Dexcom Receives CE Mark Approval for the Dexcom G4® Continuous Glucose Monitoring System
SAN DIEGO--(BUSINESS WIRE)--
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.
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.
Dexcom, Inc.
Steven R. Pacelli
Chief Operating Officer
858-200-0200
Source: Dexcom, Inc.
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