This week marked a big one for brain implants. Precision Neuroscience just received FDA approval to use their proprietary ‘strip’ on humans for up to 30 days. For now, that means recording, stimulating and mapping brain activity for the patients volunteering in the program. Down the road it could help those afflicted with paralysis (think: ALS, Parkinson’s, etc.) move a mouse with their mind. Precision was kind enough to invite me down to Santa Clara to see the product – and the progress – in person.
“This is a major milestone many years in the making.”
That was Craig Mermel, Precision’s President and Chief Product Officer. He told me the news here is the timeline – or the 30 days. Previously, Precision was limited to placing a device on a patient during surgery and removing it before the patient leaves the operating room. The FDA approval now allows the company to again place the ‘strip’ on a patient during surgery but leave it on during recovery – allowing Precision to gather more data and monitor the device’s utility (and impact) while on the brain.
So, what is this device? I’ve done reporting on this before – to me, it looks like a VIP wristband from a concert. Made of flexible film material, the device is incredibly thin (technically, a fifth of the width of a human hair) and has 1,024 electrodes to record brain activity. Precision calls it the “Layer 7 Cortical Interface” and tells me they’ve already used the device on 38 patients already. Perhaps most surprising is that the patients are awake during the procedure.
That’s a minor detail but a major point: Precision’s distinction in what is an increasingly crowded BCI (brain chip interface) market is that it’s less invasive. Competitors generally rely on craniotomies (or removal of bone from the skull) to implant their devices. Some go a step further and sew it into the brain tissue. Precision’s ‘strip’ rests on the top of the brain – making it substantially less risky. It’s implanted using a micro-slit technique (remember that human hair width?) that surgeons compare to sliding a letter into a mailbox. Except, of course, it’s brain surgery.
What doesn’t require a ton of brainpower is seeing the sector’s momentum. Here are some of the names invested in other BCI companies: Elon Musk, Bill Gates, Jeff Bezos, Peter Thiel – a who’s who of tech billionaires (and all with serious political connections). Morgan Stanley predicts this is a $400B market up for grabs. All have said, including Precision, that they want to be commercially viable by 2026… meaning the next few months are critical. Precision thinks the FDA approval could provide a crucial head start.
“Every byte of data we capture allows us to fine tune our algorithms, our electronics, our computation, our communication,” said Precision’s Chief Technology Officer Brian Otis on our tour. “Allowing us to collect more data will allow us to improve the system and then impact a broader set of patients.”
Precision’s facility in Santa Clara is one of three labs across the United States. The team showed me how the array looks under a microscope and explained that a lot is created, tested and validated at this lab. You can imagine there’s quite a bit of testing that goes into making brain implants.
Shortly after my tour, I zoomed with Precision co-founder Benjamin Rapoport (who left Musk’s Neuralink to pursue a less-invasive alternative). This is my third article on this industry and (inevitably) the first question I always get after I publish is: how can my paralyzed aunt/father/friend/grandma sign up for this technology? Rapoport again pointed to the FDA clearance as a key step toward bringing this technology to patients. For now, he’s grateful for the volunteers who made the research possible.
“That’s a very special kind of patient who, in a sense, is altruistic and future thinking,” said Rapoport. “It’s a very special group of pioneering individuals.”
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Watch my full hit on CBS News above to see more from my exclusive tour of Precision Neuroscience.
