Here are five key notes:
1. The study will now include 10 patients instead of the original five patients.
2. The implant is designed for patients with acute thoracic spinal cord injury.
3. The company plans to transition the pilot study into a pivotal probable benefit study along with using the single study as a basis for the humanitarian device exemption application.
4. The Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and designed to act as a physical substrate for nerve sprouting.
5. The company anticipates announcing the study design and updating associated timelines before the end of the year.
“I am very pleased to have come to such a positive agreement with the FDA ahead of schedule, which will avoid any disruption in patient enrollment,” said Mark Perrin, InVivo’s CEO.
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