MiniMed Files IPO Prospectus Amid Strategic FDA Approvals and Abbott Collaboration

Medtronic Diabetes Business: New Innovations Arrive Ahead of Official Spin-off.

01

Medtronic Collaborates with Abbott

Made Significant Progress

On September 2, Medtronic announced itsMiniMed™ 780G System Receives Two Key Regulatory Approvals from the U.S. FDA。

Specifically, the FDA approved its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC), integrated with Abbott's Instinct sensor for type 1 diabetes, and approved the MiniMed™ 780G system for type 2 diabetes adults aged 18 and above who require insulin.

This approval, together with the previously approved MiniMed 780G insulin pump as an Alternate Controller Enabled (ACE) pump, completes Medtronic's FDA premarket approval pathway for the integration of the Instinct sensor with the MiniMed 780G system, intended for use in individuals with type 1 diabetes.

The Instinct sensor, specifically designed by Abbott for the MiniMed™ Automated Insulin Delivery (AID) and Smart MDI systems, is the world's smallest, thinnest, and most precise integrated CGM (iCGM), offering up to 15 days of wear time.

In the coming weeks, Medtronic and Abbott plan to complete the necessary compliance documents to achieve sensor integration and marketing.. Afterwards, orders for the Instinct sensor with the MiniMed™780G system will begin. Existing customers will have priority access through the innovation program.Reservations for the Simplera Sync™ sensor will also begin later this month.

"These milestones mark an important next step in our work, bringing the mature performance and outcomes of our MiniMed™ 780G automated insulin delivery system to more people with diabetes."By integrating with the Instinct sensor and expanding the MiniMed™ 780G system to patients with type 2 diabetes，We are advancing an intelligent drug delivery ecosystem aimed at providing more choices and flexibility, as well as a more seamless experience.", said Que Dallara, current Executive Vice President of Medtronic and President of Diabetes Business, as well as the incoming CEO of MiniMed, "We are delighted to expand our solution ecosystem under one roof, providing services our customers can rely on around the clock."

Type 2 diabetes patients who require insulin face challenges every day that affect both their physical and emotional health, including frequent injections, meal planning, and blood glucose monitoring. Medtronic stated,Clinical evidence shows that the use of the MiniMed 780G system can improve glycemic outcomes and reduce treatment burden.

As early as August last year, Medtronic and Abbott established a significant partnership in the field of diabetes care. The collaboration aims to integrate Abbott's FreeStyle Libre CGM (FreeStyle Libre 3) product with Medtronic's automated insulin pump (MiniMed 780G) and smart insulin pen (InPen system) to jointly develop a comprehensive system.

At the time, Que Dallara stated: "The system is able to deliver first-class results for the most widely used CGM in the world. We are committed to simplifying diabetes management and enabling a more seamless transition to automated technology for those who wish to achieve greater success in diabetes care."

Now, this cooperation has achieved important results, and at the same time, Medtronic's diabetes business is about to welcome its spin-off and independence.

02

Medtronic at a New Turning Point

Business will be simplified and optimized

The global medical industry is entering a new phase of profound adjustment in the competitive landscape, with accelerated technological innovation, upgraded market demands, and increasingly stringent regulatory policies. Amidst the interplay of these multiple variables, even Medtronic, which has long held the top position in the global device market, needs to promptly adjust its strategy to adapt to the challenges brought by this changing landscape.

Medtronic announced in May this year that it plans to spin off its diabetes business into an independent company.MiniMed", the new diabetes company will be aThe Leading, Large-Scale Direct-to-Consumer Diabetes EnterpriseMedtronic's first quarter of fiscal year 2026 shows,Diabetes business revenue was $721 million, accounting for approximately 8% of total revenue, with a year-over-year increase of 11.5%.。

The diabetes business spin-off is expected to enable the new diabetes company to focus more on investing in its product lines, as well as manufacturing scale and automation, positioning it for success in automated insulin delivery and smart multiple daily injection (MDI) systems.

For this year's major strategic adjustments, Medtronic is actively preparing. In August this year, Medtronic announced that its board of directors had established two new special committees. The Growth Committee will be responsible for guiding growth-oriented mergers and acquisitions, organic R&D investments, and the evaluation and execution of potential asset divestitures, includingContinue to implement the recently announced diabetes business spin-off plan.

In terms of personnel, the Medtronic Board of Directors has appointed John Groetelaars and Bill Jellison as independent directors.Notably, both directors have work histories related to Baxter.

Among them, John Groetelaars once served as the CEO of Hillrom, leading the company's global expansion in operating room, monitoring, and ward solutions.Ultimately drove the 2021 Baxter's $10.6 billion acquisition of Hillrom.. His resume represents a deep understanding of mergers and acquisitions and integration in the medical device industry.

Bill Jellison once served as the Chief Financial Officer (CFO) of DENTSPLY International,Previously worked at Baxter for many years, focusing on finance and operations management. Jellison has extensive experience in cost control and capital structure optimization.

It is not difficult to see that the focus of Medtronic's personnel adjustment this time is on the upcoming spin-off of the diabetes business and the future business strategy adjustment.

CEO and Chairman of the Board Geoff Martha said,Medtronic is at an exciting inflection point and a period of strong momentum.Multiple growth drivers are already in action, and more breakthrough therapies will be launched in the coming months. With the addition of new board members and the establishment of new committees, Medtronic is accelerating its strategic growth priorities.And promote business simplification and optimizationThe separation of MiniMed is an example. By strengthening its focus on high-profit growth opportunities, Medtronic is well-positioned to deliver stronger performance and greater value for patients, customers, and shareholders.

Not only Medtronic, but also many global medical technology giants are adjusting their efforts towards a lighter organizational structure to continue increasing profit margins and long-term competitiveness through cost reduction and efficiency improvement.

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