ONWARD Medical
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ONWARD Medical® Initiates Global Pivotal Study for ARC-IM System in Spinal Cord Injury Patients
ONWARD Medical has begun a global pivotal study for its ARC-IM system, an implantable device designed to manage blood pressure instability in spinal cord injury (SCI) patients. This system aims to address autonomic dysreflexia and orthostatic hypotension by delivering targeted spinal cord stimulation. The study seeks to demonstrate the ARC-IM system’s safety and efficacy, potentially leading to a new standard of care for autonomic dysfunction in SCI individuals.
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ONWARD Medical’s ARC-EX System Cleared by FDA for Home Use
ONWARD Medical’s ARC-EX System received FDA clearance for supervised home use, expanding its indication for adults with incomplete spinal cord injury (C2–C8) to improve hand strength and sensation. ARC-EX delivers transcutaneous spinal cord stimulation and is intended for both clinical and home use. Clinical evidence, including the Up-LIFT study, showed significant improvements in strength, function, and quality of life. The system is commercially available in over 60 US clinics. This clearance marks a significant step in expanding access to SCI rehabilitation.
