BBNX

Beta Bionics, Inc. is a medical technology company committed to revolutionizing the treatment and quality of life for people with diabetes. Based in Irvine, California, the company is developing the iLet Bionic Pancreas, an innovative autonomous insulin delivery system designed to simplify diabetes management and improve glycemic control. The iLet represents a paradigm shift in diabetes care by automating insulin dosing decisions and reducing the burden on patients and caregivers. The iLet Bionic Pancreas is designed to autonomously determine and dose insulin (and potentially glucagon in future configurations) based on continuous glucose monitoring data, requiring minimal input from users. The system uses advanced algorithms to learn each individual's insulin needs and automatically adjust dosing every five minutes. This autonomous approach differs from traditional insulin pumps and hybrid closed-loop systems that require significant user interaction, carbohydrate counting, and manual adjustments. The iLet has been studied in multiple clinical trials demonstrating improvements in glucose control and reduced hypoglycemia. Beta Bionics has received FDA clearance for the iLet Bionic Pancreas for use in adults and children with Type 1 diabetes. The company is focused on commercial launch activities, manufacturing scale-up, payer contracting, and market development. The technology addresses a significant unmet need in diabetes care, potentially offering improved outcomes and quality of life for millions of people with insulin-requiring diabetes. The company competes in the growing automated insulin delivery market alongside established medical device manufacturers.