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Cyberkinetics Neurotechnology Systems, Inc. (OTCBB:CYKN) (Cyberkinetics) today announced the start of a new pilot clinical study of the BrainGate(TM) Neural Interface System, a brain-computer interface (BCI), in individuals diagnosed with amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) or other progressive motor neuron diseases. Cyberkinetics received regulatory clearance to conduct the study under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) and the study will be conducted at Massachusetts General Hospital (MGH).
"The goals of this study are to investigate the safety and feasibility of the BrainGate(TM) System in people living with ALS or other motor neuron diseases," commented Leigh R. Hochberg, M.D., Ph.D., of MGH, Principal Investigator for the study and Instructor of Neurology at Harvard Medical School. "If study participants are able to gain control over a computer cursor with the BrainGate System, this could open the door to controlling a broad range of other devices, including assistive communication devices, speech synthesizers, and, eventually, devices to re-enable limb movement. Furthermore, by recording neural activity over time in participants with ALS, this study may help to provide additional insights into the neurodegenerative process that occurs with this complex disease."
"ALS is particularly devastating because a person's intellect can remain intact throughout the course of the disease," said Merit E. Cudkowicz, M.D., an MGH neurologist and co-investigator for the study. "People with ALS are therefore aware of the gradual loss of the ability to control their muscles, to communicate, and eventually to breathe. By potentially enabling ALS patients to maintain or regain simple communication, the BrainGate(TM) System could improve quality of life and address a critical need for patients with advanced disease.
"The ultimate goal of the BrainGate(TM) System development program is to create a safe, effective and universal operating system that will allow physically disabled people to quickly and reliably control a wide range of devices using their thoughts," said John Donoghue, Ph.D., Chief Scientific Officer at Cyberkinetics. "This new study is an important step in building on our initial success with the BrainGate System in spinal cord injury patients by attempting to address the specific clinical and scientific needs of patients with a progressive disease like ALS."
Amyotrophic Lateral Sclerosis (ALS) is a rare progressive and ultimately fatal neurological disease that attacks the neurons in the brain, brain stem and spinal cord. ALS is sometimes known as Lou Gehrig's disease, after the baseball great who died of it in 1942. In order to move, speak or blink an eye, neurons must communicate commands from the brain to the muscles involved in these actions. In ALS, specific motor neurons degenerate, causing muscles to stop receiving movement commands. People with ALS ultimately lose their ability to speak and communication becomes difficult, if not impossible. However, ALS commonly does not impair a person's ability to think, intelligence or memory. Therefore, maintaining the ability to communicate is an important clinical issue. The cause of ALS is unknown, and there is no known cure.
About the BrainGate Pilot Study for ALS
The pilot (feasibility) study will enroll individuals who have been diagnosed with ALS (Amyotrophic Lateral Sclerosis or Lou Gehrig's disease) or another motor neuron disease (MND) that has already resulted in a decreased ability to use their arms and hands. The study is open to participants between the ages of 18 and 70, who live within a two-hour drive of Boston 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 participants can achieve by using their thoughts. Over the course of the 12-month study, each participant will perform tasks with the BrainGate(TM) System such as attempting to control the movement of a cursor on a screen by imagining movement of their arm to move the cursor toward a specific target. 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.
The study will be lead by four MGH investigators in Boston. The Principal Investigator for the study is Leigh R. Hochberg, M.D., Ph.D., who is on the Neurology staff at Massachusetts General Hospital and Brigham and Women's Hospital, and a Consultant in Neurology at The Spaulding Rehabilitation Hospital. Co-investigators on the study are: Robert Brown, Jr., M.D., D. Phil., Professor of Neurology at Harvard Medical School and Director of the Day Neuromuscular Laboratory and Muscular Dystrophy Association clinic at MGH; Merit Cudkowicz, M.D., Associate Professor at Harvard Medical School and co-director of the MGH ALS clinic; and Lisa Stroud Krivickas, M.D., Associate Chief of Physical Medicine & Rehabilitation at MGH and Director of Electrodiagnostic Medicine at the Spaulding Rehabilitation Hospital.
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.
Another 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, the Rehabilitation Institute of Chicago and the Sargent Rehabilitation Center.
About Massachusetts General Hospital
Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $450 million and major research centers in AIDS, cardiovascular research, cancer, cutaneous biology, medical imaging, neurodegenerative disorders, transplantation biology and photomedicine. In 1994, MGH and Brigham and Women's Hospital joined to form Partners HealthCare System, an integrated health care delivery system comprising the two academic medical centers, specialty and community hospitals, a network of physician groups, and non-acute and home health services.
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 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.
More information is available at www.cyberkineticsinc.com. For specific information about BrainGate(TM) clinical trials please send an email to firstname.lastname@example.org.
Forward Looking Safe Harbor Statement
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.