Synchron co-founder and CEO Dr. Tom Oxley discusses the race to FDA approval, lessons from the Command trial and the potential for consumer use of BCI implants.

With positive results from Synchron’s Command trial, the brain-computer interface (BCI) developer is working with the FDA toward a pivotal trial that could lead to the agency’s first premarket approval of a BCI implant.

In an interview with Medical Design & Outsourcing, Synchron co-founder and CEO Dr. Tom Oxley said his company is in ongoing conversations with the FDA about what endpoints make sense for a pivotal trial. Such a trial would take a couple years to run before submitting for FDA approval, he said.

Synchron and Elon Musk’s Neuralink are the front-runners for FDA approval, though Neuralink didn’t implant its BCI device in a human until January 2024 and reported problems soon after. While Synchron places its implants with a minimally invasive catheter procedure, Neuralink’s robot-assisted implantation procedure requires a craniectomy.

Previously: Synchron’s plan to beat Neuralink in the neuroprosthetic BCI race

Asked about Neuralink and its leader, Oxley said he’s not worried that the various controversies surrounding Musk will negatively impact the BCI field.

“Overall, there’s huge investment coming into the field. We’ve still got a long way to go,” Oxley said. “Neuralink is making huge investments into solving very hard problems and bringing the spotlight to neurotech.”

Oxley said the winner of the race for FDA approval will likely be the BCI developer with the first pivotal trial.

“I think that’s the best way to measure where the field’s at and where different companies are at,” he said. “We are getting into a position where we can start to contemplate the beginnings of a pivotal trial. It’s been five years to get to this point with safety data. You have to really understand the safety profile before you can start thinking about your efficacy endpoints, because it’s all risk/benefit. We’re moving into that stage now and that’s really what the Command study is about.”

That study found no serious adverse effects or other impacts to the brain or vasculature in six patients with the Stentrode implants. The study’s researchers also reported reliable capture and conversion of brain signals into digital motor outputs (DMOs) to control mouse cursors and devices like Apple’s Vision Pro or Amazon Alexa.

“The safety profile of our BCI product is becoming clearer with each patient that we assess, so that puts us now in a good position to think about what does that DMO need to do relative to the safety profile to build a pivotal trial around,” Oxley said.

Below are more excerpts from our interview with Oxley as we caught up on what’s new since our last interview in 2023. (The following has been lightly edited for space and clarity.)

MDO: What have you learned through the Command study that other device developers might find useful?

Oxley: “You’ve seen us going from Apple products to Alexa products to OpenAI products, and it’s not obvious that the system can be generalizable across different systems. So as we’re thinking about a commercial product, we’re wanting it to be cross-platform and easily integrated, and that’s taken a lot of work. In particular, making Bluetooth seamless has taken a lot of work. It’s interoperability, it’s generalizability. When it’s good, it’s amazing. But when it fails, it really fails, because it stops working. So we’ve put a lot of time and effort into making Bluetooth work.”

MDO: Are there any new learnings you can share through your use of nitinol?

Oxley: “With nitinol, we need the shape memory, but we don’t need as much shape memory as other stents need. It’s very sticky in the venous system, so we can get away with quite low radial force. … That means we can build the nitinol super thin. We’re learning a lot. We’re learning how to build electrical tracks on nitinol, which hasn’t really been done before [and] we’re learning how to do new things in three-dimensional construction with nitinol.”

Related: Who is Acquandas? Its thin film manufacturing goes beyond Synchron

MDO: And what about your efforts for design simplicity — anything there that other device developers could learn from?

Oxley: “Simple means the patient shouldn’t need to troubleshoot. It needs to be easy to onboard, simple to use, low training requirements, low cognitive burden, reliable, easy to turn on and off. Turning on and off has been a really interesting thing that we kind of took for granted. And it turns out if you’re going to turn on your system with your brain and then turn it back off — because when we use products, you use face recognition, you just swipe on and use, that’s a very important element of the of engaging with the device — so turning on and off, or waking it up and putting it back into sleep mode using your brain has been not an obvious thing. Although it feels like just brick-and-mortar basic stuff, it’s been a really interesting and really important effort. … The BCI field is a technophilic area, but we’re catering for patients that are not technophiles, so it needs to be simple.”

Previously: BCI basics with Synchron co-founder and CEO Dr. Tom Oxley

MDO: Is it possible that patients might turn these systems on and off while they’re sleeping? And what can you do about that?

Oxley: “Yes, brain activity during sleep is very active and there’s lots of electrical activity happening at nighttime that can be misinterpreted. We are learning that nighttime is a very electrically active portion of the day. Our model is decoding day versus night electrical features from the brain so we can make those determinations and understand how to characterize signal from noise. We’re contemplating dream activity as noise, and we just have to be able to clarify signal from noise.”

MDO: At some point, can you imagine people having BCIs implanted to control consumer products and technology rather than to address severe paralysis?

Oxley: “I think there’s a long way before we get to that point. We think there’s about 3 million people in the U.S. and 12 million globally who could benefit from a endovascular BCI. The way that we’re thinking about those people is do they have impairments in their ability? So they’ve got paralysis, some cause of their muscles not working, and do they have an impairment in their activities of daily living (ADLs)? And I think what will happen over time is the BCI functionality will improve, safety profile will become very evident and will improve as well, and the user’s willingness to undergo the procedure for the return on function, the threshold to do that will reduce over time because the device will get better and better. So it will take less and less of an insult or an injury to contemplate getting the BCI, and then eventually there will probably be a point at which — like where LASIK surgery is right now, did you really need to get LASIK surgery, or could you just wear glasses — I think BCI will hit that. But I honestly don’t think it’s anytime soon. Things move slowly in medical devices. And 12 million people globally who could get this device, [compare that to] cochlear devices at 40,000 per year or deep brain stimulation at 10,000 per year. If this field gets even into the hundreds of thousands per year — which I think it will — it’s going to become the biggest neurotechnology domain, and from there it’s going to keep growing toward that point that you’re thinking about. But there’s so much space and growth to happen in medtech before we get to that consumer.”

MDO: How many employees are you up to now?

Oxley: “We’re at 65 now. It feels like it’s a good number for where we are. I don’t think there’s huge growth to come from this point. We’ve amassed a group of incredible leaders in the organization. Evan Schnell is doing an incredible job with software. Peter Yoo is doing an incredible job with data science and neuroscience. Adam Fry is an emerging superstar in the clinical field. He was all around the FDA meeting [this month]. He’s our clinical science lead. We’ve got some really amazing talent coming together, and we’ve been working with each other for long enough now that we’re starting to understand how each other tick a little bit more. There’s really good culture emerging.”

MDO Min-Vasive Medtech Series: Watch an on-demand video interview with Synchron’s Darragh McDermott about minimally invasive device design