ARC-IM, an implanted neuromodulation platform, delivers targeted and personalized spinal cord stimulation. With the IDE, Onward can initiate the Empower BP pivotal study. This evaluates ARC-IM’s safety and efficacy in addressing blood pressure instability after spinal cord injury (SCI).

Empower BP, the company’s second global pivotal study, marks the first to evaluate the implantable system. Onward expects to involve approximately 20 leading neurorehabilitation and neurosurgical research centers across the U.S., Canada and Europe. It anticipates the first patient enrollment before the end of the year.

The study targets participants with injuries at spinal cord levels C2-T6, injury severities of AIS A-D, and blood pressure instability characterized by chronic orthostatic hypotension (OH) and episodes of autonomic dysreflexia (AD).