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ARCBCI is our investigational system that pairs ARCIM Therapy with a brain-computer interface (BCI) to restore thought-driven movement

Meet Gert-Jan and learn about his journey

ARCBCI

  • The ARCBCI System creates the ONWARD DigitalBridge™, reconnecting communication between the brain and the body to restore thought-driven movement after paralysis.

    The ARCBCI System has been awarded US FDA Breakthrough Device Designation, the 10th such award for an ONWARD Medical technology or therapy. ONWARD is also one of the first neurotechnology companies invited to join the FDA’s Total Product Life Cycle Advisory (TAP) Program, providing early and frequent strategic engagement with the FDA and other stakeholders.

    The ARCBCI System uses artificial intelligence (AI) to decode a person’s brain signals and translate their movement intentions into instructions for our ARCIM System. The ARCIM System then delivers precise spinal cord stimulation to restore thought-driven movement after paralysis.

  • As part of a research consortium, in 2021 we successfully implanted the first investigational BCI in a human to enable thought-driven movement of the legs after paralysis. The results were published in Nature in May 2023.

    In 2024, we secured exclusive rights to the WIMAGINE® BCI platform. WIMAGINE is a premier BCI technology with more than seven years of human safety data. The platform was originally developed by the prestigious French biomedical research institute, CEA-Clinatec. ONWARD now has the exclusive rights to develop and commercialize WIMAGINE as part of our ARCBCI System.

    Through mid-2025, we have successfully implanted five humans with ARCBCI Therapy to facilitate mobility (walking) and upper extremity movement.1

    We expect to advance research and technology development of the ARCBCI System in the coming years, supported by grants from the Christopher & Dana Reeve Foundation and European Innovation Council.2

    Learn more

  • 1. This project is funded by the European Innovation Council (EIC 2021-TransitionChallenges-01-01 ReverseParalysis n°101057450 and HORIZON-EIC-2021-PATHFINDERCHALLENGES-01 NEMO BMI n°101070891) and this work has received funding from the Swiss State Secretariat for Education, Research and Innovation (SERI).*

    2. This project is funded by the European Innovation Council (HORIZON-EIC-2024-PATHFINDEROPEN-01 ReverseStroke n°101187647) and this work has received funding from the Swiss State Secretariat for Education, Research and Innovation (SERI).

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The ONWARD® Medical ARCEX® System is FDA cleared for use in the United States and CE marked in accordance with EU Medical Device Regulation 2017/745. ONWARD ARCIM® and ARCBCI™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.

Indication for Use (US): The ARCEX® System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old who present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).

Indication for Use (EU): The ARCEX® System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic and with take-home exercises in the home to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).

*Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or European Innovation Council and SMEs Executive Agency (EISMEA). Neither the European Union nor the granting authority can be held responsible for them.