The Westfield, Indiana company aims to deliver a functional cure to type 1 diabetes– an implantable insulin pump leveraging the physiologic delivery of insulin to the abdomen, modern continuous glucose monitoring (CGM) technology, and stable, concentrated insulin to fully close the loop on insulin delivery for patients living with type 1 diabetes.

The Breakthrough Device Designation will facilitate priority interactions with the FDA as Portal plans clinical trials and navigates regulatory approvals, and the designation establishes eligibility for the Transitional Coverage for Emerging Technologies (TCET) pathway, expediting Medicare coverage for FDA-designated breakthrough devices. Under an Investigational New Drug application, the first two patients recently received Portal Insulin by injection into the intraperitoneal space at a clinical site in San Diego, California, marking a major milestone for the Portal Pump Combination System.