Portal Diabetes achieves Breakthrough designation from FDA for implantable insulin pump
By HME News Staff
Updated 12:15 PM CST, Tue February 17, 2026
WESTFIELD, Ind. – Portal Diabetes has received Breakthrough Device Designation by the Food and Drug Administration (FDA) for its implantable insulin pump system called Portal Pump, and the start of a Phase 1 study on its proprietary temperature-stable insulin, Portal Insulin. The 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. "We believe patients will achieve much better glycemic control for a dramatically reduced mental burden with the Portal Pump," said Stacy Chambliss, CEO. "No more meal announcements, no more exercise announcements, no more night wakings; that is our goal. Step by step, we are working diligently to bring long-awaited technology to patients living with type 1 diabetes. Today, we celebrate the first clinical injections of Portal Insulin, a momentous occasion for the combination system." Clinical trials on the combination system are planned to begin around Q4 2027.
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