Healthcare Industry News: Aspect Medical Systems
News Release - June 27, 2007
Aspect Medical Systems Receives FDA Clearance for BIS View(TM) Monitoring SystemNew monitor expands BIS(R) family of products
NORWOOD, Mass.--(HSMN NewsFeed)--Aspect Medical Systems, Inc. (NASDAQ: ASPM ) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BIS VIEW(TM) Monitoring system, the company's newest stand-alone monitor. The BIS VIEW offers customers a compact design and simplified operation for lower acuity clinical environments with limited room for monitoring equipment.
"The BIS VIEW rounds out the family of BIS products that are available to address the diverse economic and clinical requirements seen across the range of care settings," said Nassib Chamoun, president and CEO of Aspect. "The new BIS VIEW, along with our higher-end BIS VISTA(TM) system and integrated OEM partner systems, provides customers with a choice of BIS solutions to meet their needs from the operating room to the outpatient surgical facility to critical care and procedural settings. All of these products run on the BISx(TM) platform so customers have the ability to implement a facility-wide BIS solution with any combination of BIS technologies while ensuring consistent patient care."
According to the new indication for use statement cleared by the FDA, BIS monitoring may be used as an aid in monitoring the effects of certain anesthetic agents and may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Use of BIS monitoring to help guide anesthetic administration may also be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation.
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, clinicians can make informed decisions for optimal anesthesia or sedation.
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 regarding the ability of the BIS System to round out the BIS product offerings across the range of care setting and the expected benefits of the Company's BIS products. There are a number of factors that could cause actual results to differ materially from those indicated by these forward-looking statements. For example, Aspect may not be able to achieve widespread market acceptance of its BIS monitoring technology or to compete with new products or alternative techniques that may be developed by others including third-party anesthesia monitoring products approved by the FDA. Aspect also faces competitive and regulatory risks relating to its ability to successfully develop and introduce enhancements and new products. In addition, Aspect has limited sales and marketing experience both in the U.S. and internationally and if it is unable to develop and implement a successful sales and marketing strategy, including with respect to its own sales force, domestic and international distributors, original equipment manufacturers and other direct and indirect sales channels, it will not be able to generate meaningful product revenue. Aspect's ability to become and remain profitable will depend upon its ability to promote frequent use of the BIS system so that sales of its BIS sensors increase. Aspect will not be profitable if hospitals and anesthesia providers do not buy and use its BIS systems in sufficient quantities. Cases of surgical awareness during monitoring with the BIS system and significant product liability claims are among the factors that could limit market acceptance. . 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 Aspect 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 Aspect's views as of any date subsequent to the date of this press release.
BIS, the BIS logo, BISx and Bispectral Index are trademarks of Aspect Medical Systems, Inc. and are registered in the USA, EU and other countries. BIS VISTA and BIS VIEW are trademarks of Aspect Medical Systems, Inc. All other trademarks, service marks and company names are the property of their respective owners.
Source: Aspect Medical Systems
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