ONWARD Medical’s investigational ARC-BCI® Therapy represents a transformative leap in neurotechnology aimed at restoring movement in individuals with spinal cord injuries (SCI). By integrating a brain-computer interface with the company’s ARC-IM® spinal cord stimulation system, the ARC-BCI creates the DigitalBridge™—a closed-loop, AI-powered system that translates brain signals into real-time movement commands. This innovation allows patients to regain voluntary control over limbs, even after complete paralysis, by bypassing damaged neural pathways and establishing a direct wireless communication between the brain and the spinal cord.

The latest two successful implants bring the total to five participants, all conducted at CHUV in Lausanne, Switzerland. These procedures are part of a broader clinical feasibility effort supported by the European Innovation Council and the Christopher & Dana Reeve Foundation. The ARC-BCI system has shown that it can deliver accurate neural decoding with less invasive surgery compared to traditional BCI platforms, making it more feasible for clinical integration. Patients in the study are already reporting improvements that meet or exceed expectations, reflecting the potential for meaningful recovery of function and quality of life.

With Breakthrough Device Designation from the FDA and growing global attention—including features on CBS’s 60 Minutes—ONWARD’s ARC-BCI is quickly establishing itself as a frontrunner in brain-computer interface therapies. The company continues to refine its approach and collect clinical data with the aim of making thought-driven movement restoration a standard therapy. As the technology advances toward broader use, it holds the promise of revolutionizing care for millions living with paralysis, empowering them with greater independence and functional recovery.

MedTech Spectrum's Summary

Restoration of Movement Post-Paralysis: ONWARD’s ARC-BCI® Therapy creates a brain-to-spinal cord interface that enables thought-driven movement, offering new hope for spinal cord injury patients to regain voluntary control.

Clinical Progress and Safety: With five successful implants and promising early outcomes, the technology demonstrates consistent progress in feasibility studies, supported by leading European research institutions and the FDA’s Breakthrough Device Designation.

Path to Widespread Impact: As clinical validation continues, ONWARD’s innovation positions itself to redefine neurorehabilitation, potentially transforming the lives of millions affected by paralysis with a less invasive and AI-integrated therapeutic option.