Cyberkinetics plans for clinical trials


Few companies are born with as much public curiosity as Cyberkinetics Inc.



In March 2002, a team of Brown University researchers made national news by publishing the results of a study in which a sensor chip imbedded in a monkey’s brain allowed the animal to control a computer cursor simply by thinking about it.



Linking brain activity to a computer someday could help paralyzed people use their thoughts to control machines or even prosthetic limbs, and harbors potential for detecting and treating neurological disorders such as stroke and epilepsy, researchers said.

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The feat was detailed in the journal Nature and later featured in the Washington Post, the Los Angeles Times and other media. But after the spotlight dimmed, the team was left with a foreboding task: to build a business around its science-fiction breakthrough.



Fast-forward 18 months, and Cyberkinetics looks decidedly more like a company than a brainy team of Ivy League scientists.



In July it received $4.3 million in venture capital funding, bringing its total to $9.3 million.



In January it tapped a seasoned medical-device industry executive as its chief executive, and later moved its headquarters in Foxboro, Mass.



And late last year Cyberkinetics merged with Bionic Technologies, a Salt Lake City-based maker of neural-recording and stimulation devices.



The deal allowed Cyberkinetics to accelerate the development of its prototype, called BrainGate. It has 27 employees, 21 of which are in Utah.


Now Cyberkinetics is preparing to begin clinical trials of the device on paralysis
patients sometime next spring, pending approval from the U.S. Food and Drug
Administration. 




‘Proof of principle’



Timothy Surgenor, president and chief executive officer of Cyberkinetics, says the company has been tweaking the product in an effort to show that it is safe enough for human testing, as well as securing intellectual property rights.



Proving the device’s safety will be the primary goal of the initial trial. And Surgenor said the company is confident that the trial also will show “proof of principle,” or that human brain signals can control computer commands.



Even so, he said that final FDA approval is at least three or even four years away – and that’s if the trials go smoothly. Surgenor, who has an MBA from Harvard University, was previously an executive in charge of business development at Braintree, Mass.-based Haemonetics Corp., a public company that makes automated blood-processing systems.



“I think what we’re doing with spinal cord-injury patients is just the beginning, and we feel a real sense of urgency to get this done,” Surgenor said in an interview last week.



The device consists of an array, or a small black chip about the size of a pencil eraser, with 100 tiny, hair-like electrodes sticking up. It is surgically planted facedown onto the surface of the brain’s motor cortex, which controls muscle movement.



A thin wire runs from the array through the skull bone and connects to a dime-sized connector mounted on the outside of the skull. From there, the wire runs to a small processor, which interprets the brain signals and sends them to the computer via a fiber-optic cable.



The BrainGate in effect intercepts the neurological pulses that normally would be zapped to the fingers to make them move. Instead, the array gathers the neural signals and sends them to the computer, which does the work that the fingers and hands normally would do.


By the patient simply thinking about moving the arrow to, say, an AOL icon,
the device literally reads the subject’s mind and tells the cursor where to
go. In preclinical trials, a monkey was able to move a green dot around the
screen, mentally chasing a red dot in hopes of being awarded with a drop of
juice.



Science fiction meets reality



It’s the stuff of science fiction movies. But company founders say that reading the mind is not implausible when you consider the medical-device technologies that once were science-fiction pipe dreams, such as pacemakers and cochlear implants that enable near-deaf patients to hear.



“This is the dawn of the age of neurotechnology,” said Dr. John Donoghue, a Cyberkinetics founder and chairman of the Department of Neuroscience at Brown, who now serves as the company’s chief scientific officer.



“We’re working to develop a tiny, elegant device that can restore normal brain function in paralyzed people,” Donoghue said. “Restoring that quality of life would be profoundly transformational to these people.”



The company eventually hopes to make the device a wireless, implantable chip that would be able to harness brain activity to control not only computer commands but also high-tech prosthetic limbs, Donoghue said.



Cyberkinetics expects to enroll five paralysis patients in the planned clinical trial, most likely at a site in the Boston area.



At the company’s Foxboro office last week, Cyberkinetics officials gave a sneak peak at what the trial might look like, under the glare of production lights and TV cameras. A crew from the business-news channel CNBC was there to film part of a feature story on the future of medical devices.



Patients will sit in front of a computer monitor, concentrating on moving the cursor and perhaps more complex commands. Aside the patient, a technician will monitor two computer screens.



One monitor will show a video image of the subject’s brain, using bright yellow, orange and red to reflect brain activity. The other computer will measure and record the patient’s progress – exactly how well he or she is able to perform computer commands via brain signals.



Surgenor says the company has enough cash to carry it through the pilot trial, which should last well into 2005. By the end of the year it plans to file for FDA approval to conduct the pilot trial, Surgenor said.



Cyberkinetics investors include Oxford BioScience Partners of Boston; U.K.-based Global Life Science Ventures; and NeuroVentures Capital LLC of Charlottesville, Va.


Cyberkinetics also received initial investment from the Slater Center for
Biomedical Technology, a group funded by the state of Rhode Island that invests
in promising biomedical startup firms.


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