Dexcom’s CEO: FDA’s Fast Approval of the G4 CGM Was Unprecedented

It is fitting, in more ways than one, to compare the firm’s technology to GPS systems. In addition to helping diabetics navigate changes in their blood glucose levels, the company’s Gen 4 Platinum also reflects the trend of consumerization in the medical device space. The Gen 4 Platinum itself looks more like an iPod than a GPS system. The company recently announced a partnership with Tandem Diabetes Care, which also has a product, the t:slim insulin pump, that bears a resemblance to an Apple product.

Much of Gregg’s talk focused on the Gen 4, which debuted in October 2012 after having been approved by FDA in six months. “That is unheard of in this regulatory environment,” he said.

The device is 20% more accurate overall than its predecessor, the 7 Plus (for a look inside that device, see: “Inside the Dexcom Seven Plus Continuous Glucose Monitoring System”), which will help diabetics better navigate the “delicate balance between hypoglycemia and hyperglycemia,” Gregg explained. “Hyperglycemia contributes to the microvascular complications associated with diabetes: cardiovascular disease, increase in blindness, kidney failure, and nerve degeneration,” he said. “On an acute basis, hypoglycemia is even more dangerous [leading to] cognitive impairment, loss of consciousness, and potential death.”

In general, CGM can also help reduce the costs of treating diabetes, which, in the United States, exceeds $170 billion annually. “On average, a hospitalization for hypoglycemia costs $17,000,” adding that “CGM can reduce hypoglycemia by 50%.”

At present, only a handful of firms have CGM products on the market. In the United States, Medtronic and DexCom are the only players. Dexcom has working to expand its operations outside of the United States. “Today, 90% of our revenue is derived from the U.S. market,” Gregg acknowledged. “We now operate in 22 countries. As we expand beyond our shores, we will expand that to an additional 11 countries.”

The company plans on introducing a variety of new products in 2013 and 2014. “In late 2014 to 2015, we’ll introduce smartphone technology that we are currently working on,” Gregg said.

“Mobile health is at our doorstep,” he said. “And we are leading activities with FDA looking at Class III medical devices, the risk and mitigations of those risks in order to achieve wireless capability.”

The company is also involved in the artificial pancreas project, which integrates a continuous glucose sensor and insulin pump, and an algorithm, which serves as a brain for the device.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.