ONWARD Medical Empower BP trial: pivotal study for spinal cord stimulation blood pressure regulation in quadriplegia
Summary
ONWARD Medical secured an FDA Investigational Device Exemption to run the Empower BP pivotal study — targeting blood pressure regulation in quadriplegic patients through spinal cord stimulation. Blood pressure dysregulation (autonomic dysreflexia) is the leading cause of death in quadriplegics and currently has zero approved treatments. ONWARD's ARC-IM implantable SCS stimulates the preserved autonomic circuits below the injury to regulate blood pressure. Following the November 2025 FDA 510(k) clearance for the external ARC-EX system for home use, Empower BP is ONWARD's pivot toward the implantable device program that represents the company's long-term commercial opportunity.
Why it matters
Empower BP for quadriplegia blood pressure is ONWARD's highest-value clinical program — blood pressure dysregulation causes life-threatening hypertensive crises and is the number one "silent killer" and quality-of-life issue for quadriplegics. No approved treatments exist for autonomic dysreflexia. A pivotal trial in a zero-treatment indication with compelling mechanism of action is precisely the clinical program that supports a Breakthrough Device designation and priority review.
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