Company profileNeuromodulation
ONWARD Medical
Spinal cord stimulation therapies, with a brain–spine interface in development.
- Location
- Eindhoven, Netherlands
- Founded
- 2014
- Class
- NeuromodulationSpinal cord stimulation is the core therapy; the brain-spine interface adds a cortical recording implant that drives it.Not counted among core BCI companies.
- Website
- onwd.com
- Funding stage
- Public
- Sources last checked
- 7 Oct 2026
What they are building
Develops ARC-BCI, which pairs a cortical recording implant with implanted spinal stimulation so that intended movement drives the stimulation directly.
- Interface category
- Electrocorticography · Brain–spine interface
- Signal
- ECoG: Local field potentials, including high-gamma activityBrain–spine: Cortical field potentials out; epidural spinal stimulation in
- Lines of work
- ARC-BCIInvasive · ECoG · Recording and stimulation · FeasibilityARC-EXNon-invasive · Stimulation · Approved / cleared
- Device
- ARC-BCI — Cortical recording implant coupled to an implanted spinal cord stimulator
- Regulatory status
- Investigational; FDA Breakthrough Device designation (2024), which is not a clearance
- Main use cases
- Move, Restore
- Works with
- EPFL / Lausanne University Hospital · Clinatec, CEA / CHU Grenoble Alpes
Where they are clinically
ARC-BCI · Invasive
Feasibility
Small early studies that test safety and whether the device can do what it is meant to.
Access today
Experimental human research
Demonstrated in a small number of research participants. Not an established treatment.
ARC-EX · Non-invasive
Approved / cleared
Authorised by a regulator for a defined use. Always check the scope.
Access today
Available
Authorised and obtainable for a defined group of patients or users.
ARC-BCI, the brain–spine interface, is investigational. ARC-EX, the company's external spinal cord stimulator, has had FDA De Novo marketing authorisation since December 2024 and has been sold to clinics in the United States since that month, according to the company; it reads nothing from the brain.
- Shown in people
- In an academic study, one man with chronic tetraplegia stood and walked when cortical recordings drove spinal stimulation; the link calibrated in minutes and stayed reliable for a year, including at home (Nature, 2023).
- Still an aim
- ARC-BCI as a product. The published work used research implants from Clinatec.
- What stands in the way
- Scale: one published participant, and a system built from separate cortical and spinal implants.
On record here: 1 peer-reviewed paper
ARC-BCI remains experimental and is not an established treatment. Access is limited to registered clinical studies.
- 19 Dec 2024US FDA — De Novo marketing authorisation. Stimulation of the spinal cord through the skin, to improve hand strength and sensation in adults aged 18 to 75 with chronic incomplete cervical spinal cord injury. Nothing is read from the brain; the brain–spine interface remains investigational.
- Feb 2024US FDA — Breakthrough Device designation. A designation speeds interaction with the regulator. It is not a clearance or approval.
Why this company matters
ONWARD approaches BCI from the therapy side: the cortical implant is a means of controlling stimulation, not a product in itself. That gives it a clinical route through spinal cord injury rehabilitation that device-control companies do not have, and one authorised product already: ARC-EX, which stimulates through the skin and reads nothing from the brain. For the brain–spine interface itself the published evidence is one participant.
Key milestones
9 Jan 2025
Company reports its first sales of ARC-EX: UW Medicine and Next Steps Chicago bought systems in late December 2024. At that date it was authorised for use in clinics.
19 Dec 2024
FDA De Novo authorisation for ARC-EX, an external spinal cord stimulator, to improve hand strength and sensation after chronic incomplete cervical spinal cord injury.
Feb 2024
FDA Breakthrough Device designation for the investigational ARC-BCI System, according to the company.
24 May 2023
Brain–spine interface research from EPFL, CHUV and Clinatec shows walking restored in one participant with chronic tetraplegia.
Research
- 2023Walking naturally after spinal cord injury using a brain–spine interface
Lorach H et al. · Nature
Competitive context
Sources
- 01
Company reportedONWARD Medical (press release)19 Dec 2024Checked against source 6 Oct 2026
ARC-EX stimulates the spinal cord through the skin. It is not a brain-computer interface.
- 02
ONWARD Medical announces first commercial sales of ARC-EX System (opens in a new tab)
Company reportedONWARD Medical (press release)9 Jan 2025Checked against source 7 Oct 2026
Names the first two buyers, UW Medicine and Next Steps Chicago, and says the system was at that date authorised for use in clinics in the United States.
- 03
ONWARD Medical reports full year 2024 financial and operating results (opens in a new tab)
Company reportedONWARD Medical (press release)Mar 2025Source identified, not opened
Found through search and not opened. Used for the Breakthrough Device designation of the ARC-BCI System, which the company dates to February 2024.
- 04
Lorach H et al. Nature 2023;618(7963):126–133 (opens in a new tab)
Peer reviewedNature24 May 2023Checked against source 3 Oct 2026
DOI 10.1038/s41586-023-06094-5