Planned Advantages of the SMSI® Glucose Monitor

The SMSI® system is different in that it places the sensor (pictured above, right, sitting on a finger) inside the body, in continuous contact with the environment to be measured. It is powered by an external reader (pictured above, left) which receives information and provides it to the patient through a harmless, noninvasive, electromagnetic transmission. By eliminating sampling, the SMSI system overcomes both the pain and reliability issues associated with existing approaches. SMSI will conduct studies expected to demonstrate that its glucose monitoring system will be superior to competing technologies.

The key distinguishing features of SMSI's glucose monitor, which will be evaluated in pre-clincal and clinical studies, include:

  • Minimally invasive. SMSI's glucose sensor implant will be placed under the skin using a large-bore needle called a trocar. There, it will reside inside the body for up to one year, depending on the product lifetime as demonstrated in clinical studies. Using telemetry, the implant will communicate its glucose measurements to an external reader, without the need to draw blood.
  • Continuous, effortless monitoring. As long as the patient wears the external reader, the SMSI system is intended to automatically record a glucose level measurement every few minutes. Further, it will be designed to alert the user to both hypergylcemia and hypoglycemia.
  • Accurate. Because no sampling is involved, SMSI's glucose monitor is designed to reduce the risk of user error substantially.
  • May enable improved care. Clinical studies will evaluate whether use of the device allows improved treatment regimens by giving patients and healthcare providers a wealth of new data. This may require supplemental regulatory approvals. Patients and health care providers can receive tailored summaries of the data they need to make decisions.
  • Non-consuming. The SMSI glucose sensor does not need to consume or produce chemicals while operating. The sensor's interaction with glucose is fully reversible, and the device operates in equilibrium with ambient fluids.
  • Excellent Specificity. SMSI's sensor responds strongly to glucose, and in testing so far, is not significantly affected by other chemicals at concentrations typically present in interstitial fluid.

SMSI's unique approach to glucose monitoring is designed to avoid many of the problems of competing technologies, and is designed to provide an unmatched combination of convenience and reliability.


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