BTEC Entrepreneurship Seminars: Beta Bionics and the Development of the Bionic Pancreas – Featuring Ed Damiano

Ever since Ed Damiano's 25-year-old son, David, was diagnosed with type 1 diabetes at 11 months old, he set his sights on building and integrating autonomous, intelligent systems into a purpose-built, wearable medical device that he referred to as a bionic pancreas. In 2021, a 13-week pivotal clinical trial was conducted that tested the iLet Bionic Pancreas in 440 adults and children with type 1 diabetes. The clinical data from that pivotal trial was published in the New England Journal of Medicine in 2022. Based in part on that data, the iLet Bionic Pancreas received clearance by the US Food and Drug Administration on David's 24th birthday in May 2023. Since June 2023, the iLet has been commercially available for people six years and older with type 1 diabetes through commercial and government insurance across the US.