Rehabilitation Institute of Chicago Joins Cyberkinetics' BrainGate Neural Interface System Pilot Study
February 28, 2005
Feb. 28, 2005 - The Rehabilitation Institute of Chicago (RIC) and Cyberkinetics Neurotechnology Systems, Inc. (OTCBB:CYKN) (Cyberkinetics) today announced the addition of RIC as a new clinical site for the BrainGate(TM) Neural Interface System pilot study. RIC has been ranked the "Best Rehabilitation Hospital in America" by U.S. News & World Report every year since 1991.
About the BrainGate Pilot Study
Cyberkinetics received regulatory clearance from the U.S. Food and Drug Administration (FDA) in March of 2004 to study the BrainGate Neural Interface System under an Investigational Device Exemption (IDE). The first patient was enrolled through the Sargent Rehabilitation Center in Rhode Island and has successfully been able to use his thoughts and the BrainGate System to demonstrate that the System can be used to operate a computer, environmental controls and a robotic limb. These results were presented at the annual meetings of the American Academy of Physical Medicine and Rehabilitation in Phoenix, Arizona on October 8, 2004 and the Society for Neuroscience in New Orleans on October 24, 2004. In December 2004, Boston's Spaulding Rehabilitation Hospital joined as the second study site.
The pilot (feasibility) study protocol provides for the enrollment of up to five individuals with quadriplegia (unable to use their arms and legs) who are between the ages of 18 and 60 and who 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 patients can achieve using thoughts. Based on the results obtained by the first participant in the study, Cyberkinetics is working on a second generation software operating system which is intended to simplify the daily set-up of the System and to provide a standard user interface for control of a computer and other associated devices such as telephone and television. The Company intends to test this next generation of software during the BrainGate pilot study.
About the BrainGate System
The BrainGate(TM) Neural Interface System is a proprietary, investigational brain-computer interface 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 silicone chip about the size of a baby aspirin with one hundred electrodes, each thinner than a hair, that detect the electrical activity of neurons. The sensor is implanted on the surface of the area of the brain responsible for movement, the primary motor cortex. A small wire connects the sensor to a pedestal which is mounted on the skull, extending through the scalp. An external cable connects the pedestal to a cart containing computers, signal processors and monitors which enable the study operators to determine how well a study participant can control his neural output.
The ultimate goal of the BrainGate development program is to create a safe, effective and unobtrusive universal operating system which will allow physically disabled people to quickly and reliably control a wide range of devices using their thoughts, including computers, assistive technologies and medical devices. The BrainGate System has significant potential advantages over other muscle driven or brain-based computer interface approaches, including its potential to interface with a computer without weeks or months of training; its potential to be used in an interactive environment, where the user's ability to operate the device is not affected by their speech, eye movements or ambient noise; and the ability to provide significantly more usefulness and utility than other approaches by connecting directly to the part of the brain that controls hand movement and gestures. The development of BrainGate is patterned after the development of successful long-term implantable devices for the treatment of Parkinson's disease and epilepsy and for the restoration of hearing in the profoundly deaf. These neurotechnology devices are now used by over 100,000 people in the United States.
"At the Rehabilitation Institute of Chicago, we are committed to bringing the best in leading-edge research and patient care to people with spinal cord injuries and other physical disabilities. We are very excited about the promise of the BrainGate technology and look forward to advancing the science and possibly advancing the quality of life for people with spinal cord injuries," commented David Chen, M.D., Medical Director of the Spinal Cord Injury Program at RIC and principal investigator for the RIC study site.
"We are very pleased by the addition of the Rehabilitation Institute of Chicago to the BrainGate Study," said Tim Surgenor, President and CEO of Cyberkinetics. "RIC is an acknowledged leader in the field of rehabilitation medicine and its participation is expected to help us develop the BrainGate System more quickly and effectively. The anticipated enrollment of additional patients should further our efforts to develop products that improve the lives of many people with physical disabilities, including those with spinal cord injury.
"I am very pleased and excited to see that the basic science that we pursue in our laboratory continues to make the transition into the clinic with the addition of the RIC site," said Nicholas G. Hatsopoulos, Ph.D., co-founder of Cyberkinetics Neurotechnology Systems, Inc. and Assistant Professor at the University of Chicago. "The neuroscience field is rapidly advancing and the BrainGate System reflects a significant potential breakthrough for patients with severe physical disabilities."
About the Rehabilitation Institute of Chicago
Since 1954, RIC's dedication to helping people with disabilities achieve the best life possible has made it a trusted organization that attracts patients and healthcare professionals from around the world. While best known for treating the most complex cases such as brain injury, spinal cord injury and stroke, RIC brings the same level of expertise to helping those with more common conditions including arthritis, chronic pain and sports injuries.
The Institute has more than 30 centers of care throughout the Chicago-area and in southern Illinois. RIC is the home to the largest rehabilitation research program in the world, with more than 250 scientific studies underway. To learn more about RIC visit www.ric.org.
About Cyberkinetics Neurotechnology Systems, Inc.
Cyberkinetics, a publicly traded company, is a leader in an emerging field driven by advances in neuroscience, computer science, and engineering. The Company's products are focused on treating diseases and disorders of the nervous system. The Company has been widely recognized and has won multiple awards for its innovative scientific and product development achievements. Cyberkinetics' intellectual property features key technologies licensed from Brown University, the Massachusetts Institute of Technology, Emory University, and the University of Utah. Cyberkinetics is headquartered in Foxborough, Massachusetts and conducts engineering and research in Salt Lake City, Utah. More information is available at www.cyberkineticsinc.com. For specific information about the BrainGate(TM) clinical study please send an email to braingateinfo@cktrial.com.
Forward Looking Safe Harbor Statement:
This news release contains "Forward Looking Statements." These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Forward-looking statements include, but are not limited to, statements concerning our future expectations, plans, prospects and future operating results as well as projections of cash and marketable securities and sufficiency of funding for capital expenditures. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors including risks related to: our access to additional capital; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales and distribution of our products; our development of products; our ability to obtain and maintain patent protection for our discoveries and products; and our limited operating history; as well as those risks more fully discussed in the "Risk Factors" section of the Form 8-K filed with the Securities and Exchange Commission on October 8, 2004. Any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.
Pilot Study Information:
If you are a patient interested in receiving information about the BrainGate pilot study please contact: Diane Hartwig, CNP, APN, Rehabilitation Institute of Chicago: (312)238-0764, dhartwig@ric.org.
Journalists contact: mediarelations@ric.org, 312-238-6044.
All others contact: webmaster@ric.org.
