InBrain Neuroelectronics today shared findings from a first-in-human study of its brain-computer interface (BCI) technology.
The company’s technology integrates intelligent computing and graphene-based materials to decode and modulate real-time brain activity.
Join us at DeviceTalks West for our panel exploring the future of neurotech featuring Carolina Aguilar, CEO of InBrain Neuroelectronics. Register at West.DeviceTalks.com.
Graphene, a two-dimensional material made of a lattice of carbon atoms, is stronger than steel and thinner than a human hair, the company says. It utilizes a combination of electrical and mechanical properties. InBrain says its neural platform enables ultra-high signal resolution, using machine learning software to decode therapy-specific biomarkers. It delivers highly focused, adaptive neuroelectronic therapy that re-balances pathological neural networks.
Future applications of the BCI technology could include neuromodulation for Parkinson’s, stroke rehabilitation, epilepsy and potentially neuropsychiatric disorders. In 2023, InBrain received FDA breakthrough device designation for its graphene-neural platform as an adjunctive therapy for treating Parkinson’s disease. It kicked off the first-in-human study last fall, then added $50 million in a Series B funding round a month later.
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 the resection of brain tumors.
More about the InBrain BCI interim analysis
InBrain said the study has a primary objective of assessing the safety of InBrain’s BCI during brain tumor surgery. Secondary objectives include neural signal quality, brain stimulation delivery ability, performance consistency and overall suitability.
The company expects between 8–10 patients enrolled. Its study design included an interim analysis after the first four patients recruited to ensure patient safety and data quality.
Interim analysis from the first four patients demonstrated no device-related adverse events. 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 InBrain, the ultra-thin, sub-micrometer graphene electrodes proved compatible with commercially available, CE-marked electrophysiology systems. They reliably recorded real-time brain signals throughout the surgical procedures.
Throughout the procedures, the BCI enabled high-resolution brain signal monitoring, addressing a significant challenge in neurosurgery — achieving precise tumor removal while preserving essential functions such as speech, movement, and cognition. Investigators used the device in parallel with standard clinical monitoring tools to maintain consistent performance.
“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,” said Carolina Aguilar, CEO and co-founder, InBrain Neuroelectronics. “We’re moving toward a future where neurosurgeons and neurologists can rely on real-time, high-definition brain data to guide personalized interventions.”
Join us at DeviceTalks West for our panel exploring the future of neurotech featuring Carolina Aguilar, CEO of InBrain Neuroelectronics. Register at West.DeviceTalks.com.
