Here are five insights:
1. The amended protocol enforced the Objective Performance Criterion for The INSPIRE Study: InVivo Study of Probably Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury.
2. An OPC measures the safety and benefit of a device for a Humanitarian Device Exemption approval.
3. The established OPC for The INSPIRE Study outlines that 25 percent or more patients see an improvement of at least one ASIA Impairment Scale grade by six months post-implantation.
4. HDE approval is not certain, even if an OPC is met.
5. “The OPC provides additional clarity regarding our path to commercialization,” said Mark Perrin, InVivo’s chairman and CEO.
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