InVivo Therapeutics Stock Moves Higher On FDA Acceptance Of Preclinical Module For Neuro-Spinal Implant
The FDA has accepted InVivo Therapeutics Holdings Corp's (NASDAQ: 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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