ONWARD Medical Announces First Implant in New Clinical Feasibility Study Evaluating ARC-IM System to Restore Mobility After Spinal Cord Injury
ONWARD Medical (ONWRY) reported the first implant in its EIGER clinical feasibility study of the investigational ARC-IM® System to restore mobility after spinal cord injury (SCI).
Rhea-AI Summary
ONWARD Medical (ONWRY) reported the first implant in its EIGER clinical feasibility study of the investigational ARC-IM® System to restore mobility after spinal cord injury (SCI).
EIGER will assess the safety and preliminary effectiveness of ARC-IM to support recovery of standing and walking in up to 12 participants across two cohorts: people with subacute SCI (injury less than six weeks before enrollment) and people with chronic SCI (injury more than one year before enrollment). The study is being conducted at Schweizer Paraplegiker-Zentrum in Nottwil and Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, where the first procedure was performed under the direction of Dr. Jocelyne Bloch.
The ARC-IM System combines an implanted neurostimulator and a lumbar lead to activate spinal circuits involved in lower-limb and trunk movement. ONWARD is developing ARC-IM for multiple SCI-related and movement disorder indications and notes ARC-IM and ARC-BCI remain investigational, while its ARC-EX® System is commercially cleared in the US and Europe.
Positive
- First ARC-IM implant completed in EIGER feasibility mobility study for SCI
- Study will enroll up to 12 participants across subacute and chronic SCI cohorts
- EIGER study is supported by a grant from Innosuisse
- ARC-IM platform under development for multiple SCI and movement disorder indications, including Parkinson’s disease
- ARC-IM is also being evaluated in the Empower BP global pivotal study for blood pressure instability after SCI
- ONWARD’s ARC-EX® System is cleared for commercial sale in the US and Europe and the company reports 10 FDA Breakthrough Device Designations
Negative
- ARC-IM and ARC-BCI are investigational and not available for commercial use
- EIGER is an early-stage clinical feasibility study with enrollment limited to up to 12 participants
- ARC-IM remains limited by United States law to investigational use
AI-generated analysis. How Rhea-AI works. Not financial advice.
- The EIGER study will assess the safety and preliminary effectiveness of the investigational ARC-IM® System to restore mobility after both subacute and chronic spinal cord injury
- ARC-IM is an implanted neuromodulation platform designed to deliver targeted and personalized spinal cord stimulation
- EIGER is the first ONWARD mobility study to include individuals with subacute spinal cord injuries, defined as injuries sustained within 6 weeks of enrollment
EINDHOVEN, the Netherlands, Sept. 03, 2026 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the neurotechnology company pioneering spinal cord stimulation therapies to restore movement, function, and independence, today announces the first implant in the EIGER clinical feasibility study evaluating the investigational ARC-IM® System for restoring mobility in people with subacute or chronic spinal cord injury (SCI).
The EIGER study is a new clinical feasibility study designed to assess the safety and preliminary effectiveness of the ARC-IM System to support and promote recovery of standing and walking after spinal cord injury. The study will enroll up to 12 participants across two cohorts: individuals with subacute SCI who sustained an injury less than six weeks before enrollment, and individuals with chronic SCI who sustained an injury more than one year before enrollment. The study is being conducted in Switzerland at the Schweizer Paraplegiker-Zentrum (SPZ) in Nottwil and at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne. The first procedure was performed at CHUV under the direction of Jocelyne Bloch, MD, Chief of Neurosurgery at CHUV. EIGER is supported by a grant from Innosuisse.
“The EIGER study is an important next step in our drive to restore mobility after spinal cord injury," said Dave Marver, CEO of ONWARD Medical. "We intend for this study to inform the design of a pivotal study that will enable us to bring this important new therapy to market for the benefit of those with SCI and other movement disabilities.”
The Company’s ARC-IM System comprises the implanted ONWARD Neurostimulator (IPG) and the ARC-IM Lumbar Lead, designed to precisely activate spinal circuits involved in lower-limb and trunk movement to facilitate the recovery of motor function after SCI.
The Company is developing the ARC-IM platform across multiple indications in SCI and adjacent movement disorders, including Parkinson's disease. The ARC-IM System is currently being evaluated in the Empower BP global pivotal study for its initial indication to address blood pressure instability after SCI. To be kept informed about ONWARD’s technologies, research studies, and the availability of therapies in your area, please complete this webform.
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.
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.
Investigational Products: ARC-IM and ARC-BCI are investigational and not available for commercial use. ARC-IM is limited by United States law to investigational use.
