DexCom (DXCM) Reports Health Canada Approval for G5 Mobile CGM System

November 14, 2016 9:50 AM EST

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Dexcom, Inc. (NASDAQ: DXCM), the leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that Health Canada has approved its Dexcom G5 Mobile CGM system for "non-adjunctive" use by people with diabetes aged 2 years and older.

The "non-adjunctive" indication enables the use of the Dexcom G5 Mobile CGM system as a replacement to fingerstick glucose testing for diabetes treatment decisions, making it a significant new standard of care in diabetes management. This approval means that diabetes patients and their physicians can now make treatment decisions based on data reported by the Dexcom G5 Mobile CGM system alone, without the use of painful fingersticks associated with blood glucose meters (fingersticks are only needed every 12 hours to calibrate). With wireless Bluetooth® technology built into the device transmitter, the G5 Mobile CGM System is the first and only fully mobile CGM system that sends glucose data directly to a smart device, freeing users from the need to carry a separate receiver. The device transmitter securely sends vital glucose information every five minutes directly to an app on iOS-enabled devices for real-time diabetes management. Users of the system can also select up to five designated recipients, or "followers" so they can remotely monitor the user's glucose information and receive alert notifications for added protection and peace of mind.

"News of the Canadian launch of the Dexcom G5 Mobile CGM System is truly exciting. CGM technology allows people with diabetes to view real time glucose data and trends, and the built-in alarms allow for intervention by the user to minimize the risk of hypoglycemia and hyperglycemia. It has become an invaluable component of diabetes management, especially for pediatric patients," said Dr. Angelo Simone, Pediatric Endocrinologist, Trillium Health Partners, Assistant Professor, Department of Pediatrics, University of Toronto. "As a Pediatric Endocrinologist I look forward to being able to review my patient's glucose data even before the family arrives in clinic."

"As a country singer, a pilot and a person living with diabetes, I benefit tremendously from the glucose readings that I get every 5 minutes from my Dexcom CGM," says George Canyon, Canadian Country singer and type 1 diabetic. "Now, seeing my glucose levels on my phone will enable me to manage my diabetes even better and do all the things that I love most without the inconvenience and pain of fingerstick testing multiple times a day, it's like a whole new world."

Before the landmark approval by Health Canada, the Dexcom system could only be used to augment glucose meter fingerstick testing. Canada is the first country in North America to approve the device with the non-adjunctive indication as a U.S. Food and Drug Administration (FDA) Advisory Panel voted in favor of granting a non-adjunctive claim in the U.S. this summer but a final FDA decision is still pending.

"The new indication in Canada for the Dexcom G5 Mobile CGM system is an astounding milestone for people with diabetes and is a critical step forward for advancing diabetes technology to drastically change diabetes management," said Kevin Sayer, Dexcom President and Chief Executive Officer. "Now, people with diabetes in Canada who use the Dexcom G5 Mobile CGM system can make treatment decisions without having to perform multiple fingersticks daily, which has posed a significant barrier to properly managing diabetes in the past."

The Dexcom G5 Mobile CGM System will be available within the first three months of 2017.



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