This milestone represents a significant advancement in demonstrating the ability of graphene-based BCI technology beyond decoding and translating brain signals, to become a reliable tool for use in precision surgery in diseases such as cancer, and in neurotechnology more broadly. The study was sponsored by the University of Manchester, and primarily funded by the European Commission’s Graphene Flagship project.
The clinical investigation study was conducted at Salford Royal Hospital, part of the Northern Care Alliance NHS Foundation Trust in Manchester, UK. The study was led by Chief Clinical Investigator Dr. David Coope, a neurosurgeon at the Manchester Centre for Clinical Neuroscience and Brain Tumours Theme Lead at the Geoffrey Jefferson Brain Research Centre, and Chief Scientific Investigator Kostas Kostarelos, Ph.D., Professor of Nanomedicine at The University of Manchester, the Catalan Institute of Nanoscience & Nanotechnology, and Co-Founder of INBRAIN Neuroelectronics.
“The world’s first human application of a graphene-based BCI highlights the transformative impact of graphene-based neural technologies in medicine. This clinical milestone opens a new era for BCI technology, paving the way for advancements in both neural decoding and its application as a therapeutic intervention,” said Carolina Aguilar, CEO and Co-Founder of INBRAIN Neuroelectronics.
INBRAIN’s BCI platform leverages the exceptional properties of graphene, a material made of a single layer of carbon atoms. Despite being the thinnest known material to science, graphene is stronger than steel and possesses a unique combination of electronic and mechanical properties that make it ideal for neurotechnology innovation.
“We are capturing brain activity in areas where traditional metals and materials struggle with signal fidelity. Graphene provides ultra-high density for sensing and stimulating, which is critical to conduct high precision resections while preserving the patient’s functional capacities, such as movement, language or cognition,” said Dr. David Coope, the neurosurgeon who performed the procedure.
“After extensive engineering development and pre-clinical trials, INBRAIN’s first-in-human study will involve 8-10 patients, primarily to demonstrate the safety of graphene in direct contact with the human brain,” said Kostas Kostarelos, Ph.D., Co-Founder, INBRAIN Neuroelectronics. “The study will also aim to demonstrate graphene’s superiority over other materials in decoding brain functionality in both awake and asleep states.”
“The integration of graphene and AI with advanced semiconductor technology has allowed INBRAIN to pioneer a new generation of minimally-invasive BCI therapeutics designed for the personalized treatment of neurological disorders,” said Jose A. Garrido, Ph.D., Co-Founder and Chief Scientific Officer of INBRAIN and ICREA Professor at the Catalan Institute of Nanoscience and Nanotechnology.
Professor Sir Kostya Novoselov, Ph.D., Nobel Laureate and Vision Board member of INBRAIN, who first isolated stable graphene at The University of Manchester in 2004, and now at the National University of Singapore, said: “Witnessing graphene's exceptional properties unlock new frontiers in medical technology is truly rewarding. This breakthrough, a result of a decade-long development under the Graphene Flagship program, can now start to unravel its transformative societal impact.”
The study is powered by INBRAIN’s graphene-based Intelligent Network Decoding & Modulation (BCI-Tx) Platform, which has received Breakthrough Device Designation for Parkinson’s disease from the U.S. Food & Drug Administration. INBRAIN’s BCI-Tx platform leverages graphene’s unique properties to deliver ultra-high signal resolution and adaptive neuroelectronic therapy, enabling real-time decoding of biomarkers and precise modulation of cortical and subcortical structures at the micrometer scale for neural network rebalancing.
According to Carolina Aguilar, “INBRAIN is at the forefront of precision neurology, integrating BCI decoding with high-precision neuromodulation to restore function and alleviate symptoms, delivering continuous, personalized treatment to maximize benefits while minimizing side effects.”
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