Portal Diabetes Receives FDA Breakthrough for Insulin Pump

Got story updates? Submit your updates here. ›

Portal Diabetes, Inc., a Westfield, Indiana-based company, has received the Breakthrough Device Designation from the FDA for its implantable insulin pump system called 'Portal Pump.' The company has also started a Phase 1 study on its proprietary temperature-stable insulin called 'Portal Insulin.' The goal is to deliver a functional cure for type 1 diabetes by combining 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.

Why it matters

This breakthrough technology could dramatically improve the lives of people living with type 1 diabetes by reducing the mental burden of managing the condition and providing better glycemic control. The Breakthrough Device Designation from the FDA will help expedite the regulatory approval process and facilitate Medicare coverage for the device.

The details

The Portal Pump is an implantable insulin pump system that aims to deliver insulin more physiologically by injecting it directly into the intraperitoneal space. The company has also developed a proprietary temperature-stable insulin called Portal Insulin, which is currently in a Phase 1 clinical study. The first two patients have already received Portal Insulin by injection into the intraperitoneal space at a clinical site in San Diego, California.

• On February 17, 2026, Portal Diabetes announced the Breakthrough Device Designation from the FDA for its Portal Pump.
• The first two patients recently received Portal Insulin by injection into the intraperitoneal space at a clinical site in San Diego, California.

What they’re saying

What’s next

Clinical trials on the Portal Pump 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.