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FDA Clears DexCom's G4 PLATINUM Continuous Glucose Monitor


10/8/2012 7:43:43 AM

SAN DIEGO--(BUSINESS WIRE)-- Dexcom (DXCM), a leader in continuous glucose monitoring, announced today that the U.S. Food and Drug Administration has approved its eagerly anticipated new continuous glucose monitoring system, the Dexcom G4™ PLATINUM.

Clinical trials report up to approximately 19 percent improvement in overall accuracy for the Dexcom G4 PLATINUM compared to the Seven Plus, and approximately a 30 percent improvement in accuracy in the hypoglycemia range (i.e., when blood glucose is less than 70mg/dl). The overall accuracy and ease of use for the Dexcom G4 PLATINUM sets a new standard for commercially available CGMs, making the Dexcom G4 PLATINUM the most-advanced CGM system available.

“Improved accuracy in the critical hypoglycemic range is most important from a life-saving point of view,” said Terrance H. Gregg, Dexcom CEO. “The Dexcom G4 PLATINUM fulfills the promise of CGM for people with diabetes by providing accurate and reliable real-time performance.”

Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40 years. The traditional standard-of-care for glucose (blood sugar) measurement has been a finger stick meter. Although they remain an essential part of a comprehensive diabetes management program, finger stick meters are inherently limited by the fact that, like a photograph, it only provides data for the specific moment in which the measurement is completed; it doesn’t show whether glucose is going up or down – or how fast.

By contrast, CGM provides an in-motion picture that shows not only glucose levels, but also the speed and direction in which it is moving, and alerts the user to sudden changes so they can take action.

The Dexcom G4 PLATINUM offers not only outstanding accuracy and performance, but many new capabilities, including:

Longest transmission range, enabling improved patient flexibility and convenience

A smaller, discrete profile that fits busy lifestyles

A first-of-its-kind color LCD display for easy viewing

Customizable alerts with specific tones

“Hypo alert” setting at 55 mg/dl that provides an increased level of safety – a feature that no other device has.

An ideal and convenient tool for diabetes management

The Dexcom G4 PLATINUM CGM system consists of just three parts: a sensor, transmitter, and monitor.

The tiny sensor - about the diameter of a human hair —is inserted by the user under the skin on the abdomen. A small transmitter sends data wirelessly to a sleek and small monitor, which easily fits in a purse or pocket. It provides data every 5 minutes for up to 7 consecutive days, quickly and easily showing the body’s response to medication, food and exercise. If users are outside their target zones, configurable alarms alert them so that they can take action.

The Dexcom G4 PLATINUM is prescribed by a physician and covered by most insurance plans for people taking insulin, and is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The company plans to begin taking orders for the Dexcom G4 PLATINUM immediately and expects to begin shipping to patients within the next several weeks. For more information, visit www.dexcom.com.

About Dexcom, Inc.

DexCom, Inc., headquartered in San Diego, California, is developing and marketing continuous glucose monitoring systems for ambulatory use by patients with diabetes 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 ended June 30, 2012, as filed with the Securities and Exchange Commission on August 6, 2012.

Contact:

Dexcom, Inc.

John Lister, 858-875-5369


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