SAN DIEGO--()--Dexcom, Inc. (NASDAQ: DXCM) today announced that it has received CE Mark (Conformité Européene) approval for its fourth generation continuous glucose monitoring system, the Dexcom G4® system, enabling commercialization of the Dexcom G4 system in the European Union and the countries in Asia and Latin America that recognize the CE Mark.
“We have been working diligently to establish a launch plan with our network of distributors outside the United States and plan to execute a phased launch of the G4 system in Europe during the coming months”
The Dexcom G4 system is 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 366 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 Dexcom G4 system. Although we believe the Seven Plus is already the best sensor on the market, we are especially proud of the Dexcom G4 system’s improved performance and reliability, which is reflected in the G4 system data we recently presented at the American Diabetes Association’s 72nd Scientific Sessions. We look forward to working with physicians, nurses and diabetes educators to bring this important new technology to patients around the world," said Terrance H. Gregg, Dexcom's Chief Executive Officer. "We have been working diligently to establish a launch plan with our network of distributors outside the United States and plan to execute a phased launch of the G4 system in Europe during the coming months," added Mr. Gregg.
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 quarterly report on Form 10-Q for the period ending March 31, 2012, as filed with the Securities and Exchange Commission on May 2, 2012.