Category Archives: Uncategorized

Medtronic Extended Wear Infusion Set

Medtronic announced it received Investigational Device Exemption (IDE) from FDA to initiate in-human studies of a new extended wear infusion set. According to the press release, the trial will evaluate the new infusion set for up to 7 days in 150 T1DM subjects using the 670G hybrid closed-loop system. The trial has not yet been observed on CT.gov. Below, FENIX provides thoughts on the new Medtronic infusion set initiative.

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Omnipod Horizon Receives Breakthrough Device Designation; Q4 ’18 Earnings Update

Insulet hosted its Q4 ’18 earnings call and provided updates to its Omnipod business including the development of the Omnipod Horizon hybrid closed-loop. Of note, this is believed to be the first time that Insulet disclosed it received Breakthrough Device Designation for Omnipod Horizon. Below are highlights and insights from the call.

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Farxiga eGFR Cutoff Lowered; Positive Brilinta T2DM Data

AstraZeneca’s Farxiga franchise labels (Farxiga and Xigduo) have been updated to reduce the eGFR cutoff from 60 to 45 mL/min/1.73m2. Additionally, AZ announced positive topline results from the Brilinta Ph3 THEMIS study in patients with established CAD and T2DM. Below, FENIX provides insight into the lower Farxiga eGFR as well as thoughts on AZ’s strengthening CV protection market position.

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Thoughts on New Hygieia d-Nav Mobile App for Insulin Titration; New Data published in The Lancet

Hygieia recently announced it received 510(k) clearance for a mobile app that is part of the company’s d-Nav insulin guidance service. Recall, d-Nav is a T2DM-focused, cloud platform that provides personalized insulin dose recommendations based on the user’s BGM values. Additionally, results were published in The Lancet for a study showing d-Nav plus HCP support led to superior glycemic control than with HCP support alone. Below, FENIX provides thoughts on how Hygieia’s d-Nav and other similar systems could impact the diabetes market.

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Dexcom Expands Customer Support; Q4 ’18 Earnings Update

Dexcom hosted its Q4 ’18 earnings call and provided updates to its diabetes business including an announcement that the company is expanding its customer and technical support capabilities through ex-US resources. As such, Dexcom is downsizing an undisclosed portion of its US workforce. Below, FENIX provides highlights and insights from the earnings call.

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New Bydureon label update: EXSCEL now in US label

Earlier this week, the Bydureon franchise label was updated to include 3 major changes: 1) CV safety data from EXSCEL, 2) a worse label restriction at an eGFR <45, up from <30, and 3) inclusion of acute gallbladder disease under warnings. Below, FENIX provides an analysis on the updated Bydureon label in comparison to the SUSTAIN-6 CV data from the Ozempic label, and why AZ may be able to infer in their field promotion that EXSCEL was superior despite the trial’s miss.

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Biocorp/DreaMed Partnership; Abbott Libre and Valeritas V-Go RWE

Three diabetes device-related press releases were observed today including a new Biocorp/DreaMed partnership, as well as Abbott Libre and Valeritas V-Go patch pump RWE, presented at ATTD 2019. Below, FENIX provides an overview of the news as well as thoughts on how the Biocorp/DreaMed partnership appears to favor DreaMed.

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Connected Pens: New Novo and Abbott Partnership for Data Integration

Today, Abbott and Novo Nordisk announced a non-exclusive partnership to integrate insulin dosing data from Novo’s connected insulin pens into Abbott’s digital health tools compatible with the FreeStyle Libre system. Below, FENIX provides insights into the Novo/Abbott partnership.

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Connected Pens: Novo Expanded Capability with Glooko; Biocorp/AgaMatrix Partnership

Prior to the start of the 2019 ATTD conference, two diabetes technology-related press releases have been observed. First, Glooko announced that its cloud-storage platform will integrate with Novo Nordisk’s connected pens and Dexcom’s G6 CGM. Second, Biocorp and AgaMatrix entered into a partnership for the distribution of Biocorp’s wraparound connected pen device now called “Mallya” (formerly Easylog). Below, FENIX provides insight into the respective news including thoughts on why the remote upload feature is critical for Novo.

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Medtronic Receives Breakthrough Device Designation; CY Q4 ’18 (FY Q3 ’19) Earnings Update

Medtronic hosted its CY Q4 ’18 (FY Q3 ’19) earnings call and provided brief updates to its diabetes device pipeline and commercial activities. Of note, Medtronic also announced that FDA granted Breakthrough Device Designation for its Personalized Closed Loop (PCL) insulin pump system (Breakthrough Devices Program Guidance was finalized in December 2018). Below, FENIX provides highlights from the earnings call as well as perspective why Medtronic chose to pursue Breakthrough Device Designation.

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