Fleuron ultra-soft iBCI achieves stable neural recordings in 11 patients — Mass General Brigham cortical mapping results
Summary
Axoft published clinical results from their growing first-in-human program: stable high-density neural recordings from Fleuron ultra-soft probes in 11 patients across three clinical sites including Mass General Brigham. Recordings demonstrated: reliable decoding of brain signals across different cortical layers and subcortical regions; stable data capture over 20+ minutes in intraoperative settings; ability to map seizure onset zones around tumors; and language recognition tasks successfully decoded. Fleuron material achieved these results with significantly less tissue disruption than standard polyimide probes — consistent with the 80% reduced scarring demonstrated in preclinical models.
Why it matters
Eleven patients across three clinical sites including Mass General Brigham is the clinical scale that transforms Axoft from a preclinical company to a clinical-stage company. MGH's neurosurgery volume and BrainGate expertise means Axoft's clinical program is being conducted by the most experienced BCI research team in the world, generating data that will carry maximum regulatory and scientific credibility when submitted to FDA.
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