It happened so fast that Craig Mermel missed it.
He was standing in a busy operating room in West Virginia, waiting for a surgeon to place Precision Neuroscience’s neural implant system onto a conscious patient’s brain for the first time. Mermel, the president and chief product officer at Precision, said he looked away for a moment, and by the time he turned back, the company’s paper-thin electrode array was in position.
In seconds, a real-time, high-resolution rendering of the patient’s brain activity washed over a screen. According to Precision, the system had 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, I got… chills.”
The procedure Mermel observed was the company’s first-ever in-human clinical study.
Founded in 2021 by a co-founder of Neuralink, Elon Musk’s brain-computer interface startup, Precision Neuroscience is an industry competitor working to help patients with paralysis operate digital devices by decoding their neural signals. A BCI is a system that deciphers brain signals and translates them into commands for external technologies, and several companies like Synchron, Paradromics and Blackrock Neurotech have also created devices with this capability. Precision announced a $41 million Series B funding round in January.
The company’s flagship BCI system, the Layer 7 Cortical Interface, is an electrode array resembling a piece of scotch tape. Since it’s thinner than a human hair, Precision says it can conform to the brain’s surface without damaging any tissue, and in the study, Precision’s system was temporarily placed onto the brains of three patients who were already undergoing neurosurgery to have tumors removed.
Since the technology worked as expected, future studies will explore further applications in clinical and behavioral contexts, Mermel said. If the trials go according to Precision’s plan, patients with severe degenerative diseases like ALS could eventually regain some ability to communicate with loved ones by moving cursors, typing and even accessing social media with their minds.
Although an in-human study is a major milestone, the road to market for this type of technology is a long one. Precision has not yet received FDA approval for its device, and the company will have to work closely with regulators to successfully conduct several extremely thorough rounds of testing and data safety collection.
As of June, no BCI company has managed to clinch the FDA’s final seal of approval.
“The goal is to deliver a device that can help people living with permanent disability, so this is like the first step,” Mermel said. “Now the real work begins.”
A number of different academic medical centers offered 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 Neuroscience Institute, and the two organizations prepared for the procedures for more than a year in advance, Rapoport said.
Rapoport, who has been working on BCI technology for more than 20 years, said seeing Precision’s technology on the brain of a human patient for the first time was an “incredibly gratifying” milestone.
“I can’t really describe emotionally what that’s like,” he said. “It was tremendous.”
Dr. Peter Konrad, chairman of the Department of Neurosurgery at the Rockefeller Neuroscience Institute, was the surgeon who physically placed Precision’s system onto the patients’ brains during their procedures.
Konrad said it was a simple process that felt like laying a piece of tissue paper on the brain.
Patients had Precision’s system on their brains for 15 minutes. One of them remained asleep during the procedure, but two patients were woken up so the Layer 7 could capture their brain activity as they spoke.
“I’ve never seen that amount of data, 1,000 channels in real-time, of electrical activity, just washing over the brain as somebody was talking,” Konrad said in an interview with CNBC. “It was literally like you’re watching somebody think. It’s pretty amazing.”
Electrodes are already used in practice to help neurosurgeons monitor brain activity during a procedure, but the resolution provided by conventional systems is low. Konrad said standard electrodes are about four millimeters big, while Precision’s array can put 500 to 1,000 contacts on that size.
“It’s the difference between looking at the world with an old black and white camera versus seeing in hi-def,” he said.
Konrad said it is too early for the patients in this study to see the direct benefits of this technology.
Precision ultimately hopes its technology will not 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 array by making a thin slit in the skull and sliding in the device like a letter into a letter box. The slit would be less than a millimeter thick – so small that patients don’t need their hair shaved for the procedure.
Precision’s minimally invasive approach is intentional, as competing BCI companies like Paradromics and Neuralink have designed systems meant to be inserted directly into the brain tissue.
Rapoport said that inserting a BCI into the brain would provide a clear picture of what each neuron is doing, but it risks damaging the tissue and is difficult to scale. He said that level of detail is not necessary to decode speech or achieve the other functions Precision is striving for, so it was a tradeoff the company was ultimately willing to make.
In the coming weeks, Precision will carry out the same procedure with two more patients as part of its pilot clinical study. Rapoport said the company has submitted its initial results to a scientific journal, and that having the data publicly available will 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 is hoping to receive full FDA clearance for its first-generation device next year.
“The early results for us are tremendously gratifying to see,” Rapoport said. “If you’re lucky, there’s a few times in your life when you get to sort of see something before anybody else sees it in the world.”