Medtronic officials today said the planned separation of its Diabetes business (MiniMed) remains on track, with future offerings also on the horizon.
On the company’s second-quarter earnings call, CFO Thierry Piéton outlined the expected timelines for the Diabetes business, following another quarter of significant growth.
Global Diabetes revenues grew 10.3% year over year, despite a 0.8% sales decline in the U.S. due to a decline in new orders as customers anticipate the launch of new sensors. Sales growth of 11% in international markets drove overall revenue increases for the quarter. (See the full results at MassDevice and read more takeaways from the earnings at Medical Design & Outsourcing.)
The medtech giant announced in May that it planned to separate the Diabetes unit into a standalone, publicly traded company. The move sought to create “a more focused Medtronic” with a more simplified portfolio in high-margin growth markets. At the same time, it creates an independent, scaled leader in diabetes, called MiniMed.
The Medtronic Diabetes Business is one of the largest diabetes tech companies in the world — learn more about the company and the rest of the diabetes space by downloading our free Diabetes Technology Special Report.
On Medtronic’s first-quarter earnings call in August, Chair and CEO Geoff Martha said the separation is “proceeding according to plan.”
Piéton today said today that this remains the case.
“Our planned separation of MiniMed is on track,” he said. “Our preferred path continues to be a two-step IPO and split. We continue to expect the separation to be complete by the end of calendar year 2026. We have a lot of momentum with diabetes given the order inflection, and progress on the pipeline and separation.”
Updates on pipeline, MiniMed developments within Medtronic Diabetes
Piéton also updated on some significant developments within the Medtronic Diabetes portfolio, with next-generation pumps on the way.
The company in June outlined its expectations to submit a new automated insulin delivery system, the MiniMed Flex (8 series) pump, to the FDA by the end of the fiscal year. (Medtronic’s fiscal year ends in April, meaning the submission could come by spring 2026.) MiniMed Flex is “much smaller than 780G,” allowing for more discrete placement while still using the same reservoirs and infusion sets. It will also work with both the Simplera Sync and Instinct sensors.
“We also continue to make progress with our new AID systems, MiniMed Flex, and MiniMed Fit. Remain on track to submit Flex, our next-generation durable pump, to the U.S. FDA,” Piéton said. “And with Fit, our AID patch system, we intend to submit to the U.S. FDA by the fall of next year.”
MiniMed Fit, the company’s patch pump under development, looks to enter a competitive market. Insulet currently leads the way there, with Tandem Diabetes Care and Beta Bionics also planning entries in the near future.
ViCentra recently closed significant funding to bring its patch pump to the European market and has eyes on eventual U.S. expansion. PharmaSens earlier this year announced a strategic partnership with SiBionics to jointly develop an all-in-one insulin patch pump.
Also on the pump front, Piéton said the company this month won FDA approval to begin a U.S. pivotal trial for Vivera, its third-generation algorithm for automated insulin delivery.
Other developments
Piéton also pointed to several milestones in recent months for the Diabetes unit.
In July, the company received CE mark for expanded MiniMed 780G indications for the type 2 diabetes population, among other indications. Then, in September, the FDA cleared the company’s SmartGuard algorithm as an interoperable automated glycemic controller (iAGC). This enabled integration with a sensor made by Abbott, designed specifically through a landmark collaboration between the companies. Medtronic announced the launch of Instinct, that sensor, weeks later.
Piéton said the company saw 25% of its sensor orders for Simplera Sync and Instinct continuous glucose monitors (CGMs) come from users not already using the company’s CGM. The company expects sensors to accelerate U.S. growth in the back half of its fiscal year.
“There’s a lot of excitement behind both the Simplera Sync and Instinct sensors,” he said. “With the SimpleraSync, we continue to ramp manufacturing volume to support its European launch. As that ramp continues, we plan to roll it out more broadly to U.S. customers later this fiscal year. Ahead of that, we started accepting orders during the quarter. With the Instinct sensor, we started taking preorders in The U.S. during the last month of the quarter. We expect to begin shipping in late November. We accumulated more than 35,000 U.S. customer orders for Simplera Sync, and preorders for Instinct.”
