Precision Neuroscience today announced the publication of a study in Nature Biomedical Engineering supporting its brain-computer interface (BCI) system.
The study looked at the company’s high-bandwidth BCI system designed for minimally invasive delivery. The paper reported both preclinical animal studies using a novel “micro-slit” surgical technique and the first five human patients. Those patients received the device during standard neurosurgical procedures.
New York-based Precision says the study “marks a significant advance for the BCI field.” It says that previous BCIs depended on penetrating electrodes that expose patients to surgical risk and limit adoption. Work demonstrating the ability to capture and use high-resolution brain signals for decoding and stimulation with an array resting safely on the brain surface marks a potential move away from those previous methods.
Precision said its combination of bandwidth and safety could deliver a more practical, scalable path for bringing BCI technology to patients.
“Brain–computer interfaces could be life-changing for people with paralysis—helping them speak, work, and live more independently—but until now the technology has required highly invasive brain surgery,” said Dr. Benjamin Rapoport, co-founder and chief science officer of Precision Neuroscience. “People are told that they have to choose between brain safety and performance. Our goal was to prove that you can have both. This paper shows that it’s possible to get the same high-quality brain signals without opening the skull or piercing the brain.”
More about the study and the Precision Neuroscience BCI
The study details the design, preclinical validation and early human implantation of Precision’s ultra-thin cortical electrode array. The Layer 7 thin-film brain-computer interface (BCI) features 1,024 electrodes embedded in a flexible film that conforms to the brain surface. Layer 7 comes in at one-fifth the thickness of a human hair. This device aims to help users with severe paralysis operate digital devices, like computers and smartphones, using their thoughts.
Precision won FDA clearance for Layer 7 in April. With the clearance, Layer 7 got the green light for commercial use with implantation durations of up to 30 days. The company said it was the first full regulatory clearance granted to a company developing a next-generation wireless BCI. It provides a leg up in the BCI market for Precision, which is going up against the likes of Neuralink, Synchron and others in the growing space.
(Precision Neuroscience is featured on our 2023 list of BCI companies you need to know. You can also check out our lists of BCI companies to know from 2022 and 2024.)
In animal studies, the system supported high-accuracy sensory and motor decoding as well as focal electrical stimulation. In human patients, the patients received their array implants during surgeries for other conditions. After implantation, the arrays safely recorded high-resolution neural activity in both asleep and awake patients.
Since the manuscript’s acceptance, Precision says it has moved from the initial five patients reported in the paper to more than 50 patients receiving the implant. Its extended-use studies now span six major medical centers in the U.S., with patients recovering from neurosurgery using Precision’s device for tasks like typing, playing video games or controlling robotic devices with their thoughts.
The company hopes to bring its technology to people with paralysis from conditions like spinal cord injury, stroke or ALS.
“What makes this study so exciting is the resolution of the signals we’re getting from the brain,” said Craig Mermel, Precision president, chief product officer and a co-author of the study. “The more detail you can capture, the better you can translate thoughts into actions—whether that’s moving a cursor, generating speech, or controlling a device. This paper shows that it’s possible to collect high-resolution data safely and at scale, which is exactly what’s needed to bring brain–computer interfaces out of the lab and into everyday clinical use.”
