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BCI technology has long promised to restore independence to people living with paralysis , but few innovations have successfully bridged the gap between decoding brain signals and reconnecting the body. Dr. Chad Bouton, founder and CEO of Neuvotion and Vice President of Advanced Engineering and Technology at The Feinstein Institute for Medical Research, has spent over a decade pioneering this breakthrough. His 2014 clinical study, which enabled a paralyzed patient to move his hand through thought alone, marked a pivotal moment in neuroscience. Now, with Neuvotion's first FDA-cleared product, NeuStim®, set to launch this fall, Bouton is poised to bring non-invasive, AI-powered movement restoration to stroke and spinal cord injury patients across the U.S. MD+DI connected with Dr. Bouton to discuss the technical challenges that shaped his groundbreaking research, how Neuvotion's brain-body interface (BBI) approach differentiates from competitors like Neuralink , and his vision for transforming rehabilitation over the next decade. Your 2014 clinical study was groundbreaking in restoring movement to a paralyzed patient. What were the biggest technical and clinical challenges you faced, and how did those early learnings shape Neuvotion's approach to BCI technology? Bouton: One of the big challenges that we faced in that study was decoding the signals in the motor cortex that represented intended movements. You had to figure out, how can you tell when a patient is thinking about different movements. Part of my background is in AI and machine learning, so my team and I figured out new ways to crack the neural code, but we thought it would be great to be able to reproduce these movements. I proposed an idea with my team to create a neuro bypass. We enrolled our patient, Ian Burkhart, into the study around 2011 or 2012 and we set out to enable movement. We could decode when Ian was thinking about opening or closing his hand. To complete that bridge from brain to body, we had to develop high resolution stimulation devices. We could decode brain signals, but we could not reproduce those initially. So we developed wearable bands, which provide high resolution muscle stimulation. So that challenge we saw before even implanting Ian with the chip. During the study, one of the biggest challenges was that he would go to pick up an object, and we could decode his motor cortex patterns and tell what he was thinking about moving, but as soon as he moved his hand anywhere he would drop the object. Even though you're in the hand knob area of the brain, every neuron is connected to thousands of other neurons. There is lots of interconnectedness with the hand area of the brain and the shoulder and the elbow and other parts. So when he started to move and activate those other joints, it would cause the machine learning algorithms to fail. We had to develop a new method. We developed new algorithms to learn these more complex patterns. We had to train a lot more data that involved not only opening and closing the fingers, but moving around in space, and doing all sorts of different things we do like picking things up, self drinking, and there is a lot happening with brain activity so we had to train these more sophisticated algorithms. But we got through that and I still remember the day when Ian was able to open his hand, pick something up, and drink from a cup all by himself. NeuStim® uses on-board AI to recognize movement intentions non-invasively. How does this approach differ from invasive BCIs like Neuralink, and what are the trade-offs between invasive and non-invasive methods in terms of precision, safety, and patient outcomes? Bouton: Neuvotion has taken all of that brain data, and studied correlations between brain activity and body language, which allowed us to develop AI algorithms that can infer from body language what someone’s movement intentions are. If someone who has suffered a stroke or spinal cord injury is thinking about reaching to pick something up, we collect that body language information in a non-invasive wearable with built-in sensors. It uses machine learning or AI and we call it body language inference. This glide path technology can not only recognize when someone is reaching out to pick something up, but it starts to stimulate the right muscles to allow a person to successfully open a hand and pick up an object. We have had users pick up a granola bar and feed themselves. We've had them pick up Twizzlers and take a bite. For someone who is paralyzed, this is life changing. Our first product, NeuStim, is going to launch this fall, and it’s FDA cleared, wearable, non-invasive, wireless, and allows people to achieve these basic movements. It sets us apart from other companies, and can be used with any BCI wirelessly, but can also work in a standalone mode to do basic movements without a BCI. For someone who wants more advanced features, like moving individual fingers, or someone who has a higher level injury, that is when the BCI comes in and we can link it to any BCI. We are developing our own BCI model as well, and that will be coming out down the line. It makes the system very modular and flexible, and it can be adapted to the needs of any patients. NeuStim® is launching this fall at select high-profile clinical institutions. What criteria are you using to select these partner institutions, and what does the rollout timeline look like for broader availability? Bouton: We will launch the initial sites here in the fall, as a limited launch. What we were looking for is clinical, leading institutions in the U.S. with heavy volume for stroke and spinal cord injury patients. The first launch will involve systems being used in the clinics, and our timeline looks like ramping up and launching at additional sites in 2027. And also we are preparing our home version deployment of NeuStim in this coming year, late 2027, which is super exciting. We will start with the clinical launch and then prepare for the home version to be launched later in the year. Who are the ideal candidates for NeuStim® treatment? Are you focusing primarily on stroke patients, or does the technology have applications for other neurological conditions like spinal cord injury or traumatic brain injury? Bouton: NeuStim is cleared for stroke and spinal cord injury, which are the two leading causes of paralysis. We have plans for expanding indications in the future for TBI, and potentially MS as well. The BCI space is getting crowded with companies like Neuralink, Synchron, and Blackrock Neurotech. How does Neuvotion differentiate itself, and what advantages do you see in your non-invasive, body-reconnection approach? Bouton: We don't consider ourselves as just BCI. We are BCI and BBI, and we like to use that phrase Brain Body Interface. BBI allows you to then expand into more conditions and create a platform that is modular and flexible to address broader clinical needs. We are very focused on restoring function, movement, sensation, and promoting further neurological recovery. This is very beneficial for the 100 million plus patients who have suffered neurological injury or other types of neurological conditions that impair their independence. Our slogan is, “laser-focused on restoring independence.” At the end of the day, patients will talk about regaining independence and how important that is. That is why we are so focused on this. We think this really differentiates our technology, or products, and our approach, and we can reach a much larger patient population by approaching it this way. Looking 5-10 years ahead, what does success look like for Neuvotion? How do you envision BCI and BBI technology transforming rehabilitation and quality of life for people with neurological injuries? Bouton: In 5-10 years, we will have further mapped the human brain and the central nervous system and that will allow us to continue to refine our treatment modalities, our neuromodulation patterns, and improve clinical outcomes from this method. You need to be able to both read and write from the nervous system, and really decode or understand those signals before you can further improve. Reading and writing is like learning a new foreign language. You have to listen, understand what things mean, make associations, and then you start to speak with the language, and be stimulated in more sophisticated ways. We have taken that approach, and we have seen, for example, in our latest paper, we developed a technique called cortical mirroring where we first read and recorded signals from the brain while we were doing different tactile tasks with the participant. We recorded those micropatterns of activity we saw in the brain and mirrored them back. We did that and found out that previously, spinal cord stimulation did not lead to improved sensation in the hand and wrist area, but after we did this cortical mirroring, we saw 10-fold improvement in tactile sensation in the hand and wrist area after just a few weeks. We call it bio mimicry, and in this case, we did that and it really paid off. Also, we found that the participant has continued to see these 10-fold improvements in his sensation even two years later. He still has maintained these gains. Five to 10 years from now, we will be able to read and write from the human nervous system more effectively, and develop lasting treatments, and have more lasting and persistent outcomes and gains. This is incredible and super important as we are all living longer. Our kids and our grandkids will live longer than us, and live well into their 80s, 90s, and beyond. But with living longer, the probability of having a neurological injury or condition goes up dramatically. In 5-10 years, we will see even more advanced therapies because of all this work and new technologies that exist. Is there anything else you would like to expand on? Bouton: We are also working on a second product called FocalStim. We have completed pilot studies demonstrating that we can use our high resolution, non-invasive stimulation that we use for muscles. In NeuStim, we use that same core technology to stimulate the spinal cord itself. We do that non invasively as well. This technology is high resolution, and it can be linked to the AI that can perform the body language inference and infer movement. It will automatically switch the spinal cord stimulation pattern in real time while someone is attempting movements and completing their therapy, or even using it at home. Our goal is to take this second product through regulatory clearance in the later part of 27 or early part of 28. We hope to launch that product as early as 2028. That is super exciting, because FocalStim will also communicate wirelessly with NeuStim and they can work in conjunction. That brings something other companies do not have. When you can stimulate the spinal cord, as our pilot studies have shown, you can see 400-1,200% improvement of strength and recovered muscle activation. This is tremendous. We have even seen improvements in sensation. This plasticity is lasting. You can help people get stronger and more functional over time, and this can have a massive clinical impact. We have flipped the whole paradigm. We are introducing non-invasive technologies, and muscle and spinal cord stimulation, and they are all part of this BBI platform, which is very modular, very flexible. Not everyone is a good candidate for brain surgery. A lot of patients are older and not good invasive surgical candidates, so we wanted a BBI platform that can still serve and address that older population as well. We are also indeed developing a more invasive BBI for higher level injuries and strokes and more severe neurological events.