Category Archives: Insulin Delivery

Insulet Expands DASH Availability in Europe; Nemaura In-Licenses Healthimation Diabetes App; Dario Enters Distribution Agreement with HMC; Arecor uRAI to be Presented Tomorrow; Adocia to Host Business Review; EASD 2020 Key Press Releases (Sept 21)

On the first day of EASD, five key press releases were observed from Insulet, Nemaura Medical, DarioHealth, Arecor, and Adocia. Below FENIX provides insights and context from each respective announcement.

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Apple Cites T1DM Omnipod Patient Story at Tuesday Event; Jardiance Post-MI Trial (EMPACT-MI) Receives FDA FTD; Adocia Topline Results from M1Pram Ph1b Trial Extension; Welldoc/UMD Employs AI to Identify Digital Health Habits; Oramed’s Positive Diabetes Market Survey Results; Diamyd Receives $13.9M Towards Companion Medical Shares

A series of diabetes-related news items have been observed: Apple featured a T1DM patient story during the Apple Watch portion of its event; BI/Lilly announced Jardiance has received Fast Track designation for its EMPACT-MI study; Adocia announced positive topline results from its Ph1b M1Pram extension study in PWT1D; Welldoc and the University of Maryland’s Center for Health Information and Decision System (CHIDS) announced findings from a user engagement analysis; Oramed announced results from a diabetes market survey; and Diamyd received $13.9M from its divestment in Companion Medical. Below, FENIX provides highlights and insights from the respective news items.

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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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Ascensia Takes Over WW Eversense CGM Distribution; Xeris and Senseonics Q2 ’20 Earnings Update; Precigen ActoBio Announces Positive Topline Results for T1DM Modulator

Four diabetes-related news items have been observed: Ascensia announced a strategic partnership with Senseonics for world-wide commercialization and distribution of the Eversense implantable CGM; Senseonics hosted its Q2 ’20 earnings call (press release), Xeris hosted its Q2 ’20 earnings call (press release), and Precigen ActoBio announced positive topline results from its Ph1b study of AG019 for the treatment of early-onset T1DM. Below, FENIX provides highlights of the respective news items, including thoughts on the curious partnership between Ascensia and Senseonics in the context of the existing partnerships between Senseonics/Roche and Ascensia/POCTech.

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Mylan Filed for Glargine Interchangeability; Insulet, Mylan, and BD Q2 ’20 Earnings Updates

Mylan (press release; slides), Insulet (press release), and Becton Dickinson (press release; slides) hosted their respective Q2 ’20 earnings calls. Of note, Mylan disclosed it has submitted “all necessary documentation to seek biosimilar interchangeability [for Semglee]” as well as a BLA for its bs-aspart with FDA. Below, FENIX provides highlights and insights from the respective earnings calls.

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Livongo to Merge with Teladoc; AZ Partners for HF Diagnostic; ViaCyte Partners with Gore for Novel Membrane Development; Teva Q2 ’20 Earnings Update

A series of diabetes-related news items have been observed: Livongo and Teladoc Health announced they have entered into a definitive merger agreement; Eko announced it entered into a global partnership with AstraZeneca for a heart failure diagnostic tool; ViaCyte and Gore announced an agreement to further develop ViaCyte’s Encaptra Cell Delivery System to facilitate stem cell-derived islet replacement (press release); and Teva hosted its Q2 ’20 earnings call (press release; slides). Below, FENIX provides highlights for the respective news items including thoughts on the Livongo+Teladoc merger and insight into the AZ diagnostic partnership as a lead generation tool for Farxiga.

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Tandem Q2 ’20 Earnings Update

Tandem Diabetes Care hosted its Q2 ’20 earnings call (press release) and provided updates to key commercial and clinical activities including its curious partnership with Medtronic (previous FENIX insight), t:connect app launch, partnership with Abbott, and more. Below, FENIX provides highlights and insights from the call.

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