Tandem had their quarterly conference call on November 1. The transcript is available at https://seekingalpha.com/article/4217453-tandem-diabetes-care-inc-tndm-ceo-kim-blickenstaff-q3-2018-results-earnings-call-transcript
Here’s the news as I see it.
They are working with the FDA to establish the rules for iPump designation.
For the forthcoming Control-IQ hybrid closed loop algorithm, they will split the approval: get the t:slim X2 approved as an iPump (submitted to FDA in October 2018), and the Control-IQ algorithm submission (to run on any iCGM and iPump) will be in spring 2020 when the clinical trial ends so the approval of Control-IQ should arrive by summer 2020. And when the t:sport pod-like pump gets iPump approval (expected in 2020) it will immediately be able to run Control-IQ without further clinical studies. By the way, they plan to have user control of the t:sport pump from the user’s phone, not from some separate medical controller device.
They note that Tandem will hold the FDA approval for their implementation of the TypeZero algorith. So other companies with licences to TypeZero algorithms will have their own clinical studies and FDA approval processes to go through. This is a business barrier to competition from other pump manufacturers, who won’t be able to get a free-ride on Tandem’s clinical studies.
I learned something important about the iCGM and iPump designations. They will not enable the device user to automatically swap in a different iCGM or iPump while running the Control-IQ algorithm. The i-designations simply avoid the need for new clinical studies and FDA approval for the device substitution. Here’s what Tandem said about this.
“It’s also worth noting that the i-designation does not mean elements of an interoperability AID system, automatically integrated with companies from other organizations. The involved organizations must have formal agreements in place to define how the interoperability components must be integrated from both R&D and business perspective.”
In other words, if I’m running a t:slim X2 with Dexcom G6 and the Control-IQ algorithm, I can’t just swap in some other company’s iPump to run Control-IQ. First that company must make business arrangements with Tandem. For instance, medically adverse event reports need to be assigned to the right company for patient support, for reporting to the FDA and for legal liability. The involved companies need to agree on the process to do this so that the patient isn’t left hanging between companies blaming each other for a problem. Tandem already has the relevant agreements with Dexcom.
Tandem is already working on improvements for a second version of Control-IQ. The version submitted to the FDA was the unchanged algorithm from TypeZero to speed the FDA review (there were lots of relevant clinical studies already,) but Tandem already sees ways to make it better.
Tandem seems to say that it doesn’t perceive that it’s in a competition with Insulet Omnipods as pump delivery devices, and that it doesn’t see Insulet’s cooperation with the Tidepool-LOOP project as a competitive threat to the t:slim X2 with Control-IQ. I tend to think otherwise.
On the business side, it’s growing well: 60% growth over last year. They expect to reach cash-flow breakeven next year in 4Q19. They shipped 7300 pumps in the USA in Q3 and 1100 internationally. They have approvals in Canada and Australia, and distribution is ramping up in Europe. The reimbursement from a pump sold in the US is about $4000 but only $2000 for a pump sold elsewhere, but supply sales are more profitable outside the US. Presently pump sales are 67%, infusion sets are 23%, and cartridges are 10% of total sales.