-Multi-Center Trial Demonstrates Aspect's Brain Assessment
Technology Predicts Response and Remission One Week
Following Initiation of Antidepressant Treatment-
NORWOOD, 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.
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.
