Tandem Plans to Submit Insulin Pump for FDA Assessment

During a time, in which Tandem is struggling from operating losses and lower-than-expected sales.

Image credit: Tandem Diabetes

Tandem's global revenues over those three months increased 16% over the same period last year, reaching a record high of a little over $200 million, but that wasn't enough to keep the diabetic technology developer on track for its 2022 objectives. The company said it will cut its full-year sales forecast to represent growth of between 19% and 20% over 2021, totaling between $835 million and $845 million, in an earnings report released Wednesday afternoon.

That represents a change in perspective from a quarter ago when Tandem adopted a far more upbeat stance by raising projections for the year's beginning. After a strong first quarter, it increased that projection to land between $850 million and $865 million, which would have represented an improvement of up to 23% over 2021's results. It started off 2022 with an eye toward total sales between $845 million and $860 million.

The San Diego-based device maker reported operating losses of over $12 million and a net loss of $15.1 million in addition to the lower-than-expected sales; these figures had been comfortably positive at this time the previous year, reports FierceBiotech. According to a copy of the call, CEO John Sheridan blamed the dip on three things: persistent "pandemic-related pressures," increasing domestic rivalry, and economic difficulties like inflation and the impending recession.

However, now that the second quarter's problems are firmly in the past, Tandem is once again upbeat, with a promising prognosis for sales of both current and emerging technology.

The Mobi insulin pump is the most prominent member of the latter group. It is roughly half as big as Tandem's top-of-the-line t:slim pump and can be entirely operated by a user's smartphone. Additionally, Sheridan stated on the call that it will be “the first novel form factor launched in our space since we introduced t:slim a decade ago,”

“We are in the final stages of testing, as well as drafting the submission, and intend to submit a 510(k) to the FDA this quarter,” the CEO said. Furthermore, he said Tandem is already making plans for the miniature pump's commercial debut after receiving FDA certification, which it hopes to do in the first half of 2023.

Read more: MFineApp Allows To Monitor Blood Pressure and Glucose

Sheridan stated that in the interim, Tandem is also closely collaborating with partners Dexcom and Abbott to integrate its insulin pumps with their most recent CGMs: Abbott's FreeStyle Libre 3, which was recently approved by the FDA, and Dexcom's G7 device, whose own FDA review is still in progress following a request for more information from the agency.

Tandem has already had a hectic year. The company's t:connect mobile app, which can be downloaded to a user's smartphone and used to remotely schedule bolus doses through the company's t:slim X2 insulin pumps, received FDA authorization at the beginning of 2022. Just a month ago, Tandem added Capillary Biomedical, a producer of extended-wear infusion set technology based in the Los Angeles region, to its portfolio. The deal's financial details weren't made public.

Jürgen Thalmayer
September 23, 2022

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