Tag Archives: Medtronic

Medtronic Launches InPen with Integrated Guardian Connect

Medtronic announced it has launched the InPen connected insulin pen that now integrates real-time data display with Medtronic’s Guardian Connect CGM. Recall, in August 2020, Medtronic disclosed plans to acquire Companion Medical and InPen (previous FENIX insight). Below, FENIX provides thoughts on the new InPen CGM data display integration in the context of the evolving regulatory environment as well as questions about Lilly and Novo Nordisk’s connected pen solutions.

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Medtronic 2020 Investor Day Highlights

Medtronic hosted its 2020 Investor Day (view slides) and provided updates across its business, including plans to reinvigorate its diabetes business. Importantly, Medtronic disclosed that just yesterday (October 13), the company completed enrollment in its next-gen Synergy CGM sensor pivotal trial. Below, FENIX provides highlights and insights from the diabetes-related portion of the event.

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Lilly and Dexcom Partner to Promote Lyumjev and G6 CGM; Omar Ishrak to Retire from Medtronic; Patia BioPharma and Precision Diabetes Partner for Diabetes Diagnostics; Capillary Bio Receives $1.5M Loan from Helmsley

A series of diabetes-related news items have been observed: Lilly and Dexcom announced a partnership to launch a joint program for US HCPs, focusing on Lyumjev and G6 CGM’s role in PPG control; Medtronic announced its former CEO, Omar Ishrak, will retire as Executive Chairman and Chairman of the Board, succeeded by CEO, Geoff Martha; Patia Biopharma and Precision Diabetes announced a partnership for diabetes diagnostics; and Capillary Biomedical announced it has received a $1.5M loan from the Helmsley Charitable Trust to conduct trials for an extended-wear infusion set. Below, FENIX provides highlights and insights from the respective news items.

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Medtronic Recalls Guardian Connect App After Data Upload Disruptions

FDA’s medical device recalls website has been updated with a new recall alert regarding the Medtronic Guardian Connect CGM app. According to the FDA website, the recall is based on a Medtronic CareLink Personal website software update which resulted in the iOS app not automatically uploading its data to the website. Of note, the Guardian Connect app is compatible with both iOS and Android, though the recall only mentioned iOS issues. Below, FENIX provides thoughts on the Guardian Connect app recall and what it could mean for Medtronic and CGM-competitors Dexcom and Abbott.

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Medtronic to Restructure Business; Nemaura proBEAT and sugarBEAT Launch Updates

Two diabetes-related news items have been observed: yesterday, Medtronic filed a form 8-K, reporting that the company is reorganizing its current business with the intention of saving ~$450M annually (view Form 8-K) and Nemaura Medical presented at the LD 500 virtual investor conference and discussed updates to its sugarBEAT and proBEAT US and ex-US commercial plans (press release; view presentation). Below, FENIX provides insight into how the Medtronic reorganization may impact its diabetes business as well as an updated perspective on the potential impact of Nemaura’s non-invasive CGM.

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Medtronic’s 770G Pump Approved in Peds Down to 2 Years of Age

FDA has approved Medtronic’s MiniMed 770G hybrid closed-loop system in patients down to 2 years of age (view FDA press release). At the time of this publication, Medtronic had not yet issued its own press release. Recall, the 770G pump uses the same hybrid closed-loop algorithm that is available with the current 670G system, but 770G is BLE-enabled. Below, FENIX provides brief thoughts on the 770G approval.

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Medtronic CY Q2 ’20 (FY Q1 ’21) Earnings Update

Medtronic hosted its CY Q2 ’20 (FY Q1 ’21) earnings call (press release; slides) and briefly discussed its diabetes business. Of note, Medtronic rescheduled its Investor Day event for October 14, 2020. Below, FENIX provides highlights and insights from the call.

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Medtronic to Acquire Companion Medical; Thoughts on What It Could Mean for Insulin Delivery

Medtronic announced plans to acquire privately-held Companion Medical and its InPen connected insulin pen platform. According to the press release, the acquisition is expected to close within the next 1-2 months, and terms were undisclosed. Below, FENIX provides thoughts on the Companion Medical acquisition, Medtronic’s first under new President Sean Salmon, and additional insight into possible strategy changes that could affect other insulin delivery stakeholders (e.g. Novo Nordisk, Lilly, Sanofi, Dexcom, Tandem, Insulet, Beta Bionics, and especially Bigfoot+Abbott).

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Tandem and Medtronic Enter Into “Non-exclusive Patent Cross-license Agreement”

Tandem and Medtronic announced they have entered into a “non-exclusive patent cross-license agreement” for existing and new products and services relating to each companies’ diabetes portfolio; however, there are certain undisclosed exclusions. According to the press release, no payments are being exchanged, and additional terms of the deal are not being disclosed. Below, FENIX provides thoughts on this curious agreement in the context of Tandem’s recent win with UnitedHealthcare (previous FENIX insight).

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Medtronic 780G Data Impresses, but CGM Remains a Weak Point; Medtronic ADA 2020 Investor Event

Medtronic hosted its annual ADA investor event (view slides) and provided a strategic update to the company’s diabetes business. Medtronic also highlighted the 780G Advanced Hybrid Closed-loop data presented at today’s ADA conference as well as a pipeline update, including the CGM sensor roadmap. Furthermore, Medtronic announced a $337M investment from Blackstone Life Sciences (view press release) to support undisclosed diabetes development programs. Below, FENIX provides highlights from the Medtronic ADA investor event and insight into the potential market implications of 780G and Medtronic’s next-gen CGM platform.

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