Sherrielee
Fri, Dec-05-03, 14:19
ALAMEDA, Calif., Dec 02, 2003 -- TheraSense, Inc. (Nasdaq: THER), a leader in glucose monitoring and the maker of the popular, virtually painless FreeStyle(R) Blood Glucose Monitoring System, today announced that it has submitted a Premarket Approval application (PMA) with the U.S. Food and Drug Administration (FDA) for its FreeStyle Navigator(TM) Continuous Glucose Monitor. The PMA filing follows recently presented clinical data on Navigator that included results of home-use trials involving 102 subjects at 7 clinical sites.
FreeStyle Navigator is a continuous glucose monitor designed to replace traditional in vitro glucose testing by providing users with real time glucose data, hypo- and hyperglycemic alarms and trend analysis. Navigator utilizes TheraSense's patented Wired Enzyme (TM) technology and is designed to measure glucose levels in the patient's interstitial fluid every sixty seconds and transmit the results to a wireless pager-sized receiver that may be worn on a belt or carried in a pocket or purse.
"We are pleased with the submission of our PMA since this represents a key milestone in our efforts to provide the benefits of continuous monitoring to people with diabetes," said Mark Lortz, President and CEO of TheraSense. "We believe that the data from our clinical studies will support the claims we have made in our PMA submission. This submission was made possible by years of dedication and hard work by the employees at TheraSense. Our goal is to provide this tool to help prevent the devastating complications of diabetes," Mr. Lortz concluded.
FreeStyle Navigator is a continuous glucose monitor designed to replace traditional in vitro glucose testing by providing users with real time glucose data, hypo- and hyperglycemic alarms and trend analysis. Navigator utilizes TheraSense's patented Wired Enzyme (TM) technology and is designed to measure glucose levels in the patient's interstitial fluid every sixty seconds and transmit the results to a wireless pager-sized receiver that may be worn on a belt or carried in a pocket or purse.
"We are pleased with the submission of our PMA since this represents a key milestone in our efforts to provide the benefits of continuous monitoring to people with diabetes," said Mark Lortz, President and CEO of TheraSense. "We believe that the data from our clinical studies will support the claims we have made in our PMA submission. This submission was made possible by years of dedication and hard work by the employees at TheraSense. Our goal is to provide this tool to help prevent the devastating complications of diabetes," Mr. Lortz concluded.