INBRAIN Neuroelectronics Ends Enrollment for Study of Graphene Neural Interfaces

INBRAIN Neuroelectronics has completed patient recruitment in a first-in-human study evaluating its graphene cortical interface. Ten patients were enrolled in the trial, and eight patients were treated surgically, with no perioperative device failure observed during use. Complete datasets were obtained from eight patients.

Sponsored by the University of Manchester and conducted with Northern Care Alliance NHS Foundation Trust, the trial evaluated INBRAIN’s graphene-based cortical interface during neurosurgical procedures for brain tumor resection. Its primary objective was to assess safety, with secondary objectives focused on signal quality, stability, stimulation capability, and suitability for intraoperative use with standard surgical tooling and recording equipment.

“The completion of patient enrollment in this first-in-human study marks an important step for INBRAIN and the field of neurotechnology,” INBRAIN Neuroelectronics Co-Founder/CEO Carolina Aguilar said. “Graphene has the potential to fundamentally change how we interface with the brain, enabling higher resolution of neural function-specific biomarkers, safer, and more intelligent BCI systems. We look forward to announcing the full results this year, as we advance towards commercialization.”

The study demonstrated a favorable perioperative safety profile with no device-related adverse events observed in all eight patients treated up to surgical discharge. The primary endpoint of the study includes a post-operative safety monitoring period of 90 days, which includes imaging.

In the study, INBRAIN’s graphene electrodes were used alongside standard-of-care monitoring systems during tumor resection procedures. In select cases involving conscious surgery, patients performed functional tasks such as object naming, enabling researchers to evaluate the system’s performance to decode speech representation in the brain in high resolution.

“The ability to detect high-frequency neural activity with micrometer-scale precision and also modulate it provides a fundamentally new level of insight into brain–tumor interactions and functional brain decoding and mapping. This level of resolution has the potential to significantly improve surgical precision and open new avenues for treating neurological disorders,” stated Dr. David Coope, chief clinical investigator and consultant neurosurgeon at the Manchester Centre for Clinical Neurosciences at Northern Care Alliance and the Geoffrey Jefferson Brain Research Centre.

During brain surgery, graphene electrodes are used to map and monitor neural activity, helping surgeons identify and preserve critical functions such as movement and speech. However, conventional electrodes are limited by their rigidity, size, and signal sensitivity, which can restrict their ability to conform to the brain’s complex surface and capture detailed neural activity.

INBRAIN’s graphene-based electrodes represent a new class of neural interface technology designed to overcome these challenges. Ultra-thin, micrometric and highly flexible, they closely adapt to the brain’s contours and access hard-to-reach areas. By replacing metal contacts with graphene—a highly sensitive carbon-based material—these devices enable higher-resolution signal detection and more precise stimulation, supporting real-time, more detailed brain decoding and mapping during surgery.

“This study demonstrates that graphene can safely interface with the human brain, and capture neural signals with exceptional fidelity and resolution to enable precise decoding of brain and speech-related patterns metals can barely see,” said INBRAIN Neuroelectronics Co-Founder Dr. Kostas Kostarelos, the study’s chief scientific investigator. “It marks a pivotal step towards translating a new enabling technology using neural signals into meaningful clinical applications and real-world patient benefit.”

INBRAIN Neuroelectronics is a clinical-stage neurotechnology company developing graphene-based brain-computer interface therapeutics. The company’s platform leverages the unique properties of graphene to create high-resolution, minimally invasive neural interfaces to treat neurological disorders in central and peripheral nervous system applications powered by artificial intelligence. INBRAIN is advancing a pipeline of BCI-based therapies to decode and modulate neural activity with unprecedented precision and intelligence.