Emerging technologies in healthcare, part 1: Precision Neuroscience

MobiHealthNews’ Emerging Technologies Series will spotlight organizations developing, scaling and investing in innovative healthcare technologies. What follows is part one of an eight-part series:

Precision Neuroscience is developing a brain-computer interface (BCI) to help patients with neurological conditions – such as stroke, ALS and spinal cord injury – control computers and smart devices using only their thoughts.

Jayme Strauss, chief commercial and clinical officer at Precision Neuroscience, sat down with MobiHealthNews to discuss the company’s minimally invasive BCI, the Layer 7 Cortical Interface, which rests on the brain’s surface without penetrating tissue. 

MobiHealthNews: Can you tell our readers about Precision Neuroscience?

Jayme Strauss: Our mission is really to improve the lives of the millions of people that are struggling with neurological conditions and injuries, really give them autonomy and independence back into their life and be able to make connections with their family and loved ones around them and within the world.  

I think there is this ability that BCI gives people hope – hope for something that they haven’t had before – where they can connect back into the world, integrate back into the world, play video games with their loved ones, communicate, ask for help, return to work, all of these things that, until BCIs, have been impossible for them to do. So, that’s really our mission, and what we’re focused on.

MHN: Precision’s technology includes the Layer 7 Cortical Interface. How does it actually work?

Strauss: The Layer 7 Cortical Interface is an array. So, it’s a thin film microelectrode array. It is about a fifth the thickness of a human hair, and it really conforms to the surface of the brain. 

When you think about a brain, it’s like mountains and valleys, right? We have all these sulci and intricate networks into these deep sulci where there’s a lot happening in the brain.  

All of the other electrode arrays that have been used in BCI before have been penetrating, which means there is microneedles or threads or different things that have to penetrate deeper into the brain to collect the important neural data that is needed to be able to decode and then offer the intent through an enabling of a device.  

Precision’s is different. It is thin film, flat, so it does not penetrate brain tissue. You can move it around. Precision is important in these patients when you are thinking about where you are going to put the device and the millimeters actually matter. But if you’re already penetrating, or you are a stent electrode, once you are in there, you cannot pull it out and move it somewhere else. You’re there.  

So, this allows us some flexibility to make sure that we’re getting to the right part of the brain, specifically over the motor cortex. And it also is removable and reversible. Other devices that are in the process of getting to market are not removable. I mean, you could remove them, but you could not replace them because that cortex is then damaged from what was in place.  

So, you have the electrode array, and then for the permanent implant, what it will be, it is called an SGI, a subgaleal. It sits between the bone of the skull and the scalp. So, underneath. It is thin and flat. That really houses a lot of the electronics and some of the decoding. So, the data that we get from the 1,024 channels on the brain transmits to this SGI and then is processed down through a lead that goes behind the ear, down into the chest wall, and that is where the battery and transmitter is. That then allows the data to transmit out to interface with the computers or the mobile device or whatever the assistive technology that we are collecting to.  

Because we are sitting directly on the cortical surface of the brain, the resolution that we get of the data and the bandwidth of the data is much larger than any other that is currently out there.  

So, the predicate that we had for the FDA 510(k) are very old tech electrodes. There were only four electrodes compared to our 1,024, and what you’re able to see through our visualization software is actually seeing the brain sync in real time.  

We’ve already implanted in 39 patients across some pretty big centers, and every time that we go in and the surgeon sees it for the first time, they are like, “I’m actually, for the first time ever, seeing the brain think in real time.”  

So, we are able to collect that neural data in real time in high resolution, and what we’ve been able to prove and show in these patients that we’ve already implanted is we can take about 3 minutes’ worth of data and decode it and train a model, and then we run experimental task paradigms of gesture movements or speech, and we are able to predict, with fairly good accuracy, in the upward of 90%, the intent. So, my intent to move my hand, my intent to control a joystick, my intent to speak a word, and we’re able to decode that in real time.

MHN: Does it actually allow someone to do that?

Strauss: It will. So, with the fully implantable system, that is what it will do. So the 510(k) is just for the electrode array component, which is the functional component of our system. It’s the highest risk. It’s the one touching the brain tissue. It’s the one that the FDA is really worried about making sure that we meet all of those standards.  

Then there are the other components of the system that will have to go through the regulatory approval process as a fully implantable system, but that is the exact intent. 

The intent is we will truly be able to allow individuals, in real-time, to control a computer. You know, create a PowerPoint presentation, answer emails, control their home environment with smart technology. Interact just through their thoughts alone.

MHN: The 39 patients that have been implanted, what are they able to do now?

Strauss: So those patients we did ahead of the 510(k). Well, we have done a couple after the 510(k), but what those studies are – we call them investigator-initiated studies – they are driven by the investigator at the site that is wanting to answer a scientific question, but because of the safety profile of our device, we have been able to go in where a patient is already having a neurosurgical procedure, such as a craniotomy, where they are removing a brain tumor or deep brain stimulation, where they’re implanting the microelectrodes to do stimulation for a patient with Parkinson’s disease, and we’ve been able to put our device on the brain for minutes up to a couple hours and collect neural data and do these tasks and paradigms.  

Now, with the 510(k), what it allows us to do is expand that even further. So, now we can leave the device on the brain. When a patient goes to a neuro ICU, or what we call a monitor unit, we’re able to collect more data, work with the patient, understand how their brain works, understand their neural network, how their brain is functioning and working and, post-procedure or during, what is happening in the brain. That allows us to keep it in the patient for up to 30 days.  

So, it allows us to expand our research and development and look at different patient populations and for longer periods of time. And then it also allows us to be able to commercialize it. We can now sell this device through the market for mapping, recording, stimulating during these procedures and up to 30 days.

MHN: Precision Neuroscience’s direct competitor is Elon Musk’s brain implant company Neuralink. What is the difference between the two companies’ BCIs?

Strauss: It is that safety profile that we talked about. So, Neuralink does penetrate the brain. There are threads, and it has to be implanted with a robot because the way that they designed the device, there’s the hub and it implants, and then there are these threads, and the threads are so thin that a surgeon could not manipulate them. So, it has to be implanted with a robotic device. The surgeon is in the room, but they have to implant it with the robot. 

Ours does not penetrate healthy brain tissue. So, it just sits on the surface, the dual surface of the brain, the cortex. So it allows us more flexibility with where we can place the device, how we place the device, and being able to remove it. Ours is considered minimally invasive because you are not having to do a big craniotomy. We can implant our device through a small burr hole. 

Also, we have developed a technology that we will be using when we do the fully implantable device; it is called a microcranial slit, and it is patented. If you think about old doors, where you would have the mail slot and they would slide the letter through, that is what this is. So, it is literally a slit that happens on the surface and through the skull, and then we take the device and we slide it down onto the dural surface of the brain. 

MHN: What does Precision ultimately see happening with this technology?

Strauss: We would really like to take it to as many patients, families and individuals that need this. We are a really clinically focused company. We are founded by a neurosurgeon, Dr. Ben Rapoport. He is a practicing neurosurgeon at Mount Sinai. He really believes in the minimally invasive safety profile, and that’s why the design is what it is.  

But we’re really focused on clinical applications. So, helping people with ALS, spinal cord injury and stroke to be able to integrate and connect back into the world in a way that they have not been able to. To be able to have some independence and autonomy back. And that’s really our focus right now in the immediate term.