Memorandum

EOFlow receives FDA Breakthrough Device Designation for single on-body AID patch, EOPancreas – March 18, 2019

Launch in Korea “by late 2021,” with US/EU to follow; Joins FDA Breakthrough Device designations for Bigfoot Loop, Insulet Horizon, Medtronic PCL

Last week, EOFlow announced that it has received FDA Breakthrough Device Designation for its single-patch, on-body automated insulin delivery system, EOPancreas. The ambitious system includes a disposable tubeless pump with an integrated CGM sensor under the same patch, plus a control algorithm. The company told us it aims for a launch in Korea “by late 2021,” with the US/EU to follow.

EOFlow received two-year, milestone-based JDRF funding for this project one year ago and licensed TypeZero’s control algorithm shortly thereafter. Ascensia’s comments at JPM suggested the system may include POC-Tech’s CGM.

This ambitious project is several years from the US market and must overcome significant technical and business challenges; at this point, we’re not taking the launch timing too seriously. A big question is whether it makes strategic and financial sense to combine the CGM and patch pump into one device.

  • Can EOFlow get its patch pump wear out to 7-14 days, aligning with CGM wear? The company is initially aiming for a single device that gets changed twice a week (i.e., ~3.5-day wear), as it works towards a once-a-week ultimate goal. We're skeptical that a 3.5-day-wear CGM is viable, as it means two "day 1's" every single week and 4x more sensors used per year vs. Libre and G7.

  • Can EOFlow make the disposable CGM and pump extremely reliable, such that component failures are highly unlikely? Otherwise, a failure in one component would burn the entire on-body patch. (A modular design could avoid this, enabling a user to swap the CGM in and out; we’re not sure if that’s the plan.)

  • Can EOFlow make low-cost disposable electronics for both the CGM and pump and manufacture them at scale? Can it fit all of these components in a small on-body device?

  • Is the need for separate CGM and pump sites a huge barrier to AID adoption? (We’d argue cost and access hassles are the far bigger problem.)

The FDA breakthrough device designation is actually becoming common in AID: Bigfoot received this designation in November 2017 (not announced at the time), Insulet’s Horizon received it last fall, and Medtronic’s next-next-gen Personalized Closed Loop received it last month. The program enables an expedited development path and accelerated review and approval – by how much remains unclear. (For context, the first-gen MiniMed 670G was reviewed and approved in just three months; any shorter than that seems hard to imagine.) We should see this designation in action in the next 12-18 months, as Bigfoot’s Loop and Insulet’s Horizon are poised for pivotal studies this year and launches next year.

 

--by Adam Brown and Kelly Close