fully closed-loop automated insulin delivery (AID) system — NDA/BLA submission
2027
Achieved significant milestones in the Company's development of a fully closed-loop automated insulin delivery (AID) system for adults with type 2 diabetes, including presenting data from the EVOLUTION 2 trial at ATTD, which highlighted a 68% time in range with no boluses 3 as well as enrolling the first participant last week into the EVOLVE pivotal study 4 to support a 510(k) filing in 2027Source filing