that's exactly right. I mean, there's so much in neurological illness that is diagnosed by subjective descriptions. I have a headache, I feel sad, I feel anxious. How do you convert these subjective descriptions into something that is quantifiable and something that you can measure over time and something that you can compute on? It's been very difficult slash impossible to do that up until now. And I think the reason is we've lacked an ability to collect high fidelity data over time. I think this industry is going to change that.
John Furrier
>> And the AI will help you when you start getting more supercomputing power with AI factories. You can look at it and say, wow, let's take some base data, give you some synthetic data and start doing some modeling. Kind of figure things out.
Michael Mager
>> I think we're in the early days in terms of the data collection. Again, we've implanted 56 people. That's more than the rest of the industry combined. We're excited about that. It's been temporary implants, but still a wide diversity, but 56 is a drop-
John Furrier
>> On those 56 implants and customers obviously paralyzed. Someone say, "Hey, I want to communicate." What's been the results? Playing video games? What are some of the things that come out of that?
Michael Mager
>> So the people that we've implanted so far have actually been undergoing a neurosurgical procedure for another reason, and they have elected to participate in a study where our array goes on their brain during the surgery, and starting this year after our FDA clearance, they've kept the array on their brain for days and weeks at a time. This is not the group of people that we hope to help with the permanent implant. What this does though is it enables us to prove the efficacy of the system and work through the data collection and algorithm training now, not in a few years when we're going through sort of the pivotal trial and permanently implanting-
John Furrier
>> So there's no use case yet for those. Those are to test the procedure, efficacy of the data collection.
Michael Mager
>> And we've enabled them to begin to control computers with their mind. I mean, so the core function, so part of the benefit-
John Furrier
>> So the question, have they done that?
Michael Mager
>> Yeah, no, absolutely.
John Furrier
>> Okay, so that's what I was getting at.
Michael Mager
>> We're going to be releasing demo videos over the course of the next few months of the system in action to answer exactly that question because it's like what does it do and how does it look? We have film crews now coming into some of the implantations. And I think that there's something profound also about the fact that people are able to go into the hospital, walk into the hospital, have a procedure, they become superhuman for a fixed amount of time. They can do something that no other or very few other people on earth are able to do. And then they get explanted and they walk away and they talk about the experience and-
John Furrier
>> All right, Michael, what's next? What are you working on? Give a plug for what the work is doing. Are you hiring? How do people engage with you if they want to collaborate? Give a plug.
Michael Mager
>> Yeah, I mean, we're growing. The team is based in... We have three hubs, New York, Santa Clara, and then we manufacture in Dallas and Addison, Texas and North Dallas. So if you're interested, we require cutting edge expertise in a number of different disciplines, from mechanical engineering to electrical engineering to software engineering, to firmware to chip design, to clinical support. It takes a really interdisciplinary team to make this all work at the highest degree of safety and efficacy. Please visit our website at precisionneuro.io. I think we're going to... The demo videos over the course of the next several months, I think are going to be a really exciting moment for-
John Furrier
>> It's such a real world example of what people talk about and kind of like the sci-fi. I always joke on the CUBE, if I had a neural implant, I could get all the CUBE AI in my brain and be smarter or put in robots as you get more data collection. So very cool things. Thanks for coming on and sharing. Congratulations. Great technology. Very thin. You're nailing the procedure. FDA approval, which is very difficult. That's a huge accomplishment. Congratulations.
Michael Mager
>> Thanks so much. Thanks for having me.
John Furrier
>> All right. I'm John Furrier with theCUBE. We're at the NYSE. Again, MedTech series where the innovation is coming and it's going to change the world. Of course, from a healthcare perspective and helping society, you're starting to see that the hardware and the software of AI is coming and get ready for it. We're doing our part by bringing this to you. Thanks for watching.
John Furrier
