Onward Medical announced it received FDA investigational device exemption (IDE) for its ARC-IM system.
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).
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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).
ARC-IM features the implanted Onward Neurostimulator (IPG) and ARC-IM thoracic lead. A neurosurgeon in Switzerland performed a first-in-human procedure with the lead earlier this year. Onward plans to use the lumbar lead in ongoing clinical feasibility studies with and without an implanted brain-computer interface (BCI). The company also has ongoing work looking at ARC-IM’s potential to help people with Parkinson’s disease.
“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.”
