Portal Diabetes has received the US Food and Drug Administration (FDA) breakthrough device designation for its implantable insulin pump system, known as the Portal Pump.

It has also initiated a Phase I study of its temperature-stable insulin, referred to as Portal Insulin.

The company aims to provide a functional solution for people with type 1 diabetes (T1D) by combining an implantable pump delivering insulin into the abdomen, continuous glucose monitoring (CGM) technology, and concentrated insulin to create a fully automated insulin delivery system.

The designation is expected to support priority engagement with the FDA as Portal Diabetes moves ahead with clinical trials and regulatory submissions.

This designation also makes the Portal Pump eligible for transitional coverage for emerging technologies (TCET) pathway, which can accelerate Medicare coverage once approved as a breakthrough device.

Under an investigational new drug (IND) application, the initial two patients have been administered Portal Insulin through injection into the intraperitoneal space at a clinical centre in San Diego, California, US. This step marks an important milestone in developing the Portal Pump Combination System.

Clinical trials of the full combination system are expected to commence around the fourth quarter of 2027.

The Portal Pump is not authorised for sale or investigational use in the US at present. Portal Insulin remains an IND and is not commercially available in the country.

Portal Diabetes CEO Stacy Chambliss said: “We believe patients will achieve much better glycaemic control for a dramatically reduced mental burden with the Portal Pump.

“Step by step, we are working diligently to bring long-awaited technology to patients living with T1D. Today, we celebrate the first clinical injections of Portal Insulin, a momentous occasion for the combination system.”