ONWARD Medical Announces First-in-Human Use of ARC-IM Lumbar Lead Designed to Restore Standing, Stepping, and Lower Limb Mobility

The ARC-IM Lumbar Lead is the second model in the ARC-IM Lead family to be used in a clinical feasibility study

The Company is building a portfolio of purpose-designed leads to optimize delivery of ARC-IM Therapy at various locations along the spinal cord to enable restoration of movement and other functions

EINDHOVEN, the Netherlands, March 26, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, today announces the first human implant of its investigational ARC-IM^® Lumbar Lead. This milestone procedure was performed on March 17, 2025, by Dr. Jocelyne Bloch, Chief of Neurosurgery at Lausanne University Hospital (CHUV) in Switzerland.

The Company previously announced first-in-human use of the ARC-IM Thoracic Lead in May 2023. The ARC-IM Thoracic Lead is optimized for placement in the thoracic region of the spinal cord; it will be used as part of the investigational ARC-IM System in the Company’s planned Empower BP pivotal study to address blood pressure instability after SCI.

The new ARC-IM Lumbar Lead is specifically designed for placement in the lumbar region of the spinal cord, the optimal location for therapies targeting restoration of standing, stepping, and lower limb mobility after SCI. It will be used in ongoing clinical feasibility studies with and without an implanted brain-computer interface.

"I am encouraged by this initial experience with the ARC-IM Lumbar Lead," said Dr. Bloch. "The lead's design and maneuverability facilitated secure and precise placement in the lumbar region of the spinal cord. Access to ONWARD’s optimized, purpose-designed lead should enable us to improve the effectiveness of the breakthrough therapies we are currently studying.”

The ARC-IM Lead is designed to be used with the investigational ONWARD ARC-IM neurostimulator (IPG) and is purpose-built for placement along the spinal cord to stimulate the dorsal roots, with specific parameters designed for each anatomical location. The Company is developing a portfolio of ARC-IM Leads in a range of sizes, shapes, and electrode arrays for the many indications the Company is developing or exploring, such as improved blood pressure stability, mobility, upper extremity function, and bladder control in both the spinal cord injury and Parkinson’s disease populations.

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About ONWARD Medical

ONWARD Medical is a medical technology company creating therapies to restore movement, function, and independence in people with 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 now 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).

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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-IM, and the stylized O-Logo are proprietary and registered trademarks of ONWARD Medical. Unauthorized use is strictly prohibited.

Investigational products: The ONWARD ARC-IM System is investigational and not available for commercial use.