On Thursday (October 5) local time, the American neurotechnology startup PrecisionNeuroscience announced that it has acquired a microelectromechanical systems (MEMS) factory in Dallas, Texas, to produce key components of the "7th layer of cerebral cortex."
The facility will help Precision accelerate development toward its goal of regulatory approval in 2024. In the press release, the company also announced that its system has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), which will help expedite its eventual approval.
As we all know, the human cerebral cortex is composed of 6 cell layers, and Precision is trying to build a 7th layer to help paralyzed patients operate electronic devices, move cursors, type, and even directly access social media only through neural signals.
It is understood that, similar to most current brain-computer interface companies, the “7th layer of cerebral cortex” developed by Precision is essentially a flexible electrode array. However, Precision's device fits on the surface of the brain, is only 1/5 as thick as a human hair, and does not damage any human tissue.
According to reports, Precision has begun testing on human patients. The company noted that the newly acquired factory is the only facility capable of producing its electrode arrays. Co-founder and CEO Michael Mager told the media, "Now we can potentially iterate faster."
Mager explained that if manufacturing is carried out in cooperation with a third party, it will be difficult to quickly modify the design, protect trade secrets and ensure supply levels; and when Precision is directly involved in the production work, it will be much easier to ensure the high quality and safety of the electrode array.
Mager said: "The system we make runs on the human brain, and the responsibility is really big." In the current brain-computer interface (BCI) track, the most well-known company is Elon Musk's Neuralink, and the two founders of Precision, Mager and Benjamin Rapoport, are also members of the founding team of Neuralink.
The factory Precision acquired came from an unnamed Japanese multinational company, and Mager said it was able to retain 11 "key personnel" working there to help the company keep up with the tight pace of regulatory testing. Precision is preparing for additional human trials at the University of Pennsylvania and New York's Mount Sinai Health System.
"This is a longer and more capital-intensive competition." Mager also mentioned the latest "breakthrough device" designation granted by the FDA, which he said will open up more frequent communication channels between Precision and the FDA and help accelerate the company's path to commercialization.