NEWTON, Mass.--(BUSINESS WIRE)--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.
CONTACT: Neuroscience Division/Aspect Medical Systems
Amy Siegel
Mobile: 781-424-1820
or
Edelman
Lorie Fiber, 323-202-1046
Mobile: 310-383-6583
SOURCE: Aspect Medical Systems, Inc.
