INBRAIN Neuroelectronics Completes Enrolment of World’s First-in-Human Study of Graphene Neural Interfaces for Brain Decoding & Mapping

• Favorable perioperative safety profile observed with no device-related adverse events and no device failures during use

• High-resolution neural signal capture and decoding demonstrated in intraoperative setting, supporting next-generation BCI therapeutics

BARCELONA, Spain--(BUSINESS WIRE)--INBRAIN Neuroelectronics, a neurotechnology company developing graphene-based brain-computer interface therapeutics (BCI-Tx), today announced completion of patient recruitment in its first-in-human study evaluating its graphene cortical interface. A total of ten patients were recruited into its first-in-human study, and eight patients were treated surgically, with no perioperative device failure observed during use. Complete datasets were obtained from eight patients.

The study (NCT06368310), sponsored by the University of Manchester and conducted with Northern Care Alliance NHS Foundation Trust, evaluated INBRAIN’s graphene-based cortical interface during neurosurgical procedures for brain tumor resection. The primary objective was to assess safety, with secondary objectives focused on signal quality, stability, stimulation capability, and suitability for intraoperative use with standard surgical tooling and recording equipment.

The study demonstrated a favorable perioperative safety profile with no device-related adverse events observed in all eight patients treated up to surgical discharge. The primary endpoint of the study includes a post-operative safety monitoring period of 90 days, which includes imaging.

In the study, INBRAIN’s graphene electrodes were used alongside standard-of-care monitoring systems during tumor resection procedures. In select cases involving awake surgery, patients performed functional tasks such as object naming, enabling researchers to evaluate the system’s performance to decode speech representation in the brain in high resolution.

“The completion of patient enrollment in this first-in-human study marks an important step for INBRAIN and the field of neurotechnology,” said Carolina Aguilar, CEO and Co-founder, INBRAIN Neuroelectronics. “Graphene has the potential to fundamentally change how we interface with the brain, enabling higher resolution of neural function specific biomarkers, safer, and more intelligent BCI systems. We look forward to announcing the full results this year, as we advance towards commercialization.”

“The ability to detect high-frequency neural activity with micrometer-scale precision and also modulate it provides a fundamentally new level of insight into brain–tumor interactions and functional brain decoding and mapping. This level of resolution has the potential to significantly improve surgical precision and open new avenues for treating neurological disorders,” said Dr. David Coope, Chief Clinical Investigator and Consultant Neurosurgeon at the Manchester Centre for Clinical Neurosciences at Northern Care Alliance and the Geoffrey Jefferson Brain Research Centre.

During brain surgery, graphene electrodes are used to map and monitor neural activity, helping surgeons identify and preserve critical functions such as movement and speech. However, conventional electrodes are limited by their rigidity, size, and signal sensitivity, which can restrict their ability to conform to the brain’s complex surface and capture detailed neural activity.

INBRAIN’s graphene-based electrodes represent a new class of neural interface technology designed to overcome these challenges. Ultra-thin, micrometric and highly flexible, they closely adapt to the brain’s contours and access hard-to-reach areas. By replacing metal contacts with graphene, a highly sensitive carbon-based material, these devices enable higher-resolution signal detection and more precise stimulation, supporting real-time, more detailed brain decoding and mapping during surgery.

“This study demonstrates that graphene can safely interface with the human brain, and capture neural signals with exceptional fidelity and resolution to enable precise decoding of brain and speech-related patterns metals can barely see,” said Dr. Kostas Kostarelos, Co-Founder of INBRAIN Neuroelectronics and Chief Scientific Investigator of the study. “It marks a pivotal step towards translating a new enabling technology using neural signals into meaningful clinical applications and real-world patient benefit.”

About INBRAIN Neuroelectronics

INBRAIN Neuroelectronics is a clinical-stage neurotechnology company developing graphene-based brain-computer interface therapeutics. The company’s platform leverages the unique properties of graphene to create high-resolution, minimally invasive neural interfaces designed to treat neurological disorders in central and peripheral nervous system applications powered by AI. INBRAIN is advancing a pipeline of BCI-based therapies aimed at decoding and modulating neural activity with unprecedented precision and intelligence. For more information, visit www.inbrain-neuroelectronics.com.