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The accuracy matrix in neuroscience
Source: Precision Neuroscience
It happened so fast that Craig Mermel missed it.
He was standing in a crowded West Virginia operating room, waiting for a surgeon to place Precision Neuroscience’s neural implant system for the first time on a conscious patient’s brain. He looked away for a moment, said Mermel, Precision’s president and chief product officer, and by the time he got back, the company’s array of thin electrodes was in place.
In seconds, a real-time, high-resolution display of a patient’s brain activity is washed onto a screen. According to Precision, the system provided the highest resolution picture of human thought ever recorded.
“It was incredibly surreal,” Mermel said in an interview with CNBC. “The nature of the data and our ability to visualize that, you know, gave me goosebumps.”
The action Mermel noticed was the company’s first-ever clinical study.
Founded in 2021 by one of the founders of Neuralink, Precision Neuroscience is a brain-computer interface startup, an industry competitor working to help paralyzed patients operate digital devices by decoding their neural signals. BCI is a system that decodes brain signals and translates them into commands for external technologies, and several companies such as Synchron, Paradromics, and Blackrock Neurotech have built devices with this capability. Precision announced a $41 million Series B funding round in January.
The company’s flagship BCI system, Layer 7 Cortical Interface, is an electrode array that looks like a piece of tape. Because it is thinner than a human hair, Precision says it can conform to the surface of the brain without damaging any tissue. In the study, the Precision system was temporarily placed on the brains of three patients who were already undergoing neurosurgery to remove tumors.
Because the technology worked as expected, future studies will explore more applications in clinical and behavioral contexts, Mermel said. If the trials go according to plan for Precision, patients with severe degenerative diseases like ALS could eventually regain some ability to communicate with their loved ones by moving pointers, writing, and even accessing social media with their minds.
Although the human study is a major milestone, the road to commercialization of this type of technology is long. Precision has yet to receive FDA approval for its device, and the company will have to work closely with regulators to successfully conduct several very thorough rounds of testing and collect safety data.
As of June, no BCI company had managed to snatch the final seal of approval from the Food and Drug Administration.
“The goal is to offer a device that can help people who have a permanent disability, so this is like the first step,” Mermel said. “Now the real work begins.”
Doctors set up the Precision System. Precision matrix compared to a penny.
Photo: Anna von Schilling
A number of different academic medical centers have filed to support the company’s pilot clinical study, according to Dr. Benjamin Rapoport, co-founder and chief science officer at Precision. The company partnered with West Virginia University’s Rockefeller Institute for Neuroscience, Rapoport said, and the two organizations prepared for the proceedings more than a year in advance.
Rapoport, who has been working on BCI technology for more than 20 years, said seeing Precision technology on the brain of a human patient for the first time was an “incredibly satisfying” milestone.
“I can’t really describe emotionally what that was like,” he said. “It was great.”
Dr. Peter Conrad, chief of neurosurgery at the Rockefeller Institute for Neurosciences, was the surgeon who physically placed the Precision System on patients’ brains during their procedures.
It was a simple procedure, Konrad said, that felt like placing a piece of tissue paper over the brain.
The patients had the Precision System in their brains for 15 minutes. One was kept asleep during the procedure, but two patients were woken up so Layer 7 could capture brain activity as they spoke.
“I’ve never seen this much data, 1,000 channels in real time, of electrical activity, just brainwashing while someone was talking,” Conrad said in an interview with CNBC. “It was like you were watching someone think. It’s really amazing.”
Electrodes are already used in practice to help neurosurgeons monitor brain activity during a procedure, but the accuracy offered by conventional systems is low. Standard electrodes are about four millimeters in size, Conrad said, while the Precision Array can place 500 to 1,000 contacts that size.
“It’s the difference between looking at the world with an old black and white camera versus a high-resolution vision,” he said.
Conrad said it’s too early for the patients in this study to see the direct benefits of this technology.
Precision matrix compared to a penny.
Photo: Anna von Schilling
Ultimately, Precision hopes its technology won’t require open brain surgery at all. In an interview with CNBC in January, co-founder and CEO Michael Mager said a surgeon should be able to implant the matrix by making a thin incision in the skull and sliding through the device like a letter in a mailbox. The incision would be less than a millimeter thick — so small that patients would not need to shave their hair for the procedure.
Precision’s less invasive approach is intentional, as competing BCI companies like Paradromics and Neuralink have designed systems intended to be inserted directly into brain tissue.
Inserting a BCI into the brain would provide a clear picture of what each nerve cell was doing, Rapoport said, but it risks damaging tissue and is difficult to measure. The level of detail isn’t necessary to decode speech or achieve the other functionality Precision strives for, he said, so it was a trade-off the company was ultimately willing to make.
In the coming weeks, Precision will perform the same procedure on two more patients as part of its pilot clinical study. Rapoport said the company has submitted its preliminary findings to a scientific journal, and making the data publicly available would be a “huge next step.”
Precision also has similar studies in the works with health systems like Mount Sinai in New York City and Massachusetts General Hospital in Boston, and Rapoport said Precision hopes to receive full FDA clearance for the first-generation device next year.
“The early results for us are very gratifying to see,” Rapoport said. “If you are lucky, there are many times in your life when you will see something before anyone else in the world has seen it.”
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