Microneurology rival Neuralink is testing a human brain implant

As the lights dimmed in the operating room at Mount Sinai Hospital in New York City, Dr. Joshua Pederson prepared to make history.

Pederson, chief of neurosurgery at Mount Sinai Health System, is no stranger to spending long hours in the operating room. The former competitive gymnast has completed more than 6,500 routines in his career, and said he visualizes the steps of each one as if he were rehearsing a routine.

On this particular morning in April, Pederson was preparing to undergo a meningioma resection, meaning he would remove a benign brain tumor. Pederson said his primary focus is always patient care, but in some cases, he can also help advance science.

This procedure was one such case.

A small crowd gathered as Pederson took his seat in the operating room, his silhouette glowing from the bright white light shining on the patient in front of him. Health care workers, scientists and CNBC rushed forward — some looking through windows — to watch Pederson place four arrays of electrodes from Precision Neuroscience on the surface of a patient's brain for the first time.

An electrode is a small sensor that can detect and transmit an electrical signal, and an array is a network of electrodes. Neurosurgeons use electrodes during some procedures to help monitor and avoid important parts of the brain, such as areas that control speech and movement.

Precision is a three-year-old startup building a brain-computer interface, or BCI. BCI is a system that decodes neural signals and translates them into commands for external technologies. Perhaps the most famous company in this field is Neuralink, which is owned by… Tesla and SpaceX CEO Elon Musk.

Other companies such as Synchron and Paradromics have also developed BCI systems, although their goals and designs are different. The first application for Precision's system will be to help severely paralyzed patients regain functions such as speech and movement, according to its website.

Precision's main BCI is called the Layer 7 Cortical Interface. It's an array of tiny electrodes that are thinner than a human hair and resemble a piece of yellow tape. Each array consists of 1,024 electrodes, which Precision says can conform to the surface of the brain without damaging any tissue.

When Pederson used four of the company's arrays during surgery in April, he set a record for the most electrodes placed on the brain in real time, Precision reported. But perhaps more importantly, the arrays were able to detect signals from the patient's individual fingers, a much greater amount of detail than standard electrodes can pick up.

Using Precision's electrode array is like turning a low-resolution image into a 4K image, said Ignacio Saez, assistant professor of neurology, neurosurgery and neuroscience at the Icahn School of Medicine at Mount Sinai. Saez and his team oversee Precision's work with Mount Sinai.

“Instead of having 10 electrodes, you give me 1,000 electrodes,” Saez told CNBC in an interview. “The depth, resolution, and detail you'll get is completely different, even though it somehow reflects the same basic neural activity.”

Pederson said reaching this level of detail could help doctors be more sensitive in their surgeries and other interventions in the future. For Precision, the ability to record and decode signals from individual fingers will be crucial as the company ultimately works to help patients regain fine motor control.

This data represents a major milestone for Precision, but it still has a long way to go before it achieves some of its lofty goals. The company is still working on obtaining FDA approval, and has yet to implant a more sustainable version of its technology in a patient.

“I think these are small steps toward the ultimate goal of a brain-computer interface,” Pederson told CNBC in an interview.

Inside the operating room

Pederson's surgery in April wasn't Precision's first rodeo. In fact, this is the 14th time the company has put its beam into the brain of a human patient.

Precision has partnered with academic medical centers and health systems to conduct a series of first-in-human clinical studies. The goal of each study is different, and the company announced its collaboration with Mount Sinai in March.

At Mount Sinai, Precision is exploring various applications for its kit in clinical settings, such as how it can be used to help monitor the brain during surgery. In these procedures, surgeons like Pederson temporarily place the Precision Array on patients who are already undergoing brain surgery for a medical reason.

Patients give their consent to participate in advance.

It is common for neurosurgeons to map brain signals using electrodes during these types of procedures. Pedersen said the current accepted practice is to use between four and nearly 100 electrodes, a far cry from the 4,096 electrodes he was preparing to test.

Precision arrays are used for a short portion of these surgeries, so CNBC joined the operating room in April once the procedure actually began.

The patient, who requested to remain anonymous, was asleep. Pederson's team had already removed part of their skull, leaving a hole about the size of a credit card. Four of the Precision arrays were carefully placed on a nearby table.

Once the patient was stabilized, Precision personnel entered the operating room. They helped attach the arrays in an arc around the hole on the patient's head, and connect bundles of long blue wires at the other end to a cart full of equipment and monitoring devices.

Dr. Benjamin Rapoport, Precision's co-founder and chief scientific officer, was watching quietly. Every major surgery carries some risks, but the neurosurgeon's calm, calm demeanor never wavered. He told CNBC that each new case is no less exciting than the last, especially since the company is still learning.

Pederson entered the operating room as Precision's preparations came to a close. He helped make some final adjustments to the setup, and the overhead lights in the operating room were turned off.

The constant chatter calmed to hushed whispers. Pederson was ready to get going.

He began by carefully pulling back a fibrous membrane called the dura to expose the surface of the brain. He placed a standard strip of electrodes on the tissue for a few minutes, then it was time to test the Precision technology.

Using a pair of yellow forceps called long bayonet forceps, Pederson began placing Precision's four electrode arrays on the patient's brain. He placed the first two arrays easily, but the last two were a little more challenging.

Pederson was working on a small portion of brain tissue, which meant the arrays needed to be at the right angle to lie flat. For reference, imagine arranging the ends of four separate measuring tapes within a surface area approximately the size of a rubber band. It took a little reconfiguration, but after a few minutes, Pederson got it done.

Images of the patient's brain activity were displayed in real time via Precision monitors in the operating room. All four arrays were working.

In an interview after surgery, Pederson said that placing the four arrays at once was “complicated” and “a little awkward.” From a design perspective, he said two arrays with twice the number of contact points, or two longer arrays with greater spacing would have been beneficial.

Pederson compared the arrays to pasta, and the description was apt. From where CNBC was watching, it was difficult to tell where one stopped and the next began.

Once all the arrays were in place and the signals were effectively detected, Precision's Rapoport and his team stood alongside the observers to help oversee data collection. He said the research is the product of a true team effort from the company, the health system and the patient, who often cannot see the benefits of the technology at this stage.

“It takes a village to make this kind of thing go forward,” Rapoport said.

CNBC left the operating room as Pederson began removing the tumor, but he said the case went well. The patient later woke up with some weakness in his foot because the surgery was within that part of the brain, but Pederson said he expects the foot to recover within three to four weeks.

Rapoport was present for this particular surgery because of his role at Precision, but he is well acquainted with the operating rooms at Mount Sinai.

Rapoport is a practicing surgeon and serves as an assistant professor of neurosurgery at the Icahn School of Medicine at Mount Sinai. Rapoport reports to Pederson, and Pederson said the pair have known each other since Rapoport was a resident at Weill Cornell Medical College.

Dr. Thomas Oxley, CEO of BCI competitor Synchron, is also a faculty member under Pederson. Synchron has built a stent-like BCI that can be inserted through a patient's blood vessels. As of early February, the company has implanted its system in 10 human patients. It is also working on obtaining FDA approval.

Pederson owns a stake in Synchron, but told CNBC he didn't realize how much that would prevent him from participating in research with the Synchron team. He has no cash investment in Precision.

“I didn't really want to have any financial interest in Precision because I thought it had an equally promising future and I wanted to advance the science as quickly as possible,” Pederson said.

Rapoport also helped found Musk's Neuralink company in 2017, though he left the company the following year. Neuralink is building a BCI designed to be inserted directly into brain tissue, and the company recently received approval to implant it in its second human patient, according to a report from The Wall Street Journal on Monday.

With the brain-computer interface industry picking up pace, Pederson said the amount scientists understand about the brain is about to “explode” over the next several years. Companies like Precision are just getting started.

“I really feel like the future is where the excitement is,” Pederson said.

Precision hopes to gain FDA approval for the wired version of its system “within a few months,” Rapoport said. This version, which CNBC saw in the operating room, will be for use in a hospital or monitored care unit for up to 30 days at a time, he said.

Precision's permanent implant, which will transmit signals wirelessly, will go through a separate approval process with the Food and Drug Administration.

Rapoport said Precision hopes to implant the wired version of its technology in “a few dozen” patients by the end of the year. He said collecting the data would give the company a “very high level of confidence” in its ability to decode movement and speech signals in real time.

“In a few years, we will have a more advanced version of the technology,” Rapoport said.