Memorandum

Animas currently planning pivotal study of hypoglycemia-hyperglycemia minimizer with FDA – March 2, 2016

We learned from Animas management yesterday that it is currently planning a large-scale, multi-center pivotal study of its hypoglycemia-hyperglycemia minimizer (HHM) with the FDA! This is the first major timing update ever on the company’s automated insulin delivery product with Dexcom (dating back to a JDRF partnership signed in 2010!). At ATTD, Dr. Daniel Finan’s commentary in Q&A implied that the next study would have an ambulatory component, but we reported at that time that it sounded “small” and “far from a pivotal study.” It was fantastic to hear the news yesterday that this is actually not the case, and we look forward to more specific updates on size, timing, type of device, etc. This follows an exciting week of industry updates on the automated insulin delivery front, including Medtronic’s plans to submit a PMA for the MiniMed 670G hybrid closed loop by the end of June, Insulet’s plans to be in a pivotal study in late 2017 (hybrid closed loop with the UCSB algorithm, licensed from Mode AGC), and Tandem’s plans to run a pivotal study of a predictive low glucose suspend device this year. See our updated automated insulin delivery competitive landscape here.

 

-- by Adam Brown and Kelly Close