The Westfield, Indiana–based company can now begin a Phase 1 study to evaluate its proprietary, temperature-stable insulin. It aims to deliver a functional cure for type 1 diabetes.
Portal Diabetes developed its system, called the Portal Pump, to leverage the physiologic delivery of insulin to the abdomen through an implantable device. The company designed it to work with modern continuous glucose monitoring (CGM) technology and stable, concentrated insulin. Altogether, this system hopes to fully close the loop on insulin delivery for type 1 diabetes.
Currently, externally-worn insulin pumps like Insulet’s Omnipod 5, Medtronic’s MiniMed 780G, Tandem Diabetes Care’s t:slim X2 and Mobi and Beta Bionics’ iLet lead the way. These devices utilize closed-loop capabilities, although they have programmable and hybrid settings to manage insulin delivery. Insulet has a fully closed-loop system under development, while iLet aims to serve as a closed-loop “bionic pancreas” as well.
An implantable system from Portal Diabetes would mark a first on the U.S. market. The company said its breakthrough nod can facilitate priority interactions with the FDA as it progresses through the regulatory process. It already reported the first two patients receiving its insulin by injection under an investigational new drug (IND) application.
Portal Diabetes expects to begin clinical trials on its combination system around the fourth quarter of 2027.
“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.”
