Spinal Cord Injury

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.

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.