ONWARD Medical Achieves Milestone with Seven ARC-BCI Therapy Implants, Advancing Brain-Computer Interface Technology
EINDHOVEN, Netherlands – January 22, 2026 – ONWARD Medical N.V. (Euronext: ONWD), a leader in neurotechnology focused on restoring movement and function through spinal cord stimulation, today announced a significant advancement in its investigational ARC-BCI® Therapy. The company has successfully completed two additional human implants, bringing the total number of participants receiving this innovative system to seven. These procedures, conducted at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland, mark a critical step in the development of brain-computer interface (BCI) technology for individuals with spinal cord injuries (SCI).
The ARC-BCI platform represents a sophisticated integration of an epidural motor-cortex implant, advanced artificial intelligence (AI) for signal decoding, and a wireless neurostimulator. This system is designed to translate the user’s intention to move into functional limb movement by stimulating the spinal cord. The recent implants involved a 35-year-old woman and a 39-year-old man, both living with SCI, who received the therapy for upper- and lower-limb restoration respectively.
“These latest implants underscore our ongoing commitment to pushing the boundaries of what’s possible in neurorestoration,” stated Dave Marver, CEO of ONWARD Medical. “We are gaining invaluable insights from this clinical feasibility research, building upon our deep understanding of spinal cord stimulation and exploring the synergistic potential of integrating brain-computer interfaces. Our dedication to scientific rigor means we look forward to sharing comprehensive data in peer-reviewed publications.”
The ARC-BCI system benefits from a robust foundation of safety data, with over eight years of human experience informing its development. This technology has garnered significant regulatory attention, receiving FDA Breakthrough Device Designation in 2024 and inclusion in the FDA Total Product Life Cycle Advisory Program, which provides early regulatory guidance for novel medical technologies.
The clinical feasibility studies supporting ARC-BCI are fueled by substantial grants from the European Union’s Horizon Europe research and innovation program, the Christopher & Dana Reeve Foundation, and the Swiss State Secretariat for Education, Research and Innovation (SERI). This collaborative funding environment highlights the broad interest and support for advancing BCI technology in the scientific and patient advocacy communities.
From a commercial and technological perspective, the ARC-BCI platform’s multi-component approach is particularly noteworthy. The motor-cortex implant, a critical interface for capturing neural signals, is designed for minimally invasive placement. The AI-driven decoding layer is crucial for interpreting complex brain activity, a significant technical challenge in BCI development. The wireless neurostimulator then translates these decoded signals into precise electrical stimulation patterns delivered to the spinal cord, aiming to re-establish communication pathways essential for motor control. The success of this complex interplay of technologies is key to ONWARD Medical’s strategy.
While the system demonstrates promising potential, it remains investigational. The limited clinical sample size of seven implants, though a milestone, indicates that further trials are necessary to establish broader efficacy and safety profiles. The long-term implications of such implanted systems, including hardware longevity, signal integrity, and potential for patient adaptation, are areas of ongoing research and development critical for future commercialization.
About ONWARD Medical
ONWARD Medical is a neurotechnology company dedicated to developing therapies that restore movement, function, and independence for individuals with spinal cord injuries and other movement disorders. The company’s foundational ARC Therapy, built on extensive scientific research and clinical validation, has led to multiple FDA Breakthrough Device Designations. ONWARD’s ARC EX® System is currently available commercially in the US and Europe. The company is also advancing the investigational ARC-IM® system, designed to address needs such as autonomic dysreflexia post-SCI, and can be integrated with BCI and AI for thought-driven movement restoration. Headquartered in the Netherlands, ONWARD Medical maintains a Science and Engineering Center in Switzerland and a US presence in Boston, Massachusetts. The company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD) with US ADRs trading on OTCQX (ticker: ONWRY).
Forward-Looking Statements
This press release contains forward-looking statements regarding ONWARD Medical’s future expectations and projections. These statements are subject to inherent risks and uncertainties that could cause actual results to differ materially from those anticipated. Factors such as regulatory approval delays, market demand, competition, and technological advancements could impact the company’s outcomes. ONWARD Medical disclaims any obligation to update these statements based on future events or developments.
*Trademarks: ONWARD, ARC-EX, ARC-IM, ARC-BCI, and the stylized O-Logo are proprietary and registered trademarks of ONWARD Medical. Unauthorized use is strictly prohibited.*
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