On the company’s first-quarter earnings call, President and CEO John Sheridan outlined the plans for Mobi Tubeless, the company’s existing Mobi pump that utilizes a novel infusion set option for tubeless insulin delivery. Currently, Insulet offers the leading tubeless option on the market with its Omnipod 5.
Mobi Tubeless would allow for interchangeability between tubed and tubeless wear with one platform. Tandem plans to file its 510(k) submission to the FDA during the current (second) quarter.
“We are particularly excited about Mobi Tubeless, our novel infusion set option for the existing Mobi pump that transforms it into a tubeless AID system, allowing for interchangeability between tubed and tubeless wear with one platform,” Sheridan said. “This will be Tandem’s first tubeless pump offering and the world’s first with extended wear technology.”
The company said this as it shared first-quarter financial results that came in ahead of the consensus forecast on Wall Street.
Shares of TNDM rose more than 10% to $20.39 after the market closed on Thursday, May 7. They were down, though, late on Friday, dipping 14.5% to $15.78 apiece.
More on expectations for the Tandem Mobi Tubeless
Sheridan said the company aims to receive clearance for Mobi Tubeless in the second half of 2026.
“There is some uncertainty with the FDA, but they have been doing a really nice job lately in getting things done quickly,” he said.
Clearance in the second half would result in a phased commercialization process ahead of a potential full commercial launch. Tandem wants to observe the product in small groups to evaluate it before a full rollout.
“If we can get it to the market before the fourth quarter starts, I think we would want to do that, but we will have to wait and see when the actual clearance occurs,” Sheridan added.
Tandem sees a significant opportunity in the tubeless market as well, Sheridan noted.
“Today, there really is a tubed market and a tubeless market,” he said. “The tubed market is growing low-single digits, whereas the tubeless market is growing in the 20% range. That is a significant opportunity. Looking at the competition today, we are in the pharmacy now, we will have a tubeless device, and we feel like we have a better algorithm. There is a big opportunity for us to drive [multiple daily injection] conversions to our device, and at the same time, there is potential for competitive conversions.”
More on the company’s first-quarter results
The San Diego-based automated insulin delivery system developer reported losses of $20.4 million on sales of $247.2 million for the three months ended March 31, 2026.
Tandem recorded an 84.4% bottom-line gain on a sales increase of 5.4%.
Losses per share came in at 30¢, landing 14¢ ahead of expectations on Wall Street. Sales also came in ahead of estimates, as experts forecast $240.6 million in revenue.
During the quarter, Tandem achieved record first-quarter pump shipments, sales and gross margin. It shipped more than 29,000 pumps worldwide, including 19,000 in the U.S., with U.S. sales totaling $160.8 million.
Strategic milestones during the quarter included the launch of a pay-as-you-go reimbursement model in the U.S. pharmacy channel and the launch of a new Mobi app for Android. The company also priced an upsized offering worth $265 million in the quarter.
“In the first quarter, we delivered on our financial plan while initiating key operational steps to advance our strategic priorities,” said John Sheridan, president and CEO. “Our 2026 goals are firmly in focus, and we are committed to providing innovative, best-in-class diabetes technology to our customers in more efficient and cost-effective ways, while strengthening our global business model and building long-term value for shareholders.”
