Inbrain Neuroelectronics announced the completion of patient recruitment in its first-in-human study evaluating a graphene cortical interface; ten patients were recruited, and eight were treated surgically with complete datasets obtained for those eight.
The study (NCT06368310), sponsored by the University of Manchester and conducted with Northern Care Alliance NHS Foundation Trust, evaluated the device during neurosurgical tumor resections with primary safety and secondary objectives addressing signal quality, stability, stimulation capability and intraoperative compatibility with standard surgical tooling and recording equipment.
A favorable perioperative safety profile was observed, with no device-related adverse events or device failures during use up to surgical discharge. The primary endpoint includes a 90-day postoperative safety monitoring period with imaging.
High-resolution neural signal capture and decoding in the intraoperative setting, with reports of the use of graphene electrodes alongside standard monitoring systems, including in awake procedures, enabling speech mapping.
Inbrain describes its electrodes as ultra-thin, micrometric and highly flexible graphene contacts intended to improve conformability, signal sensitivity and precision stimulation; the company says full study results will be announced later this year.
