The brain-computer interface space has taken medtech by storm. This novel approach from Onward has the potential to bring it to another level.
Several companies are developing brain-computer interfaces (BCIs), many of which offer people with paralysis a chance to control external devices with their mind. Onward, a Dutch medtech company, develops technology that could utilize BCIs to go even further.
Onward’s ARC-IM stimulation system delivers targeted, programmed therapy to the spinal cord. It aims to restore movement and other functions after spinal cord injury. Combined with BCI technology, the company believes it could restore thought-driven movement.
The BCI works in tandem with ARC-IM to capture the intention of a paralyzed individual to move their upper extremities. It uses artificial intelligence (AI) to decode those thoughts and convert the information into ARC-IM therapy. Precise stimulation of the spinal cord with ARC-IM results in thought-driven movement.
Onward recently completed the first-in-human implant of this technology. The implant took place in a 46-year-old man in Switzerland who injured his neck while falling on ice. He received his implant in August with aims to recover movement of his arms, hands, and fingers.
The company’s CEO, Dave Marver, spoke with MassDevice following this implant to explain how the technology works and what Onward is aiming to do.
“We’re unique in what we do,” Marver said. “We are the only company that can do what we do — that is to stimulate the spinal cord to restore movement and function.”
Restoring movement with spinal cord stimulation
Onward’s expertise comes in stimulating the spinal cord in a very precise way to restore movement and other functions, Marver says.
The company has an external ARC-EX system, plus the ARC-IM implantable platform. With a look similar to a pacemaker, Onward’s neurostimulator has its own family of leads. Marver said this has been the basis of the company since its founding in 2015. It’s assembled an IP portfolio of more than 360 issued or pending patents. Onward also has nine FDA breakthrough device designations and positive trial results.
The ARC-IM lead works in combination with the ARC-IM neurostimulator (IPG). Onward purpose-built it for placement along the spinal cod to stimulate the dorsal roots with specific parameters outlined for each anatomical location.
Onward has a portfolio of these leads in many shapes, sizes and electrode arrays under development. Future indications the company may explore include blood pressure management, mobility, upper extremity function and bladder control. The early focus is on paralysis — and there could be another wrinkle that helps there.
“You’re talking about a company that’s oriented in a very unique way and and powerful way against this problem of paralysis,” Marver said. “Then, last year, we decided, maybe we can make our therapies that stimulate the spinal cord to restore our movement even better if we augment them with a BCI.”
Adding BCI to the mix
BCI is an exciting space with a number of entrants vying for the top spot. Names like Neuralink, Synchron, Blackrock Neurotech, Precision Neuro and more come to mind. They come from different bases — tech and medtech — with different focuses, like intravascular or neurosurgery-based.
Marver still considers the BCI space “the wild west.”
“It’s fast emerging,” he said. “There are a lot of different companies taking different approaches. … And there’s a lot that’s going to be learned over the course of the next few years about which approaches are better.”
The company teamed up with France-based CEA-Clinatec, a company with strong BCI data, according to Marver. He said five-year human data for the BCI demonstrated no degradation in quality of signal with a “pretty straightforward” implant procedure. The epidural implant requires the removal of a piece of skull, the placement of the BCI, then skin and hair grow over it.
Marver said Onward remains in touch with all BCI companies, watching the landscape to see who develops in which ways for the future. Before the company starts a pivotal trial that involves a BCI for a movement-related indication, it will consider which could work best with its own technology.
“We know how to do something with a BCI,” Marver said. “They’re all, at this point, implanting them, making sure they’re safe, recording some data to maybe control a computer mouse or keyboard. But, we’ve now shown in two people that we can implant a BCI to restore the movement of limbs. That’s why we consider ourselves the first killer app for BCI.”
On what BCI adds — or doesn’t add — to the Onward tech
Onward’s movement-restoring ARC-IM lead already demonstrated promise in restoring function on its own. The question around BCI is, what could it add to this therapy?
“We need to assess whether the BCI truly adds value,” Marver explained. “The early indication is that it does but this needs to be demonstrated and proven in feasibility and then pivotal trials. We need to make a determination on whether we want to commercialize spinal cord stimulation as a standalone therapy for restoring movement — which in and of itself is first in-human and remarkable — or whether to first commercialize spinal cord stimulation or ARC therapy plus a BCI.
“I think in any case, it’s conceivable that a BCI-augmented spinal cord stimulation therapy could be available by the end of the decade.”
For now, Marver stresses that Onward already has “realistic hope” in restoring movement with ARC therapy. Having already demonstrated it in feasibility trials, the mechanisms of understanding are there.
The company still needs to expose those to the rigors of a full pivotal trial, but he believes its “within the realm of possibility” to restore movement with Onward therapies. The company remains at the early stages of assessing the impact of a BCI in making its therapies even more effective. Until that’s determined, Marver believes ARC therapy can still be a transformational innovation.
“Sometimes, everyone talks about BCI,” Marver said. “I want the spinal cord injury community to know that we have other things like this coming within a year or so. … There are things coming more in the near-term and people don’t have to wait until the end of the decade.”