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Dr. John P. Donoghue Presents on BrainGate System at ALS/Motor Neuron Disease International Symposium

Posted on: Monday, 12 December 2005, 15:00 CST

The BrainGate(TM) Neural Interface System (BrainGate System) developed by Cyberkinetics Neurotechnology Systems, Inc. (OTCBB:CYKN) (Cyberkinetics) was the subject of a presentation to his peers at an international symposium in Europe by John P. Donoghue, Ph.D., Founder and Chief Scientific Officer of Cyberkinetics. The BrainGate System is currently being tested in a pilot clinical trial for those who have lost the ability to speak as a result of ALS (amyotrophic lateral sclerosis) or other motor neuron disease (MND).

Dr. Donoghue, who is also Professor and Chairman of the Department of Neuroscience at Brown University, addressed leading international researchers, as well as health and social care professionals, during 16th International Symposium on ALS/MND (amyotrophic lateral sclerosis/motor neuron disease) on Saturday, December 10, 2005, in Dublin, Ireland. Dr. Donoghue's pivotal closing address focused on recent advancements in the field of neuroscience and brain interface technology, as well as recent progress in the pilot clinical trial of Cyberkinetics' BrainGate(TM) Neural Interface System (BrainGate System) currently being tested in participants with spinal cord injuries and in those with ALS and other motor neuron diseases.

"In our new pilot trial, we are looking forward to testing the safety and feasibility of the BrainGate System in persons with ALS," Dr. Donoghue related. "We are eager to see if the initial proof-of-concept obtained thus far in the pilot trial of the BrainGate System for those with spinal cord injury (SCI) can be extended to persons with ALS and other motor neuron diseases."

In his address, Dr. Donoghue described how a neuromotor prosthesis system creates a direct physical communication link with the brain. Cyberkinetics' BrainGate System incorporates a novel, implanted neural activity sensor that directly detects neural signals in the primary motor cortex, the area of the brain that conveys movement commands. These neural signals can be translated by the BrainGate System's neural decoding processors into a control signal that can potentially operate a wide range of assistive technologies. According to Donoghue, preliminary from the first two participants in Cyberkinetics' spinal cord injury trial of the BrainGate System indicate that those with severe paralysis may someday be able to use the system to communicate via speech synthesizers, independently operate everyday devices, and feed themselves using robotic limbs.

About the BrainGate(TM) System

The BrainGate Neural Interface System is Cyberkinetics' 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. 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.

A pilot study of the BrainGate System is currently underway in those with severe paralysis resulting from spinal cord injury (SCI), muscular dystrophy, or with "locked-in" syndrome (tetraplegia and the inability to speak) secondary to stroke. Two participants have received BrainGate implants in this study, one of whom has recently completed one year in the trial. Previously published results from this study of the BrainGate System have demonstrated that a person with severe paralysis can control a computer cursor in order to operate external devices, as well as to operate a prosthetic hand. Enrollment for the BrainGate SCI study is currently open through the Spaulding Rehabilitation Hospital in Boston, Massachusetts, the Rehabilitation Institute of Chicago in Illinois, and the Sargent Rehabilitation Center in Providence, Rhode Island.

A second pilot study is currently enrolling individuals with ALS (Amyotrophic Lateral Sclerosis or Lou Gehrig's disease) or another motor neuron disease (MND) at the Massachusetts General Hospital in Boston, Massachusetts. The study is open to participants that live within a two-hour drive of Boston, Massachusetts, and that meet the study's selection criteria. The two primary goals of the pilot clinical study are to characterize the safety profile of the device and to evaluate the quality, type, and usefulness of neural output control that participants can achieve by using their thoughts. A long-term goal of this research is to develop a system that can be used by those with ALS or other motor neuron diseases without the assistance of a technician.

About Cyberkinetics Neurotechnology Systems, Inc.

Cyberkinetics Neurotechnology Systems, a leader in brain interface technology, is developing products to treat nervous system diseases and disorders by bringing together advances in neuroscience, computer science and engineering. Cyberkinetics' products are based on over ten years of technology development and cutting-edge neuroscience research at leading academic institutions such as Brown University, the Massachusetts Institute of Technology, Emory University, and the University of Utah.

Cyberkinetics has received FDA clearance to market the NeuroPort(TM) System, a neural monitor designed for acute inpatient applications and labeled for temporary (less than 30 days) recording and monitoring of brain electrical activity. The NeuroPort(TM) System can contribute to the diagnosis and treatment of neurological conditions in patients who have undergone a craniotomy by providing neurologists and neurosurgeons a new resource to detect, transmit and analyze neural activity.

Cyberkinetics' BrainGate(TM) System is being designed to give severely paralyzed individuals, as well as individuals with motor impairment from a variety of causes, a long-term, direct brain-computer interface for the purpose of communication and control of a computer, assistive devices, and, ultimately, limb movement.

Additional information about Cyberkinetics is available on the Company's website at www.cyberkineticsinc.com. For specific information about BrainGate(TM) clinical trials please send an email to braingateinfo@cktrial.com.

Forward-Looking Statements

This announcement contains forward-looking statements, including statements about Cyberkinetics' product development plans and progress. 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.

Source: Business Wire

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