This excerpt taken from the DXCM 10-K filed Feb 27, 2006.
Long-Term Continuous Glucose Monitoring Sensor
Our long-term implantable sensor consists of a multi-layer membrane system, circuit board, microprocessor, radio transmitter and a battery sealed in a self-contained unit. Our long-term sensor is currently implanted under the skin in the lower abdomen by a surgeon using local anesthesia. In the future we expect that the implant will be performed by trained endocrinologists. Once the sensor is implanted, it requires a stabilization period of a few weeks before becoming operational. After the stabilization period, the patient is required to calibrate the receiver with data from a single-point finger stick device. We anticipate that patients will be required to calibrate the long-term sensor with finger sticks throughout the usage period. At this time, we do not believe our long-term sensor will eliminate the need for finger sticks, although in the future we could seek a claim from the FDA that allows our long-term system to replace the use of finger stick devices.
We are designing our long-term sensor to function for up to one year. We have demonstrated nearly seven months of functional life in a clinical trial with our first generation long-term sensor and six months of functional life in a clinical trial with our second generation long-term sensor. At the end of its life, the sensor can be removed by a physician in a short procedure, and another sensor inserted.
We have investigational device exemption (IDE) approval from the FDA to conduct an 80 patient trial with the G2 sensor. To date, we have enrolled 45 patients. Prior to our QSR inspection for our STS, we moved our long-term sensor development and manufacturing to a new facility which has delayed our ability to manufacture product suitable for human implants. During this delay, we made new innovations related to our biomaterials that may improve performance. We are currently evaluating the performance of these new materials on our G3 platform in animals. We plan to fully evaluate the impact of those improvements, potentially conducting human feasibility trials outside the United States before enrolling any additional patients in our U.S. IDE.