BCI Vendors Stake Out New Ground and Applications

by James Cavuoto, editor

September 2024 issue

The market for brain-computer interfaces experienced a new round of competitive activity in recent weeks as new vendors entered the market and existing players introduced new enhancements to their offerings.

One of the most significant developments involves new materials. INBRAIN Neuroelectronics, the Barcelona, Spain manufacturer of graphene-based brain implants, announced the first human implantation of its cortical interface in a patient undergoing brain tumor resection. INBRAIN’s BCI technology was able to differentiate between healthy and cancerous brain tissue with micrometer-scale precision.

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 with 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, U.K. The study was led by chief clinical investigator David Coope, a neurosurgeon at the Manchester Centre for Clinical Neuroscience and brain tumors theme lead at the Geoffrey Jefferson Brain Research Centre, and chief scientific investigator Kostas Kostarelos, professor of nanomedicine at the University of Manchester, the Catalan Institute of Nanoscience & Nanotechnology, and co-founder of INBRAIN.

“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.

INBRAIN’s BCI platform leverages the exceptional properties of graphene, a material made of a single layer of carbon atoms. Despite being the thinnest material known 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 Coope, the neurosurgeon who performed the procedure.

“After extensive engineering development and pre-clinical trials, INBRAIN’s first-in-human study will involve 8 to 10 patients, primarily to demonstrate the safety of graphene in direct contact with the human brain,” said Kostarelos. “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 Garrido, co-founder and CSO of INBRAIN and ICREA professor at the Catalan Institute of Nanoscience and Nanotechnology.

Professor Sir Kostya Novoselov, 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 platform, which has received breakthrough device designation for Parkinson’s disease from the FDA. INBRAIN’s BCI 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.

Another vendor, Synchron, the New York-based BCI manufacturer, announced positive results from its COMMAND study evaluating the safety and efficacy of the Synchron BCI device in six participants over a 12-month period.

The study results were presented at the 2024 Congress of Neurological Surgeons in Houston, TX, by Elad Levy, co-principal investigator of the COMMAND study from the University at Buffalo and co-director of the Gates Stroke Center and Cerebrovascular Surgery at Kaleida Health’s Buffalo General Medical Center/Gates Vascular Institute.

The COMMAND study was conducted at three clinical sites: Mount Sinai Health System in New York City, UB Neurosurgery/Gates Vascular Institute, and UPMC, in collaboration with Carnegie Mellon University College of Engineering. The study was conducted with support from the NIH BRAIN Initiative. COMMAND enrolled six patients with severe chronic bilateral upper-limb paralysis unresponsive to therapy, all of whom received the BCI implant.

All six patients successfully met the primary endpoint of no device-related serious adverse events resulting in death or permanent increased disability during the 1-year post implant evaluation period. The COMMAND study results reported that patients had no serious adverse events related to the brain or vasculature during the 12-month period.

The study also demonstrated that brain signals related to motor intent can be consistently captured and transformed into digital motor outputs, allowing participants to successfully perform a range of digital tasks. In 100% of cases, the Stentrode device was accurately deployed, achieving target motor cortex coverage in the brain for all six patients. The median deployment time was 20 minutes.

“The COMMAND study results represent a major medical milestone, confirming the safety of the Stentrode BCI with no neurologic safety events reported during the 12-month study period,” said Levy.

“The users were able to generate digital motor outputs with the BCI. These are simple, thought-derived expressions of intent, converted into digital actions on computers,” said Tom Oxley, CEO and founder, Synchron, and instructor in the department of neurosurgery for Mount Sinai Health System. “Making the DMOs easy to use, stable over time, and generalizable across technology platforms, will unlock layers of independence and autonomy for patients.”

The Synchron BCI is implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein, through a minimally-invasive endovascular procedure. Once implanted, it is designed to detect and wirelessly transmit motor intent out of the brain, and intended to restore the capability for severely paralyzed people to control personal devices with hands-free point-and-click.

Not to be outdone, Neuralink announced that they received breakthrough device designation for the company’s Blindsight cortical visual prosthesis. The company also announced that its Link BCI was implanted in a second patient, who has been able to play video games using the system.

And ONWARD Medical, the Eindhoven, Netherlands BCI vendor, announced the implantation of its AR BCI system in a third patient. The procedure was performed on September 12, by Jocelyne Bloch, head of functional neurosurgery at Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland.

“While other companies race to develop BCIs to communicate with and control computers, ONWARD Medical stands alone in our commitment to exploring the potential for this promising technology to restore movement of the human body after paralysis,” said Dave Marver, CEO of ONWARD Medical. “We salute our brilliant partners at CEA-Clinatec and .NeuroRestore for their important contributions to this research.”