The $1.1 million grant supports the expansion of an ongoing early clinical feasibility study of the use of the company’s brain-computer interface (BCI). Onward’s study evaluates the use of BCI to restore thought-driven use of the hands and arms after SCI. The first participant in the study received their investigational ARC-BCI implant in August 2023. Now, investigators can enroll up to four additional participants to receive their ARC-BCI implant.
Onward’s ARC-IM delivers targeted, programmed therapy to the spinal cord to restore movement and other functions after SCI. Multiple feasibility studies demonstrated restored mobility and stabilized blood pressure with the device. The study looks at ARC-IM in tandem with the WImagine BCI from CEA-Clinatec.
The BCI works with ARC-IM to capture the intention of a paralyzed individual to move their upper extremities. It uses 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.
“While other companies are using BCI technology to interface with computers, ONWARD is leading the pursuit of BCI-augmented movement restoration,” said ONWARD Medical CEO Dave Marver. “We are grateful to the Christopher & Dana Reeve Foundation for its support, which enables us to expand this important study.”
More about Onward and its efforts on the BCI front
BCI is an exciting space with a number of entrants vying for the top spot. (MassDevice has published lists of some of the top companies to look out for in the space in 2022, 2023 and 2024.)
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? Marver spoke to MassDevice about this last year.
“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.”
Early signs remain positive for Onward, especially following that first ARC-BCI implant last year. Since then, the company won FDA breakthrough device designation for the technology in February and was accepted into the FDA’s new Total Product Lifecycle Advisory Program (TAP).
