ONWARD Medical Initiates Pivotal Study for Blood Pressure Control After Spinal Cord Injury
Key Insights
ONWARD Medical (search) enrolled the first participant in Empower BP, a global pivotal study evaluating the ARC-IM System for blood pressure instability after spinal cord injury.
Blood pressure instability affects 78% of individuals with tetraplegia, yet only 28% receive treatment, representing a significant unmet medical need.
Previous clinical feasibility studies published in Nature Medicine showed immediate blood pressure increases and reduced hypotensive symptoms lasting up to two years.
ONWARD Medical (search) has enrolled the first participant in Empower BP, a landmark global pivotal study evaluating the safety and effectiveness of the investigational ARC-IM System in managing symptomatic blood pressure instability in people with chronic spinal cord injury. The first participant was enrolled at Craig Hospital in Denver, Colorado, marking a significant milestone for the neurotechnology company.
Addressing Critical Unmet Medical Need
Blood pressure instability represents a key unmet need after spinal cord injury, characterized by chronic orthostatic hypotension and episodes of autonomic dysreflexia. Among individuals with tetraplegia, 78% are diagnosed with orthostatic hypotension, yet only 28% receive treatment. Of those who do receive treatment, 91% continue to experience symptoms including dizziness, lightheadedness, blurred vision, and fatigue.
"Blood pressure instability is a silent yet debilitating complication of spinal cord injury, with serious consequences for cardiovascular health and quality of life," said Dr. Candy Tefertiller, Executive Director of Research and Evaluation at Craig Hospital and Empower BP Principal Investigator. "We are eager to evaluate the potential of ARC-IM Therapy to improve hemodynamic stability through precise stimulation of the spinal cord region responsible for blood pressure regulation."
Study Design and Scope
The Empower BP study represents the first global pivotal study to evaluate ONWARD Medical (search)'s implantable spinal cord stimulation system. The randomized, double-blinded, sham-controlled study is expected to involve participants across approximately 20 leading neurorehabilitation and neurosurgical research centers in the US, Canada, France, Germany, Spain, and the UK. The study targets individuals with injuries at spinal cord levels C2-T6 and injury severities of AIS A-D.
Technology Platform
The ARC-IM System comprises the implanted ONWARD Neurostimulator and the ARC-IM Thoracic Lead, optimized for surgical placement in the specific region of the thoracic spinal cord containing a high density of neurons that regulate blood pressure. The system is designed to address several unmet needs after spinal cord injury, including symptomatic blood pressure instability.
Promising Clinical Feasibility Results
Detailed results from multi-year clinical feasibility studies, published in Nature Medicine in September 2025, demonstrated that participants who received ARC-IM Therapy experienced immediate and robust increases in blood pressure, as well as reduced frequency and severity of hypotensive symptoms. The enhanced hemodynamic stability resulted in improved quality of life and greater engagement in rehabilitation and daily life activities.
Additional benefits observed in the feasibility studies included reduced fatigue, improved bowel management, and increased tolerance of upright postures. Participants were able to reduce or discontinue traditional treatments for low blood pressure, including compression garments and medications. These benefits were observed for the duration of the studies, which lasted up to two years following implant.
Company Leadership Perspective
"The initiation of Empower BP marks another significant milestone in our journey to restore critical autonomic functions impacted by spinal cord injury," said Dave Marver, CEO of ONWARD Medical (search). "The ARC-IM System is designed to address several unmet needs after SCI, including symptomatic blood pressure instability. The clinical feasibility results published last year in Nature Medicine were outstanding, and we are hopeful Empower BP will provide the data needed to bring this important therapy to hospitals and clinics worldwide."
Over time, persistent low blood pressure can threaten neurological recovery and negatively impact cardiovascular health, making the development of effective treatments crucial for the spinal cord injury community.