Clinical_Development

  • Designed as 20-patient pivotal study to be used for HDE application
    • Pilot study converted to a pivotal probable benefit study
    • Pilot study patients included in the 20
  • Primary Endpoint (Objective Performance Criterion) – at least 25% of patients improve ASIA Impairment Scale (AIS) grade by 6 months
  • Additional Endpoints: ISNCSCI sensory and motor scores, bladder and bowel function, Spinal Cord Independence Measure (SCIM III), pain, quality of life
  • To learn more about our ongoing clinical study, visit: http://clinicaltrials.gov/ct2/show/study/NCT02138110