Please replace the release dated August 24, 2006 with
the following corrected version due to multiple revisions.
The corrected release reads:
AUSTRALIAN AND NEW ZEALAND COLLEGE OF ANAESTHETISTS AND MADRID
CENTRO SOCIETY FOR ANESTHESIA PUBLISH RECOMMENDATIONS FOR MONITORING
DURING ANAESTHESIA
Aspect Medical Systems (NASDAQ: ASPM) today announced that the
Australian and New Zealand College of Anaesthetists (ANZCA) and the
Madrid Centro Society for Anesthesia (MCSA) have each published
recommendations for monitoring level of consciousness during
anaesthesia. These recommendations were written to guide ANZCA and
MCSA members in recognizing the problem of unintended awareness and
adopt a consensus on how to reduce the incidence of inadvertent
surgical wake-ups. Unintended awareness occurs when patients do not
receive enough anaesthesia, leaving them at risk for becoming aware of
what is happening and remembering this experience after the surgery is
over.
"The ANZCA and MCSA recommendations are consistent with the
clinical guidance provided by other medical societies in the United
States and Europe and reflect an increasing global recognition of the
need to address awareness as a patient safety concern," said Nassib
Chamoun, president and CEO of Aspect. "We believe this is an important
step toward improving patient safety and reducing the risk of
awareness. BIS is the only brain monitoring technology or clinical
intervention that has been shown in large scale, prospective clinical
research to reduce the incidence of awareness."
Australian and New Zealand College of Anaesthestists Guidance to
Clinicians
The ANZCA has stated that, when clinically indicated, equipment to
monitor the anaesthetic effect on the brain should be available for
use on patients at high risk of awareness during general anaesthesia.
To view the ANZCA recommendations, visit
http://www.medeserv.com.au/anzca/pdfdocs/PS18-2006.pdf.
Madrid Centro Society for Anesthesia Guidance to Clinicians
The MCSA issued a consensus statement recommending that depth of
consciousness monitors should be available for patients at high risk
for awareness during general anaesthesia and supports education on how
to best use the monitors to reduce the incidence of intraoperative
awareness. The Society defines preventative measures that apply to the
clinician, the equipment, the medical staff, and the patient,
identifying a list of high-risk patient characteristics. To view the
complete statement of the MCSA working group regarding unintended
awareness, visit
http://www.sarmadrid.org/pdf/despertar_intraoperatorio_maqueta1.pdf.
The ANZCA and MCSA recommendations follow similar statements made
by the American Society of Anesthesiologists
(www.asahq.org/publicationsAndServices/AwareAdvisoryFinalOct05.pdf),
JCAHO
(www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_32.htm)
the American Association of Nurse Anesthetists
(http://www.aana.com/Resources.aspx?ucNavMenu_TSMenuTargetID=51&
ucNavMenu_TSMenuTargetType=4&ucNavMenu_TSMenuID=6&id=1747), and the
Royal College of Anaesthetists and the Association of Anaesthetists of
Great Britain and Ireland
http://www.aagbi.org/release_lossofconsciousness.html.
About BIS Monitoring
Using a sensor placed on the patient's forehead, BIS monitoring
translates information from the electroencephalogram (EEG) into a
single number that represents each patient's level of consciousness.
This number - the BIS value - ranges from 100 (indicating an awake
patient) to zero (indicating the absence of brain activity). Using the
BIS value to guide administration of anesthetic medication, in
conjunction with other vital signs, allows clinicians to make
better-informed decisions to achieve optimal anesthesia.
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
16.3 million patients and has been the subject of approximately 2,370
published articles and abstracts. BIS technology is installed in
approximately 68 percent of hospitals listed in the July 2006 U.S.
News and World Report ranking of America's Best Hospitals and in
approximately 49 percent of all domestic operating rooms. In the last
twelve months BIS technology was used in approximately 15 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
role of brain function monitoring and its effect on the safety and
quality of anesthesia care. 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, the
Company may not achieve widespread market acceptance of its BIS
monitoring technology among anesthesiologists. 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, including products to aid
in the treatment of neurological disorder. 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 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 July 1, 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.
