The Tandem conference call for Q1 2019 was held on 4/30/19. A transcript is available via https://seekingalpha.com/article/4258368-tandem-diabetes-care-inc-tndm-ceo-john-sheridan-q1-2019-results-earnings-call-transcript
Here’s the news as I see it.
The clinical trial for the Control-IQ algorithm is complete. Researchers will give the results at ADA on June 9, and Tandem expects to get access to the data shortly thereafter. This should enable an FDA submission (for age 14+) in July and a launch in Q4.
From the clinical trial they are anticipating time-in-range in the mid-70s (as a percent of the full 24-hour day, which is a more stringent criterion than the time in range only while the pump remains in closed loop mode as is reported by some other unnamed pump manufacturer.) They also anticipate that the pumps will remain in closed loop for over 90% of the time, and the users will report good quality of life improvements.
They still haven’t decided whether there will be an upgrade fee. They would like to get paid, but the are aware that if they release Control-IQ but people can’t or won’t buy it, that would be strategically very bad.
They anticipate FDA submission for the t:sport smaller patch-like pump in mid 2020 with approval anticipated by the end of 2020. They don’t yet know whether they will be required to accompany it with a medical device-grade controller or whether they will be allowed to do all the pump control via a pump app.
They’re approaching app control of the pump in steps. The first release will be a mobile app to upload from t:slim to their t:connect web data service. It will need FDA approval for the pump software changes to support it. The next step will be to display the t:connect data via the app, with the ability to handle alerts without touching the pump. Finally there will be full control of the t:sport pump via the app. They didn’t say whether or not the t:slim will also be able to be controlled via the app.
There’s no news with respect to getting United HealthCare insurance coverage for the t:slim.
There’s insurance coverage for the t:slim in Ontario. They hope to get coverage in additional provinces. In Europe they’re working through small distributors who handled Animas and are now working to convert those pumpers to t:slim by September. Then they will try to grow the business.
They say they have nearly 100,000 pump users. The Device Updater software had about 20,000 runs.