Artificial Pancreas to Transform Lives

Ed Damiano Professor of Biomedical Engineering at Boston University and father of a 16 year old boy with type 1 diabetes has worked very hard to develop a device which can regulate blood sugar levels by automatically delivering precisely calibrated doses of insulin and glucagon. While most systems automate only the delivery of insulin, Damiano’s device has a bihormonal pump that supplies both insulin and glucagon.

The bionic pancreas mimics the efficiency of the natural pancreas which fine tunes the body’s glucose level both by lowering it with small amounts of insulin and by raising it with tiny doses of glucagon.

The bionic pancreas called the “iLet” about the size of an iPhone 3, does all the calculating, adjusting, and dosing autonomously and automatically. The only information that users have to enter is their weight.

Damiano’s lab is one of a half dozen teams working on various kinds of artificial pancreases or closed-loop, automated insulin delivery systems which are expected to become commercially available over the next few years.

Most academics would have turned their invention over to industry to push it through the cumbersome regulatory and commercialization maze. Instead Damiano and researcher Firas El-Khatib have started an unorthodox, socially minded medical device company. The company called Beta Bionics, Inc. referred to as a public benefit corporation, will bring their bionic pancreas through final clinical trials and obtain regulatory approval.

A public benefit corporation is unlike traditional companies which are all about maximizing profits. However, Beta Bionics while a for-profit entity is also socially responsible. This company is the first medical device company to enter the public benefit realm and it now happens that Massachusetts is among 30 states that allow this business model.

Eli Lilly has invested $5 million in the new company and NIH has awarded Damiano $1.5 million for the “Bionic Pancreas Bridging Study” which will begin later this year. This will be the first home use trial to test the “iLet” in adults and children with type 1 diabetes. The final Bionic Pancreas Pivotal Trial is scheduled to begin in 2017.

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