Healthcare Industry News: amyotrophic lateral sclerosis
News Release - August 23, 2006
Cyberkinetics Provides Update on Ongoing Clinical Trials of BrainGate Neural Interface SystemReport Includes Initial Results From Use of BrainGate by a Person with ALS
FOXBOROUGH, Mass.--(HSMN NewsFeed)--Aug. 23, 2006--Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN; "Cyberkinetics") announced that preliminary results from the pilot trials of Cyberkinetics' BrainGate Neural Interface System (BrainGate) were presented at the Neural Interfaces Workshop in Bethesda, Maryland, sponsored by the National Institute of Neurological Disorders and Stroke. The report included the first update on a participant with amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).
Leigh R. Hochberg, M.D., Ph.D., a Principal Investigator for the pilot trial of the BrainGate System, and John P. Donoghue, Ph.D., a founder and Chief Scientific Officer of Cyberkinetics and Director of the Brain Science Program at Brown University, presented data that demonstrate the ability of the BrainGate System to record cortical activity from an individual with ALS. They also presented data showing that a participant in the trial, who is unable to speak due to a brainstem stroke, has used the BrainGate System to type messages using a virtual keyboard interface.
"We have recorded cortical signals from our first participant with ALS, and we're further encouraged that this participant has been able to use the signals recorded from motor cortex to control a computer cursor in a manner similar to previous participants in our trial" stated John P. Donoghue, Ph.D. "It is significant that we have been able to record volitionally modulating cortical activity in the motor cortex of someone with advanced ALS, despite the fact that this part of the brain may show signs of degeneration in the disorder. In addition, we are pleased with the continued improvement in the quality of cursor control provided by our latest decoding software."
"We are especially optimistic that the BrainGate System could ultimately provide a 'voice' to those who are currently unable to speak or to write due to nervous system injury or disease," added Tim Surgenor, President and Chief Executive Officer of Cyberkinetics. "We plan to continue to develop our innovative technology in the hope of providing products that improve the quality of life and provide independence for those with severe paralysis, as well as other nervous system conditions."
Additional results from the ongoing study of the BrainGate System will be presented at the Annual Meeting of the Society for Neuroscience in mid-October 2006.
In addition to his role as Principal Investigator in the BrainGate clinical trial, Dr. Hochberg is Associate Investigator, Rehabilitation Research and Development Service, Center for Restorative and Regenerative Medicine, Department of Veterans Affairs, Providence, Rhode Island, a member of the neurology staff at Massachusetts General Hospital, Brigham and Women's Hospital and the Spaulding Rehabilitation Center, and is 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 Andara(TM) Oscillating Field Stimulator (OFS) Device, an investigative device designed to stimulate regeneration of the neural tissue surrounding the spinal cord; the BrainGate System, an investigative device designed to provide communication and control of a computer, assistive devices, and, ultimately, limb movement; and the FDA cleared-to-market 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. Additional Information is available at Cyberkinetics' website at http://www.cyberkineticsinc.com.
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.
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