CAS Medical Systems, Inc. Announces FDA 510(k) Clearance for Neonatal FORE-SIGHT® Cerebral Oximeter
FOR IMMEDIATE RELEASE:
Branford, Conn. February 28, 2008 CAS Medical Systems, Inc. (NASDAQ: CASM), a medical device company focused on innovative, non-invasive monitoring that is vital to patient care, today announced receipt of FDA 510(k) clearance for expanded indications for use of its FORE-SIGHT Cerebral Oximeter Infant Sensor to include the neonatal patient population above 2500g weight.
CASMED is the first and only company currently in the marketplace to have received FDA regulatory clearance for Cerebral Oximetry for use in Neonatal and Infant populations. The FDA guidance describes neonatal (newborn) as patients from birth to one month. The infant population is described as 1 month to 2 years.
“With expanded indications for use into the neonate setting, an additional essential patient population can now benefit from non-invasive, continuous absolute cerebral oxygen saturation measurements,” stated Andrew Kersey, President and CEO of CASMED. “The FORE-SIGHT Cerebral Oximeter can accurately detect low cerebral oxygen saturation events during critical periods, thereby allowing clinicians to intervene and reverse potentially life threatening events before brain damage occurs. Measuring cerebral oxygen saturation is vital for a variety of neonatal patients, including those born with congenital heart defects that affect the ability of the heart to supply oxygenated blood to the brain.
“The large population of babies that can immediately benefit from the use of this technology is heartening,” commented Kersey. “There are approximately 550 hospitals with Neonatal Intensive Care Units (NICU) in the US alone, with 13,000 high acuity Level 3 beds. Approximately four million births occur in the US each year. Of these, nearly 4% of babies are born with a birth defect and about 12% are born preterm (less than 37 weeks gestation).
“We are thrilled to be able to expand the use of FORE-SIGHT into the neonatal population. CASMED is proud to have a long history serving this vulnerable patient group with innovative products designed to improve patient outcomes. Our premium brand Klear-Trace® electrodes have long been a gold standard for this environment due to our core competency in providing products designed to maintain neonatal skin integrity. The introduction of the FORE-SIGHT Neonatal Cerebral Oximeter affirms our on-going commitment to providing innovative products to neonatal and infant patients,” continued Kersey.
The FORE-SIGHT Neonatal / Infant Sensors will be sold primarily into the hospital market for use in the Neonatal / Infant Cardiovascular OR, the Cardiac Intensive Care Unit and the Neonatal Intensive Care Unit. Customer preference testing is currently underway at five key neonatal / infant clinical locations throughout the U.S. to support the commercial launch of the FORE-SIGHT Infant Sensor planned for the second half of this year.
For further information regarding CAS Medical Systems, Inc., visit the Company’s website at www.casmed.com.
Director of Corporate Communications