ONWARD Medical Completes Two Additional Brain-Computer Interface Implants Paired with Spinal Cord Stimulation Technology to Restore Thought-Driven Movement
MWN-AI** Summary
ONWARD Medical N.V., a pioneering neurotechnology firm, has successfully implanted its investigational ARC-BCI® Therapy in two additional individuals with spinal cord injuries (SCI), bringing the total number of participants to seven. This innovative therapy aims to restore thought-driven movement, marking a significant advancement in the field of spinal cord stimulation and brain-computer interface (BCI) technology. The latest procedures were conducted at Centre Hospitalier Universitaire Vaudois in Switzerland, led by Dr. Jocelyne Bloch. The participants, a 35-year-old woman and a 39-year-old man, received the therapy to aid in restoring movement in their paralyzed limbs.
The ARC-BCI system represents the world's first purpose-designed platform that integrates brain-computer interface technology with an implantable spinal cord stimulator. Utilizing artificial intelligence, the system decodes brain signals related to movement intentions and transmits them to the neurostimulator, which then precisely stimulates targeted spinal cord areas. This promising approach is backed by over eight years of human safety data and has garnered Breakthrough Device Designation from the FDA.
ONWARD Medical is committed to advancing this technology through rigorous clinical feasibility studies supported by various grants from the European Union and other organizations. CEO Dave Marver emphasized the company’s dedication to learning from these studies to further develop solutions for restoring independence to individuals facing paralysis. As ONWARD continues to innovate in neurorehabilitation, it remains focused on partnering with the SCI community to enhance the quality of life for those with movement disabilities. The company's ARC EX® system is already cleared for commercial use, while additional investigational products, including ARC-IM, are under development to address further unmet needs in SCI management.
MWN-AI** Analysis
ONWARD Medical N.V. (Euronext: ONWD), a leader in neurotechnology focused on restoring movement in individuals with spinal cord injuries, recently announced significant advancements in its investigational ARC-BCI® Therapy. The company successfully completed two additional brain-computer interface implants, expanding its human trial cohort to seven participants. This development not only demonstrates ONWARD's commitment to innovation but reinforces its position at the forefront of the emerging neurotechnology market.
The ARC-BCI Therapy uniquely integrates brain-computer interface and spinal cord stimulation technologies, offering a potential breakthrough in restoring voluntary movement for individuals living with paralysis. This dual approach allows patients to regain control of their limbs through thought, marking a pivotal shift in rehabilitation protocols. Given the FDA's Breakthrough Device Designation awarded to the ARC-BCI System, the company is well-positioned to navigate the regulatory landscape favorably, which could lead to expedited pathways for commercialization.
Investors should consider the implications of this technology beyond its immediate therapeutic applications. The consistent clinical advancements and growing interest from regulatory bodies position ONWARD Medical as a frontrunner in a burgeoning market. With an aging population and increasing incidences of spinal cord injuries, the demand for such innovative therapies is likely to increase significantly.
From a financial perspective, ONWARD Medical presents an attractive opportunity. The stock may be undervalued relative to its potential, particularly as clinical trials progress and more data becomes available. However, investors should remain cognizant of the inherent risks associated with biotechnological ventures, such as regulatory delays or competitive pressures.
In conclusion, ONWARD Medical stands to benefit from its innovative approach to spinal cord injury treatments. Investors looking for exposure to the burgeoning neurotechnology market should consider monitoring developments closely, as the implications of the ARC-BCI Therapy could be transformative—not only for the company but for the industry as a whole.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- 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
For Investor Inquiries:
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 has the successful implementation of ARC-BCI Therapy in seven participants impacted ONWARD Medical's (ONWRY) approach to future trials and product development in restoring thought-driven movement for spinal cord injury patients?
What are the key performance indicators that ONWARD Medical (ONWRY) is monitoring in the ongoing clinical feasibility studies for ARC-BCI Therapy, and how might these influence the timeline for broader market release?
Given the complexities of combining brain-computer interfaces with spinal cord stimulation, what technological or operational challenges does ONWARD Medical (ONWRY) foresee as it continues to advance ARC-BCI Therapy?
With the ARC-BCI System having received Breakthrough Device Designation from the FDA, how does ONWARD Medical (ONWRY) plan to leverage this status to enhance investor confidence and attract further funding for research and development?
**MWN-AI FAQ is based on asking OpenAI questions about Onward Medical N (OTC: ONWRY).
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