Precision Neuroscience Acquires U.S. Manufacturing Facility and Receives FDA Breakthrough Device Designation

By: Precision Neuroscience via GlobeNewswire

October 05, 2023 at 09:00 AM EDT

NEW YORK, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Brain–computer interface (BCI) company Precision Neuroscience Corporation (Precision) today announced it has acquired a microelectromechanical systems (MEMS) foundry outside Dallas, TX. The facility acquisition, completed through a wholly owned subsidiary, Precision BioMEMS Corporation, brings the company’s supply chain in-house and establishes Precision as one of the leading-edge manufacturers of biomedical MEMS in the United States. Further, the company also announced that its system has been awarded Breakthrough Device designation from the U.S. Food and Drug Administration. The designation expedites the review of new technologies designed to treat debilitating or life-threatening conditions.

Founded in 2021 by a team including neurosurgeon Benjamin Rapoport and business leader Michael Mager, Precision has created a direct communication pathway between the human brain and computers. The company completed first-in-human clinical studies of its device in April, mapping the human brain’s activity at an unprecedented level of detail. In coming years, the company anticipates that its minimally invasive brain implant will enable people with severe neurological conditions such as speech deficits and paralysis to regain independence, communicate with loved ones, and rejoin the workforce. The foundry acquisition gives Precision full production control of its core technology—a thin-film microelectrode array, called the Layer 7 Cortical Interface, which packs 1,024 electrodes into an area spanning 1.5 square centimeters—enabling a greater degree of quality management and the ability to iterate rapidly on future versions.

The facility comprises a 22,000 square foot building, including a 5,500 square foot ISO class 5 clean room (a low-particle zone for manufacturing), more than 500 square feet of ISO class 6 post-processing and assembly space, and over fifty specialized tools. Precision BioMEMS retained the facility’s team, which has deep expertise in both biomedical and general-purpose MEMS manufacturing. In addition to its work for Precision, Precision BioMEMS will continue to operate as a foundry serving other cutting-edge companies in the United States.

“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’s 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.”

Precision’s brain–computer interface is an investigational device and is not available for sale in the United States.

About Precision Neuroscience
Precision Neuroscience is working to provide breakthrough treatments for the millions of people worldwide suffering from neurological illnesses. The company is building the only brain–computer interface designed to be minimally invasive, safely removable, and capable of processing large amounts of data. To learn more about how Precision is connecting human intelligence and artificial intelligence, visit www.precisionneuro.io.

Contact: media@precisionneuro.io