Beta Bionics has secured breakthrough device designation status from the US Food and Drug Administration (FDA) for its iLet Bionic Pancreas System.

iLet Bionic Pancreas is a wearable, autonomous system that leverages artificial intelligence (AI) and machine learning to deliver insulin and glucagon analogues for treating type 1 diabetes.

The device is intended for autonomous and continuous adaption to individual patient’s changing insulin needs.

Contrary to insulin pump therapy, iLet Bionic Pancreas System requires only the bodyweight of the user to initialise therapy.

As soon as users enter their body weight, the device automatically starts controlling blood glucose levels without needing the user to count carbohydrates, set insulin delivery rates, or deliver bolus insulin for meals or corrections.

Beta Bionics president and CEO Ed Damiano said: “We believe the iLet Bionics Pancreas System represents a true breakthrough therapy for the management of glycemia, particularly in type 1 diabetes.

“We are particularly excited by the possibility that the iLet may be able to provide safer and more effective therapy in far more people than current therapies due to its simplicity of use.”

The device has been granted breakthrough designation in insulin-only, glucagon-only and bihormonal configurations.

It has also been approved for use alongside Zealand Pharma’s dasiglucagon, a glucagon analogue with a unique stability profile in a ready-to-use aqueous solution.

Beta Bionics partnered with Zealand Pharma on co-development activities.

In June, Beta Bionics announced favourable outcomes from a home-use study of its iLet Bionic Pancreas System using pre-filled cartridges of Zealand Pharma’s dasiglucagon.

In May, the randomised, two-period, cross-over, home-use trial evaluated iLet’s operational performance when used with bihormonal configuration compared to insulin-only configuration.