Use of Somanetics’ INVOS Cerebral Oximeter Significantly Decreased Stroke Rate and Adverse Clinical Outcomes

Somanetics Corporation (Nasdaq: SMTS, news) today announced that the results of the first randomized, prospective and blinded study using the Company’s INVOS® Cerebral Oximeter brain oxygen monitoring system showed statistically significant reductions in both stroke and the overall number of adverse clinical outcomes when the monitoring system was used to help manage regional brain blood oxygen saturation in cardiac surgery patients.

The 199-patient study was conducted by John Murkin, MD, professor of anesthesiology at the University of Western Ontario, and presented at Outcomes 2004: Neurobehavioral Assessment, Physiological Monitoring and Cerebral Protective Strategies held in Key West, Fla.

In the overall study, one percent of the intervention group cardiac surgery patients experienced a stroke, compared to four percent in the control group. Taking all complications into account, two percent of the intervention group patients experienced adverse clinical outcomes, compared to 14 percent of the control group’s patients. The complication criteria were those reported by cardiac surgeons to the Society of Thoracic Surgeons National Database. These complications consist of common adverse outcomes following cardiac surgery that can significantly add to patient morbidity and hospital costs.

“In our study, patients in both the control and intervention groups were monitored with the INVOS Cerebral Oximeter during their operations. Control group patients were ‘blinded,’ or managed routinely without benefit of information from the Cerebral Oximeter,” explained Dr. Murkin. “Intervention group patients were managed using information from the Cerebral Oximeter by following a series of steps to keep the brain oxygen saturation levels at or above 75 percent of the patients’ brain oxygen levels at the beginning of the operation. Independent observers assessed all of the patients for adverse clinical outcomes.”

“We found that regional brain oxygen desaturations are quite common and are related to adverse outcomes,” said Dr. Murkin. “In addition, managing patients with the use of cerebral oximetry was associated with significant reductions in both the perioperative stroke rate and adverse clinical outcomes.”

The use of cerebral oximetry to prevent adverse outcomes in cardiac surgery was a major focus of this year’s Outcomes Meeting sessions. In addition to the presentation of Dr. Murkin’s study, lectures included the use of cerebral oximetry to reduce hospital stay and prolonged ventilation in cardiac surgery patients, stroke prevention strategies and the benefits of monitoring the brain during beating heart surgery.

“The significant findings in this trial and Dr. Murkin’s reputation as a scientist and expert in brain protection during surgery lead us to believe these results will be a catalyst for adoption of the INVOS System in cardiac surgery, especially when published,” said Bruce Barrett, Somanetics’ president and chief executive officer.

“In today’s health care environment, definitive data is required to justify investment in new technology, and we believe this study is an important step forward in providing compelling data about the benefits of cerebral oximetry,” Barrett said.

The INVOS System, the only commercially available cerebral oximeter in the U.S., is a technology that uses near infrared spectroscopy to monitor noninvasively regional oxygen saturation of blood in the brain. The INVOS System consists of disposable sensors, called SomaSensors, that are painlessly placed on both sides of the patient’s forehead (noninvasively, without needles or catheters), and a monitor that displays the results in numeric and graphic form. This “window to the brain” system continuously monitors changes in a patient’s regional brain blood oxygenation.

If a patient experiences a significant decline in brain oxygenation, the medical team can intervene and adjust medications, blood pressure or make other physiologic changes to correct the low brain oxygenation.

About Somanetics

Somanetics develops and markets two medical devices focused on the cardiac surgery market that offer solutions to help meet critical medical needs. The INVOS® Cerebral Oximeter is the only noninvasive and continuous monitor of changes in regional brain blood oxygen saturation that is commercially available in the U.S. The CorRestore® System is a cardiac implant for use in cardiac repair and reconstruction, including a procedure called Surgical Ventricular Restoration, SVR, a treatment for patients with certain types of severe congestive heart failure.

To learn more about Somanetics, please visit the Company’s web site at http://www.somanetics.com.