Cyberkinetics Receives Neuroport 510K Clearance; Acute Neural Monitor is Company's First Commercial Clinical Product.FOXBOROUGH, Mass. -- Cyberkinetics Neurotechnology Systems, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : CYKN) (Cyberkinetics) today announced that it has obtained 510(k) clearances of its NeuroPort(TM) Cortical Microelectrode mi·cro·e·lec·trode n. A very small electrode, often used to study electrical characteristics of living cells and tissues. microelectrode, n Array (NeuroPort(TM) Array) and NeuroPort(TM) Neural Signal Processor (NeuroPort(TM) NSP (1) (Network Service Provider) An organization that provides a high-speed Internet backbone to ISPs and other service providers. Sprint, MCI and UUNET are examples of NSPs. See Internet backbones. ). Taken together, the NeuroPort(TM) Array and NeuroPort(TM) NSP comprise a neural monitoring system (the NeuroPort(TM) System) designed for acute inpatient applications, and labeled for temporary (less than 30 days) recording and monitoring of brain electrical activity. E[acute accent]Potential clinical applications for invasive brain monitoring with the NeuroPort(TM) in the United States 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 (approximately 5,000/year) and patients undergoing emergency craniotomies for brain injury and strokes (approximately 70,000/year). E[acute accent]The NeuroPort(TM) System is capable of providing neurologists and neurosurgeons a new resource to detect, transmit and analyze neural activity of patients who have undergone 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. . The Array allows the collection of aggregate or individual neural signals from the cortical region of the brain. The NSP allows these signals to be recorded and analyzed by the physician as a part of the diagnosis and treatment of neurological conditions Neurological conditions A condition that has its origin in some part of the patient's nervous system. Mentioned in: Pervasive Developmental Disorders . The NeuroPort(TM) System is covered by two issued patents, and system elements are including in a number of additional patent applications. E[acute accent]Cyberkinetics anticipates a limited market introduction of the NeuroPort(TM) System early in 2006, after completing necessary manufacturing upgrades during the remainder of 2005. Cyberkinetics is evaluating distribution strategies to support a broad product launch before the end of 2006. E[acute accent]"Marketing clearance of the NeuroPort(TM) System, our first commercial clinical product, is an important first step in our strategy to develop a broad family of products to diagnose, monitor and treat neurological diseases and injuries," said President and Chief Executive Officer Timothy R. Surgenor. "NeuroPort(TM) will provide us with entry into an established and growing invasive brain monitoring market of approximately $100 million annually. It also allows us work with clinicians to begin to explore applications of our technology in potentially much larger markets for long-term monitoring and treatment of neurological disease." E[acute accent]"The NeuroPort(TM) Array and the NeuroPort(TM) NSP are both critical components derived from our BrainGate(TM) Neural Interface System," Surgenor continued. "These approvals testify to the strong pre-clinical foundation of our technology platform. Furthermore, clinical use of the NeuroPort(TM) System will help familiarize neurologists and neurosurgeons with the characteristics and capabilities of our core technology and will provide invaluable clinical experience that will accelerate all of our programs, including the BrainGate(TM) program." E[acute accent]About Cyberkinetics Neurotechnology Systems, Inc. E[acute accent]Cyberkinetics Neurotechnology Systems, a leader in brain-machine 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 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. . Cyberkinetics is publicly traded on the Over the Counter Bulletin Board under the ticker symbol Ticker Symbol An arrangement of characters (usually letters) representing a particular security listed on an exchange or otherwise traded publicly. When a company issues securities to the public marketplace, it selects an available ticker symbol for its securities which investors CYKN. The Company is headquartered in Foxborough, Massachusetts and conducts engineering and research in 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. . Additional information is available at www.cyberkineticsinc.com. E[acute accent]Forward Looking Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement: E[acute accent]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 Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has 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 Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 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. |
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