As the lights darkened in an operating room at The Mount Sinai Hospital in New York City, Dr. Joshua Bederson began to make history.
Bederson, system head of the Department of Neurosurgery at Mount Sinai Health System, is used to working long hours in the operating room. The former professional gymnast has performed over 6,500 surgeries in his career, and he says he visualizes the processes for each one as if he were practicing a routine.
On this particular morning in April, Bederson was preparing for a meningioma resection, which meant removing a benign brain tumor. Bederson stated that his initial focus is always on caring for the patient, but in some circumstances, he is able to help progress research.
This procedure was one such example.
A small throng gathered as Bederson took his seat in the operating room, his silhouette illuminated by the bright white light shining on the patient in front of him. Healthcare workers, scientists, and CNBC viewers craned forward, some gazing through windows, to observe Bederson put four Precision Neuroscience electrode arrays onto the patient’s brain for the first time.
An electrode is a tiny sensor that detects and transmits electrical signals, while an array is a grid of electrodes. During some surgeries, neurosurgeons utilize electrodes to monitor and avoid sensitive areas of the brain, such as those that govern voice and movement.
Precision is a three-year-old startup developing a brain-computer interface (BCI). A BCI decodes brain signals and converts them into commands for external technology. Tesla and SpaceX CEO Elon Musk owns Neuralink, one of the most well-known companies in the industry.
Other firms, like as Synchron and Paradromics, have produced BCI devices, but their goals and designs differ. Precision’s device will first be used to help people with severe paralysis regain functions like as speech and movement, according to company website.
Precision’s flagship BCI is known as the Layer 7 Cortical Interface. It’s a microelectrode array that is thinner than a human hair and looks like a piece of yellow scotch tape. Precision claims that each array, which consists of 1,024 electrodes, can contour to the brain’s surface without causing tissue damage.
When Bederson used four of the company’s arrays during the April surgery, he set a record for the most electrodes implanted on the brain in real time, according to Precision. But, perhaps more critically, the arrays were able to detect impulses from the patient’s individual fingers, capturing far more detail than ordinary electrodes.
According to Ignacio Saez, an associate professor of neuroscience, neurosurgery, and neurology at the Icahn School of Medicine at Mount Sinai, using Precision’s electrode array is equivalent to converting a pixilated, low-resolution photograph into a 4K image. Saez and his crew manage Precision’s work with Mount Sinai.
“Instead of having 10 electrodes, you’re giving me 1,000 electrodes,” Saez told CNBC during an interview. “The depth and the resolution and the detail that you’re going to get are completely different, even though they somehow reflect the same underlying neurological activity.”
According to Bederson, having access to this degree of data may allow surgeons to be more gentle with future surgeries and interventions. Precision’s capacity to record and decode signals from individual fingers will be critical as the business strives to assist patients regain fine motor control.
The data represents a significant milestone for Precision, but it still has a long way to go before it can accomplish some of its loftier objectives. The business is still attempting to get approval from the US Food and Drug Administration, and it has yet to implant a patient with its more permanent technique.
“I think these are little baby steps towards the ultimate goal of brain-computer interface,” Bederson told CNBC during an interview.
Inside the surgery room.
Bederson’s operation in April wasn’t Precision’s first rodeo. In reality, it was the 14th time the business had implanted its array on a human patient’s brain.
Precision has collaborated with university medical institutes and health systems to conduct a number of first-in-human clinical trials. The objectives of each study differ, and the corporation announced its collaboration with Mount Sinai in March.
Precision is researching various therapeutic applications for its array at Mount Sinai, such as how it might help monitor the brain after surgery. In these treatments, doctors like as Bederson temporarily implant Precision’s array into patients who are already undergoing brain surgery for medical reasons.
Patients offer their agreement to participate in advance.
Neurosurgeons often map brain impulses with electrodes during these surgeries. Bederson stated that the current established practice is to employ anything from four to nearly 100 electrodes, a far cry from the 4,096 electrodes he was about to test.
Precision’s arrays are only used for a part of these surgeries, thus CNBC entered the operating room in April after the surgery had already begun.
The patient, who requested anonymity, was asleep. Bederson’s crew had previously removed a portion of their skull, leaving an opening around the size of a credit card. Four Precision arrays were carefully arranged on a nearby table.
Precision personnel gradually entered the operation room once the patient had been stabilized. They assisted in attaching the arrays in an arc around the patient’s head opening, as well as connecting bundles of long blue wires to a cart containing equipment and monitors.
Precision’s co-founder and chief scientific officer, Dr. Benjamin Rapoport, watched in silence. Every big treatment carries some danger, but the soft-spoken neurosurgeon maintained a cool tone throughout. He told CNBC that each new instance is just as interesting as the last, especially given the company’s ongoing learning.
Bederson entered the surgery room as Precision’s preparations were nearing completion. He assisted with some final adjustments to the setup, and the overhead lights in the operating room were turned off.
The ongoing talk subsided to low murmurs. Bederson was ready to get started.
He began by carefully pushing back a fibrous barrier known as the dura, revealing the brain’s surface. He applied a conventional strip of electrodes to the tissue for a few minutes before testing Precision’s technology.
Bederson began applying all four of Precision’s electrode arrays to the patient’s brain with a pair of yellow tweezers known as long bayonet forceps. He positioned the first two arrays with ease, but the last two proved very difficult.
Bederson was dealing with a small slice of brain tissue, thus the arrays needed to be precisely oriented to lay flat. For example, imagine putting the ends of four different tape measures on a surface area about the size of a rubber band. It took some reconfiguration, but Bederson was able to complete the task in a matter of minutes.
Precision’s operating room displays displayed real-time visualizations of the patient’s brain activity. All four arrays were operational.
Bederson claimed it was “complicated” and “a little bit awkward” to implant all four arrays at once in an interview after the procedure. From a design standpoint, he believes two arrays with twice as many points of contact, or longer arrays with wider spacing, would have been advantageous.
Bederson compared the arrays to spaghetti, and the analogy was appropriate. From where CNBC was observing, it was difficult to discern where one ended and another began.
Once all of the arrays were in place and actively detecting signals, Precision’s Rapoport and his crew stood by the monitors to oversee data collecting. He stated that the research is the result of a truly collaborative effort between the industry, the health system, and the patient, who frequently does not recognize the benefits of the technology at this time.
“It takes a village to make this sort of thing move forward,” Rapoport stated.
CNBC exited the operating room as Bederson began removing the tumor, but he stated that the procedure went smoothly. Because the surgery was performed in that area of the brain, the patient awoke with some weakness in their foot, but Bederson predicted that the foot would heal in three to four weeks.
Rapoport was present for this procedure because to his job with Precision, although he is familiar with Mount Sinai’s operating rooms.
Rapoport is a practicing surgeon and assistant professor of neurosurgery at Mount Sinai’s Icahn School of Medicine. Rapoport reports to Bederson, and Bederson says they’ve known each other since Rapoport was a resident at Weill Cornell Medicine.
Dr. Thomas Oxley, CEO of Synchron, a competitive BCI company, is also a teaching member at Bederson. Synchron developed a stent-like BCI that may be put into a patient’s blood arteries. As of early February, the business had implanted its technology in ten human patients. It is also working towards FDA approval.
Bederson owns stock in Synchron, but he told CNBC he had no idea how much it would restrict him from conducting research with the Synchron team. He has made no monetary investment in Precision.
“I really did not want to have any financial interest in Precision because I think it has an equally promising future and wanted to advance the science as fast as I could,” Bederson stated.
Rapoport also co-founded Musk’s Neuralink in 2017, although he left the firm the next year. Neuralink is developing a BCI that can be implanted directly into brain tissue, and the business recently gained approval to implant its second human patient, according to The Wall Street Journal on Monday.
As the BCI sector grows, Bederson predicts that scientists’ understanding of the brain will “explode” in the coming years. Precision is still in its early stages.
“I really feel like the future is where the excitement is,” Bederson stated.
According to Rapoport, Precision hopes to gain FDA certification for its wired version of the device “within a few months.” This version, which CNBC witnessed in the operating room, would be used in a hospital or monitored care unit for up to 30 days at a time, he explained.
Precision’s permanent implant, which will wirelessly transmit signals, will undergo a separate FDA approval process.
Rapoport stated that Precision hopes to implant “a few dozen” patients with the wired version of their technique before the end of the year. He stated that the data collecting would provide the corporation with a “very high level of confidence” in its capacity to decode movement and speech signals in real time.
“Within a few years, we’ll have a much more advanced version of the technology out,” Rapoport stated.
