SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps with continuous glucose monitoring (CGM) integration, today announced that it has received a Heath Canada Medical Device License for the t:slim X2™ Insulin Pump. The t:slim X2 Pump features Dexcom G5® Mobile CGM integration,1 making it the only CGM-integrated insulin pump approved in Canada for making daily diabetes treatment decisions without fingersticks.2 The Company plans to launch the t:slim X2 Insulin Pump on a province-by-province basis throughout the fourth quarter of 2018 pending the completion of pre-launch activities, including product registration with provincial health programs.
The simple-to-use t:slim X2 Insulin Pump includes advanced features like a large color touchscreen, rechargeable battery, USB connectivity and watertight construction (IPX7)3. As the only insulin pump integrated with Dexcom G5 Mobile CGM, dynamic glucose data can be easily accessed and shared using a compatible mobile device.4 The t:slim X2 Pump is up to 38% smaller than other insulin pumps and holds up to 300 units of insulin.5
“People with diabetes in Canada have been asking for our simple-to-use pump technology since the inception of Tandem and I am thrilled that we are now able to offer a fresh, new choice in insulin pump therapy,” said Kim Blickenstaff, President and CEO of Tandem Diabetes Care. “This launch is especially important since insulin pump options in Canada have become increasingly limited in recent years, and this approval will allow us to bring the benefits of our technology to more people with diabetes.”
For additional t:slim X2 Pump product and safety information in Canada, or to begin the order process, visit www.tandemdiabetes.ca.
Diabetes in Canada
According to Diabetes Canada (www.diabetes.ca), there are more than 3.4 million Canadians living with diabetes, of which approximately 10 percent have type 1 diabetes.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. Tandem takes an innovative, user-centric approach to the design, development and commercialization of products for people with diabetes who use insulin. Tandem manufactures and sells the t:slim X2™ Insulin Pump, which features integrated continuous glucose monitoring. Tandem is based in San Diego, California.
Tandem Diabetes Care, t:slim X2, and t:simulator are trademarks, registered trademarks, and/or the subject of a pending trademark application in the US and other territories worldwide. Dexcom and Dexcom G5 are registered trademarks of Dexcom, Inc. All other trademarks are the property of their respective owners.
Forward-Looking Statement
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 anticipated timing for the commercial launch of the t:slim X2 Pump in Canada and our ability to complete pre-launch activities, including product registration with provincial health programs in Canada in 2018. These statements are subject to numerous risks and uncertainties, including our ability to recruit, hire and train new personnel to support our operations in Canada, manufacture commercial quantities of a new version of the t:slim X2 Pump for the Canadian market, our ability to launch a new system, which may include entering into agreements with third parties for customer ordering, training and logistics, and the risk that we may encounter other challenges that may delay the commercial launch of t:slim X2 Pump in Canada, as well as other risks identified in our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, 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. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors.
1 Dexcom G5 Mobile CGM System sold separately. The Dexcom G5
Mobile CGM transmitter can only be paired with one medical device
(either a Dexcom receiver or t:slim X2 Pump) and one consumer device
(phone or tablet) at the same time.
2 If glucose alerts
and CGM readings do not match symptoms or expectations, use a blood
glucose meter to make diabetes treatment decisions. A fingerstick is
needed every 12 hours to calibrate.
3 Tested to a depth
of 3 feet for 30 minutes.
4 Following your shared data
requires the Dexcom Follow app.
5 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.
6
Estimated diabetes statistics in Canada are generated by the Canadian
Diabetes Cost Model; 2015.
7 http://www.diabetes.ca/about-cda/public-policy-position-statements/access-to-diabetes-medication-supplies-medical-devices.
