Neuralink rival Precision Neuroscience buys factory in brain implants

Neurotech startup Precision Neuroscience announced Thursday it has acquired a factory in Dallas, where it can construct the important thing component of its brain implant, the Layer 7 Cortical Interface. The power will help the corporate speed up development and move closer to the regulatory approval it’s hoping to clinch in 2024.

The corporate has began testing its brain implant on human patients and believes it could ultimately help individuals with paralysis operate digital devices with their brain signals. Precision said the manufacturing plant is the one facility capable of manufacturing its “sophisticated” electrode array.

“It allows us to iterate really quickly, improve performance, longevity, different form aspects of the device — all of the things that we have all the time desired to do, we will now do in much quicker succession,” co-founder and CEO Michael Mager told CNBC in an interview. 

Precision’s electrode array is thinner than a human hair and will easily be mistaken for a bit of Scotch tape. The system’s flexible design allows it to rest on the brain’s surface and generate a real-time, high resolution rendering of neural activity without damaging any tissue.

As a member of the fast-growing brain-computer interface (BCI) industry, Precision is developing its technology alongside other corporations like Synchron, Paradromics, Blackrock Neurotech and Elon Musk’s Neuralink. Precision’s co-founder and chief science officer, Dr. Benjamin Rapoport, also helped co-found Neuralink before departing the corporate in 2018.

Neuralink is probably the best-known company within the BCI space due to the high profile of Musk, who’s the CEO of Tesla and SpaceX. The corporate is taking a more invasive approach with its implant than Precision. Neuralink also manufactures its technology in-house. 

Mager said it may be difficult to make rapid design changes, protect trade secrets and keep supply levels up when working with third parties throughout the manufacturing process. He added that it’s much easier to be certain that Precision’s arrays are secure and of top of the range when the corporate is directly involved with production.  

“We manufacture systems that go on human brains. The responsibility is basically tremendous,” Mager said. 

On the request of the vendor, a Japanese multinational corporation, Precision declined to share how much the manufacturing facility cost. Mager said the corporate was in a position to retain the 11 “key personnel” who were working there, and there is a possibility that number will grow with time. Keeping the staff on board was an enormous victory for Precision, because it meant the corporate didn’t need to teach latest employees the best way to handle the complex technology. 

Precision has been up and running at the ability since May, and it has already made a cloth difference in the corporate’s supply levels. Mager said previously that Precision worked with a facility that took over a 12 months to fabricate six arrays, and now, the corporate can manufacture greater than 100 arrays in a single week. 

The arrays coming from the brand new facility will help Precision sustain with the extreme pace of regulatory testing, and it can also aid the corporate because it gears up for added human trials on the University of Pennsylvania and on the Mount Sinai Health System in Latest York City.

“I believe, ultimately, the worth that we now have the potential to create is rather a lot greater because of this of being in complete control and owning 100% of the ability that helps to drive all this innovation,” Mager said. “Nevertheless it is an extended, more capital-intensive game.”  

Precision has been working closely with regulators, but the corporate still must undergo several rounds of rigorous safety and efficacy testing before it can receive approval from the Food and Drug Administration to commercialize its technology. 

However the FDA recently gave Precision a nod, as the corporate announced Thursday it has received a Breakthrough Device designation from the agency. The designation is awarded to medical devices which have the potential to supply improved treatment for debilitating or life-threatening conditions, and the FDA has granted 109 of them in fiscal 2023 thus far, in keeping with its website. 

Mager said the designation will open a more frequent line of communication between Precision and the agency that can help expedite the corporate’s path toward commercialization. He said that with the manufacturing facility, the Breakthrough Device designation and in-patient trials within the works, Precision has the momentum it needs to maneuver forward.  

“It’s never been more exciting,” he said.