Healthcare Industry News: amyotrophic lateral sclerosis
News Release - February 8, 2006
Cyberkinetics Provides Update on BrainGate(TM) System Pilot Clincal TrialsTotal of Four Participants Have Enrolled in Ongoing Trials of BrainGate System
FOXBOROUGH, Mass.--(HSMN NewsFeed)--Feb. 8, 2006--Cyberkinetics Neurotechnology Systems, Inc. (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 due to spinal cord injury, stroke or muscular dystrophy ("SCI trial"); and the second is for those diagnosed with ALS (amyotrophic lateral sclerosis or Lou Gehrig's disease) 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) 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 that enables those with quadriplegia to control their own arms and hands in a way that allows them to, for example, feed themselves.
"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, 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 may contribute to the diagnosis and treatment of neurological conditions in patients who have undergone a craniotomy 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 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 (Chicago, IL). The ALS trial, which was announced in August 2005, is being conducted at Massachusetts General Hospital (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.
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.
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