Medical technology firm Beta Bionics has secured breakthrough device status from the US Food and Drug Administration (FDA) for its iLet bionic pancreas system.
The iLet Bionic Pancreas System is a pocket-sized and wearable investigational medical device developed to autonomously control blood sugar in people with diabetes and other conditions.
The on-body wear, which is similar to an insulin pump, uses the bodyweight of the users to initiate therapy.
Later, the iLet system automatically starts controlling blood-sugar levels, helping the user to avoid the counting of carbohydrates, set insulin delivery rates and deliver bolus insulin for meals or corrections.
The iLet bionic pancreas system is guided by mathematical dosing algorithms
The iLet system is guided by mathematical dosing algorithms, which integrate lifelong autonomous learning to automatically control glycemia.
The mathematical dosing algorithms have been developed in the Damiano Lab at Boston University.
Beta Bionics has designed the iLet system to function as three medical devices in one. The device can be configured an insulin-only bionic pancreas, a glucagon-only bionic pancreas, or a bihormonal bionic pancreas using insulin and glucagon.
The insulin-only and bihormonal configurations will help treat diabetic patients, while the glucagon-only configuration facilitates to treat patients with rare conditions, including low blood-sugar conditions such as congenital hyperinsulinism (CHI).
According to the company, the FDA designation for the iLet bionic pancreas system envisages configurations with most insulin analogues approved for pumping, as well as Zealand Pharma’s stable pumpable glucagon analogue dasiglucagon.
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.”
In July this year, Beta Bionics signed a signed collaboration and development agreement with ConvaTec for iLet bionic pancreas system.
