Healthcare Industry News: Aspect Medical Systems
News Release - May 22, 2006
Aspect Antidepressant Response Index Accurately Predicts Patient Response to SSRI's after One Week on Medication
NEWTON, Mass.--(HSMN NewsFeed)--May 22, 2006--Findings from two studies presented today at the annual meeting of the American Psychiatric Association document the capability of Aspect Medical System's EEG-based research technology to predict an individual's likelihood of responding to treatment of depression with an SSRI at one week after initiating medication. Typically, it takes several weeks to determine if a patient has responded to a specific antidepressant regimen, causing some patients to stop taking medications early and delaying the identification of a more efficacious regimen.The studies, conducted at Massachusetts General Hospital (MGH; Boston, MA) and Cedars Sinai Medical Center (Los Angeles, CA), were designed to assess whether Aspect's technology can accurately predict treatment efficacy in major depressive disorder (MDD). Using an array of electrodes placed on the patient's forehead and earlobes, Aspect's technology employs a proprietary algorithm to translate information from the electroencephalogram (EEG) into a single number representing a patient's likelihood of clinical response to treatment with the study SSRI. The technology is being developed as a tool to help doctors determine the best course of antidepressant treatment based on each patient's unique response profile. Aspect Medical Systems, the developer of the technology, provided funding for the studies.
In the MGH open-label SSRI study, Aspect's technology predicted 8-week clinical response at one week into treatment with 86 percent accuracy in the subset of subjects who receive no dose changes after the week 1 EEG assessment, and 73 percent accuracy across all 84 study subjects. In the 26 subject Cedars-Sinai study, the technology predicted 8-week patient response to citalopram with 81 percent accuracy. As with the MGH study, the predictive accuracy was higher (88 percent) in the eight subjects whose citalopram dosage remained constant following the 1-week EEG assessment.
"These studies support previous research that highlighted the potential of Aspect's technology to predict within a few days of initiating treatment the effectiveness of antidepressant medications for a specific patient," said Dan V. Iosifescu M.D., director of Neurophysiology Studies at Mass General Hospital, assistant professor of Psychiatry at Harvard Medical School and the principal investigator for the MGH study. "This technology holds great potential as a tool to aid doctors in more quickly identifying the most effective course of therapy for a patient."
Based on the positive results from multiple proof-of-concept studies, Aspect is pursuing larger trials of its depression technology. In March 2006, Aspect Medical Systems announced that it has collaborated with leading depression researchers at nine academic facilities across the United States to initiate the BRITE Major Depression trial (Biomarkers for Rapid Identification of Treatment Efficacy in Major Depression). More information about the BRITE trial can be found at www.brite-md.org.
"The results from these two studies are encouraging and support our belief that brain monitoring can be beneficial to clinicians treating depressed patients," said Philip Devlin, vice president and general manager of Aspect's neuroscience division. "The results from the BRITE trial expected in early 2007 will help us to better understand the role that our technology can play in improving the care of these patients."
In the United States alone, more than 15 million people experience a major depressive episode each year, and nearly 17 percent of adults will experience major depression in their lifetime. The landmark NIH-sponsored STAR-D study found that only a minority of depressed patients achieve remission with their first course of treatment with an SSRI and may require a second, third or even fourth treatment regimen to experience relief.
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 more than 15.2 million patients and has been the subject of approximately 2,300 published articles and abstracts. BIS technology is installed in approximately 70 percent of hospitals listed in the July 2005 U.S. News and World Report ranking of America's Best Hospitals and in approximately 47 percent of all domestic operating rooms. In the last twelve months, BIS technology was used in approximately 14 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 seven 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 regarding the use of the Company's technology to assess the efficacy of pharmaceuticals for the treatment of depression, the time required to assess efficacy of any pharmaceutical to assess depression and the size of the market. There are a number of important factors that could cause actual results to differ materially from those indicated by these forward-looking statements. For example, there can be no assurance that future clinical studies will yield positive results, or that any such product will be successfully developed or achieve regulatory approval. The Company also faces other barriers to market penetration and acceptance. The Company may not be able to compete with new products or alternative techniques that may be developed by others, including third-party anesthesia monitoring products approved by the FDA, and also faces competitive and regulatory risks relating to its ability to successfully develop and introduce enhancements and new products. There are additional factors that could cause the Company's actual results to vary from its forward-looking statements, including without limitation those set forth under the heading "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the fiscal quarter ended April 1, 2006, 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.
The Web sites identified herein are not incorporated into this press release.
Source: Aspect Medical Systems
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