Dexcom Receives FDA Approval For STS™ Continuous Glucose Monitoring System

Dexcom Receives FDA Approval For STS(TM) Continuous Glucose Monitoring System – a first generation device designed to help people with diabetes more conveniently and effectively manage their blood sugar levels. This is the second CGMS that has hit the market, and you can expect at least one more this year. More Information

Dexcom Receives FDA Approval For STS™ Continuous Glucose Monitoring System

Novel Technology Designed To Help People With Diabetes Manage Blood Sugar Levels. The federal government’s approval of another medical device that continuously monitors glucose is an important step in the development of an artificial pancreas, a closed loop system.

San Diego, CA – March 27, 2006 – DexCom, Inc. today announced that it has received Food and Drug Administration (FDA) approval for its STS™ Continuous Glucose Monitoring System, a first generation device designed to help people with diabetes more conveniently and effectively manage their blood sugar 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 are very pleased the FDA has approved the DexCom STS Continuous Glucose Monitoring Product and are hopeful this novel technology will improve the quality of life for people living with diabetes,” said Andrew P. Rasdal, DexCom President and Chief Executive Officer.

The DexCom STS consists of a tiny wire-like sensor that is inserted by the patient just under the skin. The sensor continuously measures glucose levels which are transmitted wirelessly to the cell phone-like STS Receiver. With the push of a button, the handheld Receiver conveniently provides the patient with real-time glucose measurements and trends, as well as providing alerts to warn of high and low glucose levels. The results of a study on the DexCom STS published in the January 2006 edition of Diabetes Care, a publication of the American Diabetes Association, demonstrated patients could achieve better control of glucose levels when using the information from the DexCom STS.

“We are appreciative of the efforts by the FDA and FCC to help make this technology available to people with diabetes,” said Rasdal. “Further, we are especially thankful for the support of the patients, physicians, nurses, and diabetes educators who have participated in our clinical studies supporting this approval.”

DexCom held a conference call yesterday and the following is some information that was discussed on the call.

The DexCom continuous blood glucose monitor is approved for adults 18 and older. It can be used for 72 hours and can be used at health care facilities or for use at home.

It is to be used to monitor blood sugars for detection of hypo and hyperglycemia.

It is not recommend for use to change treatment therapies as insulin dosing or change of medications. It is recommended that it be used along with a blood glucose monitor for changes in therapies or doses of medication.

It will require a prescription and will be distributed by DexCom only.

Initially will be sold as a Kit, which will include the transmitter, receiver, sensors, case and batteries which will last for about a year.

DexCom has some inventory and will begin distribution within a week or two.

There sales force will begin with 15 sales reps and will increase over time.

The FDA approval was for the 3 day sensor, but they will begin a small study shortly with the use of the sensor for 7 days and will submit to the FDA within a very short time.

The sensors which are 2 ½ inches square, have a shelf life of 4 months at room temperature

There is no reimbursement at this time, but they hope to resolve that shortly.

The important thing to remember is that the values from the CGMS should not be used to adjust medications and treatments. Blood Glucose monitoring should be used to change treatments.