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Northstar Neuroscience Announces Feasibility Study of its Cortical Stimulation System for Treatment-Resistant Depression

03 Aug 2006

Today announced that the U. S. Food and Drug Administration (FDA) has granted approval for the company to conduct a clinical feasibility study of its cortical stimulation therapy system for the treatment of depression.

SEATTLE, WA, USA | Aug 03, 2006 | Northstar Neuroscience, Inc. (NASDAQ: NSTR), a developer of medical devices for the

treatment of neurological diseases and disorders, today announced that the U. S. Food and Drug Administration (FDA) has granted approval for the company to conduct a clinical feasibility study of its cortical stimulation therapy system for the treatment of depression. The study will assess the safety and effectiveness of investigational cortical stimulation for patients diagnosed with major depressive disorder who are not responsive to other antidepressant treatments. Depression is a crippling disease that affects over 20 million people in the U.S., and it is estimated that 4 million of these do not respond to standard antidepressant treatments.

Cortical stimulation therapy refers to the precise delivery of low levels of electricity to the cortex (the outer layer of the brain) via an implanted stimulator system. The cortex controls or influences many neurological functions and is easier to access than deeper brain structures. Cortical stimulation involves a procedure to place a small electrode over the tough membrane that protects the cortex. The flexible electrode, which is about the size of a postage stamp, is then connected via a lead wire to a pulse generator implanted just below the patient's collarbone.

This is the first study of an implantable cortical stimulation device in depression patients. Up to 12 patients will be studied at the following three sites: the Medical College of Wisconsin in Milwaukee, Massachusetts General Hospital in Boston, and the University of Pittsburgh in Pennsylvania.

"Depression affects all aspects of a sufferer's life as well as the lives of their family and friends," said Dr. Darin Dougherty of Massachusetts General Hospital. "It is a necessity for patients suffering from major depression who have not responded to traditional therapies to have alternative treatment options available to them."

"There are numerous potential clinical applications for cortical stimulation," said Alan Levy, Ph.D., President and Chief Executive Officer of Northstar Neuroscience. "We have achieved promising results in previous feasibility studies of cortical stimulation for arm/hand disability following stroke. This is the first study that will explore our cortical stimulation therapy in the growing and important neuropsychiatric field."

Patients may be eligible to participate in the study if they are 18 years of age or older, have been diagnosed with treatment-resistant depression disorder, have failed to respond to at least four different antidepressant treatments and are willing and able to undergo a surgical procedure to implant the cortical stimulation system. For more information about this and other clinical trials at Northstar go to www.northstarneuro.com.

About Depression

Worldwide approximately 340 million people suffer from depression. According to the National Institute of Mental Health (NIMH), major depression is a serious medical illness affecting over 20 million American adults, or approximately 9.5 percent of the adult population in a given year. The illness is persistent and can significantly interfere with an individual's thoughts, behavior, mood, activity and physical health. Among all medical illnesses, major depression is the leading cause of disability in the U.S. and worldwide.

About Northstar Neuroscience

Northstar Neuroscience, Inc. is a medical device company focused on developing and commercializing innovative neurostimulation therapies that restore function and quality of life for people suffering from stroke and other neurological diseases and disorders. Northstar's cortical stimulation therapy system is an investigational device that is in clinical trials for several indications, including stroke motor recovery, aphasia, tinnitus and depression. The company will provide an update on its clinical programs, including additional information about its depression clinical trial, during its upcoming 2006 second quarter conference call on August 9, 2006. For more information, visit www.northstarneuro.com.

Forward-Looking Statements

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 historical results or 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 enroll patients in our clinical trials, including the Treatment-Resistant Depression clinical trial referenced above, our ability to complete our ongoing or any future clinical trials, delays in conducting or completing any of our clinical trials, the results of any of our clinical trials, or our ability to secure regulatory approval for our products. We encourage you to review other factors that may affect our future results in our Quarterly Report on Form 10-Q filed on June 6, 2006 and in other documents we file periodically with the Securities and Exchange Commission.

CONTACT: Schwartz Communications
Sally Bain / Wendy Ryan
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SOURCE: Northstar Neuroscience

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