DexCom Receives FDA Approval For 7-Day STS Continuous Glucose Monitoring System

San Diego, CA - DexCom, Inc. recently announced that it has received Food and Drug Administration (FDA) approval for SEVEN, its 7-Day STS Continuous Glucose Monitoring System. SEVEN is DexCom's second generation device designed to help people with diabetes better manage their diabetes and control their glucose levels. Widely recognized as one of the leading causes of death and disability in the United States, diabetes is a chronic disease with no known cure that afflicts approximately 20 million people in the U.S., according to the Center for Disease Control (CDC). In the U.S., diabetes is the leading cause of adult blindness, end stage kidney failure and lower limb amputations. People suffering from diabetes are also more significantly at risk for cardiovascular disease and stroke.

"We continue to believe that the introduction of new, better performing products is key to the development of the continuous glucose monitoring category. We are pleased to have approval for the SEVEN, our second-generation continuous glucose monitoring product, after only approximately one year following our original PMA approval for the STS. We are hopeful that the SEVEN will help healthcare professionals and patients improve their management of diabetes," said Andrew P. Rasdal, DexCom President and Chief Executive Officer.

Mr. Rasdal continued, "We are appreciative of the efforts by the FDA to help make our next generation technology available to people with diabetes and we are especially thankful for the support of the patients, physicians, nurses, and diabetes educators who have participated in our clinical studies and efforts supporting this approval. We hope to initiate a limited launch of SEVEN near the end of our second quarter and a more robust launch in the third quarter."

DexCom also announced today that it has received approval for its DM2 Data ManagerTM software which allows healthcare professionals and patients to download continuous glucose data from their receivers to their computers. The DM2 Data Manager is DexCom's second generation download software, with new tools and analytical capabilities to provide further insight into their diabetes and facilitate more appropriate care. DexCom anticipates launching the DM2 Data Manager in conjunction with the SEVEN.

SOURCE: DexCom, Inc.