Barcelona-based InBrain Neuroelectronics shared interim findings from a first-in-human clinical study of its graphene-based brain-computer interface (BCI) technology.
InBrain says its technology utilizes the unique properties of graphene, a material known for its strength, flexibility and conductivity, combined with machine learning software to provide highly targeted and adaptive neuroelectronic therapy. InBrain's implant is only 10 micrometers thick—thinner than a human hair—and is designed to safely decode and modulate neural signals with high accuracy. The company has set its sights on developing personalized treatments for conditions such as Parkinson’s disease, epilepsy and stroke rehabilitation.
According to the company, ultra-flexible, thin-film graphene semiconductors conform more precisely to the brain surface than conventional strip electrodes.
In 2023, InBrain's Intelligent Network Modulation System was granted Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) as an adjunctive therapy for treating Parkinson’s disease.
The study, sponsored by the University of Manchester and conducted at the Manchester Centre for Clinical Neurosciences (Northern Care Alliance NHS Foundation Trust), is evaluating the safety and functional performance of graphene-based electrodes when used during surgery for resection of brain tumors.
Interim analysis of the results from the first cohort of four patients enrolled in the study demonstrated no device-related adverse events, a key component of the primary endpoint of the study. 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, according to the company.
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 company said.
InBrain says it's the first safety study of a graphene-based neural interface in humans.
“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,” 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, said in a statement. “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 addresses one of the most pressing challenges in neurosurgery. Surgeons aim for precise tumor removal while preserving essential functions such as speech, movement and cognition.
Secondary objectives of the study include evaluating the quality of neural signals captured by the device, its ability to deliver targeted brain stimulation, the consistency of its performance throughout the procedure and its overall suitability for use in the neurosurgical operating room.
A total of eight to 10 patients are expected to be enrolled to validate the safety and functional performance of the graphene-based BCI. The study design included an interim analysis after the first four patients had been recruited to ensure patient safety and data quality.
The company contends that 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.
“This milestone demonstrates that graphene-based [BCIs] can be deployed in the operating room and deliver a level of neural fidelity not achievable with traditional materials,” Carolina Aguilar, CEO and co-founder of InBrain Neuroelectronics, said in a statement. “We’re moving toward a future where neurosurgeons and neurologists can rely on real-time, high-definition brain data to guide personalized interventions.”
Through subsidiary Innervia Bioelectronics, the company has a strategic collaboration with Merck KGaA to explore peripheral nerve and systemic disease applications in the areas of neurotechnology and bioelectronics.
The company picked up a $50 million series B financing round in October.
Other companies are developing innovations in BCI tech, most notably Elon Musk's Neuralink. The startup recently secured $650 million in series E funding to expand patient access to its technology and build new devices.