Category Archives: Topics

Senseonics Eversense CGM approved in the US; sPMA for insulin-dosing claim to follow

Senseonics has announced approval of Eversense, their implantable CGM, in the US and held an investor call. Of note, Senseonics did not mention anything regarding the updated components discussed during the adcom (sensor end cap and insertion tool); however, it was approved with the smaller gen 2 transmitter. Below, FENIX has conducted an analysis of the approval, safety labeling, and market implications.

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Tandem’s t:slim X2 pump approved with Basal-IQ; Medtronic 670G approved for ages 7-13

Tandem announced FDA approval of its t:slim X2 insulin pump with Basal-IQ technology which utilizes a predictive low-glucose suspend (PLGS) feature, curiously with Dexcom G6 rather than G5 as previously communicated. Additionally, FDA has expanded the approval of the Medtronic MiniMed 670G to include children aged 7 to 13 with T1DM.

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Novo Suspends Ph1 Stable Glucagon Analog Study

The CT.gov record for Novo’s Ph1 stable glucagon analog study (NN9030) has been updated, and the trial is now listed as “Suspended (Evaluation of data).” Below, FENIX provides potential scenarios for the recruitment suspension.

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Voluntis and Monarch Medical Partnership Will Compete with Glytec

Voluntis and Monarch Medical Technologies have announced a strategic collaborationto integrate Voluntis’s personal T2DM diabetes platform (Insulia) with Monarch’s in-patient insulin titration tools (EndoTool IV and EndoTool SubQ). Below, FENIX provides insight into the collaboration including perspective on competition to Glytec who provides a similar product.

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Novo’s Oral Semaglutide Beats Victoza and Januvia

Novo Nordisk has announced topline results from the Ph3 PIONEER 4 (vs. 1.8mg Victoza) and PIONEER 7 (3, 7, and 14 mg oral sema dose escalation vs. Januvia) studies. Both trials met their primary outcomes (non-inferiority to Victoza and superiority to Januvia), and oral semaglutide also demonstrated statistically significant A1C and weight reduction vs. Victoza. Additionally, FENIX provides insight into a potential relationship between PIONEER 7 dose escalation and discontinuation rates observed in the reported PIONEER studies.

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Thoughts on Medtronic iPro2 Updated Professional CGM App

Medtronic announced it has expanded its partnership with Nutrino to integrate an updated FoodPrint App with the iPro2 professional CGM. Below, FENIX provides insight into the potential impact of the new feature and future application.

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GlySens Implantable CGM Trial Completed

The FIGS-2 trial for GlySens’s implantable CGM, Eclipse, has completed according toCT.gov- two and a half years after the originally scheduled completion date of December 2015. The primary endpoint of the 20-subject study was adverse events. FENIX has conducted a headwinds/tailwinds analysis of the Eclipse system in the context of the larger CGM market.

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Montreal dual-hormone AP System: Implications to Closed-Loop Development

A Montreal-based research group presented data at ADA on a dual-hormone artificial pancreas using both insulin and pramlintide. The study, presumed to be the clinical trial MAP-1, showed significantly improved glucose levels compared to an insulin-only artificial pancreas. Below, FENIX has provided context and insight regarding this study and its potential implications to the AP development space.

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