Two people with spinal cord injuries have received BCI therapy, a brain-computer interface designed to restore movement.
The procedures bring the total number of people to receive ONWARD Medical’s investigational ARC-BCI system to seven.
A brain-computer interface allows direct communication between the brain and external devices, translating brain signals into commands that can control movement.
Both procedures were performed at the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, under the direction of Jocelyne Bloch, chief of neurosurgery.
They involved a 35-year-old woman who sustained a spinal cord injury two years ago and a 39-year-old man who sustained a spinal cord injury seven years ago.
Study participants received the treatment for upper and lower limb movement restoration, respectively.
Dave Marver, chief executive of ONWARD Medical, said: “We continue to learn from this clinical feasibility research, leveraging our understanding of spinal cord stimulation to restore movement after paralysis, and exploring the potential advantages offered by the addition of a brain-computer interface.
“We look forward to sharing more details in a peer-reviewed forum, continuing our commitment to scientific rigour.”
The company’s system comprises an implant placed epidurally on the motor cortex, the part of the brain that controls voluntary movement.
The epidural space is the area just outside the protective membrane covering the brain.
The implant is designed to record brain signals associated with movement intention.
The system uses artificial intelligence to decode these signals and translate them into instructions that are wirelessly transmitted to an implanted neurostimulator, which stimulates targeted regions of the spinal cord via purpose-designed leads.
The company says its brain-computer interface is supported by more than eight years of human safety data.
The ARC-BCI system was awarded Breakthrough Device Designation by the US Food and Drug Administration in 2024.
It is also included in the FDA’s Total Product Life Cycle Advisory Program that provides early regulatory guidance to support the development of technologies the regulator considers innovative.
The latest implants are part of ongoing clinical feasibility studies supported by grants from the European Union’s Horizon Europe research and innovation programme through the European Innovation Council, the Christopher & Dana Reeve Foundation, and the Swiss State Secretariat for Education, Research and Innovation.
ONWARD Medical has developed what it describes as a proprietary technology called ARC Therapy and has been awarded 10 Breakthrough Device Designations from the FDA.
The company’s ARC EX system is cleared for commercial sale in the US and Europe.
The company is also developing an investigational implantable system called ARC-IM, designed to address unmet needs including blood pressure instability after spinal cord injury.
It can also be paired with a brain-computer interface and artificial intelligence to restore what the company describes as thought-driven movement.
Headquartered in the Netherlands, the company has a science and engineering centre in Switzerland and a US office in Boston, Massachusetts.
