InVivo Therapeutics Stock Moves Higher On FDA Acceptance Of Preclinical Module For Neuro-Spinal Implant

  • The FDA has accepted InVivo Therapeutics Holdings Corp's NVIV preclinical module, which is one of three individual modules required for the Company's humanitarian device exemption (HDE) application for its Neuro-Spinal Scaffold implant. 
  • Acceptance of the module indicates that FDA has completed its review of this module of the HDE and has no outstanding questions. 
  • The FDA previously approved the review process for the Neuro-Spinal Scaffold implant, which includes three modules: Preclinical studies module, manufacturing module, and clinical data module.
  • InVivo is actively enrolling patients with acute spinal cord injury into its INSPIRE 2.0 study, a pivotal trial of the Neuro-Spinal Scaffold.
  • The 20-patient trial is designed to expand upon the existing clinical evidence for the Neuro-Spinal Scaffold from the Company's INSPIRE 1.0 study.
  • Price Action: NVIV shares are up 16.7% at $0.79 during the premarket session on the last check Tuesday.
  • Related content: Benzinga's Full FDA Calendar.
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