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 — 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 ARCIM® 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.