INBRAIN Completes First-in-Human Trial of Graphene Brain Interface with No Safety Issues
Key Insights
INBRAIN Neuroelectronics (search) successfully completed patient enrollment for its first-in-human study of a graphene-based cortical interface, with eight of ten recruited patients undergoing surgery without any device failures or safety issues.
The ultra-thin, flexible graphene electrodes (search) demonstrated superior performance compared to conventional rigid electrodes, successfully capturing high-resolution brain (search) signals during awake surgeries where patients performed tasks like naming objects.
The study enters a 90-day follow-up phase with full results expected later this year, marking a significant advancement toward commercializing next-generation brain (search)-computer interface systems for neurological disorders (search).
Spanish neurotechnology company INBRAIN Neuroelectronics (search) has successfully completed patient enrollment for its groundbreaking first-in-human study evaluating a graphene-based cortical interface, marking a significant milestone in brain (search)-computer interface technology. The safety-focused pilot trial recruited ten participants, with eight patients undergoing surgery using the innovative graphene interface without any device failures or safety-related complications.
Revolutionary Graphene Technology Shows Promise
The study, conducted in collaboration with the University of Manchester and Northern Care Alliance NHS Foundation Trust, tested INBRAIN's graphene electrodes (search) during brain tumor (search) surgeries to evaluate safety and performance alongside standard surgical tools. Unlike conventional electrodes that are often too rigid and bulky to capture clear data, the graphene-based interface offers a major technological advancement for neurosurgery.
"The completion of patient enrollment in this first-in-human study marks an important step for INBRAIN and the field of neurotechnology," said Carolina Aguilar, CEO and Co-founder of INBRAIN Neuroelectronics (search). "Graphene has the potential to fundamentally change how we interface with the brain (search), enabling higher resolution of neural function-specific biomarkers, safer, and more intelligent BCI systems."
Superior Performance in Critical Surgical Applications
The graphene neural interface (search) demonstrated exceptional performance during the most demanding surgical scenarios. The ultra-thin, highly flexible electrodes are designed to conform closely to the brain (search)'s surface and access difficult-to-reach areas, enabling high-resolution signal detection and more precise stimulation. This capability proved particularly valuable during awake surgeries, where the device successfully captured high-resolution brain signals as patients performed functional tasks such as naming objects.
"This study demonstrates that graphene can safely interface with the human brain (search), and capture neural signals with exceptional fidelity and resolution to enable precise decoding of brain and speech-related patterns metals can barely see," said Dr. Kostas Kostarelos, Co-Founder of INBRAIN Neuroelectronics (search) and Chief Scientific Investigator of the study.
Clinical Impact and Future Applications
The device's precision capabilities address a critical need in neurosurgery, where even a single millimeter can determine whether a patient retains vital functions such as speech and movement. The graphene electrodes (search) use sensitive carbon rather than metal to deliver signals that are much clearer and more precise, enabling surgeons to map and understand brain (search) activity in real time with unprecedented detail.
Complete datasets were obtained from all eight treated patients, with researchers observing a favorable perioperative safety profile and no device-related adverse events occurring through surgical discharge. The study's primary endpoint involves a post-operative monitoring period of 90 days, including imaging follow-ups to assess ongoing device safety.
Expanding Therapeutic Horizons
While this trial focused on brain tumor (search) resection, the implications extend far beyond surgical applications. INBRAIN is reportedly combining graphene's capabilities with Microsoft (search)'s AI to create a system that not only records brain (search) signals but actually understands them. The company aims to commercialize next-generation BCI systems that improve surgical accuracy and offer new treatment pathways for neurological disorders (search) including Parkinson's disease (search) and epilepsy (search).
With a new partnership at the Mayo Clinic already underway and full results expected later this year, this technology is rapidly evolving from a specialized surgical tool to a potential permanent solution for various neurological conditions. The successful completion of this first-in-human study represents a crucial step toward the era of intelligent BCI therapeutics becoming a clinical reality.