The Food and Drug Administration (FDA) has granted Breakthrough Device designation to the iLet Bionic Pancreas System, a wearable device designed to autonomously control blood sugar levels in patients with diabetes and other conditions.

According to Beta Bionics, the biotechnology company developing the system, the pocket-sized, wearable device is similar to an insulin pump, however, it only requires users to enter their body weight in order for the system to initialize therapy. The iLet system uses mathematical dosing algorithms based on home-use clinical trial results in adults and children with type 1 diabetes. The system can be configured to function as an insulin-only, glucagon-only, or a bihormonal bionic pancreas using insulin and glucagon. 

In a press release, the Company stated that the Breakthrough designation for the iLet Bionic Pancreas System “contemplates configurations with most insulin analogs approved for pumping.” 

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Beta Bionics is partnering with Zealand Pharma in the development of iLet. Zealand CEO Emmanuel Dulac said, “We […] look forward to progressing dasiglucagon in the bihormonal artificial pancreas system into phase 3 development.” Dasiglucagon is a glucagon analog designed to be stable in aqueous solutions and is currently being investigated for the treatment of congenital hyperinsulinism and severe hypoglycemia.  

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