Tag Archives: Medtronic

Biocon/Mylan Bs-glargine Approved; Novo to Acquire Corvidia; Lifescan Launches Verio Reflect; Lannett FDA Bs-glargine Meeting; Medtronic 780G CE Mark; Dexcom Launches G6 Pro; ADA ’20 Key Data and Partnership Press Releases (June 11)

Ahead of the ADA 2020 conference start, a series of diabetes-related press releases have been observed: Biocon/Mylan received FDA approval for its bs-glargine, Novo Nordisk is set to acquire Corvidia, Lannett provided an update on its meeting with FDA for bs-glargine, LifeScan launched the Verio Reflect BGM, Medtronic received CE Mark for the 780G system, Dexcom launches G6 Pro, and DarioHealth entered into new partnership agreements. Below, FENIX provides context and analysis for the announcements.

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Medtronic Guardian Connect CGM Android Approval; Xeris PBH Ph2 Results; Capillary Biomedical Initiates Extended-wear Infusion Set Trial

Three diabetes-related news items have been observed today: Medtronic’s Guardian Connect is now compatible with Android, Xeris announced positive topline results from ready-to-use (RTU) glucagon in patients at risk of postprandial hypoglycemia following bariatric surgery, and Capillary Biomedical initiated a trial for its extended-wear infusion set. Below, FENIX provides highlights and insights from the respective news items.

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Medtronic CY Q1 ’20 (FY Q4 ’20) Earnings Update

Medtronic hosted its CY Q1 ’20 (FY Q4 ’20) earnings call and briefly discussed its diabetes business. Of note, Medtronic disclosed plans to launch a BLE-enabled 770G pump platform with remote updating functionality in the US ahead of the advanced hybrid closed-loop (AHCL) algorithm approval. Additionally, Medtronic will be presenting two AHCL data sets at the upcoming virtual ADA conference (June 12-16). Below, FENIX provides highlights and insights from the call.

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Medtronic To Move Away From Its Non-Intensive Diabetes Strategy

According to a March 18 Medtronic research note from Morgan Stanley entitled “Diabetes Group Restructured”, Medtronic is restructuring its diabetes group to focus its core efforts on insulin-dependent T1DM+T2DM patients while moving away from their non-intensive strategy. Below, FENIX provides thoughts on the new direction for Medtronic’s business.

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Medtronic CY Q4 ’19 (FY Q3 ’20); Cigna Reimburses Eversense Implantable CGM; Diasome HDV-Lispro Ph2 Topline Data

Yesterday, a series of diabetes-related news were observed including Medtronic’s CY Q4 ’19 (FY Q3 ’20) earnings call, Senseonics’s positive coverage decision from Cigna for the Eversense implantable CGM, and Diasome’s topline data from its Ph2 OPTI-1 study. Below, FENIX provides highlights and insights from the respective news items.

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Medtronic Recalls 630G/670G Pumps After Thousands of Injuries and One Death

FDA’s medical device recalls website has been updated with a new recall alert regarding the Medtronic 600 series pump platform (630G and 670G products). According to the FDA website, the recall is based on a faulty or missing retainer ring which helps lock the insulin cartridge into place. Medtronic is said to have received over 26k complaints about the defect with at least 2,175 injuries and 1 patient death. Below, FENIX provides thoughts on the Medtronic insulin pump recall including insight as to why Tandem may be the big winner.

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JPM 2020 Day 1: DXCM, LVGO, Novo, Bigfoot Biomedical, Companion Medical, MDT

On the first day of JPM 2020, FENIX has provided coverage of presentations by major diabetes manufacturers including Dexcom, Medtronic, Teva, J&J, and Merck. Additionally, four separate diabetes-related news items have been observed including new collaborations between Dexcom/Livongo and Novo Nordisk/Fauna Bio as well as funding rounds from Companion Medical and Bigfoot Biomedical. Below, find a topline summary of key takeaways by company followed by more in-depth coverage.

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Medtronic Acquires Klue; New Tandem SGLT2i+Closed-loop Trial

Medtronic announced it has completed the acquisition of “Klue,” a company developing behavior tracking technology to “provide real-time insights into when a person is consuming food.” Additionally, a new CT.gov record has been observed for an investigator-initiated trial evaluating Tandem’s closed-loop systems (Basal IQ and Control IQ) in T1DM patients on an SGLT2i. Below, FENIX provides thoughts on the news items including how Klue may help to enhance Medtronic’s PCL while still leaving some potential hurdles.

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Medtronic CY Q3 ’19 (FY Q2 ’20) Earnings Update

Medtronic hosted its CY Q3 ’19 (FY Q2 ’20) earnings call (press release) and provided a brief update to its diabetes business including the development of its 780G advanced hybrid closed-loop system which is projected to launch in FY H2 ’20 (CY late 2020/early 2021). Of note, Medtronic has also initiated a new “Next-Tech Pathway” program for pump upgrades (described below). Below, FENIX provides highlights and insights from the call.

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Thoughts on Medtronic Diabetes Leadership Change

Medtronic announced it has replaced Hooman Hakami as the head of its diabetes division with Sean Salmon, the former Senior Vice President and President of Medtronic’s Coronary and Structural Heart business. Below, FENIX provides brief thoughts on the change in Medtronic leadership and the potential impact to the diabetes business.

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