Beta Bionics Inc., Artificial Pancreas: Public Benefit Corporation Seeks Regulatory Approval

Ed Damiano, the father of a 16-year-old boy with type 1 diabetes, has been racing for nearly 13 years to develop an artificial, or bionic, pancreas that could transform the lives of millions of people who have the same disease as his son, freeing them from the round-the-clock burden of managing a potentially life-threatening disorder themselves. The College of Engineering professor of biomedical engineering’s device, which regulates blood sugar levels by automatically delivering precisely calibrated doses of insulin and glucagon, will start the final round of US Food and Drug Administration–approved human clinical trials in the first half of 2017.

Most academics would have long since turned their invention over to industry to push it through the cumbersome regulatory and commercialization maze. Instead, Damiano and BU senior research scientist Firas El-Khatib have started an unorthodox socially minded medical device company to bring their bionic pancreas through final clinical trials and regulatory approval and into the hands of the people with type 1 diabetes who have been eagerly awaiting this kind of breakthrough tool. Damiano says his team moves faster, more efficiently, and more aggressively than has been usual in the medical device industry.

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