Medtronic and Abbott's First Collaborative Product Receives FDA Approval: MiniMed 780G with Instinct CGM

Medtronic announces FDA approval for two of its projects:

The first project: The SmartGuard algorithm equipped in the MiniMed 780G has been approved as an interoperable Automated Glycemic Controller (iAGC), enabling integration with Abbott's Instinct continuous glucose monitoring sensor for the treatment of type 1 diabetes;

Project Two: MiniMed 780G Approved for Use in Adults Aged 18 and Above with Type 2 Diabetes Who Require Insulin Therapy.

Executive Evaluation

"These milestones mark significant progress in providing more diabetes patients with the clinically proven performance and efficacy of the MiniMed 780G automated insulin delivery system. By enabling integration with the Instinct sensor and expanding the MiniMed 780G to type 2 diabetes patients, we are advancing the development of a smart drug delivery ecosystem that aims to offer more choices, greater flexibility, and a more seamless experience. We look forward to integrating a solution ecosystem with reliable, round-the-clock service."

---Que Dallara President of Medtronic Diabetes and Incoming Chief Executive Officer of MiniMed

"We are working together for the best interests of people with diabetes. Abbott's biowearable technology has long set the standard for accurate, accessible, and easy-to-use continuous glucose monitoring. Connecting it with the MiniMed 780G system aims to reduce the mental burden of daily management and improve patients' quality of life.""

---Chris Scoggins  Executive Vice President of Abbott's Diabetes Care Business

MiniMed 780G+The approval of Instinct marks the first collaboration between Medtronic and Abbott, two industry giants.Instinct is Abbott's dedicated product for MedtronicMiniMed 780GThe CGM under design and development isThe world's smallest, thinnest, and most discreet integrated CGM (iCGM), with a maximum wear time of up to 15 days.

According to MedtronicInsTinct compared with Medtronic's most advanced CGM (Simplera Sync), with significant advantages. FirstMean Absolute Relative Error (MARD) become smaller and can be worn for a longer time (Simplera Sync can only be worn for 7 days.), in additionInstinct is also smaller andThin (Better protection of patient privacy)）。

Currently, MiniMed 780G+Instinct is only available inType 1 Diabetes Treatment: In the future, Medtronic hopes to expand MiniMed 780G+Instinct toType 2 Diabetes Treatment.

Background

Last August, Medtronic and Abbott reached a historic cooperation agreement to integrate the world's best insulin pump and the best CGM technology, bringing better treatment outcomes for diabetes patients.

Subsequently, Medtronic and Abbott began collaborative development and submitted to the FDA in April this year regardingMiniMed 780G+Instinct Registration Application.

From the announcement of cooperation between the two companies to obtaining certification and going public, the entire process took only 13 months.This not only reflects the high efficiency of both parties but also indicates that the two companies highly value their cooperation.

However, with the entry of aggressive investors, Medtronic has begun to undergo changes from top to bottom. Medtronic's diabetes business was the first to be impacted, and in May this year, Medtronic announced the spin-off of its diabetes business. The reason is simple: Medtronic's diabetes business has performed poorly in the market, not only being the smallest business unit of Medtronic but also having very weak profitability. At the same time, it faces challenges in the insulin pump field.When competing with new forces like Insulet, it feels a bit overwhelmed. LikeInsulet's annual growth rate is as high as 30% or more, andMedtronic Diabetes BusinessGrowth rate of about 10%, and revenue is also about to beInsulet surpasses (the difference between the two last quarter was less than 100 million US dollars).

MiniMed 780G+Instinct Collaboration Could Very Possibly Become the Final Chapter of Medtronic and Abbott's Partnership in the Diabetes Field. In the Future, Abbott Can Only Collaborate with New Companies.MiniMed Collaborates to Develop New Products (New Insulin Pump + Most Advanced CGM).