Precision Neuroscience announced today that its brain-computer interface (BCI) technology won FDA breakthrough device designation.
The company also acquired a microelectromechanical systems (MEMS) foundry outside Dallas, Texas. Completed through its Precision BioMEMS subsidiary, the acquisition brings its supply chain in-house. It also establishes Precision as a leading-edge manufacturer of biomedical MEMS in the U.S., according to a news release.
Precision Neuroscience develops the Layer 7 Cortical Interface, designed with 1,024 tiny electrodes spanning an area of one square centimeter. The company embedded the electrodes in a flexible film that conforms to the brain surface. This film — one-fifth the thickness of a human hair — is designed for implantation and removal by neurosurgeons without damaging brain tissue.
The company designed it to map a large area of the brain’s surface at resolutions higher than typical neurosurgical procedures. Founded in 2021, Precision Neuroscience began the first-in-human pilot clinical study for the implant in June of this year.
Benjamin Rapoport, a founding member of Elon Musk’s Neuralink BCI venture, started the company with private equity investor Michael Mager. Mager serves as CEO of Precision Neuroscience.
The Precision Neuroscience BCI remains investigational and not for sale in the U.S. According to a CNBC report, the company has its eyes on regulatory approval in 2024.
Precision Neuroscience says it expects its brain implant to enable people with severe neurological conditions, like speech deficits and paralysis, to regain independence, communicate with loved ones and rejoin the workforce.
More about the Precision Neuroscience foundry acquisition
Acquiring the foundry enables full production control over the company’s core Layer 7 technology. It also enables a greater degree of quality management and the ability to iterate rapidly on future versions.
The 22,000-square-foot building includes a 5,500-square-foot ISO class 5 clean room. It features more than 500 square feet of ISO class 6 post-processing and assembly space, plus more than 50 specialized tools. Precision BioMEMS retained the facility’s team and its expertise in biomedical and general-purpose MEMS manufacturing. The subsidiary intends to supplement its work for Precision Neuroscience by operating as a foundry for other U.S. companies.
“To deliver brain-computer interface technology to the millions of people who stand to benefit, we need to rethink the medical device supply chain,” said Michael Mager, Precision Neuroscience CEO. “High-precision microfabrication is critical to building powerful brain-computer interfaces, and it will play an increasingly important role in medical device manufacturing going forward. Precision BioMEMS will help us build the neural technology of tomorrow while also advancing the broader U.S. medical device industry.”
Keeping an eye on BCI
Musk’s Neuralink, from which one of Precision’s founders came, is one of many big names pushing forward in the BCI space. The company just recently announced the opening of enrollment for its first-in-human trials.
Synchron develops the catheter-delivered Stentrode BCI implant, believing itself to be the only BCI company tapping into blood vessels to capture signals from the brain. The company has financial support from Bill Gates and Jeff Bezos. Only last month, it completed enrollment in its own FDA IDE trial, potentially getting a leg up on Neuralink.
Blackrock Neurotech, another competitor, develops the Utah Array, which has been implanted in patients since 2004 through research studies, with zero FDA-reported serious adverse events. It also unveiled a next-gen BCI — like a thin piece of lace — that’s thinner than an eyelash.
In September, InBrain announced that it received FDA breakthrough device designation for its intelligent network modulation system. The semiconductor-derived brain-computer interface (BCI) technology could decode and modulate brain activity.