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Dexcom, Foundation Working to Develop Diabetes Device

DEXCOM INC.

CEO: Terrance Gregg.

Revenue: Total revenue of $76 million and product revenue of $66 million in 2011; total revenue of $48.6 million and product revenue of $40 million 2010.

Net loss: $45 million in 2011; $55 million in 2010.

No. of local employees: About 400.

Headquarters: San Diego.

Year founded: 1999.

Stock symbol and exchange: DXCM on Nasdaq.

Company description: Continuous glucose monitoring developer.

Key factors for success: Diabetes is the fastest-growing chronic medical disease in the world. In 2007, $170 billion was spent in the U.S. on treating diabetes, which makes it an epidemic. There’s no cure for diabetes, so glucose monitoring is extremely important to avoid long-term and short-term complications associated with the disease.

Dexcom Inc. is on a quest to make wireless advancements that will give diabetes patients convenient tools to manage their disease.

The San Diego-based medical device company’s ambitious project is tied to a recently announced partnership with the Juvenile Diabetes Research Foundation, a global type 1 diabetes research organization based in New York City. The duo are joining forces to accelerate the development of a wireless “smart transmitter” that would allow a continuous glucose monitoring system to communicate directly with an artificial pancreas control device used in JDRF research studies.

The research is aimed at bringing about conveniences for people with type 1 diabetes who need to determine the right amount of insulin to dose at the right time, multiple times every day. Even with diligent monitoring, blood sugar levels can fluctuate, placing sufferers at risk for complications.

An artificial pancreas under development will be an external device that people with type 1 diabetes could use to do what their bodies cannot ― automatically control their blood sugar around the clock. It will work by combining an insulin pump and a continuous glucose monitor, which provides glucose readings every one to five minutes, with sophisticated computer software that allows the two devices to communicate to determine and then automatically provide the right amount of insulin at the right time.

Current artificial pancreas studies use wires and cables to connect a continuous glucose monitoring system and an insulin pump to laptop computers or smartphones, which act as the artificial pancreas controllers. But having a smart transmitter would eliminate the need for study participants to carry multiple devices all wired together while testing an artificial pancreas system’s ability to manage glucose levels.

Critical Juncture

Aaron Kowalski, assistant vice president for treatment research at JDRF, said their flagship artificial pancreas program is at a critical juncture in moving from hospital studies to a real-world environment. Although their systems in place now have communicated via radio frequencies, not too many handheld devices can hear those radio frequencies, he said. Having a sensor that could communicate with a cellphone and an insulin pump would make the system incredibly mobile and benefit their outpatient studies, he said.

“Carrying a laptop to a job or restaurant is not ideal in a real-world study,” he said. “Having the ability to get rid of the laptop and move to a mobile platform is really important to us.”

Kowalski said diabetes is a real challenge for people like himself who carry an insulin infusion pump, a continuous glucose monitoring device, a cellphone and a PDA in addition to a wallet.

“It’s too much,” he said. “If you’re a 5-year-old kid going to kindergarten or a teenager it makes the burden of diabetes higher to have such equipment. Having the ability to easily communicate out to a variety of devices would ease the burden for people with diabetes.”

Out-Patient Studies

With the first out-patient studies of the artificial pancreas approved by the FDA within the last month, the goal is to accelerate the smart transmitter’s development and have it available within the next 12 to 18 months, Kowalski said. According to JDRF, the research organization will provide Dexcom up to $500,000 throughout 12 months in milestone-based funding to complete the development, testing and manufacturing of the smart transmitter prototype.

Although Dexcom has been involved with JDRF’s continuous glucose monitoring trials for more than eight years, this joint partnership with the artificial pancreas technology was just announced last month.

Dexcom CEO Terrance Gregg said the technology itself has been in development for two-and-a-half years to open the connectivity of the transmitted information to a variety of receivers, particularly smartphones and tablets. The focus has been on Android-based systems, but future iterations would include connectivity with the IOS operating system from Apple Inc., Gregg said. Still in the development phase, Gregg said Dexcom will eventually apply to the FDA for approvals to commercialize the sensor, transmitter and handheld receiver.

“Moving to a smart transmitter we can remove the wiring systems to allow remote monitoring,” Gregg said. “This gives patients the freedom to move out of the clinical research center and into their home. That provides a real-world situation for patients to function in a normal way in their home environment and work environment.”

Health care professionals will have the ability to monitor the patients remotely and be alerted through alarm systems if events such as glucose levels run high, he added.

“They’re never without extra eyes to watch them as they go through the investigational period of the study with these systems.”

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