Precision Neuroscience has obtained a fabrication plant in Dallas, capable of constructing the integral element of their brain implant. The firm has launched trials of the appliance on human participants and is optimistic it can eventually help those with paralysis manipulate digital devices utilizing their brain signals. This optimism has been supported by the Breakthrough Device designation granted to Precision by the FDA, an accolade designated for medical devices offering improvements in the treatment of severe or fatal conditions.
On Thursday, neurotech startup Precision Neuroscience acquired a factory in Dallas to build the key component of its brain implant, the Layer 7 Cortical Interface. This facility is expected to significantly speed up development of the implant and help move the company closer toward its goal of receiving regulatory approval in 2024. Testing of the implant on human patients has already begun, and the company believes it could help people with paralysis operate digital devices with their brain signals. The facility is the only one capable of producing the ultra-thin, "sophisticated" electrode array – thinner than a human hair and looking like a piece of Scotch tape – which has a flexible design that rests on the brain's surface and captures a real-time, high resolution rendering of neural activity without damaging any tissue. According to co-founder and CEO Michael Mager, the factory "allows us to iterate really quickly, improve performance, longevity, different form factors of the device — all the things that we've always wanted to do, we can now do in much quicker succession."
Precision, a participant in the rapidly growing brain-computer interface (BCI) sector, is developing its technology alongside Synchron, Paradromics, Blackrock Neurotech, and Elon Musk's Neuralink. Dr. Benjamin Rapoport, Precision's co-founder and chief science officer, aided in the founding of Neuralink prior to leaving in 2018. Neuralink, Musk's firm, is probably the most renowned in the BCI arena. Unlike Precision, it is taking a more intrusive method with its implant. The company also manufactures its own technology. According to Mager, producing with third parties can make it hard to create design changes quickly, safeguard trade secrets, and uphold sufficient supply levels. He clarified that being hands-on with production enables them to ensure Precision's arrays are both safe and of top-notch quality. "We produce systems that go on human brains. The responsibility is really tremendous," Mager said. At the seller's request, Precision declined to reveal how much money the manufacturing facility cost. Mager revealed that the company was able to retain the 11 "key personnel" who were working there and there is a potential for that number to increase in the future. Keeping the employees on board was a major victory for Precision, since it meant they did not have to educate new workers on how to manage the intricate technology.
Since May, Precision has been running at the facility and has already made a tangible impact on the organization's supply capacity. According to Mager, it once took over a year to build six arrays at the previous facility, while now more than a hundred are made in a week. These arrays will assist Precision in keeping up with intense regulatory testing and support it as it sets the stage for additional human trials at the University of Pennsylvania and the Mount Sinai Health System in New York City. “Complete control and ownership of the 100% facility driving all this innovation likely generates greater value," Mager said. "But it’s a longer, more capital-intensive game.”
Precision has been working with regulators, though there are still additional safety and efficacy testing phases to complete before receiving approval from the FDA for commercialization. On Thursday, the FDA gave a Breakthrough Device designation to Precision, noteworthy for a medical device that could provide improved treatment for life-threatening conditions. The Breakthrough Device designation awards Precision a stream of communication with the FDA, helping to shorten the path to commercialization. Mager said the facility, designation, and in-patient trials all provide the necessary impulse for Precision to keep going. “It’s never been more exciting," he concluded.
Comments