Beta Bionics, Inc.

We are a commercial-stage medical device company focused on designing, developing, and selling innovative solutions to improve the health and quality of life for people with diabetes who require insulin. We achieve this by using advanced adaptive closed-loop algorithms to simplify and improve their disease treatment. Our product, the iLet Bionic Pancreas (iLet), received clearance from the U.S. Food and Drug Administration (FDA) for treating Type 1 diabetes in adults and children aged six years and older. The iLet was commercially launched in May 2023 in the United States. As of December 31, 2025, our installed base has grown to 35,011 iLets. Diabetes is a serious, chronic condition characterized by high blood glucose levels due to the body's inability to produce or effectively use insulin. People with diabetes must follow a strict daily insulin regimen to avoid serious complications. Type 1 diabetes (T1D) is an autoimmune disorder, often developing in childhood, where the immune system destroys insulin-producing cells. Approximately 1.9 million people in the United States have T1D and require daily insulin. Type 2 diabetes (T2D) is a metabolic disorder, typically developing in adulthood, where the body becomes insulin resistant, requiring increased insulin production or replacement.