Healthcare Industry News: Northstar Neuroscience
News Release - May 31, 2007
Northstar Neuroscience Announces the Completion of Subject Enrollment and Randomization in the EVEREST Pivotal Trial for Upper Extremity Motor Recovery in Stroke Survivors
SEATTLE--(HSMN NewsFeed)--Northstar Neuroscience, Inc. (NASDAQ: NSTR ), a developer of medical devices for the treatment of neurological diseases and disorders, today announced the completion of subject enrollment and randomization in the EVEREST investigational study. EVEREST is Northstar's pivotal trial of cortical stimulation for the treatment of hand/arm impairment in chronic stroke survivors."This is a significant milestone for our company and is the culmination of several years of research and focused effort on the part of our employees and clinical collaborators," said Alan Levy, CEO of Northstar Neuroscience. "We are enthusiastic that our cortical stimulation therapy may offer hope to the millions of stroke survivors who live with hand and arm impairment. Completion of enrollment and randomization is a key step toward making this therapy available to improve the lives of stroke survivors."
EVEREST is a national, multi-center, single-blinded, randomized clinical trial investigating whether cortical stimulation in conjunction with intense physical rehabilitation improves hand and arm function in chronic stroke survivors as compared to survivors that have received intense physical rehabilitation alone. The trial is being conducted at 21 leading stroke centers throughout the United States and when complete will include data from over 150 subjects. "The commitment of the EVEREST teams at each of our trial sites has really been phenomenal," says Nawzer Mehta, VP of Clinical Affairs. "Northstar is proud of our combined achievements in meeting this important milestone on the way to study completion."
"The EVEREST trial design was based on a strong foundation of preclinical science and prior feasibility clinical studies," said Robert Levy, M.D., Ph.D., the primary investigator of the trial at Northwestern University Medical School. "EVEREST is one of the largest trials ever performed to try to improve function after stroke, and we look forward to seeing trial results later in the year."
Over the coming months, therapy will be completed on the final subjects in EVEREST and follow up data regarding functional improvement and other outcome measures will be collected and analyzed. Completion of the trial's enrollment phase keeps Northstar Neuroscience on track to file a Premarket Approval Application (PMA) submission with the FDA for the Renova-ST(TM) Cortical Stimulation System for stroke motor recovery by the end of 2007.
About Northstar Neuroscience
Northstar Neuroscience is a medical device company focused on developing neurostimulation therapies that offer greater hope for recovery from neurological injury, disorder and disease. Northstar's proprietary Renova(TM) Cortical Stimulation System is an investigational device that delivers targeted electrical stimulation to the outer surface of the brain - the cerebral cortex. The Renova system is currently under investigation for several indications, including stroke motor recovery, aphasia, tinnitus and depression. For more information, visit www.northstarneuro.com.
This release contains information about management's view of our future expectations, plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of a variety of factors including, but not limited to, risks and uncertainties associated with our ability to complete the EVEREST clinical trial, the results of the EVEREST clinical trial, and our ability to obtain regulatory approval for, or to commercialize, our Renova Cortical Stimulation System. We encourage you to review other factors that may affect our future results in our Annual Report on Form 10-K filed with the Securities and Exchange Commission and in other documents and reports we file periodically with the Securities and Exchange Commission.
Caution: Investigational device. Limited by Federal (or United States) law to investigational use.
Source: Northstar Neuroscience
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