This strategic move is aimed at accelerating the development process and bringing the company closer to achieving regulatory approval by 2024.
Precision Neuroscience has commenced human trials of its brain implant and envisions its potential to enable individuals with paralysis to control digital devices using brain signals. The acquisition of this manufacturing facility is essential for producing Precision's "sophisticated" electrode array, which is a fundamental part of their technology.
Michael Mager, co-founder and CEO of Precision Neuroscience, highlighted the advantages of this manufacturing facility: "It 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's electrode array is remarkably thin, resembling a piece of Scotch tape, and its flexible design allows it to safely rest on the brain's surface, providing real-time, high-resolution neural activity monitoring without causing damage to the brain tissue.
As a player in the rapidly growing brain-computer interface (BCI) industry, Precision is developing its technology alongside other companies such as Synchron, Paradromics, Blackrock Neurotech, and Elon Musk's Neuralink. Dr. Benjamin Rapoport, Precision's co-founder and chief science officer, also contributed to the founding of Neuralink before leaving the company in 2018.
Neuralink, led by Elon Musk, is one of the most prominent companies in the BCI space, known for its invasive approach to brain implants and in-house manufacturing of its technology.
Mager emphasized the benefits of in-house manufacturing, citing the challenges of rapid design changes, protection of trade secrets, and maintaining supply levels when working with third-party manufacturers. He highlighted that Precision can ensure the safety and quality of its arrays when directly involved in production, given the tremendous responsibility of manufacturing devices for human brains.
The acquisition cost of the manufacturing facility, owned by a Japanese multinational corporation, was not disclosed at the request of the seller. Precision successfully retained 11 key personnel from the facility, potentially leading to further growth in their workforce. This was a significant achievement for the company, as it eliminated the need to train new employees in handling complex technology.
Precision has been operational at the facility since May, significantly boosting its production capacity. Mager noted that their previous manufacturing partner took over a year to produce six arrays, whereas they can now manufacture over 100 arrays in a single week.
The arrays produced at the new facility will support Precision's efforts to keep pace with rigorous regulatory testing and upcoming human trials at the University of Pennsylvania and the Mount Sinai Health System in New York City.
Mager acknowledged that the company's journey toward commercialization is a longer and capital-intensive endeavor. While Precision has been collaborating closely with regulators, it still needs to undergo multiple rounds of rigorous safety and efficacy testing to obtain approval from the Food and Drug Administration (FDA).
However, there is positive news for Precision, as they recently received a Breakthrough Device designation from the FDA. This designation is granted to medical devices with the potential to enhance treatment for debilitating or life-threatening conditions. In fiscal year 2023, the FDA has granted 109 such designations, according to its website.
Mager believes that this Breakthrough Device designation will facilitate more frequent communication with the FDA, expediting Precision's path toward commercialization. With the manufacturing facility, Breakthrough Device designation, and ongoing in-patient trials, Precision Neuroscience is poised for continued progress.
"It's never been more exciting," Mager concluded."
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