The study evaluates the company’s brain-computer interface (BCI), the Layer 7 Cortical Interface. Precision Neuroscience designed the Layer 7 with 1,024 tiny electrodes spanning an area of one square centimeter. The company embedded the electrodes in a flexible film that conforms to the brain surface. This film — one-fifth the thickness of a human hair — is designed for implantation and removal by neurosurgeons without damaging brain tissue.
Precision Neuroscience designed the device to map a large area of the brain’s surface at resolutions higher than typical neurosurgical procedures.
The study aims to record and map the brain’s activity in unprecedented detail. Precision Neuroscience partnered with West Virginia University’s Rockefeller Neuroscience Institute to conduct it. The company said it marks a major step toward its goal of restoring function to people with neurological illnesses and disorders.
According to a news release, Precision Neuroscience expects to complete an application to the FDA for its device. The company seeks clearance for use in diagnostic electrophysiology mapping procedures lasting up to 30 days. Earlier this year, the company closed a $41 million Series B funding round.
“This is a remarkable achievement in real-time detection of electrical brain activity mapped with such high resolution,” said Dr. Peter Konrad, chair of the Dept. of Neurosurgery at the RNI and the principal investigator leading the study at West Virginia University Medicine in collaboration with Precision Neuroscience. “It’s as if I was seeing the patient’s brain think.”
About the study
During the study, a patient undergoing brain tumor resection received the temporary placement of Layer 7 on the brain. Neurosurgeons safely deployed the implant for a portion of the surgery. They read, recorded and mapped electrical activity from the surface of the brain.
Since the first procedure completed in mid-April, two additional patients underwent similar operations. These operations required surgery to remove tumors involving brain regions responsible for language, according to Precision Neuroscience.
The company plans to enroll up to five patients in the first phase of the study. It expects related studies at several other major medical centers to come. Those include Mount Sinai Health System in New York, Penn Medicine in Philadelphia and Massachusetts General Hospital in Boston.
“Precision technology has the potential to redefine the standard of care in clinical neuroscience,” said Dr. Benjamin Rapoport, a neurosurgeon and chief science officer at Precision Neuroscience. “In the years ahead, we hope to restore function to people with a number of neurological conditions. Even in these first patients, we have begun to view human brain activity in ways that have never before been possible.”
More on Precision Neuroscience and the brain-computer interface space
Precision Neuro, co-created by a founding member of Elon Musk’s Neuralink BCI venture, has been developing its BCI since 2021. Benjamin Rapoport, a former part of the Neuralink effort, started the company with private equity investor Michael Mager.
Neuralink, meanwhile, faced troubles in the past, including alleged animal welfare violations. Previously, the FDA denied attempts to conduct in-human trials for the BCI. However, last month, Musk said the FDA approved first-in-human trials for the implant.
Other players in the market include Blackrock Neurotech, a leader in the BCI space for multiple decades. Synchron, meanwhile, has the backing of the likes of investors such as Bill Gates and Jeff Bezos.