Precision, a Neuralink competitor, conducts its first clinical study

It happened so quickly that Craig Marmell missed it.

He stands in a crowded operating room in West Virginia, waiting for surgeons to implant the first-ever Precision Neuroscience neural implant system into the brain of a conscious patient. Murmel, Precision’s president and chief product officer, said he looked away for a moment, but by the time he turned around, the company’s paper-thin electrode array was in place.

Within seconds, real-time, high-definition renderings of the patient’s brain activity streamed onto the screen. Precision says the system provided the highest-resolution images 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 it… gave me chills.”

The procedure Mermel observed was the company’s first human clinical study.

Founded in 2021 by the co-founders of Elon Musk’s brain-computer interface startup Neuralink, Precision is committed to helping paralyzed patients operate digital devices by decoding nerve signals. Competitors in the industry. A BCI is a system that decodes brain signals and translates them into commands for external technology, and several companies such as Synchron, Paradromics and Blackrock Neurotech are also developing devices with this capability. Precision announced his $41 million Series B funding round in January.

The company’s flagship BCI system, the Layer 7 Cortical Interface, is an electrode array similar to scotch tape. Because it’s thinner than a human hair, it can conform to the surface of the brain without damaging tissue, says Precision, and the study included three patients who had already undergone neurosurgery to remove the tumor. A Precision system was temporarily installed in his brain.

The technology worked as expected, so future studies will explore further applications in clinical and behavioral contexts, Marmel said. If the trial goes according to Precision’s plan, patients with severe degenerative diseases such as ALS will eventually have the ability to move the cursor, type and even access social media to communicate with their loved ones. can be recovered to some extent.

Human studies are a big milestone, but this kind of technology has a long way to go to market. Since Precision has not yet received U.S. Food and Drug Administration approval for its device, the company has worked closely with regulatory agencies to conduct several rounds of very thorough testing and safety data collection, which have been successful need to let

As of June, no BCI companies have received final FDA approval.

“The goal is to provide a device that can help people living with permanent disabilities, so this is kind of a first step,” said Marmel. “This is where the real work begins.”

According to Dr. Benjamin Rapoport, co-founder and chief scientific officer of Precision, several different academic medical centers have offered to support the company’s pilot clinical studies. The company is affiliated with the Rockefeller Institute for Neuroscience at West Virginia University, Rapoport said, and the two institutions have been preparing for the procedure for more than a year.

Rapoport, who has been working with BCI technology for more than 20 years, said it was an “incredibly gratifying” milestone to see Precision’s technology applied to the brains of human patients for the first time.

“I can’t explain emotionally what it’s like,” he said. “It was amazing.”

Dr. Peter Conrad, director of neurosurgery at the Rockefeller Institute for Neuroscience, was the surgeon who physically installed Precision’s system into a patient’s brain during surgery.

Conrad said it was a process as simple as placing a tissue over your brain.

Patients had the Precision system attached to their brains for 15 minutes. One of them remained asleep during the procedure, but two patients woke up so that Layer 7 could capture brain activity as they spoke.

“I’ve never seen so much data — 1,000 channels of electrical activity in real time — flowing into the brain while someone is talking,” Conrad said in an interview with CNBC. Told. “I literally felt like I was watching someone think. It was amazing.”

Electrodes are already in practical use to help neurosurgeons monitor brain activity during surgery, but the resolution offered by conventional systems is low. A typical electrode is about 4 millimeters in size, but Precision’s array can have 500 to 1,000 contacts in that size, Conrad said.

“It’s the difference between seeing the world with an old black and white camera and seeing the world in hi-def,” he said.

Conrad said it’s too early for the patients in the study to see the immediate benefits of the technology.

Precision ultimately 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 the surgeon made a thin slit in the skull and slid the device in like a letter in a letterbox. You said you should be able to embed the array. The slit is less than one millimeter thick and is small enough that patients do not need to shave for surgery.

Precision’s minimally invasive approach is intentional, as competing BCI companies such as Paradromics and Neuralink have designed systems intended for direct insertion into brain tissue.

Inserting a BCI into the brain would give a clear picture of what each neuron was doing, Rapoport said, but there was a risk of tissue damage and it was difficult to expand. He said this was the trade-off the company ultimately wanted, as the level of detail is not needed to decipher speech or achieve other features Precision is aiming for.

In the coming weeks, Precision plans to perform the same procedure on two more patients as part of a pilot clinical study. Rapoport said the company has submitted its first results to a scientific journal, and making the data available to the public would be a “big next step.”

Precision is also pursuing similar research in medical systems such as Mount Sinai in New York City and Massachusetts General Hospital in Boston, and Rapoport said Precision hopes to get full FDA clearance for its first-generation device next year. said he was thinking.

“We are very pleased to see early results,” Rapoport said. “There are times in life when you are lucky enough to see something before the rest of the world sees it.”