The brain-computer interface developer Precision Neuroscience has put forward a study detailing the experiences of its first human patients—showing its minimally invasive approach is capable of both collecting high-bandwidth neural data and delivering stimulation without penetrating deep into tissue.
Published in Nature Biomedical Engineering, the paper examines the design of the company’s Layer 7 cortical interface as well as its preclinical testing and clinical pilot, which included five patients who underwent brain activity mapping during neurosurgery.
The Fierce Medtech Fierce 15 winner describes its approach as modular, scalable and reversible: the Layer 7 is designed to be temporary, with 1,024 electrodes placed on a strip of thin, flexible film that can be slipped onto the surface of the brain through a straight, sub-millimeter incision in the skull. More than one can be used at a time, and Precision Neuroscience has previously deployed four of the postage stamp-sized implants to cover as much as eight square centimeters of gray matter.
The device received a clearance from the FDA earlier this year, greenlighting it for open surgery to help clinicians avoid critical areas of the brain during a procedure—and allowing its use while the company continues to develop its software platforms for decoding brain signals, as it works towards its goals of aiding patients with paralysis, ALS and other conditions.
The Nature study also explored the performance of the planned “micro-slit” insertion technique in animal models and human cadavers, avoiding the need for drilling burr holes or performing craniotomies. The company said its procedure can be performed safely in under 20 minutes, and that after the devices were removed from a subset of animals, no neurological impairments or tissue disruption were observed.
“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,” Benjamin Rapoport, co-founder and chief science officer of Precision Neuroscience, said in a statement.
“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,” added Rapoport, a neurosurgeon who previously served as a founding member of Elon Musk’s Neuralink.
In the clinical pilot, the system was able to detect when a person was trying to speak with nearly 80% accuracy—while using only four minutes of training data and 54 utterances recorded during the short window of time when a patient is awake during a craniotomy.
Meanwhile, in pig brains, researchers said they were able to record separate, independent channels of activity across a single implant’s 1,024 electrodes—even when spaced 300 micrometers apart, or the width of just a few human cells. That suggests that even at this level, there may still be more neural data left to find.
“What makes this study so exciting is the resolution of the signals we’re getting from the brain,” said Craig Mermel, the study’s co-author and Precision’s president and chief product officer.
“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,” Mermel said. “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.”
Precision also noted that, in the time since it submitted its manuscript for review, it has now implanted its Layer 7 in more than 50 patients—with extended-use studies underway at six U.S. medical centers, examining its ability to record thoughts and translate them into computer inputs and the movement of robotic devices.