ONWARD Medical Completes Two Additional Brain-Computer Interface Implants Paired with Spinal Cord Stimulation Technology to Restore Thought-Driven Movement
Rhea-AI Summary
ONWARD Medical (OTC: ONWRY) announced two additional human implants of its investigational ARC-BCI® Therapy on Jan 22, 2026, bringing the total to seven participants receiving the combined brain-computer interface and implantable spinal cord stimulation system.
Both procedures were performed at CHUV in Lausanne for upper- and lower-limb restoration. The ARC-BCI platform uses an epidural motor-cortex implant, AI decoding, and a wireless neurostimulator. The system has >8 years of human safety data and received FDA Breakthrough Device Designation (2024)/b) and inclusion in the FDA Total Product Life Cycle Advisory Program. Studies are supported by Horizon Europe grants (No 101057450, 101070891), Reeve Foundation, and Swiss SERI.
Positive
- Seven human ARC-BCI implants completed to date
- ARC-BCI received FDA Breakthrough Device Designation (2024)
- Included in FDA Total Product Life Cycle Advisory Program
- Supported by eight+ years of human safety data
- Clinical work funded by Horizon Europe grants (101057450, 101070891) and major foundations
Negative
- ARC-BCI remains an investigational therapy in clinical feasibility studies
- Only seven human implants to date, indicating limited clinical sample size
- Investigational ARC-BCI® Therapy is being developed to restore thought-driven movement in people living with spinal cord injuries and other movement disabilities
- ARC-BCI is the world’s first and most advanced purpose-designed platform pairing a brain-computer interface with an implantable spinal cord stimulation system
- Seven study participants have now received ARC-BCI Therapy to restore movement of their own paralyzed limbs
EINDHOVEN, the Netherlands, Jan. 22, 2026 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD – US ADR: ONWRY), the neurotechnology company pioneering spinal cord stimulation therapies to restore movement, function, and independence, announces that two additional individuals living with spinal cord injuries (SCI) have received the Company’s investigational ARC-BCI® Therapy. These groundbreaking procedures bring the total number of human implants to seven, extending the Company’s leadership in the development of brain-computer interface (BCI) platforms to restore thought-driven movement for people living with paralysis.
Both procedures were performed at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland, under the direction of Jocelyne Bloch, MD, Chief of Neurosurgery. They involved 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. Study participants received ARC-BCI Therapy for upper- and lower-limb movement restoration, respectively.
“We continue to learn from this groundbreaking clinical feasibility research, leveraging our unique understanding of spinal cord stimulation to restore movement after paralysis, and exploring the potential advantages offered by the addition of a brain-computer interface,” said Dave Marver, CEO of ONWARD Medical. “We look forward to sharing more details in a peer-reviewed forum, continuing our commitment to scientific rigor.”
The Company’s BCI platform comprises an implant placed epidurally 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 Company’s BCI is supported by more than eight years of human safety data. The ARC-BCI System was awarded Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA) in 2024. ARC-BCI is also included in the FDA’s Total Product Life Cycle Advisory Program that provides early regulatory guidance to support the development of innovative technologies.
These latest implants are part of ongoing clinical feasibility studies supported by grants from the European Union’s Horizon Europe research and innovation program through the European Innovation Council (EIC, under grant agreements No 101057450 and 101070891), the Christopher & Dana Reeve Foundation, and the Swiss State Secretariat for Education, Research and Innovation (SERI).
About ONWARD Medical
ONWARD Medical is the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries (SCI) and other movement disabilities. Building on decades of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company developed its proprietary ARC Therapy. It has subsequently been awarded 10 Breakthrough Device Designations from the FDA. The Company’s ARC EX® System is cleared for commercial sale in the US and Europe. The Company is also developing an investigational implantable system called ARC-IM®, designed to address several unmet needs including blood pressure instability after spinal cord injury. It can also be paired with a brain-computer interface (BCI) and artificial intelligence (AI) to restore thought-driven movement.
Headquartered in the Netherlands, the Company has a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD) and its US ADRs can be traded on OTCQX (ticker: ONWRY).
To learn more about ONWARD Medical’s commitment to partnering with the spinal cord injury community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit ONWD.com.
To be kept informed about the Company’s technologies, research studies, and the availability of therapies in your area, please complete this webform.
For Media Inquiries:
Sébastien Cros, VP Communications
media@onwd.com
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investors@onwd.com
Disclaimer
Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, delays in regulatory approvals, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
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.
ARC-EX Indication for Use: The ARC-EX 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, nonprogressive neurological deficits resulting from an incomplete spinal cord injury (C2-C8 inclusive). The ARC-EX System is intended to be operated in medical centers by rehabilitation professionals and at home by patients and persons providing assistance to patients, as needed.
Other Investigational Products: All other ONWARD Medical devices and therapies including ARC-IM and ARC-BCI are investigational and not available for commercial use.
FAQ
How many people have received ONWARD Medical's ARC-BCI therapy as of Jan 22, 2026 (ONWRY)?
What regulatory designations does ARC-BCI hold for ONWRY?
Where were the two latest ONWRY ARC-BCI implant procedures performed and what limbs were targeted?
What technology does ONWRY's ARC-BCI system use to restore thought-driven movement?
Who is funding the ONWRY clinical feasibility studies for ARC-BCI?
Does ARC-BCI have long-term human safety data for investors evaluating ONWRY?
