SAN DIEGO, Dec 01, 2008 (BUSINESS WIRE) --
DexCom, Inc. (NASDAQ:DXCM) today announced that it has received CE Mark (Conformite Europeene) approval for the SEVEN(R), its seven-day 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 is DexCom's second 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 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 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 saw at the European Association for the Study of Diabetes (EASD) meeting this summer in Rome. We hope to initiate a limited launch of SEVEN in Europe before the end of 2008 and a more robust launch in 2009."
As a reminder, DexCom will present an update on the company at the Piper Jaffray 20th Annual Health Care Conference in New York on Tuesday, December 2, 2008, at 3:00 p.m. (EST). The presentation, which will occur live at the New York Palace Hotel in New York, will be concurrently webcast. The link to the webcast will be available on the DexCom, Inc. website at www.dexcom.com under the investor webcast section and will be archived for future reference.
About DexCom, Inc.
DexCom, Inc., headquartered in San Diego, California, is developing and marketing continuous glucose monitoring systems for use by patients at home and by healthcare providers in the hospital.
Cautionary Statement Regarding Forward Looking Statements
DexCom is a medical device company with a limited operating history. Successful commercialization of the company's products is subject to numerous risks and uncertainties, including a lack of acceptance in the marketplace by physicians and patients, the inability to manufacture products in commercial quantities at an acceptable cost, possible delays in the company's development programs, the inability of patients to receive reimbursement from third-party payors and inadequate financial and other resources. Certain of these risks and uncertainties, in addition to other risks, are more fully described in the company's quarterly report on Form 10-Q for the period ending September30, 2008, as filed with the Securities and Exchange Commission on November10, 2008.
SOURCE: DexCom, Inc.
Steven R. Pacelli
Senior Vice President of Corporate Affairs
Copyright Business Wire 2008
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