CAS Medical Systems, Inc.'s FORE-SIGHT(R) Absolute Tissue Oximeter Gains FDA Clearance for Use on Neonatal Abdomen
"We are proud to have the first tissue oximeter with a specific abdominal claim to be cleared by the FDA," said Thomas M. Patton, President and CEO of CASMED. "After many years of clinical study, we were able to develop a specific FORE-SIGHT algorithm for the monitoring of the newborn abdomen with a high degree of accuracy. This clearance is further evidence of CASMED's continued commitment to provide science-based solutions to our clinician customers."
CASMED's Small Sensor is now indicated for monitoring the absolute regional hemoglobin oxygen saturation of the abdomen of infants weighing less than four kilograms. Preterm and low birth weight babies often have under-developed mechanisms to regulate blood flow and are therefore susceptible to injury from dangerously low levels of oxygen in brain and abdominal tissues. There are approximately 400,000 newborns born prematurely each year in the U.S. that could benefit from the use of the FORE-SIGHT system.
"Clinicians now have a non-invasive and reliable monitoring solution that provides absolute oximetry values to guide clinical intervention for these vulnerable preterm infants," said K. Rais-Bahrami, M.D., Director of the Neonatal Perinatal Fellowship Program at Children's National Medical Center in Washington, D.C. Along with Mariam Said, M.D., Dr. Rais-Bahrami led a pivotal clinical validation study that supported CASMED's FDA filing. "Our data confirmed the accuracy of the FORE-SIGHT values compared to the invasive reference and showed a standard deviation of just +/- 5%. The ability of a non-invasive monitor to provide this level of quantitative accuracy is a meaningful milestone in the advancement of tissue oximetry as a critical tool in the care of newborns," Dr. Rais-Bahrami added.
"Given a newborn's unique physiology, a custom algorithm was necessary to provide accurate quantitative tissue oximetry values," Mr. Patton continued. "We believe these new and specific indications will aid clinicians in their care of babies and in the expansion of the applications for tissue oximetry monitoring of newborns."
CASMED expects that FORE-SIGHT Absolute Tissue Oximeters with this new neonatal abdomen capability will be available to the market in the second quarter of 2012.
About CASMED(R) - Monitoring What's Vital
CAS Medical Systems, Inc. is a leading developer and manufacturer of medical devices for non-invasive patient monitoring. The Company's FORE-SIGHT Absolute Tissue Oximeter is used in critical care settings to monitor the oxygenation of the brain and other tissue to aid clinicians in treating patients with dangerously low levels of cerebral oxygen. The FORE-SIGHT Absolute Tissue Oximeter is the only cerebral oximeter available with FDA clearance for non-invasive, continuous measurement of absolute cerebral tissue oxygen saturation for all patients -- adult, pediatric and neonatal -- regardless of age or weight.
The Company also provides a line of traditional vital signs monitoring products, including bedside patient vital signs monitors, proprietary non-invasive blood pressure measurement technology, and neonatal intensive care supplies.
For further information regarding CAS Medical Systems, Inc., visit the Company's website at www.casmed.com.
Company Contacts
CAS Medical Systems, Inc.
Jeffery Baird
Chief Financial Officer
203-315-6303
ir@casmed.com
Investors
LHA
Kim Sutton Golodetz (kgolodetz@lhai.com)
(212) 838-3777
or
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(310) 691-7100