TROY, Mich., Nov. 7 /PRNewswire-FirstCall/ -- Somanetics Corporation announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the INVOS(R) technology to monitor changes in blood oxygen saturation in regions of the body other than the brain.
This new application of the INVOS technology is intended as an adjunct trend monitor of hemoglobin oxygen saturation of blood in skeletal muscle tissue beneath the sensor in infants, children and adults at risk of reduced- flow or no-flow ischemic states in critical care settings.
“This is an important milestone for Somanetics,” said Bruce Barrett, Somanetics’ president and CEO. “Our initial focus will be to capitalize on emerging opportunities to combine cerebral and skeletal muscle oxygen monitoring for the benefit of infants and children in the intensive care setting. There may also be numerous other applications where monitoring of the skeletal muscle tissue may assist in important clinical decision making.”
About Somanetics
Somanetics develops and markets the INVOS(R) Cerebral Oximeter, which, since 1996, has occupied a unique position in U.S. hospitals as the only commercially available monitoring system that noninvasively and continuously monitors changes in a patient’s regional brain blood oxygen saturation. Use of the INVOS Cerebral Oximeter helps medical professionals, such as surgeons, anesthesiologists, perfusionists and the critical care team, identify regional brain blood oxygen imbalances and take corrective action. Such action can prevent or reduce neurological injuries related to adverse events during surgery or in the critical care unit and reduce the associated cost of care. The device is used in situations where there is a high risk of brain oxygen imbalances, such as adult and pediatric cardiac surgeries, other major surgeries involving elderly patients and some intensive care unit applications. Somanetics also markets the CorRestore(R) System, a cardiac implant used in cardiac repair and reconstruction, including an operation called Surgical Ventricular Restoration, or SVR, a surgical treatment for patients with certain types of severe congestive heart failure. Somanetics’ web site is http://www.somanetics.com .
Safe-Harbor Statement
Except for historical information contained herein, the matters discussed in this news release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. Actual results may differ significantly from results discussed in the forward-looking statements. Actual results may be affected by, among other things, economic conditions in general and in the healthcare market, the demand for and market for our products in domestic and international markets, our history of losses, our current dependence on the Cerebral Oximeter and SomaSensor, the challenges associated with developing new products and obtaining regulatory approvals if necessary, research and development activities, the uncertainty of acceptance of our products by the medical community, the lengthy sales cycle for our products, third party reimbursement, competition in our markets, including the potential introduction of competitive products by others, our dependence on our distributors, physician training, enforceability and the costs of enforcement of our patents, potential infringements of our patents and the other factors set forth from time to time in Somanetics’ Securities and Exchange Commission filings, including Somanetics’ Registration Statement on Form S-1 (file no. 333-74788) effective January 11, 2002, its 2004 Annual Report on Form 10-K filed on February 22, 2005 and its first Quarterly Reports on Form 10-Q filed on April 11, 2005, July 8, 2005 and October 12, 2005.
Somanetics Corporation
CONTACT: Mary Ann Victor, Vice President, Communications of SomaneticsCorporation, +1-248-689-3050 ext. 204, or Fax: +1-248-689-4272
Web site: http://www.somanetics.com/
