SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps, today announced its submission of a medical device license application to Health Canada to market its t:slim X2™ Insulin Pump with Dexcom G5® Mobile continuous glucose monitoring (CGM) integration1. The Company plans to launch the pump in Canada in the second half of 2018, subject to regulatory approvals.
“This application is another important step toward achieving our strategic goal of bringing the benefits of the t:slim X2 Insulin Pump to people outside of the United States," said Kim Blickenstaff, President and CEO of Tandem Diabetes Care. "When available, the t:slim X2 will provide people in Canada a competitive choice in the durable insulin pump market, which we believe will be of particular interest as the only pump with Dexcom G5 Mobile CGM integration."
The Company anticipates that the t:slim X2 Insulin Pump offered in Canada will be capable of displaying both English and French, offer a 24-hour clock, and will display glucose readings in millimoles per liter (mmol/L).
Canadian residents interested in signing up for email updates on Tandem’s plans in Canada can visit www.tandemdiabetes.com/canada.
About the t:slim X2 Insulin Pump
The simple-to-use t:slim X2 Insulin Pump includes advanced features like a large color touchscreen, Bluetooth® radio, rechargeable battery, USB connectivity and watertight construction (IPX7)2. It is the only pump that integrates with Dexcom G5® Mobile CGM, the first CGM-enabled pump approved in the United States to let users make treatment decisions without pricking their finger.3 The t:slim X2 Pump is up to 38% smaller than other insulin pumps and holds up to 300 units of insulin.4
Diabetes in Canada
According to Diabetes Canada (www.diabetes.ca), there are more than 3.4 million people with diabetes in the country.5 By 2020, diabetes is expected to account for more than 3.5% of total public health care spending, accounting for CAN$16.9 billion in annual health care costs.6 Insulin pumps and diabetes supplies are a covered benefit for qualifying recipients of disability tax credit, assistive devices programs, and qualifying expenses for registered disability savings plans offered in various forms across Canadian provinces.7
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical device company dedicated to improving the lives of people with diabetes through relentless innovation and revolutionary customer experience. The Company takes an innovative, user-centric approach to the design, development and commercialization of products for people with diabetes who use insulin. Tandem is based in San Diego, California.
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Tandem Diabetes Care and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. Dexcom G5 is a registered trademark of Dexcom, Inc.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements relate to, among other things, the timing of review of a Canadian health care medical device license application, the anticipated launch of a Tandem product in Canada in the second half of 2018 and the expected features of Tandem’s future products. These statements are subject to numerous risks and uncertainties, including the risk that Health Canada will approve the Company’s license when expected, or at all, the Company’s ability to establish the commercial and logistical infrastructure to support the planned launch of Tandem products outside the United States on a timely basis and without unanticipated expenses, the Company’s ability to develop, manufacture, supply and support Tandem products in conformance with applicable laws in Canada, as well as other risks identified in the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, respectively, and other documents that we file with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors.
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1 Dexcom G5 Mobile CGM
sold separately.
2 Tested to a depth of 3 feet for 30
minutes
3 CGM-based treatment requires fingersticks for
calibration; may result in hypoglycemia if calibration not performed,
when taking acetaminophen, or if symptoms/expectations do not match CGM
readings.
4 38% smaller than MiniMed 630G and 670G and
at least 28% smaller than MiniMed 530G, Animas Vibe and Omnipod System.
Data on file, Tandem Diabetes Care.
5 Estimated diabetes
statistics in Canada are generated by the Canadian Diabetes Cost Model;
2015
6 An Economic Tsunami: the Cost of Diabetes in
Canada, Canadian Diabetes Association, December 2009
7 http://www.diabetes.ca/about-cda/public-policy-position-statements/access-to-diabetes-medication-supplies-medical-devices