Portal Diabetes Inc. has earned U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its implantable insulin pump system (Portal Pump), and the start of a Phase 1 study on its proprietary temperature-stable insulin (Portal Insulin).

The Westfield, Ind., company is working to deliver a functional cure to type 1 diabetes through an implantable insulin pump that leverages physiologic insulin delivery to the abdomen, modern continuous glucose monitoring (CGM) technology, and stable, concentrated insulin to fully close the loop on insulin delivery for type 1 diabetes patients.

The Breakthrough Device Designation will facilitate priority FDA interactions as Portal plans clinical trials and navigates regulatory approvals; the designation also 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, marking a major milestone for the Portal Pump Combination System.

“We believe patients will achieve much better glycemic control for a dramatically reduced mental burden with the Portal Pump,” Portal Diabetes CEO Stacy Chambliss said. “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 in Q4 2027. Endocrinologists, surgeons, and their clinical sites interested in participating should contact the company to express their interest.  

The Portal Pump is not available for U.S. sale or investigational use; Portal Insulin is an investigational new drug and is not available for U.S. sale.

Portal Diabetes is developing an implantable insulin pump system and a concentrated, stable insulin. With physiologic insulin delivery to the abdomen integrated with modern iCGM technology, the Portal Pump with Portal Insulin could fully close the insulin delivery loop to improve patient well-being.