-Multicenter trial underway to evaluate Aspect's brain assessment
technology as a one week indicator of response to antidepressant
treatment-
NORWOOD, Mass.--(BUSINESS WIRE)--May 21, 2007--Interim study
results from the BRITE (Biomarkers for Rapid Identification of
Treatment Effectiveness) trial in major depression will be presented
today at the annual meeting of the American Psychiatric Association
taking place in San Diego, CA. Interim findings from BRITE suggest
that Aspect Medical System's EEG-based research technology is a
significant predictor of patient response to treatment of depression
with a selective serotonin reuptake inhibitor (SSRI) after one week of
treatment. Further, the study results suggest that the technology may
help expedite the process of identifying effective antidepressant drug
therapy.
"There are more than 20 antidepressants available on the market
today, and all of them are effective for relieving the symptoms of
depression. The problem is that the majority of patients will not
respond adequately to the first antidepressant treatment they are
prescribed," 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. "Given that the current trial and error
approach to finding an efficacious regimen typically takes many weeks,
having the ability to determine treatment response more quickly would
be an important clinical advance. The interim findings from BRITE are
encouraging in that they are consistent with results from prior
studies suggesting that there is an early brain signal of response to
antidepressant treatment."
Interim BRITE study results indicate that Aspect's Antidepressant
Treatment Response (ATR) index achieved statistical significance in
predicting seven week clinical response as measured by the standard
Hamilton Depression Rating Scale after just one week on treatment with
an SSRI. In addition, a retrospective analysis of BRITE trial subjects
demonstrated that patients who received treatment in accordance
with the ATR index were significantly more likely to respond to
treatment than the other patients in the trial. "These findings
suggest that the ATR index may also help us identify the right
antidepressant treatment to provide relief for patients," said Dr.
Leuchter.
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 SSRI. 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.
"These interim BRITE trial results are encouraging and support our
belief that we can develop a practical, easy-to-use brain assessment
device to help clinicians optimize care for patients suffering from
depression," said Nassib Chamoun, president and CEO of Aspect Medical
Systems. "We look forward to evaluating the final BRITE study data
later this year."
Aspect is conducting the BRITE trial in collaboration with leading
depression researchers at ten prestigious facilities across the United
States. Enrollment for the 375+ subject trial was completed in March
2007 and an analysis of the full study results is planned for the
second half of the year. More information about the BRITE trial is
available at www.brite-md.com.
Aspect Conference call
Aspect Medical Systems, Inc. will host a conference call and live
Webcast at 5:00 p.m. Eastern time for all interested parties,
including financial analysts, portfolio managers, individual investors
and members of the press. To participate in the call, please dial
1-866-406-5408 (domestic), 1-973-582-2770 (international), or access
the Webcast at www.aspectmedical.com on the Investor page, or at
www.earnings.com. Supplemental information about the BRITE trial will
also be available to guide the conference call and will be posted on
the investor page of the Aspect Medical Systems Web site at
http://investor.aspectmedical.com. Telephone replays will be available
by dialing 1-877-519-4471 (domestic), or 1-973-341-3080
(international), access code 8805001. The Webcast replay will be
available from May 21, 2007 at 8:00 p.m. Eastern time to May 28, 2007
at 11:59 p.m. Eastern time.
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 20 million patients and has been the subject of more
than 2,800 published articles and abstracts. BIS technology is
installed in approximately 75 percent of hospitals listed in the July
2006 U.S. News and World Report ranking of America's Best Hospitals
and in approximately 55 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 potential ability of the Company's brain assessment technology to
predict the effectiveness of antidepressant medications and expedite
the process of identifying effective antidepressant drug therapy, the
anticipated outcomes and benefits of the BRITE trial, the Company's
anticipated timing with respect to the release of data from the trial
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 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 other. There are other 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
quarter ended March 31, 2007 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
Emily Anderson, 617-559-7032
eanderson@aspectms.com
Media Relations
or
Mike Falvey, CFO, 617-559-7363
Investor Relations
SOURCE: Aspect Medical Systems, Inc.
