Beta Bionics said the FDA has cleared Mint, its patch pump featuring a reusable and disposable architecture that does not require recharging, integrates with existing continuous glucose monitors (CGM) and enables smartphone control for iOS and Android users.
Additionally, the company is unveiling 3D Intelligence, its next-generation insulin dosing algorithm, which has been submitted to the FDA through a 510(k) application. 3D Intelligence is designed with three algorithm experiences intended to enable a more customizable treatment approach tailored to each user’s unique insulin requirements.
Subject to regulatory clearance by the FDA, Mint 3D and iLet 3D will represent Beta Bionics’ next-generation automated insulin delivery (AID) platforms.
The company expects to initiate the full commercial launch of Mint in the United States in the first quarter of 2027, ahead of its previous target, and anticipates manufacturing capacity to produce at least 1.5 million total disposable units in the full year 2027. The company believes it may be able to exceed the 1.5 million unit target by accelerating staffing, improving efficiency through additional automation, and enhancing manufacturing yield.
Mint is expected to launch exclusively through the pharmacy channel, with approximately 40% of insured U.S. lives expected to be able to purchase it using their pharmacy benefit. The company anticipates coverage for Mint to increase to at least 50% of insured U.S. lives within the first year of full commercialization as it leverages its market access footprint.
