Aspect Medical Systems Announces Publication of BRITE-MD Trial Results in Psychiatry Research

"The publication of BRITE trial results is a major milestone in our efforts to develop clinically useful biomarkers for predicting treatment response in Major Depressive Disorder. The BRITE results demonstrate that early changes in frontal EEG may help predict treatment outcome in as short a time as one week after the start of medication. We are hopeful that these results will be replicated by other researchers, and that an EEG biomarker can be used to help clinicians improve the care of patients suffering from depression," said Andrew Leuchter, M.D., professor of Psychiatry at the Semel Institute for Neuroscience and Human Behavior at UCLA, principal investigator for the trial, and chair of Aspect's Neuroscience Advisory Board.

The BRITE trial was conducted in collaboration with leading investigators from nine facilities across the United States and enrolled 375 patients. Patient response was defined by researchers as a 50 percent improvement in depression symptoms as measured by the Hamilton Depression Rating Scale (HAM-D) after seven weeks of treatment, and remission was defined as recovery from depression (HAM-D <7) after seven weeks of treatment. In the BRITE study, ATR at one week predicted response and remission with 74 percent accuracy in subjects treated for seven weeks with escitalopram, which was statistically significant. Modeled study data also indicates that subjects who were ATR predicted non-responders to escitalopram had better outcomes if they were randomized to switch to bupropion, an antidepressant with a different mechanism of action than escitalopram.

"BRITE study results suggest that ATR could potentially provide the greatest clinical benefit for those patients who might be receiving a medication that is unlikely to help them. Our results suggest that it may be possible to switch these patients to a more effective treatment quickly. This would help patients and their physicians avoid the frustration, risk and expense of long and ineffective medication trials," said Leuchter. "Research has shown that depression patients who do not get better with a first treatment attempt experience prolonged suffering, are more likely to abandon treatment altogether from lack of efficacy and may become more resistant to treatment over time." An estimated 15 million people in the United States experience a depressive episode each year, and nearly 17 percent of adults will experience major depression in their lifetime.

Data from a study at Massachusetts General Hospital (MGH) investigating ATR as a predictor of treatment response was also recently published in European Neuropsychopharmacology. The MGH study evaluated ATR in 82 major depression patients receiving selective serotonin reuptake inhibitors (SSRI), and venlafaxine, and showed that use of ATR after the first week of antidepressant treatment may be predictive of treatment efficacy.

Continuing the ATR research effort, BRITE trial investigator Dr. Ian Cook at UCLA received a significant grant from the National Institutes of Mental Health to conduct a multi-year follow-on study of ATR called the PRISE-MD study (Personalized Response Indicators of SSRI Effectiveness in Major Depression). The PRISE-MD study will prospectively evaluate the ability of ATR to predict response to escitalopram as well as the clinical utility of ATR-directed treatment with escitalopram or an alternate treatment with bupropion.

"There is now a growing body of literature supporting the potential role of frontal EEG, and ATR specifically, in the management of patients with major depression. We believe that the use of biomarkers such as ATR to optimize treatment efficacy and efficiency is well aligned with the objectives of current healthcare reform efforts," said Nassib Chamoun, President and CEO of Aspect Medical Systems. "The UCLA grant award helps to validate the importance of this research and also cost-effectively advances the ATR program. We will continue to explore the commercial potential and partnership opportunities for ATR."

About Aspect Medical Systems, Inc.

Aspect Medical Systems, Inc. (NASDAQ: ASPM | Quote | Chart | News | PowerRating) is a global market leader in brain monitoring technology. To date, the Company's Bispectral Index (BIS) technology has been used to assess approximately 34 million patients and has been the subject of more than 3,300 published articles and abstracts. BIS technology is installed in approximately 78 percent of hospitals listed in the July 2009 U.S. News and World Report ranking of America's Best Hospitals and in approximately 74 percent of all U.S. operating rooms. In the last twelve months BIS technology was used in approximately 19 percent of all U.S. surgical procedures requiring general anesthesia or deep sedation. Aspect Medical Systems has OEM agreements with nine leading manufacturers of patient monitoring systems. For more information, visit Aspect's Web site at http://www.aspectmedical.com.

Safe Harbor Statement

Certain statements in this release are forward-looking and may involve risks and uncertainties, including statements with respect to the potential ability of the Company's brain assessment technology to rapidly predict the effectiveness of antidepressant medications and expedite the process of identifying effective antidepressant drug therapy, the anticipated benefits of the BRITE trial and the Company's belief that it can develop a practical, easy-to-use brain assessment device to help clinicians optimize care for patients suffering from depression. There are a number of factors that could cause actual results to differ materially from those indicated by these forward-looking statements. For example, the Company may not be able to successfully develop and/or obtain required regulatory approvals for its products under development for the diagnosis, management and treatment of neurological diseases, such as depression, achieve widespread market acceptance of any such products that it may develop or to compete with new products or alternative techniques that may be developed by others. In addition, the Company may not achieve comparable or confirmatory results in later trials, including its planned PRISE trial, as those achieved in earlier studies. There are other factors that could cause Aspect's actual results to vary from its forward-looking statements, including without limitation those set forth under the heading "Risk Factors" in Aspect's Annual Report on Form 10-K for the year ended December 31, 2008 and Aspect's Quarterly Report on Form 10-Q for the fiscal quarter ended July 4, 2009, each as filed with the Securities and Exchange Commission. In addition, any forward-looking statements represent the Company's views only as of the date of this press release and should not be relied upon as representing the Company's views as of any subsequent date. While the Company may elect to update forward-looking statements in the future, it specifically disclaims any obligation to do so, even if its expectations change. Therefore, you should not rely on these forward-looking statements as representing the Company's views as of any date subsequent to the date of this press release.

Aspect, Bispectral Index and BIS are registered trademarks of Aspect Medical Systems, Inc. All other trademarks, service marks and company names are the property of their respective owners.

SOURCE: Aspect Medical Systems, Inc.

Aspect Medical Systems 
Emily Anderson, 617-559-7032 
Media Relations 
eanderson@aspectms.com