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Press Release Source: Cyberkinetics Neurotechnology Systems, Inc.

Findings from First Participant in Cyberkinetics' BrainGate Study Published in Nature
Wednesday July 12, 1:05 pm ET
Discoveries Support Feasibility of Brain-Controlled Prosthetic and Assistive Devices for Paralyzed Patients

FOXBOROUGH, Mass.--(BUSINESS WIRE)--July 12, 2006--Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN; "Cyberkinetics") today reported that scientific findings from the first participant in the Company's ongoing pilot clinical trials of the BrainGate Neural Interface System (BrainGate) are featured on the July 13, 2006, cover of the journal Nature. This research, which has unlocked new information about how to restore movement following damage to the nervous system, was published by a team of clinical trial collaborators from Cyberkinetics, Brown University, Rhode Island Hospital, the Massachusetts General Hospital, the Spaulding Rehabilitation Center, the Sargent Rehabilitation Center, the Rehabilitation Institute of Chicago and the University of Chicago.


In the Nature article, the authors describe the technology advances that allowed the first pilot trial participant, a 25-year-old with spinal cord injury, to control a computer and robotic devices using brain activity detected by the BrainGate System. The team also discusses the performance of a second trial participant, a 55-year-old with spinal cord injury, who remains a participant in the pilot trial of the BrainGate System.

As reported in Nature, these data represent the first peer-reviewed, published clinical evidence that support important steps in the creation of useful brain-controlled assistive technologies to provide independence to persons with paralysis. These findings include the first evidence that a person with severe paralysis, years after a spinal cord injury, continues to have the ability to voluntarily generate movement signals in his primary motor cortex, the area of the brain responsible for voluntary movement. The researchers also found that neural spiking - the language of the brain - can be recorded in humans, routed outside the brain and decoded into movement commands. Importantly, the report describes that a paralyzed person can successfully use the intention to move, in the form of neural spiking patterns, to demonstrate real-time, continuous, two-dimensional control of a computer cursor, as well as to operate a prosthetic hand and control a multi-joint robotic arm.

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, "We now have direct, 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."

Donoghue continued, "Furthermore, we now have a greater understanding of how the human brain controls movement. Our findings suggest that limb movement originates in the brain as distinct and predictable patterns of neural activity. The fact that these patterns can be changed by imagining movement and can also be quickly translated into a control signal by computer algorithms holds promise for the ability to create a useful interface to aid persons with paralysis. These results also hold promise to one day be able to activate limb muscles with these brain signals, effectively restoring brain-to-muscle control via a physical nervous system."

"As a physician, I do whatever I can to optimize the recovery of patients with paralyzing disorders such as stroke, spinal cord injury or neuromuscular disease," stated Leigh R. Hochberg, M.D., Ph.D., lead author and a Principal Investigator in Cyberkinetics' pilot trial of the BrainGate System. "The available assistive technologies, however, provide neither sufficient independence nor mobility. Thanks to the generosity and pioneering spirit of our initial trial participants, who have volunteered without expecting to derive any personal benefit, important progress is being made in developing a real-time neuromotor prosthesis. Though much work remains to be done, hopefully one day, I'll be able to say, 'we have a technology that will allow you to move again.'"

"The findings reported today highlight the power of Cyberkinetics' neural interface technology and clearly demonstrate our leadership position in the rapidly growing field of neurotechnology," said Timothy R. Surgenor, President and Chief Executive Officer of Cyberkinetics. "We are eager to expand on this initial proof-of-concept and continue the development of the BrainGate System to provide an important new operating system for people with severe disabilities."

About the BrainGate System

The BrainGate Neural Interface System is a proprietary, investigational brain-computer interface (BCI) that consists of an internal sensor to detect brain cell activity and external processors that convert these brain signals into a computer-mediated output under the person's own control. The sensor is a tiny silicon chip about the size of a baby aspirin with one hundred electrodes, each thinner than a human hair, that can detect the electrical activity of neurons. The sensor is implanted on the surface of the area of the brain responsible for movement, the motor cortex. A small wire connects the sensor to a pedestal that is placed on the skull, extending through the scalp. An external cable connects the pedestal to a cart containing computers, signal processors and monitors that enable the study operators to determine how well study participants can control devices driven by their neural output - that is, by thought alone.

The ultimate goal of the BrainGate System development program is to create a safe, effective and unobtrusive universal operating system that will enable those with motor impairments resulting from a variety of causes to quickly and reliably control a wide range of devices, including computers, assistive technologies and medical devices, simply by using their thoughts. The fundamental groundwork for this human clinical work was conducted in the Donoghue lab at Brown University and made possible by preclinical funding from the National Institute of Neurological Disorders and Stroke.

Through funding from the National Center for Medical Rehabilitation Research and the National Institute of Child Health and Human Development, Cyberkinetics is working with collaborators at Case Western Reserve University and the Cleveland FES Center (Functional Electrical Stimulation) to develop a neuroprosthesis designed to work with the BrainGate System to restore partial arm and hand function to individuals with paralysis caused by spinal cord injury.

In June, researchers reported preliminary results at the American Society of Stereotactic and Functional Neurosurgeons and the American Spinal Cord Injury Association annual meetings in Boston, Massachusetts. Data reported from the first three participants in the study of the BrainGate System demonstrated that each participant had the ability to modulate their neuronal signals to voluntarily and cognitively control computer software. The first participant elected to have his BrainGate implant removed following the completion of his participation and has since fully recovered without incident. To date, there have been no unanticipated adverse events.

Co-authors of the study include: Leigh R. Hochberg, M.D., Ph.D., the Massachusetts General Hospital, Spaulding Rehabilitation Hospital and Instructor, Harvard Medical School; John P. Donoghue, Ph.D., Founder and Chief Scientific Officer of Cyberkinetics, Professor and Director of the Brain Science Program, Brown University; David Chen, M.D., Medical Director, Spinal Cord Injury Program, Rehabilitation Institute of Chicago; Richard Penn, M.D., Professor of Neurosurgery, University of Chicago Hospitals; Mijail D. Serruya, M.D., Ph.D., Founder of Cyberkinetics and Department of Neuroscience, Brown University; Jon Mukand, M.D., Ph.D., Sargent Rehabilitation Center; Gerhard Friehs, M.D., Founder of Cyberkinetics, Associate Professor of Clinical Neuroscience, Brown Medical School and Director of Functional Neurosurgery at Rhode Island Hospital; Maryam Saleh, Cyberkinetics and the University of Chicago; Almut Branner, Ph.D., Cyberkinetics; and Abraham H. Caplan, Cyberkinetics.

Dr. Hochberg is a member of the neurology staff at Massachusetts General Hospital, Brigham and Women's Hospital and the Spaulding Rehabilitation Hospital. He is also Associate Investigator, Rehabilitation Research and Development Service Center for Restorative and Regenerative Medicine, Department of Veterans Affairs, Providence, Rhode Island, as well as an Investigator in Neuroscience at Brown University.

About Cyberkinetics Neurotechnology Systems, Inc.

Cyberkinetics Neurotechnology Systems, Inc., a leader in the neurotechnology industry, is developing neural stimulation, sensing and processing technology to improve the lives of those with severe paralysis resulting from spinal cord injuries, neurological disorders and other conditions of the nervous system. Cyberkinetics' product development pipeline includes: the NeuroPort(TM) System, a cleared-to-market neural monitor designed for acute inpatient applications and labeled for temporary (less than 30 days) recording and monitoring of brain electrical activity; the Andara(TM) Oscillating Field Stimulator (OFS) Device, an investigative device designed to stimulate regeneration of the neural tissue surrounding the damaged spinal cord; and the BrainGate System, an investigative device designed to provide communication and control of a computer, assistive devices, and, ultimately, limb movement for persons with movement disabilities. Additional Information is available at Cyberkinetics' website at http://www.cyberkineticsinc.com.

Forward-Looking Statements

This announcement contains forward-looking statements, including statements about Cyberkinetics' product development plans and progress, potential development of proprietary inventions and benefits that may be realized by certain research programs. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and can be identified by the use of forward-looking terminology such as "may," "will," "believe," "expect," "anticipate" or other comparable terminology. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected in forward-looking statements and reported results shall not be considered an indication of our future performance. Factors that might cause or contribute to such differences include our limited operating history; our lack of profits from operations; our ability to successfully develop and commercialize our proposed products; a lengthy approval process and the uncertainty of FDA and other governmental regulatory requirements; clinical trials may fail to demonstrate the safety and effectiveness of our products; the degree and nature of our competition; our ability to employ and retain qualified employees; compliance with recent legislation regarding corporate governance, including the Sarbanes-Oxley Act of 2002; as well as those risks more fully discussed in our public filings with the Securities and Exchange Commission, all of which are difficult to predict and some of which are beyond our control.