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BrainsGate’s platform uses a minimally invasive implantable neurostimulator to electrically stimulate the Spheno-Palatine Ganglion (SPG), increasing cerebral blood flow. The company completed early pilot and pivotal trials with promising safety results but did not achieve statistical significance for efficacy in its pivotal trial for acute ischemic stroke. An FDA advisory panel in December 2021 found the device safe but not sufficiently effective to recommend approval at that time. The company continues to explore applications and further studies.
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