Blackrock Neurotech nabs FDA breakthrough nod for system that uses thoughts to control devices

Nearly two decades after its NeuroPort Array scored the FDA’s first approval for an implanted electrode panel that sends brain signals to a computer for translation, Blackrock Neurotech is back on the agency’s radar.

Its newest brain-computer interface is the MoveAgain system, which picks up neurological signals from the brain of a paralyzed patient, then parses out their intent to control cursors and keyboards, mobile devices, wheelchairs and prosthetic devices.

The technology was developed based on decades worth of clinical research by dozens of institutions attempting to program a computer to unravel the meaning of individual brain signals, then use those findings to control external devices. With that backing, Blackrock’s system has garnered the FDA’s breakthrough device designation, indicating its potential to meet an urgent medical need and allowing it a speedier pathway toward regulatory clearance.

“We look forward to working closely with the FDA to prioritize development of the MoveAgain brain-computer interface system, which will bring us closer to our goal of commercialization in 2022,” said Marcus Gerhardt, Blackrock’s co-founder and CEO. “Patients with tetraplegia are eager to get access, and we are committed to advancing their ability to increase their independence with our BCI technology.”

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The brain-computer interface relies on Blackrock’s existing electrode array technology, a wired device that’s just four millimeters wide and loaded with 96 millimeter-long electrodes. Once implanted on the brain, the array collects neurological activity and sends it to a connected computer. Those data are then transferred wirelessly to the desired smartphone, prosthetic or other device, allowing for huge improvements in the mobility of patients with paralysis.

Even as it pursues FDA clearance for that iteration, Blackrock—which is unrelated to investment firm BlackRock—is already working on a next-generation version of the interface that’s even smaller and completely wireless.

“We are confident we have sufficient safety and efficacy data to support the first applications. Further miniaturization of our technology will not only enable our robust wireless version, but provide the basis for already planned future smart systems,” said Florian Solzbacher, Blackrock’s chairman and president.

“We are seeing the beginning of a revolution in the diagnosis and treatment of neurological disorders and disabilities,” Solzbacher continued. “Ten years from now, neural implants could be as common as cardiac pacemakers are today—offering patients a whole new world of options that restore their independence.”

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If approved by the FDA, the MoveAgain system will join an exclusive club—so exclusive, in fact, that only one other brain-computer interface has so far been cleared for commercialization. The IpsiHand Upper Extremity Rehabilitation System from Neurolutions was approved in April of this year and uses a headpiece dotted with electrodes to collect brainwaves that wirelessly control a connected arm brace for patients recovering from stroke.

Blackrock will be competing against Synchron to become the first to receive approval for an implanted brain-computer interface. The latter company got the FDA’s go-ahead in July to begin clinical trials of its Stentrode device, which is inserted in the jugular vein to gather neurological signals that are then used to control a computer mouse and keyboard.