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25 Clinical Abstracts at National Conference Spotlight Clinical Utility of Somanetics INVOS System in Neonates
Date:5/6/2009

Early neonatal studies indicate cerebral/somatic oximetry data may help identify difficult to diagnose disease states and guide patient management

TROY, Mich., May 6 /PRNewswire-FirstCall/ -- Somanetics Corporation (Nasdaq: SMTS) announced today that its INVOS(R) System was featured in 25 posters and presentations at the Pediatric Academic Societies (PAS) annual conference held in Baltimore, Maryland May 2 - 5. The studies focused on early applications of the technology in the neonatal intensive care unit (NICU), including investigations of how cerebral/somatic blood oxygen data may correlate to severe conditions that are traditionally difficult to diagnose such as necrotizing enterocolitis and patent ductus arteriosis as well as to the need for blood transfusions.

"The prevalence of INVOS System studies within our first year of entering the neonatal intensive care market reflects the high level of interest and wide range of at-risk neonates who may benefit from cerebral/somatic oximetry," explains Bruce Barrett, Somanetics' president and chief executive officer. "Many ongoing studies are exploring patterns in regional oxygen values to evaluate whether they may be indicative of disease states that often cannot be identified until the condition escalates and causes damage."

One disease elusive to detect is necrotizing enterocolitis (NEC), a dying off of the intestinal and bowel tissue that often leads to death. It often arises unexpectedly due to unknown causes, and typically does not exhibit definitive signs until damage has already been done. Treatment in the NICU can span months, adding financial burden to an already emotionally devastated family. When NEC is suspected, one standard response is to stop feedings so that the affected gut is not taxed.

"While useful to combat NEC, cessation of feedings has its own drawbacks such as stunting organ development in an already fragile neonate," explains Michael Wider, PhD., co-author of two of the PAS studies and Somanetics' vice president of technology and market development. "To better confirm which patients should not be fed, investigators are studying whether cerebral/somatic oximetry values have a correlation to feeding intolerance and the eventual development of NEC."

Six PAS studies explored the technology's role in caring for neonates with patent ductus arteriosus (PDA). This is a congenital heart defect where a blood vessel called the ductus arteriosus remains open - or patent - after birth instead of closing naturally as expected. In these cases, the PDA causes abnormal blood circulation, often straining the heart and impairing blood flow throughout the body. Studies are exploring how cerebral/somatic oximetry via the INVOS System may potentially be used to help detect oxygen deficits indicative of PDAs and to help determine whether surgical or drug intervention is required.

Another study examined four drugs, commonly used in the NICU to manage a range of severe conditions, and their effect on cerebral and somatic (e.g., abdomen, kidney area, muscle) regional oxygen saturation (rSO2). The INVOS System showed that each drug produced distinct medication-specific changes to rSO2, and that this pattern was also tied to dosage.

"While drug therapy is very successful at managing numerous conditions in the NICU, clinicians may not have fully appreciated its impact on vital and non-vital organ area oxygenation because this type of data was simply not available before," adds Wider. "Arming clinicians with this previously unavailable data gives them important additional information to consider when assessing patients and care protocols."

The INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter noninvasively monitors site-specific blood oxygen levels in patients at risk for restricted or no blood flow. It helps hospital critical care teams detect and correct blood oxygen deficiencies that can cause brain and vital organ area damage. Sensors simply adhere to the skin like a Band Aid(R). In infants and neonates the most commonly monitored areas are the brain, abdomen and kidney area.

About Somanetics

Somanetics Corporation (Nasdaq: SMTS) develops, manufactures and markets the INVOS(R) Cerebral/Somatic Oximeter which noninvasively provides accurate, real-time blood oxygen measurements in patients greater than 2.5 kilograms, and trend monitoring of this parameter for individuals of any weight. The INVOS System is the only commercially-available cerebral/somatic oximeter proven to improve outcomes in patients above 2.5 kilograms, and is the only cerebral/somatic oximeter system cleared for use on neonates less than 2.5 kg. Surgeons, anesthesiologists and other medical professionals can use data provided by the INVOS System, in conjunction with other available data, to identify oxygen imbalances in brain or other body tissue beneath the sensor and take necessary corrective action, potentially improving patient outcomes and reducing the costs of care. The INVOS System is the clinical reference standard in cerebral/somatic oximetry, with an 11-year market track record, more than 600 clinical references and implementation at more than 700 U.S. hospitals. Somanetics also is developing a technology that integrates data from bedside devices into a single system for enhanced patient assessment and decision making, data management and data storage. Somanetics supports its customers through a direct U.S. sales force and clinical education team. Covidien markets INVOS System products in Europe, Canada, the Middle East and South Africa and Edwards Lifesciences represents INVOS System products in Japan. For more information visit www.somanetics.com.


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