Cyberkinetics Inc. released details of plans for its first human clinical trial
of the human-computer interface device known as BrainGate.
According to Tim Surgenor, CEO and president of Cyberkinetics, paperwork for an Investigational Device Exemption (IDE) will be filed by the end of the year for approval from the Food and Drug Administration.
“We’re ready,” he said. “This has been a program with over a decade of work.”
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The Foxboro company released plans at the annual meeting of the Society of Neuroscience.
Cyberkinetics plans to begin its work in the spring with approximately five quadriplegic participants. The device will be implanted into the brains of the individuals and researchers will look at the safety and effectiveness of the device.
The device, which is smaller than baby aspirin, translates signals from the brain into an output signal under the person’s control. The aim is for the tiny chip to allow those with paralyzed patients to work a computer without the aid of their limbs.
Previous research showed that primates were able to control the cursor of a screen when the device was applied.
Surgenor said that although other researchers are doing similar human-computer interface work, Cyberkinetics is the first formed company in this line of research. This fact, he said, makes the company the leader in this biotech area.
“There are other academic groups out there but only a company can move forward in terms of a commercial product,” he said.
The company most recently received $4.3 million in its final Series A financing; this followed an initial investment of $5 million, which coincided with the merger of the company with Utah-based Bionic Technologies LLC.
The BrainGate system was created by John Donoghue, chairman of the Department of Neuroscience at Brown University.
