Healthcare Industry News: neurostimulation
News Release - October 15, 2007
Northstar Neuroscience Announces Final Patient Completes Four Week Follow-up in EVEREST Pivotal TrialThird Quarter 2007 Earnings Release and Conference Call Scheduled for Thursday October 25, 2007
SEATTLE--(HSMN NewsFeed)--Northstar Neuroscience, Inc. (NASDAQ: NSTR ), a medical device company developing therapies for the treatment of neurological diseases and disorders, announced today that the last patient in the Company's EVEREST pivotal trial(a) for stroke motor recovery completed four week follow-up, the primary endpoint for the trial.
EVEREST is a national, multi-center, single-blinded, randomized clinical trial investigating whether Northstar's proprietary Renova-ST(TM) Cortical Stimulation System(a) in conjunction with physical rehabilitation improves hand and arm function in stroke survivors compared to those receiving 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.
"EVEREST is a landmark trial, the largest study of its kind, and we expect it to yield a wealth of clinical data regarding Northstar's Renova-ST cortical stimulation therapy. This milestone enables the Company to move forward with analysis on the extensive EVEREST data set," said John Bowers, Northstar's President and CEO. "The Company has been blinded to the EVEREST efficacy data throughout the trial, and will remain blinded for several weeks during this process. We anticipate releasing EVEREST primary efficacy and safety data in the first half of December, and continue to plan for submission of our premarket approval application by the end of the year."
Northstar also announced that it plans to release third quarter 2007 financial results after market close on Thursday October 25, 2007. Management will hold a conference call starting at 4:30 p.m. EDT (1:30 p.m. PDT) on the same day to discuss these financial results. The conference call will be concurrently webcast.
To listen to the conference call on your telephone, please dial 1-866-362-5158 (US/Canada) or 1-617-597-5397 (International) and use the participant code "31432103" approximately ten minutes prior to the start time. To access the live audio broadcast or the subsequent archived recording, visit the Northstar Neuroscience website at www.northstarneuro.com under the investor relations section.
About Northstar Neuroscience
Northstar Neuroscience is a medical device company focused on developing neurostimulation therapies to treat neurological injury, disorder and disease. Northstar's proprietary Renova 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.
(a)CAUTION: Investigational Device. Limited by Federal Law (U.S.) to investigational use. The results of the EVEREST study have not been shared with the FDA and there can be no definitive claims of safety and effectiveness until the FDA has reviewed and approved the labeling for this product.
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 the results of any of our clinical trials, including the results of the EVEREST clinical trial, our ability to release EVEREST clinical trial data by the first half of December 2007, our ability to submit the premarket approval application by the end of 2007, the timing of release of results related to any of our other clinical trials, our ability to complete our ongoing or any future clinical trials, or decisions whether to conduct additional clinical trials, and delays in conducting or completing any of our clinical trials. Results from our feasibility trials may not be indicative of success in any later clinical trials involving larger numbers of patients. We encourage you to review other factors that may affect our future results in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 3, 2007 and in other documents and reports we file periodically with the Securities and Exchange Commission.
Source: Northstar Neuroscience
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.