Onward Medical announced that two additional individuals with spinal cord injuries (SCI) have received the company’s investigational ARC-BCI therapy.

These procedures bring the total number of human implants to seven, growing the company’s leadership in developing brain-computer interface (BCI) platforms to restore thought-driven movement for people living with paralysis.

Both procedures were performed at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland, under the direction of Jocelyne Bloch, MD, 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 ARC-BCI therapy for upper- and lower-limb movement restoration, respectively.

The company’s BCI platform is comprised of an implant placed epidurally on the motor cortex to record brain signals related to movement intention. The system leverages artificial intelligence (AI) to decode the signals and translate them into instructions that are wirelessly transmitted to an implanted neurostimulator, which stimulates targeted regions of the spinal cord via leads.

The BCI is supported by over eight years of human safety data. ARC-BCI was granted breakthrough status from the U.S. Food and Drug Administration (FDA) in 2024. It’s also included in the agency’s Total Product Life Cycle Advisory Program that provides early regulatory guidance to support the development of innovative technologies.

“We continue to learn from this groundbreaking clinical feasibility research, leveraging our unique understanding of spinal cord stimulation to restore movement after paralysis, and exploring the potential advantages offered by the addition of a brain-computer interface,” said Dave Marver, CEO of Onward Medical. “We look forward to sharing more details in a peer-reviewed forum, continuing our commitment to scientific rigor.”

These latest implants are part of ongoing clinical feasibility studies supported by grants from the European Union’s Horizon Europe research and innovation program through the European Innovation Council (EIC), the Christopher & Dana Reeve Foundation, and the Swiss State Secretariat for Education, Research and Innovation (SERI).