Abbott’s Continuous Blood Glucose Monitor Approval Soon

Abbott's Freestyle Navigator is expected to win U.S. Food and Drug Administration approval by year-end, making the company the third this year to get the nod from U.S. regulators for the sophisticated devices that help diabetics better manage their disease.
Medtronic Inc., the No. 1 maker of insulin pumps, and DexCom Inc., a smaller player that went public in April 2005, also got approval for continuous glucose monitors this year.

Medical device makers and drug companies are clamoring to develop products to address the diabetes epidemic, which is growing at a rate of about 7 million new cases worldwide a year.

Ed Fiorentino, president of Abbott's diabetes unit, said he believes Abbott's product will set the bar for these high-tech tools, which the company estimates could represent an annual $1 billion market. "When you think about our product, you think about two things: better accuracy and better information for the patient," he said.

Some on Wall Street agree and think that Abbott's Freestyle Navigator could be the device of choice in this segment, given its accuracy and ease of use.

Instead of sporadic readings, the new devices track blood sugar constantly and sound alarms if it goes outside of safe ranges. The pager-sized tools take readings from a tiny sensor inserted just under the skin and held in place by an adhesive patch. A transmitter relays the minute-by-minute findings to a wireless receiver. Anybody who needs a lot of information about their blood glucose levels probably will be using one of these at some poin. The Abbott device will kick off a "marketing dogfight" over product features.

Better accuracy and longer-wearing sensors -- five days with the Abbott product vs. three days with the Medtronic and DexCom devices -- will give Abbott an edge. It’s first approval will be labeled for use with the current finger-stick method for tracking diabetes.. The next step will be to claim a so-called "reportable result," meaning the patient won't have to verify the findings with a finger-stick test. They already have the studies to submit after they get their first approval.

A replacement claim may be key to winning support from payers and private insurance companies, which will likely pay for the lion's share of the devices. Analysts think that it will take at least two years before companies develop a "reasonable number of payers." But they expect to see a lot more positive pay decisions in the next 12 months.

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