Connected (Mobile) Health Offerings

Our expanding digital health platform now includes our mobile app, our t:connect web application, the Tandem device updater and our customer portal. We are working to advance each of these offerings as part of our vision for enabling better insulin therapy management leveraging next generation digital assets. In the 4th quarter of 2020, we submitted a regulatory filing to the FDA for a mobile bolus delivery feature using our app. Future updates of our mobile app are also subject to FDA review and approval and are planned to include additional pump control features, enhancements to our data insights, integration with other health-related information from third-party sources, and support for future products under development.

We are also developing Tandem Source, our second-generation data management platform. With Source, we are working to provide opportunities for customers to personalize how they engage with their data and for HCPs to manage their care. We intend to launch Source globally, beginning in select countries outside the United States in the second half of 2021.

t:sport Insulin Delivery System

Our next-generation hardware platform is referred to under its development name, t:sport. Approximately half the size of our t:slim X2 pump, the t:sport pump is being designed for people who seek even greater discretion and flexibility with the use of their insulin pump. We anticipate that t:sport will feature a 200-unit cartridge, an on-pump bolus button, a rechargeable battery, an AID algorithm, and a Bluetooth radio. We anticipate that t:sport will be our first insulin pump to support full pump-control from our mobile application, subject to FDA review and approval.

Next Generation Algorithms

We intend to further enhance our automated insulin delivery system and are considering alternative strategies to deliver new features and benefits to our customers on a regular basis. In addition to algorithm enhancements intended to improve clinical outcomes, we are also developing new features for greater personalization and refinements to the overall system usability.

In the 4th quarter of 2020, we submitted a filing to the FDA for feature enhancements to our Control-IQ technology, which is subject to review and approval.

Adding & Enhancing System Components

Building a robust ecosystem and portfolio around our flagship insulin pumps requires product development efforts to integrate, add and enhance complimentary system components. This includes integration with CGM, expansion of insulin administration and infusion set technology, and the use of alternative insulins.

In November 2020, we entered into an agreement with Dexcom to extend our current collaboration to include integration with their future G7 CGM technology. Following integrated product development work, and required regulatory clearances or approvals, this will be the fourth generation of Dexcom CGM that we intend to integrate with our devices.

In June 2020, we announced an agreement with Abbott Laboratories (Abbott), to develop and commercialize integrated diabetes solutions that combine Abbott’s CGM technology with our insulin delivery systems. Following the completion of our integrated product development work, and after obtaining required regulatory clearances or approvals, we intend to focus our initial commercial activities on integrated products in the U.S. and Canada, with additional geographies considered in the future.