Posted by jrbecker on July 1, 2004, at 9:48:20
http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=ASPM&script=410&layout=0&item_id=577594
Interim Results of Massachusetts General Hospital Study Demonstrate Aspect Medical Systems' Brain Monitoring Technology Predicts Treatment Response in Depressed Patients
Study Presented at Scientific Conference Sponsored by the National Institute of Mental Health
NEWTON, Mass.--(BUSINESS WIRE)--June 2, 2004-- Interim analysis of a study being performed at Massachusetts General Hospital (MGH) has demonstrated that Aspect Medical Systems' (NASDAQ: ASPM) brain monitoring technology was able to predict the effectiveness of antidepressant medications in treating depressed patients with 83 percent accuracy. The study, which is currently being conducted at the Depression Clinical and Research Program at Massachusetts General Hospital (MGH) and Harvard Medical School, will be presented this week at the New Clinical Drug Evaluation Unit meeting (NCDEU; June 1-4, 2004; Phoenix, Ariz.), sponsored by the National Institute of Mental Health.The MGH study was initiated in May 2003 to provide prospective validation of earlier research that showed that Aspect's brain monitoring technology was able to predict the effectiveness of antidepressant treatment. The technology works by analyzing the electroencephalogram (EEG), or electrical activity in the brain.
"Fewer than 50 percent of patients achieve remission after their first antidepressant therapy. Given that it typically takes several weeks to determine if a patient has responded to a specific treatment, many patients suffer long periods while they wait and undergo multiple changes in therapy to identify an effective antidepressant regimen," said Maurizio Fava, M.D., lead investigator in the study and associate chief of Psychiatry for Clinical Research and director of the Depression Clinical and Research Program at MGH. "Our study provides further evidence that brain monitoring may help us address this challenge by predicting antidepressant treatment response within a few days of starting treatment. The ability to identify the success or failure of an antidepressant treatment at an earlier time could help clinicians significantly improve the management of depression."
Study results are based on the evaluation of 36 patients taking selective serotonin reuptake inhibitors (SSRI), which are typically used as the first-line drug treatment for depression. Investigators were given the flexibility to adjust dosing for each patient according to their standard practice to ensure that study participants were evaluated in a context that is consistent with routine clinical practice. Patients were then monitored at the start of therapy and after one week of SSRI treatment using a simplified EEG system with electrodes that were placed on the forehead (rather than a full-head recording). Patients were monitored to determine if Aspect's technology could predict a response to treatment well before obvious signs of clinical improvement or failed treatment became apparent. The trial will ultimately enroll 100 patients and is expected to be complete at the end of 2004.
"This study marks the first prospective evaluation of Aspect's frontal EEG technology to predict antidepressant treatment response," stated Philip Devlin, general manager of Aspect's Neuroscience Division. "These results further validate that it may be possible to develop an easy-to-use clinical assessment tool that predicts drug efficacy and enables clinicians to improve the management of antidepressant therapy. We look forward to further exploring this possibility as we complete this study in the coming months."
Aspect's Neuroscience Division was founded in 2001 to leverage the company's expertise in brain monitoring to help improve patient care for people suffering from neurologically-based diseases. In addition to depression-based research, the company has active research programs investigating the benefits of EEG-based brain monitoring for diagnosing and treating dementia and Alzheimer's disease.
About Aspect Medical Systems, Inc.
Aspect Medical Systems, Inc. (NASDAQ: ASPM) is a global market leader in brain monitoring technology. Aspect's BIS(TM) technology directly measures the effects of anesthetics and sedatives on the brain. The technology has been used to assess more than 8.7 million patients and has been the subject of approximately 1,400 published articles and abstracts. BIS technology is installed in approximately 32 percent of all domestic operating rooms and is available in more than 160 countries. Aspect Medical Systems has OEM agreements with seven leading manufacturers of patient monitoring systems. Aspect is also investigating how other methods of analyzing EEG may aid in the diagnosis and management of neurological diseases, including depression and Alzheimer's disease. Based in Newton, Mass., Aspect employs approximately 200 people worldwide. 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 expected results of the Company's study to measure the ability of its technology to predict treatment response to 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 successfully complete enrollment of its trial to assess how its technology may aid in the treatment of depression and the results of such study, even if successfully completed, may not demonstrate the effectiveness of the Company's technology. In addition, the Company is subject to a number of other risks facing its business. For example, the Company be able to achieve widespread market acceptance of its BIS monitoring technology or 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, including regulatory approval of its XP technology in Japan. In addition, the Company has limited sales and marketing experience both in the U.S. and internationally, and if it is unable to develop and implement a successful sales and marketing strategy, including with respect to its own sales force, domestic and international distributors, original equipment manufacturers and other direct and indirect sales channels, it will not be able to generate meaningful product revenue. In addition, the Company's ability to become and remain profitable will depend upon its ability to promote frequent use of the BIS system so that sales of its BIS sensors increase. The Company will not be profitable if hospitals and anesthesia providers do not buy and use its BIS systems in sufficient quantities. Cases of awareness with recall during monitoring with the BIS system and significant product liability claims are among the factors that could limit market acceptance. There are factors that could cause Aspect's actual results to vary from its forward-looking statements, including without limitation those set forth under the heading "Factors Affecting Future Operating Results" in Aspect's Quarterly Report on Form 10-Q for the fiscal quarter ended April 3, 2004, as filed with the Securities and Exchange Commission. In addition, any forward-looking statements represent Aspect's views only as of the date of this press release and should not be relied upon as representing Aspect's views as of any subsequent date. While Aspect 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 Aspect's views as of any date subsequent to the date of this press release.
Bispectral Index and BIS are registered trademarks of Aspect Medical Systems, Inc. A-2000 is a trademark of Aspect Medical Systems, Inc. All other trademarks, service marks and company names are the property of their respective owners.
CONTACT: Aspect Medical Systems, Inc.
Emily Anderson, 617-559-7032
Cell: 617-515-2000
[email protected]SOURCE: Aspect Medical Systems, Inc.
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