Tandem Diabetes Care and Dexcom Announce the t:slim X2 Insulin Pump with Dexcom G7 CGM Compatibility is Authorized for Sale by Health Canada

Rhea-AI Summary

Tandem Diabetes Care and Dexcom have announced that the t:slim X2 insulin pump with Dexcom G7 CGM compatibility has been authorized for sale by Health Canada. This integration makes it the only Automated Insulin Delivery (AID) system in Canada compatible with both Dexcom G7 and G6 CGM technologies. The updated software is expected to be commercially available this fall, with existing users receiving a free remote update.

Key features of the integration include:

• Dexcom G7's smaller, all-in-one sensor and transmitter
• 30-minute sensor warmup time
• 12-hour grace period for sensor replacement
• Increased connectivity with digital health apps

The t:slim X2 pump with Control-IQ technology is rated as the #1 AID system in Canada, offering customizable profiles and various infusion set options.

Positive

• Health Canada authorization for t:slim X2 insulin pump with Dexcom G7 CGM compatibility
• First AID system in Canada compatible with both Dexcom G7 and G6 CGMs
• Free remote software update for existing t:slim X2 pump users
• t:slim X2 pump with Control-IQ technology rated as #1 AID system in Canada
• Integration with Dexcom G7, offering 60% smaller sensor and faster 30-minute warmup time

Negative

• None.

Medical Device Analyst

The authorization of the t:slim X2 insulin pump with Dexcom G7 CGM compatibility by Health Canada marks a significant milestone in diabetes management technology. This integration offers several key advantages:

• Enhanced User Choice: Patients can now choose between Dexcom G7 and G6 CGM systems, providing flexibility in their diabetes management approach.
• Improved Technology: The Dexcom G7 CGM is 60% smaller than its predecessor, offering greater discretion and comfort for users.
• Faster Warm-up: With a 30-minute sensor warmup time, users can experience more time in closed-loop operation, potentially improving glucose control.
• Extended Grace Period: The 12-hour grace period for sensor replacement adds convenience and reduces potential gaps in glucose monitoring.

From a market perspective, this authorization strengthens Tandem's position in the Canadian diabetes technology sector. As the #1 rated automated insulin delivery (AID) system in Canada, the t:slim X2 pump's compatibility with the latest Dexcom CGM technology could drive increased adoption and market share growth.

However, it's important to note that commercial availability is slated for fall, which may impact immediate financial implications. The free remote software update for existing users is a customer-friendly move but may not directly contribute to short-term revenue growth.

Overall, this development reinforces the ongoing partnership between Tandem and Dexcom, potentially setting the stage for future innovations in AID systems. Investors should monitor the market response and adoption rates following the commercial launch to gauge the long-term impact on Tandem's financial performance.

Healthcare Market Analyst

This Health Canada authorization for the t:slim X2 insulin pump with Dexcom G7 CGM compatibility represents a significant competitive advantage in the Canadian diabetes care market. Here's why:

• Market Differentiation: Being the only AID system in Canada compatible with both Dexcom G7 and G6 CGMs sets Tandem apart from competitors.
• Brand Strength: Tandem's position as the #1 recommended insulin pump brand in Canada is likely to be reinforced by this latest approval.
• Expanded User Base: The compatibility with both G7 and G6 systems could attract a broader range of users, potentially increasing market penetration.
• Customer Retention: Offering free software updates to existing users promotes customer loyalty and reduces churn.

From a market dynamics perspective, this move aligns with the growing trend towards more integrated and user-friendly diabetes management solutions. The emphasis on choice and flexibility caters to the diverse needs of the diabetes community, which could translate to increased market share.

However, it's important to consider potential challenges:

• Adoption Rate: The success will depend on how quickly users transition to the new system and whether healthcare providers actively recommend it.
• Competitive Response: Rival companies may accelerate their R&D efforts or adjust pricing strategies to compete.
• Reimbursement Landscape: The extent of insurance coverage for this new system will play a important role in its market success.

Investors should closely monitor initial uptake rates, user feedback and any shifts in market share following the fall launch. Long-term, this authorization could strengthen Tandem's position in the Canadian market and potentially pave the way for similar approvals in other regions.

– Only Automated Insulin Delivery System in Canada to Feature Both Dexcom G7 and G6 CGM Technology Now Authorized for Sale by Health Canada –

MARKHAM, Ontario--(BUSINESS WIRE)-- Tandem Diabetes Care, Inc. (Nasdaq: TNDM) and Dexcom, Inc. (Nasdaq: DXCM) today announced the updated t:slim X2™ insulin pump software is compatible with both Dexcom G7 and Dexcom G6 Continuous Glucose Monitoring (CGM) Systems and is authorized for sale by Health Canada. This integration allows users of the t:slim X2 insulin pump with Control-IQ technology, the #1 rated automated insulin delivery (AID) system in Canada,* to have even more choice in how they manage their diabetes.

t:slim X2 Insulin Pump with Dexcom G7 CGM Compatibility is Authorized for Sale by Health Canada (Photo: Business Wire)

Commercial availability is expected to begin this fall. Tandem will email instructions to all users in Canada with an in-warranty t:slim X2 pump to offer the option to choose between Dexcom G7 and Dexcom G6 via a free remote software update. New customers will receive t:slim X2 pumps pre-loaded with the updated software.

“This integration marks the first time an AID system in Canada is compatible with both Dexcom G7 and Dexcom G6 CGMs, demonstrating our commitment to continued leadership in advancing AID systems and offering choice,” said Mark Novara, executive vice president and chief commercial officer of Tandem Diabetes Care. “We are proud to celebrate more than 10 years of partnership with Dexcom through this milestone that allows users in Canada to benefit from our #1 recommended insulin pump brand,^† now with Dexcom's most advanced CGM technology.”

“Studies have shown that an AID system powered by Dexcom CGM allows people with diabetes to experience more time in range and can help users reduce nighttime lows,”¹ said André Côté, executive vice president and general manager of Dexcom Canada. “Sensor accuracy is key to automated insulin delivery, and we are thrilled that Canadians using the t:slim X2 insulin pump with Control-IQ technology will soon be able to benefit from integration with Dexcom G7, our smallest and most accurate CGM ^2‡. This milestone underscores the shared commitment between Dexcom and Tandem to provide cutting-edge technology that empowers individuals with diabetes to live better and feel better every day.”

Dexcom G7 users benefit from:

• Greater discretion with Dexcom G7’s low-profile all-in-one sensor and transmitter, which is 60% smaller³ than Dexcom G6;
• More time in closed loop with a 30-minute sensor warmup time⁴;
• A 12-hour grace period⁴ to replace finished sensors for a more seamless transition between sessions and flexibility for when to change sensors;
• Increased connectivity that Dexcom G7 offers with leading digital health apps.

t:slim X2 insulin pump with Control-IQ technology features:

• #1 Rated AID System in Canada* with Control-IQ Technology – Uses data from the Dexcom CGM to predict glucose levels 30 minutes ahead and automatically adjust insulin, if needed, to help prevent highs and lows.
• Activity Settings: Includes customizable Personal Profiles and optional settings for Sleep Activity or Exercise Activity that adjust the range of treatment values.
• Infusion Set Options: A variety of on-body infusion sets allow users to temporarily disconnect from their pump for convenience and provide the flexibility of more than 30 mix-and-match infusion set and tubing length combinations.

The t:slim X2 pump with Dexcom G7 integration launched in the U.S. in December 2023 and additional countries in early 2024.

To check coverage and start the process of getting a Tandem insulin pump, please visit tandemdiabetes.ca.

To learn more about Dexcom G6 or Dexcom G7, please visit dexcom.com or ask your healthcare provider.

* dQ&A Canada Patient Panel H2 2023
† dQ&A Canada Patient Panel H2 2023
‡ When compared with CGM systems commercially available in Canada as of July 2024.

1 Brown SA, Kovatchev BP, Raghinaru D, et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Engl J Med. 2019;381(18):1701-1717. doi: 10.1056/NEJMoa1907863.
2 Dexcom, Data on File, 2023.
3 Garg SK, Kipnes M, Castorino K, et al. Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes. Diabetes Techol Ther. 2022;24(6):373-380. doi: 10.1089/dia.2022.0011.
4 Dexcom G7 User Guide

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company’s pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ advanced hybrid closed-loop technology. Tandem Diabetes Care is based in San Diego, California. For more information, visit tandemdiabetes.com.

Follow Tandem Diabetes Care on X @tandemdiabetes; use #tslimX2 and #TandemDiabetes.
Follow Tandem Diabetes Care on Facebook at facebook.com/TandemDiabetesCanada.
Follow Tandem Diabetes Care on LinkedIn at linkedin.com/company/tandemdiabetes.

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. These forward-looking statements relate to, among other things, the anticipated timing for the Canadian availability of the t:slim X2 pump with Dexcom G7 integration as well as our ability to provide the software update for current t:slim X2 pump users and the t:slim X2 pumps pre-loaded with Dexcom G7 integration software. These statements are subject to numerous risks and uncertainties, including our ability to start commercial scale manufacturing of the t:slim X2 pumps pre-loaded with Dexcom G7 integration software for the Canadian market, our ability to operate and maintain a system to facilitate online training for existing t:slim X2 pump customers upgrading their existing devices, and the risk that we may encounter other challenges that may delay the availability of t:slim X2 pumps pre-loaded with Dexcom G7 integration software. These and other risks are identified and described in greater detail under the “Risk Factors” heading of our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other documents filed 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. Actual results could differ materially from those anticipated or projected in the forward-looking statements. 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.

Responsible use of Control-IQ technology

Control-IQ technology does not prevent all highs and lows. Users must still bolus for meals and actively manage their diabetes. Visit tandemdiabetes.com/safetyinfo for additional important safety information.

This product may not be right for you. Always read and follow the label.

Important Safety Information: The t:slim X2 insulin pump with Control-IQ technology (the System) consists of the t:slim X2 insulin pump, which contains Control-IQ technology, and a compatible continuous glucose monitor (CGM, sold separately). The t:slim X2 insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in people requiring insulin. The t:slim X2 insulin pump can be used solely for continuous insulin delivery and as part of the System. When used with a compatible CGM, the System can be used to automatically increase, decrease, and suspend delivery of basal insulin based on CGM sensor readings and predicted glucose values. The System can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. The pump and the System are indicated for use in individuals 6 years of age and greater. The pump and the System are intended for single user use. The pump and the System are indicated for use with NovoRapid, Admelog, Trurapi, or Humalog U-100 insulin. The System is intended for the management of Type 1 diabetes.

WARNING: Control-IQ technology should not be used by anyone under the age of 6 years old. It should also not be used in users who require less than 10 units of insulin per day or who weigh less than 25 kilograms.

The System is not indicated for use in pregnant women, people on dialysis, or critically ill users. Do not use the System if using hydroxyurea.

Users of the pump and the System must: be willing and able to use the insulin pump, CGM, and all other system components in accordance with their respective instructions for use; test blood glucose levels as recommended by their healthcare provider; demonstrate adequate carb-counting skills; maintain sufficient diabetes self-care skills; see healthcare provider(s) regularly; and have adequate vision and/or hearing to recognize all functions of the pump, including alerts, alarms, and reminders. The t:slim X2 pump must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information.

© 2024 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, the Tandem logo, Control-IQ, and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. Dexcom, Dexcom G6, Dexcom G7, and any related logos and design marks are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries. All other third-party marks are the property of their respective owners.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240725748503/en/

Tandem Diabetes Care Media Contact:

858-366-6900

media@tandemdiabetes.com

Tandem Diabetes Care Investor Contact:

858-366-6900

IR@tandemdiabetes.com

Source: Tandem Diabetes Care, Inc.

FAQ

When will the t:slim X2 insulin pump with Dexcom G7 compatibility be available in Canada?

Commercial availability of the t:slim X2 insulin pump with Dexcom G7 compatibility is expected to begin in fall 2024 in Canada.

How can existing t:slim X2 pump users in Canada get the Dexcom G7 compatibility update?

Tandem will email instructions to all users in Canada with an in-warranty t:slim X2 pump, offering a free remote software update to choose between Dexcom G7 and Dexcom G6 compatibility.

What are the key benefits of the Dexcom G7 integration with the t:slim X2 pump (TNDM)?

Key benefits include a 60% smaller all-in-one sensor and transmitter, 30-minute sensor warmup time, 12-hour grace period for sensor replacement, and increased connectivity with digital health apps.

Is the t:slim X2 insulin pump with Control-IQ technology highly rated in Canada?

Yes, the t:slim X2 insulin pump with Control-IQ technology is rated as the #1 Automated Insulin Delivery (AID) system in Canada according to the dQ&A Canada Patient Panel H2 2023.