Cyberkinetics Gives Update on BrainGate Clinical Trial.FOXBOROUGH, Mass. -- - - Second Patient Implanted; Further Updates to Come Quarterly - Cyberkinetics Neurotechnology Systems, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). - CYKN) today provided an update on the status of the pilot clinical trial of the BrainGate(TM) Neural Interface System, and announced its intention to provide future updates on a quarterly basis. As of March 31, 2005, two patients have been implanted and are active in the pilot BrainGate(TM) trial. The trial is being conducted under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) from the 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. , which provides for implanting the BrainGate(TM) System in five patients with quadriplegia quadriplegia: see paraplegia. due to 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. , stroke or muscular dystrophy muscular dystrophy (dĭs`trōfē), any of several inherited diseases characterized by progressive wasting of the skeletal muscles. There are five main forms of the disease. for a period of 12 months. The 12 month period for the first study patient will end during June 2005. In February 2005, interim results of the pilot study of the BrainGate(TM) Neural Interface System were presented at the Association of Academic Physiatrists. This report summarized the initial findings from the first trial participant six months after implantation. The BrainGate(TM) device appears to be functioning as planned and the first participant continues to be able to use the system to control a computer using thoughts. There have been no reported adverse patient events observed in the trial to date. The current roster of BrainGate(TM) clinical sites includes Sargent Rehabilitation Center (Warwick, RI), Spaulding Rehabilitation Center (Boston, MA) and the Rehabilitation Institute of Chicago The Rehabilitation Institute of Chicago is a rehabilitation hospital located in Chicago, Illinois, United States. It is a part of the McGaw Medical Center of Northwestern University. (Chicago, IL). The Chicago site joined the trial during the most recent quarter. There is no present intention to further expand the number of sites for this initial trial. "All of our clinical sites are actively engaged in recruiting additional patients into the BrainGate(TM) trial," said Timothy R. Surgenor, Cyberkinetics' President and Chief Executive Officer. "We are making good progress in developing the next generation of BrainGate(TM) software, including patient interface upgrades and we look forward to working with our partners and with FDA to integrate those enhancements into the ongoing clinical trial." "With this update, we are initiating a policy of providing BrainGate(TM) trial status summaries on a quarterly basis," Surgenor said. "We will continue to keep the identity and location of patients in the trial confidential, until such time as an individual patient and his or her physician decide to be identified to the public. We will also continue to report results which are clinically or scientifically meaningful through posters, presentations or publications." About the BrainGate(TM) System The BrainGate(TM) Neural Interface System is a proprietary, investigational brain-computer interface 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 silicone 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 hair, that detect the electrical activity of neurons. The sensor is implanted on the surface of the area of the brain responsible for movement, the primary motor cortex The primary motor cortex (or M1) works in association with pre-motor areas to plan and execute movements. M1 contains large neurons known as Betz cells which send long axons down the spinal cord to synapse onto alpha motor neurons which connect to the muscles. . A small wire connects the sensor to a pedestal which extends through the scalp. An external cable connects the pedestal to a cart containing computers, signal processors and monitors which enable the study operators to determine how well a study participant can control his neural output. About the BrainGate(TM) Pilot Study The ongoing pilot (feasibility) study will enroll up to five quadriplegic quadriplegic /quad·ri·ple·gic/ (-ple´jik) 1. of, pertaining to, or characterized by quadriplegia. 2. an individual with quadriplegia. individuals between the ages of 18 and 60 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 patients can achieve using thoughts. Participants will undergo surgery to implant the sensor portion of the BrainGate(TM) neural interface on the area of the brain responsible for movement. During the study, they will perform tasks with the device such as attempting to control the movement of a cursor on a screen toward a specific target with their thoughts. The study is expected to last for about 12 months for each patient. At the end of the study, each participant will undergo another surgery to have the device removed or may have the option to participate in future studies. For specific information about the BrainGate(TM) clinical study please send an email to braingateinfo@cyberkineticsinc.com. About Cyberkinetics Neurotechnology Systems, Inc. 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. . More information is available at www.cyberkineticsinc.com. 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: This press release contains forward-looking statements, including statements about plans for expansion of the BrainGate(TM) initial clinical trial and ongoing refinements of the BrainGate(TM) System. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the near future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see our filings with the Securities and Exchange Commission. |
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