Beta Bionics announced FDA clearance of Mint, its patch pump, and submitted a 510(k) application for 3D Intelligence, its next-generation insulin dosing algorithm. The company expects full U.S. commercial launch of Mint in Q1 2027 with manufacturing capacity for at least 1.5 million units in 2027. Revenue guidance for 2026 was lowered to $121–$126 million from $131–$136 million due to anticipated deferral of up to $10 million as customers await Mint. Additionally, a securities class action lawsuit (Holtzman vs. Beta Bionics) was filed on September 4, 2026, alleging misstatements regarding iLet safety and efficacy. Beta Bionics is a medical device company developing automated insulin delivery systems for diabetes management.

Beta Bionics reported second quarter 2026 financial results with net sales of $32.0 million, a 38% increase from the prior year period. Gross margin expanded to 59.0%, up 524 basis points year-over-year. The company incurred a net loss of $23.4 million and an adjusted EBITDA loss of $17.7 million. Beta Bionics updated its full year 2026 revenue guidance to approximately $131 million to $136 million, unchanged from previous estimates, while raising the estimated gross margin range to 58.5%–59.5%. The company initiated enrollment for a pivotal trial of its iLet device in adults with type 2 diabetes and updated expectations to fully commercialize its Mint patch pump by the end of the second quarter of 2027. Beta Bionics operates in the medical device industry, designing and commercializing automated insulin delivery systems for people with diabetes.