-National Multicenter Trial Underway to Assess Accuracy of
Aspect's Brain Assessment Technology in Predicting the Effectiveness
of Antidepressant Medications-
NORWOOD, Mass.--(BUSINESS WIRE)--Dec. 11, 2006--Aspect Medical
Systems, Inc. (NASDAQ: ASPM) today is providing a scheduled update on
the status of the BRITE (Biomarkers for Rapid Identification of
Treatment Effectiveness) major depression trial. Patient enrollment
for the study is running on schedule and is expected to be completed
by the end of the first quarter of 2007. Results from a planned
interim analysis of data from the first 156 enrolled subjects have
been presented to the data safety monitoring board and have shown that
Aspect's EEG biomarker technology is a significant predictor of
patient response. Two abstracts describing interim study results have
been submitted for presentation at the annual meeting of the American
Psychiatric Association taking place in May. If accepted, updated
study results will be released publicly at that time. Additional
abstracts are being prepared for submission to other 2007 psychiatric
conferences.
"We are pleased with the results of the BRITE trial interim
analysis," said Nassib Chamoun, president and CEO of Aspect Medical
Systems. "The results further our understanding of the role of
Aspect's brain assessment technology and bring us one step closer to
our goal of developing products that help clinicians improve the care
of patients suffering from depression."
Aspect is conducting the BRITE trial in collaboration with leading
depression researchers at ten prestigious facilities across the United
States. The goal of the study is to determine the accuracy of using
Aspect's brain assessment technology to predict the effectiveness of
antidepressant medications. In addition, the study seeks to determine
the most effective alternative treatment for subjects who show a poor
response to a selective serotonin reuptake inhibitor (SSRI) and to
expand the company's database to allow further optimization of
Aspect's technology. Future trials are expected to focus on assessing
the potential impact of Aspect's technology in helping clinicians to
improve patient outcomes.
"Antidepressant medications are highly effective, but the current
approach to medication selection for an individual patient is based on
trial and error. It usually takes many months before an effective
antidepressant is identified and a patient 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.
"Patients and clinicians involved with the BRITE trial have been very
positive about the potential of using this brain assessment technology
to optimize care and are enthusiastic about the ease-of-use of the
technology in practice."
More information about the BRITE trial is available at
www.brite-md.com.
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
17.4 million patients and has been the subject of approximately 2,570
published articles and abstracts. BIS technology is installed in
approximately 70 percent of hospitals listed in the July 2006 U.S News
and World Report ranking of America's Best Hospitals and in
approximately 51 percent of all domestic operating rooms. In the last
twelve months BIS technology was used in approximately 16 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 eight 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 expected ability of the Company's brain assessment technology to
predict the effectiveness of antidepressant medications, the
anticipated outcomes and benefits of the BRITE trial, the Company's
expectation that the enrollment of patients for the BRITE trial will
be completed in the first quarter of 2007 and the Company's
anticipated timing with respect to the release of data from the trial,
the Company's plans for future studies, the Company's ability to
successfully develop tools for the diagnosis and treatment of
neurological diseases, such as depression and Alzheimer's disease and
the benefits of such tools, if developed, for the general population
of patients with such diseases. 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 completion of
the Company's BRITE trial could be delayed and/or the trial could be
unsuccessful as a result of various factors including delays in
patient enrollment, lower than anticipated retention rates for
patients in the trial, negative trial outcomes and the failure of the
trial to establish the predictive accuracy of the Company's brain
assessment technology in predicting the effectiveness of
antidepressant medications. In addition, even if the trial achieves
its outcome objectives, 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. 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 Annual Report on Form 10-K for the fiscal
year ended December 31, 2005 and the Company's Quarterly Report on
Form 10-Q for the fiscal quarter ended September 30, 2006, 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.
CONTACT: Aspect Medical Systems
Media Relations
Emily Anderson, 617-559-7032
eanderson@aspectms.com
or
Investor Relations
Mike Falvey, 617-559-7363
CFO
SOURCE: Aspect Medical Systems, Inc.
