Groundbreaking procedures extend ONWARD’s leadership in the rapidly emerging brain-computer interface (BCI) field
ARC-BCI Therapy is designed to restore thought-driven movement after spinal cord injury and other movement disabilities
ONWARD’s BCI breakthroughs were recently featured on CBS 60 Minutes with Anderson Cooper

EINDHOVEN, the Netherlands, May 21, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function and independence in people with spinal cord injury (SCI) and other movement disabilities, today announces that two additional individuals with spinal cord injury have received ONWARD’s investigational ARC-BCI^® Therapy, bringing the total number of successful implants to five.

These achievements further reinforce ONWARD’s leadership in developing BCI-enabled movement solutions for individuals with spinal cord injury. Both procedures were performed at Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland, under the direction of Jocelyne Bloch, MD, Chief of Neurosurgery.

The fourth procedure involved a 48-year-old man with an injury sustained in 2024. The fifth procedure was performed on a 37-year-old woman with an injury from 2011. Detailed results for both participants are expected to be shared in a peer-reviewed scientific publication, consistent with the Company’s longstanding reputation for scientific rigor.

"With five successful procedures now completed, we are gaining important information about this potentially transformative therapy for individuals with spinal cord injury," said Dave Marver, CEO of ONWARD Medical. "Each procedure advances our understanding and refines our approach, bringing us closer to our vision to make thought-driven movement a reality for people living with paralysis."

The investigational ARC-BCI System pairs the Company’s BCI with its ARC-IM^® System, an implanted spinal cord stimulation technology, to create the ONWARD DigitalBridge™, a wireless connection between the brain and the body that enables thought-driven movement after paralysis. It uses artificial intelligence (AI) to decode brain signals and translate intention into movement. The ARC-BCI System was awarded Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA) in February 2024.

These latest implants are part of ongoing clinical feasibility studies investigating the use of thought-driven spinal cord stimulation after spinal cord injury. The research is supported by grants from the European Innovation Council and the Christopher & Dana Reeve Foundation under the oversight of Grégoire Courtine, PhD, Jocelyne Bloch, MD, and Guillaume Charvet, Head of Neurotechnology at CEA.

"We continue to have excellent experience with ONWARD ARC-BCI Therapy, which provides the data and resolution we need with a less invasive surgery than is required with other BCI platforms,” said Jocelyne Bloch, MD. “Our research is progressing well, and the study participants are showing improvements that meet or surpass our expectations. We look forward to sharing more details in a peer-reviewed setting."

ONWARD ARC-BCI Therapy was recently featured on CBS 60 Minutes with Anderson Cooper, one of the most respected and longest-running US news programs. The segment highlighted the experience of study participants who received the breakthrough therapy. The complete 60 Minutes segment is available for viewing on the CBS News website. A 60 Minutes Overtime segment is also available for viewing here.

About ONWARD Medical

ONWARD Medical is the leading neurotechnology company pioneering therapies to restore movement, function and independence in people with spinal cord injury (SCI) and other movement disabilities. Building on more than a decade of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy, which has been awarded ten Breakthrough Device Designations from the US Food and Drug Administration (FDA). The Company’s ARC-EX System is cleared for commercial sale in the US. In addition, the Company is developing an investigational implantable system called ARC-IM with and without an implanted brain-computer interface (BCI).

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 (US): The ARC-EX 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 that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).

Other Investigational Products: All other ONWARD Medical devices and therapies including ARC-IM and ARC-BCI are investigational and not available for commercial use.

This item of content is a press release from a third party provider who make no warranties or representations in connection with this content and therefore PA can make no warranties in respect of its use.

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