First patient responds well to InVivo Spinal Scaffold
- The first acute spinal cord injury patient who received InVivo Therapeutics' (OTCQB:NVIV) Neuro-Spinal Scaffold has progressed from a complete AIS A injury to an incomplete AIS C injury with motor, sensory, bowel and bladder function improvements three months post implantation.
- Nicholas Theodore, M.D., Chief of Spinal Surgery, Barrow Neurological Institute at St. Josephs Hospital and Medical Center, Phoenix, AZ says, "I am very pleased with the first subject's progress since the scaffold was implanted. In my experience, this degree of sensory and motor improvement is unexpected. However, this is only one patient and we do not want to over-interpret the data."
- The is InVivo's first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption (NYSE:IDE) allows investigators to capture safety and efficacy data from five subjects with acute thoracic spinal cord injury. Following this pilot trial, the company expects to move into a pivotal study to support FDA approval and commercialization under a Humanitarian Device Exemption (HDE).
- The Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and acts by appositional healing to spare spinal cord tissue, decrease post-traumatic cyst formation and decrease spinal cord tissue pressure.
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