SAN DIEGO, Oct 01, 2009 (BUSINESS WIRE) -- DexCom, Inc. (NASDAQ: DXCM) today announced that it has received CE Mark (Conformité Européene) approval for the SEVEN(R) 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 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 ambulatory use by patients 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 annual report on Form 10-Q for the period ending June 30, 2009, as filed with the Securities and Exchange Commission on August 3, 2009.
SOURCE: DexCom, Inc.
Steven R. Pacelli
Chief Administrative Officer
Copyright Business Wire 2009