Portal Diabetes Gets FDA Breakthrough for Pump, Starts Insulin Study
Two steps toward bringing a functional cure to T1D
WESTFIELD, Ind., Feb. 17, 2026 /PRNewswire/ -- Today, Portal Diabetes, Inc. ("Portal") announced its receipt of the 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 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.
"We believe patients will achieve much better glycemic control for a dramatically reduced mental burden with the Portal Pump," expressed Stacy Chambliss, Chief Executive Officer (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. Endocrinologists, surgeons, and their clinical sites interested in participating may contact the Company to express their interest.
The Portal Pump is not available for sale or investigational use in the United States. Portal Insulin is an investigational new drug and is not available for sale in the United States.
Media Contact: Company Contact: [email protected]
About Portal Diabetes
Portal Diabetes is developing an implantable insulin pump system and a concentrated, stable insulin. With the physiologic delivery of insulin to the abdomen integrated with modern iCGM technology, the Portal Pump with Portal Insulin stands to fully close the insulin delivery loop to improve patient well-being. To learn more about how Portal Diabetes is disrupting diabetes care, visit www.portaldiabetes.com.
SOURCE Portal Diabetes, Inc.
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