Spanish brain-computer interface (BCI) therapeutics company INBRAIN Neuroelectronics has completed the first human procedure using its graphene-based cortical BCI technology.
The first procedure was conducted in a patient undergoing brain tumour resection at Salford Royal Hospital in Manchester, UK in a study sponsored by the University of Manchester.
The study, funded by the European Commission’s (EC) Graphene Flagship project, was led by Dr David Coope as chief clinical investigator and Kostas Kostarelos as chief scientific investigator.
David Coope is a neurosurgeon at the Manchester Centre for Clinical Neuroscience and brain tumours theme lead at the Geoffrey Jefferson Brain Research Centre.
Kostas Kostarelos is a professor of nanomedicine at The University of Manchester and the Catalan Institute of Nanoscience & Nanotechnology, and co-founder of INBRAIN.
David Coope said: “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.”
Kostas Kostarelos said: “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.
“The study will also aim to demonstrate graphene’s superiority over other materials in decoding brain functionality in both awake and asleep states.”
INBRAIN’s graphene-based Intelligent network decoding and modulation (BCI-Tx) platform has received Breakthrough Device Designation from the US Food and Drug Administration (FDA).
The BCI-Tx platform leverages the unique material properties of graphene to deliver ultra-high signal resolution and adaptive neuroelectronic therapy.
Also, it enables real-time decoding of biomarkers and precise modulation of cortical and subcortical structures at the micrometre scale for neural network rebalancing.
In the study, the graphene-based BCI technology could differentiate between healthy and cancerous brain tissue with micrometre-scale precision.
The first-in-human procedure confirms the ability of its BCI technology beyond decoding and translating brain signals, for use in cancer surgery, and in neurotechnology, said the company.
INBRAIN Neuroelectronics CEO and co-founder Carolina Aguilar said: “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.
“INBRAIN is at the forefront of precision neurology, integrating BCI decoding with high-precision neuromodulation to restore function and alleviate symptoms, delivering continuous, personalised treatment to maximise benefits while minimising side effects.”
