Medical Device Daily

Mark down 2006 as the point in time when the phrase “I think, therefore I am,“was significantly expanded - to “If all I can do is think, I can still move and act.“

Such is the primary claim emanating from research byCyberkinetics Neurotechnology Systems (Foxborough, Massachusetts) concerning its BrainGate Neural Interface System, just published in the July issue of Nature, along with a variety of other studies demonstrating similar abilities for brain/device systems. The research was considered significant enough to win a front-page story yesterday in The New York Times, headlined “Paralyzed Man Uses Thoughts to Move a Cursor.“

The article in Nature details how a research subject, who had lost most control of his arms and hands, was implanted with the BrainGate system and then was able to manipulate a cursor on a screen. Doing so, he drew an Etch-a-Sketch-type circle using only neural control - his thoughts.

This provides, according to Cyberkinetics, definite proof of BrainGate's potential and the possibilities for manipulating other devices, such as electro-prosthetic hands, and thus helping the paralyzed achieve a significant level of independence.

According to John Donoghue, senior author of the paper, chief scientific officer of Cyberkinetics, professor and director of the Brain Science Program at Brown University (Providence, Rhode Island), the research is “compelling evidence that the area of the brain that controls movement remains functional even years after a spinal cord injury in the absence of a neural connection from the brain to the limbs.“

“Furthermore, we now have a greater understanding of how the human brain controls movement,“ he said. “Our findings suggest that limb movement originates in the brain as distinct and predictable patterns of neural activity.“

Since all of this is considerably more complex than “I think, therefore I am,“ the path to commercializing BrainGate will require considerably more work, acknowledged Tim Surgenor, president/CEO of Cyberkinetics.

In a phone interview from Washington, where he said he is on a “scientific/legislative“ trip, Surgenor told Medical Device Daily that before achieving commercial sale, Cyberkinetics has “very specific goals.“

The first, he said, is to develop trials to determine the population of disabled people to target for application approval; the second, to improve the various sub-systems of the BrainGate to develop next-generation products.

For the first goal, the company is expanding its clinical trial work, with a current enrollment of four people and FDA permission to enroll up to 10 patients. These trials, Surgenor said, will be used to study “the power of the interface, how good the control system is that we're developing and the safety and the robustness of the device.“

Among the four persons currently enrolled is one with amyotrophic lateral sclerosis (ALS), who can't move or talk, and Surgenor suggested that BrainGate use in ALS patients could be the most important initial application. “That [may be] most compelling,“ he said. “When you lose the ability to move and talk, the main issue is communication.“

The second goal is improvement of the three systems BrainGate is composed of: a smaller-than-a-penny silicone chip, with hair-like sensors for detecting neural activity, implanted on the surface of the brain; via wiring, sensor connection to external computer hardware and a monitor; and thirdly, the software which “runs the interface“ for the system, Surgenor said.

So far, the company has focused on refining BrainGate's software, he said, but he sees various possibilities for altering the architecture of the other systems, such as putting all of the electronics in the implanted sensor - where, currently there are no “active electronics“ - so that it can communicate wirelessly with the hardware.

That BrainGate is an implanted device is one issue raised in The Times article as a possible commercial barrier, when compared to systems that are placed on the skull and using EEG-type signals for control.

In response, Surgenor cites research conclusions, “independent of ours,“ that implantable devices can perform “far in excess of an EEG system“ being so much closer to the brain's activity.

Additionally, he noted the broad acceptance of current implantable systems, such as pacemakers and defibrillators, and that the BrainGate may be considered simply another type of these devices.

“We're right at the beginning,“ he said, and that it will be “common to have devices in the brain.“

The Times article also notes that currently the BrainGate, in use, receives daily programming by a technician. Surgenor acknowledges this but said the next generations of the device will not require daily programming, or that such programming could be one of its automatic functions, or even done by the patient.

Equity-backed, Cyberkinetics so far has raised around $26 million, enough to support the company “well into 2007,“ Surgenor said. “We've made a lot of progress with that amount of capital.“

He acknowledged that the company would need “substantial capital“ for the future, with Cyberkinetics pursuing this “through partnering“ and “looking for a distribution partner for the final product.“

He said that the Nature and Times publications will certainly give a large boost to the hunt for more financing, but he also pointed to the company's other activities as equally important.

Last year, Cyberkinetics received FDA 510(k) clearance for its NeuroPort Cortical Microelectrode Array and NeuroPort Neural Signal Processor products, together making up the NeuroPort System for temporary recording and monitoring of brain electrical activity (MDD, April 7, 2005).

And in February, the company acquired Andara (Indianapolis), developer of the Oscillating Field Stimulator (OFS) device, in a stock exchange deal (MDD, Feb. 16, 2006). Andara's technology derives from research concerning the repair and regeneration of neural tissues at the Center for Paralysis Research at Purdue University (West Lafayette, Indiana).

The OFS Device takes the ability of weak electrical fields to prevent the dieback, and promote the growth, of nerve fibers. About the size of a lipstick container - implanted within days of an injury and removed 14 weeks later - the device addresses a range of neural stimulation therapies, and Cyberkinetics has said it expects to submit an FDA application this year, with hope for approval in 2007.

Addition of that technology “moves [Cyberkinetics] from neuro-sensing so that now we actually have a full portfolio of neuromodulation and sensing products,“ Surgenor said. “That has helped us in terms of financing discussions and partnering discussions.“

Overall, Cyberkinetics has put the market for neuro-stimulation devices at more than $1.6 annually, with expectations for growth to $10 billion in 10 years.

As rhetorical punctuation, Surgenor pointed to the recent “huge IPO“ of Northstar Neuroscience (Seattle), also working in the neurostimulation market and garnering about $100 million with its offering (MDD, May 8, 2006).

Cyberkinetics offers “a very competitive program“ at “a fraction of [Northside's] value,“ according to Surgenor. “That helps in terms of discussions. We have a lot of upside.“