Aspect Medical Systems Announces Positive Results of BRITE Major Depression National StudyNORWOOD, Mass.--(BUSINESS WIRE)--Dec 11, 2007 - Aspect Medical Systems, Inc. (NASDAQ: ASPM) today announced that study results from the BRITE (Biomarkers for Rapid Identification of Treatment Effectiveness) trial in major depression demonstrate that the company's EEG-based Antidepressant Treatment Response (ATR) indicator is a significant predictor of patient response and remission from depression when utilized one week following initiation of treatment with escitalopram.
The BRITE trial was conducted in collaboration with leading investigators from 10 facilities across the United States and enrolled more than 300 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 less than 7) after seven weeks of treatment. The BRITE results also suggest that the technology may help clinicians expedite the process of identifying effective antidepressant drug therapy for their patients suffering from depression. Results will be presented this week at a closed scientific meeting. Aspect will host a conference call at 9:00 a.m. ET today to discuss the trial.
"Research has shown that the majority of patients seeking treatment for depression will not respond adequately to the first antidepressant treatment they are prescribed, and in many cases, it can take months before a patient responds to antidepressant medication and feels better," 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. "We are very encouraged by the results of the BRITE trial, as they provide further evidence that Aspect's technology is able to detect an early brain signal of antidepressant response. It is particularly exciting to see ATR emerge as a demonstrated predictor of remission, as remission occurs less frequently and takes longer to achieve than response. We believe that being able to predict this outcome, which is the goal of depression treatment, would be especially valuable to physicians and their patients."
In the United States alone, an estimated 15 million people experience a depressive episode each year, and nearly 17 percent of adults will experience major depression in their lifetime. The majority of patients being treated for major depression are prescribed a selective serotonin reuptake inhibitor (SSRI), such as escitalopram (a commonly prescribed first-line antidepressant). While treatment with antidepressants will eventually lead to remission in the majority of treated patients, many will require a second, third or fourth treatment before experiencing relief.
"We are pleased with the success of the BRITE trial, which brings us one step closer to our goal of developing a medical technology that we believe will help clinicians improve the care of patients suffering from depression," said Nassib Chamoun, president and CEO of Aspect Medical Systems. "We look forward to initiating a confirmatory trial in the second quarter of 2008 as a final step toward preparing an FDA submission for this important technology."
Aspect is also presenting a poster this week at the annual meeting of the International Neuromodulation Society in Acapulco, Mexico, titled "EEG ATR May Predict Clinical Response to Cortical Stimulation Therapy: Initial Findings from the PROSPECT Study." The poster outlines preliminary findings from a pilot study that suggest the company's ATR treatment response biomarker may also be a predictor for treatment outcome with device-based neurostimulation approaches.
Aspect Conference Call
Aspect Medical Systems, Inc. will host a conference call at 9:00 a.m. Eastern time for all interested parties, including financial analysts, portfolio managers, individual investors and members of the press and public. To participate in the call, please dial 1-888-256-0990 (domestic), or 1-913-312-0651 (international), or access the Webcast at www.aspectmedical.com on the Investor page, or at www.earnings.com. Additional support materials are available at www.aspectmedical.com on the Investor page. Telephone replays will be available by dialing 1-888-203-1112 (domestic), or 1-719-457-0820 (international), replay access code: 7466352. The replay will be available from December 11, 2007 to December 18, 2007.
About Aspect Medical Systems, Inc.
Aspect Medical Systems, Inc. (NASDAQ: ASPM) is a global market leader in brain monitoring technology. To date, the Company's Bispectral Index (BIS) technology has been used to assess approximately 23 million patients and has been the subject of more than 3,100 published articles and abstracts. BIS technology is installed in approximately 80 percent of hospitals listed in the July 2007 U.S News and World Report ranking of America's Best Hospitals and in approximately 60 percent of all domestic operating rooms. In the last twelve months BIS technology was used in approximately 17 percent of all U.S. surgical procedures requiring general anesthesia or deep sedation. BIS technology is available in more than 160 countries. Aspect Medical Systems has OEM agreements with nine leading manufacturers of patient monitoring systems. The company is also investigating how other methods of analyzing brain waves may aid in the diagnosis and management of neurological diseases, including depression and Alzheimer's disease. 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, the Company's anticipated timing with respect to initiating a confirmatory trial in the second quarter of 2008 as a final step toward preparing an FDA submission for the technology 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 products for the diagnosis and treatment of neurological diseases, such as depression and Alzheimer's disease, 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 results in later trials of BRITE as those achieved in earlier studies. There are other factors that could cause the Company's actual results to vary from its forward-looking statements, including without limitation those factors described under the heading "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarter ended September 29, 2007, which is on file 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.
Aspect Medical Systems
Emily Anderson, 617-559-7032
Mike Falvey, 617-559-7363
Posted: December 2007