ONWARD Medical N.V. (ONWD,ONWD.BR, ONWRY), a neurotechnology company, announced that two additional individuals living with spinal cord injuries have received the company's investigational ARC-BCI therapy, developed to restore thought-driven movement in people living with spinal cord injuries and other movement disabilities.
Following the positive update, ONWD.BR is surging 7% at 4.66 euros in the Brussels market.
ONWARD Medical develops spinal cord stimulation therapies to restore movement, function, and independence.
In 2024, the ARC-BCI System received Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA).
Developed under ONWARD's proprietary ARC Therapy, the BCI platform includes an epidural implant 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 procedures for the individuals were performed at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland, under the direction of Jocelyne Bloch, MD, Chief of Neurosurgery.
The participants received ARC-BCI therapy for upper and lower-limb movement restoration, respectively.
The persons implanted with the device was 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. This brings the total number of human implants to seven.
ONWARD has received 10 Breakthrough Device Designations from the FDA for the devices developed under its ARC Therapy platform.
Notably, ARC EX enables individuals with spinal cord injuries (SCI) to use the device at home and in clinical settings, and it has received clearance for commercial sale in the US and Europe.
Also, ONWARD is developing an investigational implantable system called ARC-IM to address several unmet needs, including blood pressure instability after spinal cord injury.
Over the year, ONWD.BR is trading in a range of 3.49 euros and 7.24 euros.
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