(2005-12-02) Cyberkinetics Neurotechnology Systems/Judy Katz (2
Clinical Trial Participant with Quadriplegia Uses His Own Thoughts to Control a Computer and a Prosthetic Hand
FOXBOROUGH, Mass.--Dec. 2, 2005--Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN) (Cyberkinetics) announced today that John Donoghue, Ph.D., Founder and Chief Scientific Officer of Cyberkinetics and Chairman of the Department of Neuroscience at Brown University was interviewed in the Thursday's segment of the Today Show entitled "Mind-moving Machines to Help the Disabled." Hosted by Katie Couric, the program also featured Matthew Nagle, the first participant in Cyberkinetics' ongoing clinical trial of its BrainGate(TM) Neural Interface System (BrainGate). The segment was the fourth program in the Today Show's weeklong series called "Saving Your Life: Modern Medical Miracles." The segment was taped previously during the actual clinical trial and at the Company's headquarters in Foxborough, Massachusetts.
Matthew Nagle, the first participant in Cyberkinetics' ongoing clinical trial of the BrainGate System, demonstrated his ability to use his own thoughts to control a computer and command the prosthetic hand on a table beside him to open and close. Mr. Nagle is currently paralyzed from the neck down due to an injury four years ago that severed his spinal cord.
On the Today Show, Dr. Donoghue discussed the scientific and practical implications of Cyberkinetics' breakthrough brain interface technology, including Cyberkinetics' progress toward development of the BrainGate System technology to enable those with quadriplegia to perform a variety of everyday living tasks that would, if the Company is successful, enable them to become more self-sufficient and independent.
Commenting on the excitement surrounding Cyberkinetics' BrainGate technology, Dr. Donoghue continued, "The preliminary success we have seen with Matthew and the second participant in the trial support our continued development of the BrainGate System as we move closer to our ultimate objective: the creation of a thought-controllable operating system for people with severe paralysis that enables them, eventually we hope, to move their own limbs."
About the BrainGate(TM) 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.
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.
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.