ONWARD Medical enrolls first Empower BP patient at Craig Hospital Denver — global pivotal study of ARC-IM for SCI blood pressure
Summary
ONWARD Medical announced on February 4, 2026 the enrollment of the first participant in Empower BP — the global pivotal study assessing the safety and effectiveness of the ARC-IM implantable spinal cord stimulation system for symptomatic blood pressure instability in people with chronic SCI. The first participant was enrolled at Craig Hospital in Denver, Colorado — one of the world's leading SCI rehabilitation centers. The randomized, double-blinded, sham-controlled study will involve approximately 20 leading neurorehabilitation and neurosurgical research centers across the US, Canada, France, Germany, Spain, and the UK. The study targets individuals with cervical and upper thoracic SCI (C2-T6, AIS A-D). ARC-IM feasibility results published in Nature Medicine (September 2025) showed immediate blood pressure increases, reduced hypotensive symptoms, improved quality of life, and benefits lasting up to two years. ONWARD CEO Dave Marver: "The ARC-IM System is designed to address several unmet needs after SCI, including symptomatic blood pressure instability."
Why it matters
First patient enrolled at Craig Hospital — the gold standard SCI rehabilitation center — is the strongest possible US site selection for Empower BP. Craig Hospital's deep SCI patient community, physician expertise, and institutional credibility will drive enrollment and ensure the data quality FDA needs for marketing authorization. A global trial across 20 centers in 6 countries generates the multinational safety and effectiveness data that supports simultaneous US and European regulatory submissions.
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