INBRAIN Neuroelectronics is sharing encouraging interim results from the world’s first-in-human clinical study of its graphene-based brain-computer interface (BCI) technology. Sponsored by the University of Manchester and conducted at the Manchester Centre for Clinical Neurosciences (Northern Care Alliance NHS Foundation Trust), the study is evaluating the safety and functional performance of graphene-based electrodes used during surgery for brain tumor resection.

The study primarily aims to assess the safety of INBRAIN’s brain-computer interface (BCI) during brain tumor surgery. Secondary objectives include evaluating the quality of neural signals captured by the device, its ability to deliver targeted brain stimulation, performance consistency throughout the procedure, and its overall suitability for use in neurosurgery. Eight to 10 patients eventually will be enrolled to validate graphene-based BCI’s safety and functional performance. The study design included an interim analysis after the first four patients had been recruited to ensure patient safety and data quality.

Interim results from the first four-patient study cohort showed no device-related adverse events, a key component of the trial’s primary endpoint. During awake language mapping, the device captured distinct high gamma activity linked to different phonemes, the smallest units of sound in speech, showcasing exceptional spatial and temporal resolution, even with micrometer-scale contacts. The ultra-thin, sub-micrometer graphene electrodes also proved compatible with commercially available, CE-marked electrophysiology systems, reliably recording real-time brain signals throughout the surgical procedures.

“The ability to detect high-frequency neural activity with micrometer-scale precision opens new possibilities for understanding brain-tumor interactions and broader brain function in neuro-related disorders,” said David Coope, chief investigator and consultant neurosurgeon at the Manchester Centre for Clinical Neurosciences, the Geoffrey Jefferson Brain Research Centre, and the University of Manchester. “This technology could be transformative, not only for improving surgical outcomes but for unlocking new treatment pathways.”

Throughout the procedures, INBRAIN’s BCI enabled high-resolution brain signal monitoring, addressing one of the most pressing challenges in neurosurgery: achieving precise tumor removal while preserving essential functions such as speech, movement, and cognition. The device was used in parallel with standard clinical monitoring tools, maintaining consistent performance across the surgical window.

“This milestone demonstrates that graphene-based brain-computer interfaces can be deployed in the operating room and deliver a level of neural fidelity not achievable with traditional materials,” INBRAIN Neuroelectronics CEO/Co-Founder Carolina Aguilar stated. “We’re moving toward a future where neurosurgeons and neurologists can rely on real-time, high-definition brain data to guide personalized interventions.”

INBRAIN’s platform is powered by ultra-flexible, thin-film graphene semiconductors that conform more precisely to the brain surface than conventional strip electrodes. The BCI features high-density, multiscale, bidirectional contacts for superior decoding and modulation, and reduced graphene oxide (rGO) nanoporous matrices that enhance sensitivity and signal resolution. In preclinical studies, the GCI significantly outperformed platinum-based electrodes in detecting high gamma frequencies (80–130 Hz) critical for speech decoding, with statistical significance (p < 0.01).

Graphene technology offers several benefits for neurosurgical procedures. It enhances surgical precision by enabling smaller and more densely packed electrodes, allowing surgeons to define and preserve critical functional areas during tumor resection. Its flexibility enables accurate decoding and mapping in anatomically complex or hard-to-access brain regions, including the walls of the tumor resection cavity. Additionally, the device’s ability to decode high-frequency activity offers huge scientific opportunities including the potential to reveal in situ interactions between glioma cells and neurons, offering potential insights into new therapeutic targets for halting tumor progression.

“We’re not delivering incremental innovation, we’re enabling entirely new capabilities,” said Kostas Kostarelos, INBRAIN co-founder, study chief scientific investigator, and professor of Nanomedicine at the University of Manchester, the Catalan Institute of Nanoscience and Nanotechnology (ICN2) in Barcelona, and Programme Lead for the Next Generation Therapeutics Theme of the National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre (BRC). “This convergence of advanced materials science, neuroscience, and AI is shaping the future of real-time, precision neurology.”

As the first safety study of a graphene-based neural interface in humans, this study marks a foundational step toward developing BCI therapeutic systems for chronic neurological diseases.

INBRAIN Neuroelectronics is developing real-time precision neurological solutions with the world’s first graphene-based brain-computer interface (BCI) therapeutics platform. The technology combines precise BCI decoding with micrometric modulation to deliver adaptive, personalized treatments for conditions such as Parkinson’s disease, epilepsy, and stroke rehabilitation. By providing continuous real-time monitoring and autonomous therapy adjustments, the company’s artificial intelligence-driven platform maximizes therapeutic outcomes while minimizing side effects. Through strategic collaborations, including with Merck KGAa and its subsidiary INNERVIA Bioelectronics, INBRAIN is extending its solutions to peripheral nerve and systemic disease applications, unlocking the potential of neurotechnology and bioelectronics.

Northern Care Alliance NHS Foundation Trust provides hospital and community healthcare services in Salford, Oldham, Bury, and Rochdale. Its team of around 20,000 staff delivers care and experience excellence to more than 1 million people across Greater Manchester and beyond.

The National Institute for Health and Care Research (NIHR) aims to improve the health and wealth of the nation through research. NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through U.K. international development funding from the U.K. government.

The NIHR Manchester Biomedical Research Centre (BRC) transforms scientific breakthroughs into diagnostic tests and life-saving treatments for patients. NIHR Biomedical Research Centres (BRCs) are collaborations between NHS organizations and universities. They bring together academics and clinicians to translate scientific discoveries into potential new treatments, diagnostics and technologies. Manchester BRC is hosted by Manchester University NHS Foundation Trust and The University of Manchester in partnership with five NHS trusts; Blackpool Teaching Hospitals NHS Foundation Trust, The Christie NHS Foundation Trust, Greater Manchester Mental Health NHS Foundation Trust, Lancashire Teaching Hospitals NHS Foundation Trust, and the Northern Care Alliance NHS Foundation Trust.

The University of Manchester is recognized globally for its research, teaching, and learning. The Russell Group institution is ranked the sixth best university in the U.K. and 38th in the world (Academic Ranking of World Universities). The University is considered a powerhouse of research and discovery; 25 Nobel laureates are among its former staff and students; and it was ranked fifth for research power in the U.K. government’s Research Excellence Framework (REF) 2021.