Here are five key facts:
1. ReActiv8 is an implantable neurostimulation system designed to reduce chronic low back pain.
2. The planned trial will be an international, multi-center trial that will evaluate the safety and efficacy of ReActiv8.
3. The trial will be conducted at up to 40 clinical trial sites and include the implantation of ReActiv8 in 128 subjects.
4. The principal investigator for the trial is Christopher Gilligan, MD, MBA, chief of the division of pain medicine at Beth Israel Deaconess Medical Center in Boston and assistant professor of anesthesiology at Harvard Medical School.
5. If the results of the clinical trial are successful, the company will submit an application for a pre-market approval.
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