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