Spinal Cord Injury
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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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NervGen Pharma Announces Third Quarter Financial Results and Corporate Update
NervGen Pharma announced positive Q3 2025 results highlighting progress in the CONNECT SCI study, where NVG-291 showed clinically meaningful improvements in spinal cord injury patients versus placebo. 75% of the NVG-291 group reported global improvement compared to 33% in the placebo arm. The FDA confirmed potential regulatory pathways for NVG-291, with an End-of-Phase 2 meeting planned for early 2026. A $10.05M private placement was completed. Cash reserves stood at $11.4M. Preclinical data showed promise in hearing loss and nerve injury models.
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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.
