Memorandum

Senseonics partners with Rubin Medical to commercialize implantable CGM in Norway, Sweden, and Denmark – May 7, 2015

Maryland-based Senseonics has announced an exclusive partnership with insulin pump distributor Rubin Medical to commercialize its implantable CGM system in Sweden, Norway, and Denmark (fluorescence-based, subcutaneous, 180-day sensor, body-worn transmitter with Bluetooth connectivity, and a mobile smartphone app). The partnership represents a major milestone for Senseonics, and comes at a critical juncture – the company expects a CE Mark for its system this year (!). An EU pivotal trial (n=82) in both type 1 and type 2 patients started in November 2014 (the ClinicalTrials.gov posting has not been updated), and 90-day interim data is expected by this summer (it will support the CE Mark submission). The subsequent 180-day data will come this fall, at which point the label will be updated. This announcement did not discuss the US timeline, though management has previously said that a US pivotal trial would begin in 2015 – in a follow-up conversation, management told us this is still in line with expectations. Ultimately, the partnership announcement suggests an early vote of confidence in Senseonics, especially considering that Rubin Medical is the exclusive distributor of Animas insulin pump products in Scandinavia. Cost, provider requirements, and real-world patient usability/accuracy, and provider hassles are unanswered questions – we hope to try this during EASD (admittedly, we haven’t got a provider there yet)! Senseonics is clearly serious about commercialization, and we look forward to listening to and seeing how patients like the device relative to other CGM options out there. For more details on Senseonics’ system, see our detailed coverage of the company’s most recent data from DTM 2014. We support alternatives for patients that will help create a thriving commercial market for CGM that help an even greater number of patients adopt CGM.