Cyberkinetics Neurotechnology Systems Celebrates Completion of Improvements to Salt Lake City Manufacturing Facility; Facility Upgrades Completed as Cyberkinetics Prepares to Launch the 510(K)-Approved NeuroPort(TM) System.SALT LAKE CITY, Utah For ships of the United States Navy of the same name, see . Salt Lake City is the capital and the most populous city of the U.S. state of Utah. The name of the city is often shortened to Salt Lake, or its initials, S.L.C. and FOXBOROUGH, Mass. -- Cyberkinetics Neurotechnology Systems, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : CYKN) (Cyberkinetics), today celebrated the grand opening of its Salt Lake City, Utah Engineering Research and Manufacturing Facility in Salt Lake City, Utah. Cyberkinetics' proprietary NeuroPort(TM) System and the BrainGate(TM) System are manufactured for human use in the Class 10,000 cleanroom at the facility. At the opening, Utah Governor John Huntsman, Jr., addressed Cyberkinetics' employees, friends, members of the faculty and staff of the University of Utah The University of Utah (also The U or the U of U or the UU), located in Salt Lake City, is the flagship public research university in the state of Utah, and one of 10 institutions that make up the Utah System of Higher Education. , representatives from the Governor's Office of Economic Development and the State Advisory Council on Science and Technology concerning the importance of cutting-edge technology companies like Cyberkinetics to the overall economic development for the State of Utah and to those who will benefit from its development. Cyberkinetics newly opened cleanroom, a controlled environment where products for human use are manufactured, is contained within the Company's 10,000 square-foot Engineering Research and Manufacturing Facility located adjacent to the University of Utah campus in Salt Lake City. The complex includes laboratories and offices and currently supports 23 engineers, researchers and manufacturing personnel. The Company plans to expand the facility and to increase the number of employees when necessary to meet demand for its NeuroPort(TM) System, which is on track for product launch in 2006. "We are honored that Cyberkinetics has chosen to invest in its Engineering Research and Manufacturing Facility in Utah," said Jon Huntsman, Jr., Governor of Utah. "Companies like Cyberkinetics boost our economy, offer high-paying technical opportunities for our children, as well as attract other scientific and technology-based companies to our state. We are pleased, too, that such wonderful technology that originated at the University of Utah is now being developed to improve the lives of those with severe paralysis." "The completion of our cleanroom upgrades represents a significant milestone in the Company's development," said Timothy R. Surgenor, President and Chief Executive Officer of Cyberkinetics. "Completion of these upgrades keeps us on track for the launch of our NeuroPort(TM) System in 2006 and will be essential as we continue production of our BrainGate(TM) System for additional participants in our two ongoing pilot clinical trials. We now have the capacity we need to meet manufacturing demands for our products for the next several years. "We also would like to acknowledge the efforts of Senator Bob Bennett of Utah to increase federal funding that supports our cutting-edge research," Surgenor continued. "He has recognized the potential for our BrainGate(TM) System technology to improve the lives of motor-impaired people by providing them with the ability to communicate, to operate computers and other devices and, ultimately, to move their own limbs - simply by thinking." About the NeuroPort(TM) System The NeuroPort(TM) System is an FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. cleared medical device intended for temporary (less than 30 days) recording and monitoring of brain electrical activity. The NeuroPort(TM) System is based on Cyberkinetics' BrainGate(TM) technology and is designed for acute inpatient applications. Potential clinical applications for invasive brain monitoring currently include patients undergoing elective surgery elective surgery Surgery Any operation that can be performed with advanced planning–eg, cholecystectomy, hernia repair, colonic resection, coronary artery bypass for diagnosis and treatment of severe epilepsy, as well as patients undergoing craniotomies for traumatic brain injuries and stroke. Cyberkinetics expects to launch the NeuroPort(TM) System in 2006. About the BrainGate(TM) System The BrainGate Neural Interface System is a proprietary brain-computer interface (BCI BCI Bat Conservation International BCI Brain-Computer Interface BCI Business Continuity Institute BCI Business Cycle Indicators BCI Banco de Credito e Inversiones (Chilean bank) BCI Bell Canada International ). BrainGate is an investigational device currently in pilot clinical trials 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 baby aspirin Therapeutics A popular term for a formulation that contains 81 or less mg of aspirin, used to ↓ blood coagulability. See 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 motor cortex n. The region of the cerebral cortex influencing movements of the face, neck and trunk, and arm and leg. Also called excitable area, motor area, Rolando's area. . 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, and in this implementation (project) the muscles of a person with paralysis, simply by using their thoughts. Cyberkinetics is currently conducting two pilot clinical trials of the BrainGate(TM) System. In its first pilot clinical trial currently underway, clinical researchers are testing the safety and feasibility of the BrainGate in those with severe paralysis resulting from spinal cord injury Spinal Cord Injury Definition Spinal cord injury is damage to the spinal cord that causes loss of sensation and motor control. Description Approximately 10,000 new spinal cord injuries (SCIs) occur each year in the United States. (SCI (Scalable Coherent Interface) An IEEE standard for a high-speed bus that uses wire or fiber-optic cable. It can transfer data up to 1GBytes/sec. (hardware) SCI - 1. Scalable Coherent Interface. 2. UART. ), muscular dystrophy, or with "locked-in" syndrome (tetraplegia tetraplegia /tet·ra·ple·gia/ (-ple´jah) quadriplegia. tet·ra·ple·gia n. See quadriplegia. tetraplegia paralysis of all four extremities; quadriplegia. and the inability to speak) secondary to stroke. Previously published results from this study of the BrainGate System have demonstrated that a person with severe paralysis may be able to control a computer cursor in order to operate external devices, as well as to operate a prosthetic pros·thet·ic adj. 1. Serving as or relating to a prosthesis. 2. Of or relating to prosthetics. prosthetic serving as a substitute; pertaining to prostheses or to prosthetics. hand. In a second pilot trial, researchers are testing the BrainGate System in those with ALS Als (äls), Ger. Alsen, island, 121 sq mi (313 sq km), Sønderjylland co., S Denmark, in the Lille Bælt, separated from the mainland by the narrow Alensund. (amyotrophic lateral sclerosis amyotrophic lateral sclerosis (ALS) (ā'mīətrōf`ik, sklĭrō`sĭs) or motor neuron disease, or Lou Gehrig's disease Lou Geh·rig's disease n. See amyotrophic lateral sclerosis. ) and other motor neuron diseases. The study is being conducted at Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world (MGH MGH Massachusetts General Hospital MGH McGraw-Hill Companies MGH Montreal General Hospital (Montreal, Canada) MGH Monumenta Germania Historica MGH May Go Home MGH Minneapolis General Hospital ). 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 Massachusetts Institute of Technology, at Cambridge; coeducational; chartered 1861, opened 1865 in Boston, moved 1916. It has long been recognized as an outstanding technological institute and its Sloan School of Management has notable programs in business, , 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 Craniotomy Definition Surgical removal of part of the skull to expose the brain. Purpose A craniotomy is the most commonly performed surgery for brain tumor removal. 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 par·a·lyze tr.v. par·a·lyzed, par·a·lyz·ing, par·a·lyz·es 1. To affect with paralysis; cause to be paralytic. 2. To make unable to move or act: paralyzed by fear. 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 braingateinfo@cktrial.com. Forward Looking Safe Harbor Statement This announcement contains forward-looking statements, including statements about Cyberkinetics' manufacturing capabilities, plans and progress, 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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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