SAN DIEGO, Aug. 25, 2015
/PRNewswire/ -- Dexcom, Inc., (NASDAQ: DXCM), a leader in
continuous glucose monitoring (CGM) for patients with diabetes,
announced today that the U.S. Food and Drug Administration (FDA)
has approved the Dexcom G5® Mobile Continuous Glucose Monitoring
(CGM) System. With wireless Bluetooth® technology built into the
device transmitter, the G5 Mobile CGM System is the first and only
fully mobile CGM system approved by the FDA for both adults and
children as young as 2 years of age that sends glucose data
directly to a smartphone, freeing users from the need to carry a
separate receiver. The new transmitter securely sends vital
glucose information directly to an app on iOS-enabled devices for
real-time diabetes management. Android applications will follow
early next year. Like its predecessor, the G4 PLATINUM CGM with
Share, users can also select up to five designated
recipients, or "followers". These followers can remotely
monitor a patient's glucose information and receive alert
notifications from almost anywhere.
"Dexcom is rapidly advancing technology for continuous glucose
monitoring devices to improve diabetes management. Since January,
the company has introduced the G4 PLATINUM CGM with Share,
apps to enable the first CGM on the Apple Watch™ and
now the Dexcom G5® Mobile CGM. These advances are making
diabetes management more convenient and flexible than ever before,"
stated Kevin Sayer, President and
Chief Executive Officer of Dexcom. "We are excited for the promise
this new technology holds for patients and caregivers."
About the Dexcom U.S. G5 Mobile Launch
- The G5 Mobile system is anticipated to begin shipping in late
September 2015.
- All purchasers of a G4 Platinum with Share system from
August 1, 2015, until the G5 Mobile
system is shipped, will be eligible to receive a no-cost upgrade to
the G5 Mobile system.
- There will be a low cost cash upgrade to the G5 Mobile system
for those patients who are still under warranty with their existing
system.
"Obviously there are a lot of moving parts to our commercial
launch plans given this sooner-than-expected approval, and the
financial ramifications, such as inventory adjustments and revenue
recognition policies are being evaluated and will be discussed in
detail on the Q3-2015 earnings call in early November," remarked
Sayer.
Enhanced Mobility and Flexibility
Available by prescription, the Dexcom G5 Mobile CGM System
features the most accurate glucose sensor on the market while
providing enhanced mobility and flexibility to view and share
personal glucose data and trends. The only CGM with single digit
MARD (Mean Absolute Relative Difference), the Dexcom G5 Mobile
comes with the longest-wear sensor on the market and features
customizable alerts and a built-in low glucose alarm (55 mg/dL
alarm) to warn patients of highs and lows and how quickly they may
be happening through a simplified mobile interface. Data from the
Dexcom G5 Mobile can be integrated with Dexcom
CLARITY™, a Cloud-based reporting software, for
personalized, easy-to-understand analysis of trends that may
improve diabetes management.
Continuous glucose monitoring is considered the most significant
breakthrough in diabetes management in the past 40
years1. The traditional standard-of-care for glucose
(blood sugar) monitoring has been a finger stick meter. CGM
augments the use of glucose meters for the management of diabetes.
Meters are still required to calibrate CGMs and for guidance in
making therapy and meal decisions. CGM is important because, in
addition to providing the glucose level, it provides the direction
and rate of glucose change with the push of a button and alerts
users when glucose is too low or too high.
Diabetes affects 29.1 million Americans and is the 7th leading
cause of death in the United
States.2 With diabetes, the body cannot produce
or use the hormone insulin effectively, causing a buildup of
glucose, or sugar, in the blood. It is estimated that approximately
86 million Americans over the age of 20 years old are at risk for
developing diabetes (primarily Type 2), largely due to obesity,
physical inactivity and poor diet.2 People with diabetes
who take insulin must monitor their blood glucose levels
frequently. Uncontrolled glucose can cause health complications and
even death.3,4
About Dexcom, Inc.
Dexcom, Inc., headquartered in San
Diego, CA, is dedicated to helping people better manage
their diabetes by developing and marketing continuous glucose
monitoring (CGM) products and tools for adult and pediatric
patients. With exceptional performance, patient comfort and
lifestyle flexibility at the heart of its technology, users have
consistently ranked Dexcom highest in customer satisfaction and
loyalty. For more information on the Dexcom CGM, visit
www.dexcom.com.
Cautionary Statement Regarding Forward Looking
Statements
This press release contains forward-looking statements that are
not purely historical regarding Dexcom's or its management's
intentions, beliefs, expectations and strategies for the future,
including those relating to the intended use and technical
specifications of the CGM products, the potential impact on
outcomes associated with diabetes care. Because such
statements deal with future events, they are subject to various
risks and uncertainties, and actual results could differ materially
from Dexcom's current expectations. Factors that could cause actual
results to differ materially include risks and uncertainties such
as those relating to: the inability to successfully development new
products and obtain regulatory approval; 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 section entitled "Risk Factors" in
Dexcom's Annual Report on Form 10-K, its most recent Quarterly
Report on Form 10-Q, and its other reports filed with the
Securities and Exchange Commission.
MEDIA CONTACT:
Caren Begun, 201-396-8551
To view multimedia assets, please visit:
http://www.dexcom.com/media.
INVESTOR CONTACT:
Steven Pacelli, 858-200-0200
References
- Clarke SF and Foster JR. A history of blood glucose meters and
their role in self-monitoring of diabetes mellitus. Br J Biomed
Sci. 2012;(3)2:83-93.
- 2014 National Diabetes Statistics Report. Centers for Disease
Control and Prevention.
http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf
Accessed March 31, 2015.
- Hyperglycemia (High blood glucose). American Diabetes
Association Web site.
http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hyperglycemia.html.
Updated August 5, 2013. Accessed
December 3, 2013.
- Hypoglycemia (Low blood glucose). American Diabetes Association
Web site.
http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hypoglycemia-low-blood.html.
Updated July 16, 2013. Accessed
December 3, 2013.
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SOURCE Dexcom, Inc.