ONWARD Medical N.V., a neurotechnology company, has received a significant green light from the U.S. Food and Drug Administration (FDA). The company has secured an investigational device exemption (IDE) to initiate the Empower BP pivotal study. This study will assess the safety and efficacy of its innovative ARC-IM System, an implantable spinal stimulation system designed to address blood pressure instability following a spinal cord injury (SCI).
This is ONWARD's second global pivotal study and the first to evaluate their implantable ARC-IM System. The randomized, double-blinded, sham-controlled study is projected to include around 20 top neurorehabilitation and neurosurgical research centers across the U.S., Canada, and Europe. Patient enrollment is expected to begin before the end of the year. The study will focus on individuals with SCI at levels C2-T6 who experience chronic orthostatic hypotension (OH) and episodes of autonomic dysreflexia (AD), which are characterized by unstable blood pressure.
Blood pressure instability affects more than half of all people with a spinal cord injury, impacting nearly 350,000 individuals in the U.S. and Europe. This condition can severely threaten neurological recovery, negatively affect cardiovascular health, and significantly diminish quality of life. Symptoms often include dizziness, lightheadedness, blurred vision, and fatigue. This instability is one of the most hidden and unrecognized functional complications of SCI, and addressing it is crucial for improving long-term outcomes.
The ONWARD ARC-IM System is a revolutionary neuromodulation platform designed to deliver targeted and personalized spinal cord stimulation. It is the first neuroprosthetic system specifically created to manage blood pressure instability in individuals with SCI. The system includes an implanted neurostimulator (IPG) and an ARC-IM Thoracic Lead, which is optimized for surgical placement in a region of the thoracic spinal cord known as the “Hemodynamic Hotspot.” This critical location was first identified by ONWARD's research partners in a study published in Nature in 2021.
The FDA has recognized the potential of this technology by granting ONWARD one of its 10 Breakthrough Device Designations. This designation is given to novel, cutting-edge therapies that address unmet medical needs and can lead to potential regulatory and reimbursement benefits.
ONWARD Medical aims to restore movement, function, and independence for people with SCI and other movement disabilities. Building on over a decade of scientific discovery, the company has developed its ARC Therapy and has an investigational implantable system called ARC-IM, which can be paired with a brain-computer interface (BCI) to restore thought-driven movement.
The company’s ARC-EX® System is already cleared for commercial sale in the U.S. and this new study represents a significant step forward in bringing another innovative therapy to the SCI community.