DexCom™ Receives CE Mark Approval For The SEVEN(R) PLUS Continuous Glucose Monitoring System

Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 04 Oct 2009 - 0:00 PDT

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DexCom, Inc. (NASDAQ: DXCM) announced that it has received CE Mark (Conformité Européene) approval for the SEVEN® PLUS continuous glucose monitoring system, enabling commercialization of the system in the European Union and the countries in Asia and Latin America that recognize the CE Mark.

The SEVEN PLUS is DexCom's third generation device designed to help people with diabetes better manage their diabetes and control their glucose levels. Widely recognized as one of the leading causes of death and disability globally, diabetes is a chronic disease with no known cure that afflicts an estimated 246 million people worldwide, according to the International Diabetes Federation. Diabetes is a leading cause of adult blindness, end stage kidney failure and lower limb amputations. People suffering from diabetes are also more significantly at risk for cardiovascular disease and stroke.

"We are pleased to have CE Mark approval for the SEVEN PLUS and we look forward to working with physicians, nurses and diabetes educators to bring this important technology to patients around the world," said Terrance H. Gregg, DexCom's President and Chief Executive Officer. "We are particularly pleased with the timing of this approval in light of the excitement surrounding continuous glucose monitoring we are seeing at the European Association for the Study of Diabetes (EASD) meeting currently taking place in Vienna. We have been working diligently to establish a network of distributors outside the United States and plan to launch the SEVEN PLUS in up to 10 countries in Europe in the fourth quarter."

As a reminder, Steven R. Pacelli, Chief Administrative Officer, will present an update on DexCom at the Fourth Annual JMP Securities Healthcare Focus Conference in New York City on Monday, October 5th, 2009, at 12:00 p.m. (EDT). The presentation, which will occur live at The New York Palace Hotel, will be concurrently webcast. The link to the webcast will be available on the DexCom, Inc. website at http://www.dexcom.com under the investor webcast section and will be archived for future reference.

Source
DexCom, Inc.