ONWARD Medical wins FDA nod for pivotal spinal cord study
The Dutch company received a green light from the American public health agency to test its spinal cord injury treatment system.
Published on August 20, 2025
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ONWARD Medical, a pioneering medical technology company, has received approval from the American public health federal agency, the Food and Drug Administration (FDA), for a clinical study on its ARC-IM System. This implantable neurostimulation device is designed to address blood pressure instability - a major unmet need for individuals with spinal cord injuries. The Empower BP pivotal study, involving 20 leading research centers, is expected to begin enrolling patients before the end of 2025, marking a significant milestone for the spinal cord injury (SCI) community.
The Eindhoven-based ONWARD Medical is at the forefront of developing innovative therapies for SCI patients. Their focus includes restoring movement and function through advanced technological solutions. Building on over a decade of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company developed ARC Therapy.
The ARC-IM System, which will be tested in the pivotal study approved by the FDA, is specifically designed to stabilize blood pressure in individuals who have suffered a spinal cord injury. Blood pressure instability is a prevalent and often overlooked complication of SCI, affecting over 50% of individuals with SCI, which translates to approximately 350,000 people in the US and Europe. This condition significantly impacts cardiovascular health and overall quality of life, making effective management a critical unmet need.
The Empower BP Pivotal Study
The FDA's Investigational Device Exemption (IDE) approval allows Onward Medical to proceed with the Empower BP pivotal study. This global, randomized, double-blinded, sham-controlled study will evaluate the safety and efficacy of the ARC-IM System. The study is set to involve approximately 20 leading neurorehabilitation and neurosurgical research centers across the United States, Canada, and Europe. Enrollment of the first patients is anticipated to begin before the end of 2025.
“Blood pressure instability, especially chronic low blood pressure, is one of the most hidden and unrecognized functional complications of spinal cord injury,” explains Dr. James Guest, neurosurgeon and Professor of Neurological Surgery at the University of Miami. “It leaves people feeling unwell and can significantly impact their overall quality of life. Blood pressure instability also increases the risk of cardiovascular disease, making addressing this unmet need critical for improving the long-term outcomes of SCI.”
“This is an important milestone for ONWARD and the SCI community,” said Dave Marver, CEO of ONWARD. “Our ARC-IM System is designed to address several unmet needs, including blood pressure instability, which is a major recovery target after spinal cord injury. With this IDE approval, we continue to advance our innovation pipeline and inspire realistic hope in restoring autonomic functions and independence after SCI and other movement disabilities.”
