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TheraSense Receives FDA Clearance for Labeling Changes to
FreeStyleTM Blood Glucose Monitoring System
FreeStyle System offers the smallest sample size and widest array of alternate sites
Alameda, CA - December 6, 2001 - TheraSense, Inc. (NASDAQ:THER) today announced that the U.S. Food And Drug Administration (FDA) has cleared the company's labeling changes for its FreeStyle Blood Glucose Monitoring System. The changes to labeling provide consumers with new information about the use of alternative sites for testing blood glucose. The FreeStyle System offers less painful testing, requires the smallest blood sample and allows the broadest array of body sites for testing of any blood glucose monitoring system cleared for marketing by the FDA.
The specific sites cleared by the FDA's action are the forearm, thigh, calf, upper arm and hand as well as the fingertip. Testing on sites other than the fingertip is significantly less painful than using the traditional fingertip test site. This is because fingertips are densely populated with highly sensitive nerve endings as well as capillaries, yielding the larger blood volumes required by competitive products. The FDA permitted TheraSense to continue selling the FreeStyle System while the revised labeling 510(k) was being considered.
"TheraSense is very proud of the FreeStyle product. The ability to easily and accurately measure blood glucose with less pain has made a tremendous difference for many people. They have brought their diabetes into better control," said Mark Lortz president and chief executive officer of TheraSense. "TheraSense is also very proud of its leadership role in examining alternate site testing through extensive clinical trials and publishing these findings. We submitted this clinical data to the FDA in support of our labeling changes in April 2001. We are very pleased with the outcome."
Results from numerous clinical studies which were part of TheraSense's clinical data submitted to the FDA are the subject of an article in the fall 2001 issue of Diabetes Technology & Therapeutics, a peer-reviewed journal.
TheraSense develops, manufactures and sells easy to use glucose monitoring systems that dramatically reduce the pain of testing for people with diabetes. The company began selling its first product, FreeStyle, in June 2000. FreeStyle has wide distribution in the United States through national retailers including Walgreens, Wal-Mart, CVS, Eckerd and Rite Aid. FreeStyle is distributed in Germany and Sweden by Disetronic Group, the leading provider of insulin pumps in Europe. TheraSense's headquarters and test strip manufacturing facility are located in Alameda, California.
Last Updated: Thursday August 29, 2002 20:59:48
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