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Cyberkinetics Provides Update on BrainGate(TM) System Pilot Clincal Trials; Total of Four Participants Have Enrolled in Ongoing Trials of BrainGate System.


FOXBOROUGH, Mass. -- Cyberkinetics Neurotechnology Systems, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:CYKN; "Cyberkinetics") today provided a quarterly update on two pilot clinical studies currently underway of the Company's BrainGate(TM) Neural Interface System. The first trial is for those 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.  ("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.
 trial"); and the second is for those diagnosed 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.
) or other motor neuron diseases ("ALS trial").

The Company reported that:

--A total of four participants have enrolled in two pilot clinical trials, including three in the SCI trial and one in the ALS trial.

--The Company is actively working with researchers at Brown University, under a recently announced collaborative research agreement, to leverage the expanded stream of clinical data to further the development of the BrainGate Operating System. Through the agreement, certain researchers have access to Cyberkinetics' valuable clinical data and the Company gains exclusive rights to intellectual property derived from the research based on Cyberkinetics' clinical data.

--Under the terms of a five-year, $4.4 million contract awarded in 2005 by the National Center for Medical Rehabilitation Research, a component of the National Institute of Child Health and Human Development, Cyberkinetics and Case Western Reserve University and the Cleveland FES (Functional Electrical Stimulation Functional electrical stimulation (commonly abbreviated as FES) is a technique that uses electrical currents to activate nerves innervating extremities affected by paralysis resulting from spinal cord injury (SCI), head injury, stroke or other neurological disorders, ) Center will combine the limb-movement electrical stimulation technology developed at Case and the FES Center with Cyberkinetics' brain-interface technology. The goal of the collaboration is to develop a neural prosthesis neural prosthesis Neurology Any electronic and/or mechanical device that connects with the nervous system and supplements or replaces functions lost by disease or injury. See Nerve regeneration.  that enables those with quadriplegia to control their own arms and hands in a way that allows them to, for example, feed themselves.

"Over the last few months we have increased the pace of development and clinical testing of the BrainGate system significantly," said John Donoghue, Ph.D., Founder and Chief Scientific Officer of Cyberkinetics and Chairman of the Department of Neuroscience at Brown University. "What we have seen to date indicates that we are making important progress toward our goal of allowing people with severe disabilities to use the BrainGate System to operate ordinary, everyday devices simply by thinking - which could provide a greater sense of independence and control."

"The expansion of our clinical trial enrollment and the initiation of key academic partnerships have accelerated our progress toward Cyberkinetics' ultimate goal of developing a safe, effective and unobtrusive BrainGate neural interface that is designed to allow severely disabled individuals to control computers and other everyday devices using their thoughts," said Tim Surgenor, Cyberkinetics' President and Chief Executive Officer. "We look forward to reporting on the results of these efforts at scientific and medical conferences during the rest of 2006."

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 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 has received 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.
 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 may 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 ("BrainGate System"; "BrainGate") 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. Conducted under Investigational Device Exemptions (IDE) from the FDA, the goal of the SCI and ALS pilot studies is to demonstrate initial proof of principle of the ability of severely disabled individuals to control the BrainGate computer interface by thinking. The SCI pilot trial of the BrainGate System is being conducted at three clinical sites, including 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 ALS trial, which was announced in August 2005, 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  (Boston, MA).

Cyberkinetics, as a matter of policy, adheres to the following guidelines concerning communication about its ongoing clinical trials:

--Cyberkinetics will report its clinical trial(s) status in regular updates on a quarterly basis.

--The Company comments on clinical trial results only after the data supporting those results have been presented at a scientific forum, such as a scientific or clinical conference.

--Cyberkinetics, in keeping with applicable regulations, does not provide the names or any other personal information concerning participants enrolled in the Company's clinical trials. The decision to make such information public is exclusively a matter between participant and physician.

For additional information about Cyberkinetics, visit the Company's website at www.cyberkineticsinc.com. 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 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.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Feb 8, 2006
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