Tag Archives: Insulet

Abbott Q1 ’20 Earnings Update; Provention Bio Initiates Rolling BLA for Teplizumab; Lilly Launches Additional Humalog AGs; Insulet’s COVID-19 Response

A series of diabetes-related news has been observed: Abbott hosted its Q1 ’20 earnings update, Provention Bio announced the initiation of a rolling BLA submission for teplizumab, Lilly announced the launch of lispro authorized generics (LAG) for Humalog Mix 75/25 and Humalog Junior, and Insulet initiated its COVID-19 response plan. Below, FENIX provides highlights and insights for the respective news items.

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Omnipod Horizon Pivotal Trial Delayed

Insulet announced it will be pausing Omnipod Horizon pivotal trial due to a recently-discovered “software anomaly.” The updated software is expected to be available by the end of April 2020; however, the Omnipod Horizon launch timeline has been pushed back to early 2021. Below, FENIX provides potential insights on the delay as well as implications to other insulin delivery algorithm developers.

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Insulet Q4 ’19 Earnings Update

Insulet hosted its Q4 ’19 earnings call (press release) and provided updates to its Omnipod business including the Omnipod Horizon closed-loop system. Of note, Insulet disclosed that it has completed enrollment in the Omnipod Horizon pivotal trial and indicated its intentions to deprioritize concentrated insulin development. Below are highlights and insights from the call.

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Insulet Partners with Dexcom and Abbott; ATTD 2020 Key Press Releases (Feb 19)

With the start of the ATTD 2020 conference, a series of diabetes technology-related press releases have been observed including partnerships between Insulet/Dexcom, Insulet/Abbott, Dexcom/Dreamed, and Biocorp/iSage Rx. Additionally, Dario Health presented new data at ATTD 2020 for its connected BGM platform, and Diabeloop initiated a trial to support 510(k) clearance of its automated insulin delivery algorithm. Below, FENIX provides highlights and insights from the respective news items.

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Insulet Omnipod DASH Software Bug; No Injuries Reported

Insulet announced it has initiated a “voluntary Medical Device Correction” for all Omnipod DASH devices. According to Insulet, on some rare occasions when the bolus calculator is left open or an alarm interrupts a bolus calculation, DASH may suggest incorrect boluses based on older glucose values. Below, FENIX provides thoughts on the Omnipod DASH issue in the context of Medtronic’s recent 630G/670G pump recall as well as potential readthrough to Tandem, Bigfoot, and Beta Bionics.

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Xeris Positive Ph2 Data in PBH; Oramed Partnership with Tianhui; Glooko Privacy Shield Certification

Three news items have been observed today across diabetes players including Xeris, Oramed, and Glooko. Xeris announced positive data from their Ph2 trial in post-bariatric hypoglycemia, Oramed has partnered with Tianhui Incubator of Technologies to launch ORMD-0801 in China in 2 years, and Glooko announced Privacy Shield certification from the US Department of Commerce. Below, FENIX provides context and insights on these news items. Xeris Reports Positive Ph2 Data in Post-Bariatric Hypoglycemia Xeris announced positive results from the in-clinic stage of the Ph2 study evaluating their ready-to-use (RTU) glucagon in patients at risk of postprandial hypoglycemia following bariatric surgery. Participants in the trial were……

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Insulet Q3 ’19 Earnings Update

Insulet hosted its Q3 ’19 earnings call and provided updates to its Omnipod business including the ongoing launch of Omnipod Dash as well as the development of the Omnipod Horizon hybrid closed-loop system. Below, FENIX provides highlights and insights from the call.

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Omnipod Approved to use Novo’s Fiasp; Senseonics Now Covered on Humana

Insulet announced it has received 510(k) clearance to use Novo’s Fiasp in Insulet’s Omnipod patch pump. Recall, earlier this week, Novo announced it received FDA approval for Fiasp pump compatibility in adult patients requiring insulin therapy. Additionally, Senseonics announced that Humana will now be providing coverage for the Eversense implantable CGM system and insertion procedure (effective October 22, 2019). Below, FENIX provides brief thoughts and potential market implications for each news item.

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Insulet Omnipod DASH Pump Receives Interoperability Designation

Insulet announced it received FDA clearance for the “Omnipod DASH ACE Pump” to be classified as an alternate controller enabled (ACE) pump which allows for integration with other interoperable components (e.g. iCGM and eventually an “iAlgorithm” although no “iAlgorithms” are approved as of yet). Recall, ACE is FDA’s new designation for pump interoperability which requires manufacturers to meet a set of special controls. Below, FENIX provides thoughts on the Omnipod ACE pump designation including read-through to Insulet’s closed-loop developments (Omnipod Horizon and Tidepool Loop).

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Insulet Q2 ’19 Earnings Update

Insulet hosted its Q2 ’19 earnings call and provided updates to its commercial and pipeline activities including the Omnipod Horizon hybrid closed-loop development. Below are highlights and insights from the call.

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