ONWARD Medical N.V., the neurotechnology company pioneering spinal cord stimulation therapies to restore movement, function, and independence, announces that two additional individuals living with spinal cord injuries (SCI) have received the Company’s investigational ARC-BCI Therapy. These groundbreaking procedures bring the total number of human implants to seven, extending the Company’s leadership in the development of 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.

“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 rigour.”

The Company’s BCI platform comprises an implant placed epidurally on the motor cortex, designed to record brain signals associated with movement intention. The system uses Artificial Intelligence (AI) to decode these signals and translate them into instructions that are wirelessly transmitted to an implanted neurostimulator, which precisely stimulates targeted regions of the spinal cord via purpose-designed leads. The Company’s BCI is supported by more than eight years of human safety data. The ARC-BCI System was awarded Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA) in 2024. ARC-BCI is also included in the FDA’s Total Product Life Cycle Advisory Program that provides early regulatory guidance to support the development of innovative technologies.