The emerging technologies series of MobiHealthNews will bring organizations to the attention of organizations that develop, scales and invest in innovative health care technologies. What follows is part one of an eight -part series:
Precision neuroscience Develops a Brain-Computer interface (BCI) to help patients with neurological disorders – Such as stroke, ALS and spinal slut – Control computers and smart devices that only use their thoughts.
Jayme Strauss, Chief Commercial and Clinical Officer at Precision Neuroscience, sat down with MobiHealthNews To discuss the minimum invasive BCI of the company, the layer of 7 cortical interface, which is on the surface of the brain without penetrating tissue.
MobiHealthNews: Can you tell our readers about Precision Neuroscience?
Jayme Strauss: Our mission is really to improve the lives of millions of people who struggle with neurological conditions and injuries, really give them autonomy and independence back in their lives and are able to make connections with their families and loved ones around them and within the world.
I think there is a possibility that BCI gives people hope – hope for something that they have not had before – where they can come into contact in the world again, can integrate into the world again, play video games with their loved ones, communicate, to ask for help, go back to work, all these things that have been impossible for them to do. So that is really our mission, and what we concentrate on.
MHN: The technology of Precision includes the layer of 7 cortical interface. How does it actually work?
Strauss: The layer of 7 cortical interface is an array. So it is a thin film micro -electrode -Array. It is about one fifth of the thickness of a human hair, and it is really in accordance with the surface of the brain.
If you think of a brain, it is like mountains and valleys, right? We have all these sulci and complicated networks in this deep sulci where a lot happens in the brain.
All other electrode arrays used earlier in BCI are penetrating, which means that there are micronal or threads or different things that must penetrate deeper into the brain to collect the important neural data needed to decode and then offer the intention by a device.
Precision’s is different. It is a thin film, so flat, so it does not penetrate brain tissue. You can move it. Precision is important in these patients when you think about where you are going to place the device and the millimeters actually matter. But if you penetrate already, or you are a stentelectrode, once you get there, you can’t take it off and go somewhere else. You’re there.
This gives us some flexibility to ensure that we reach the right part of the brain, in particular about the motor cortex. And it is also removable and reversible. Other devices that are on the market are not removable. I mean, you could remove them, but you could not replace them because that cortex is then damaged by what was in place.
So you have the electrode sarray, and then for the permanent implant, what it will be, it is called an SGI, a subgaleal. It is 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 part of the decoding. So the data we receive from the 1,024 channels on the brain are transferred to this SGI and are then processed by a lead that goes behind the ear, in the chest wall, and that is where the battery and channel is. Therefore, the data can then send to communicate with the computers or the mobile device or whatever the auxiliary technology is in which we collect.
Because we are directly on the cortical surface of the brain, the resolution we get from the data and the bandwidth of the data is much greater than any others there is currently there.
So the designation that we had for the FDA 510 (K) are very old technical electrodes. There were only four electrodes compared to our 1,024, and what you can see through our visualization software is seeing the brain synchronization in real time.
We have already implanted in 39 patients in a number of quite large centers, and every time we go inside and the surgeon sees it for the first time, they say: “I am actually, for the first time ever, seeing the brain thinking in real time.”
So we can collect that neural data in high resolution in real time, and what we have been able to prove with these patients and show that we have already implanted, is that we can take about 3 minutes of data and can decode and then we can train a model, and then we have experimental task paradigms of the steering movements or speech, and we can save, with the intent. So my intention to move my hand, my intention to control a joystick, my intention to speak a word, and we can decode that in real time.
MHN: Does it really 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 only for the electrode -Array component, which is the functional component of our system. It is the highest risk. It is the one who touches the brain tissue. It is the one who really worries the FDA to ensure that we meet all those standards.
Then there are the other components of the system that must go through the approval process of the regulations as a fully implantable system, but that is the exact intention.
The intention is that we can really allow individuals to drive a computer in real time. You know, create a PowerPoint presentation, answer e -mails, check their home environment with smart technology. Interaction only through their thoughts alone.
MHN: The 39 patients who are implanted, what can they do now?
Strauss: So those patients we have done before the 510 (K). Well, we did a few after the 510 (k), but what those studies are – We call them studies initiated by researcher – They are powered by the researcher on the site who wants to answer a scientific question, but because of the safety profile of our device we have been able to go where a patient already has a neurosurgical procedure, such as a craniotomy where they have a brain tumor or deep brain stimulation, where they are able to stimulate a few minutes for a few hours. Up to a few hours and collect neural data and do these tasks and paradigms.
Now, with the 510 (K), it is able to expand that even further. So now we can leave the device on the brain. When a patient goes to a Neuro-IC, or what we call a monitor unit, we can collect more data, work with the patient, understand how their brains work, understand their neural network, how their brains function and work and, post procedure or during, what happens in the brain. This enables us to keep it with the patient for up to 30 days.
It therefore enables us to expand our research and development and to look at various patient populations and for a longer period of time. And then it also enables us to commercialize it. We can now sell this device through the market for mapping, recording, stimulating during these procedures and a maximum of 30 days.
MHN: The direct competitor of Precision Neuroscience is the brain implant company of Elon Musk Neuralink. What is the difference between the BCIs of the two companies?
Strauss: It is that safety profile we were talking about. So, Neuralink penetrates the brain. There are threads, and it must be implanted with a robot because the way they designed the device, there is the hub and the implants, and then there are these threads, and the threads are so thin that a surgeon could not manipulate them. It must therefore be implanted with a robot machine. The surgeon is in the room, but they have to implant it with the robot.
Our ours does not penetrate a healthy brain tissue. So it’s just on the surface, the double surface of the brain, the cortex. So it gives us more flexibility with where we can place the device, how we place the device and remove it. The ours is considered at least invasive because you do not have to do a large craniotomy. We can implant our device via a small burr.
We have also developed a technology that we will use when we do the fully implantable device; It is called a microcranial crack and it is patented. If you think of old doors, where you would have the mail slot and they would transfer the letter, that is what this is. So it is literally a crack that happens on the surface and through the skull, and then we take the device and we slide it down on the dural surface of the brain.
MHN: What does precision ultimately see happening with this technology?
Strauss: We really want to bring it to so many patients, families and individuals who need this. We are a truly clinically focused company. We were founded by a neurosurgeon, Dr. Ben RapoPort. He is a practicing neurosurgeon on Mount Sinai. He really believes in the minimum invasive safety profile, and that is why the design is what it is.
But we are really focused on clinical applications. So helping people with ALS, spinal cord and stroke to be able to integrate and to include it again in the world in a way they have not been able to do. To be able to have some independence and autonomy. And that is really our focus at the moment in the immediate term.
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