Beta Bionics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared its Mint patch pump. The device features a reusable and disposable architecture that does not require recharging and integrates with continuous glucose monitors (CGM). The company also submitted a 510(k) application to the FDA for its 3D Intelligence insulin dosing algorithm.
The Mint pump is expected to launch exclusively through the pharmacy channel in the first quarter of 2027. The company anticipates manufacturing capacity to produce at least 1.5 million disposable units during the full year 2027. Approximately 40% of insured U.S. lives are expected to be able to purchase the device using their pharmacy benefit, with coverage anticipated to reach at least 50% within the first year of commercialization.
Mint features include a two-piece reusable and disposable design, a 200-unit insulin reservoir, and three days of wear time with a 12-hour grace period. The device is waterproof with an IPX8 rating and compatible with Dexcom G7 and Abbott’s FreeStyle Libre 3 Plus CGMs.
Beta Bionics also detailed its 3D Intelligence algorithm, which is designed to offer three selectable experiences: Original, Optimized, and Conservative. Subject to regulatory clearance, the algorithm is expected to power both iLet 3D and Mint 3D. Commercialization of iLet 3D is expected by the end of 2026, while Mint 3D is expected to launch simultaneously with the full Mint launch in the first quarter of 2027.
The company provided updated full-year 2026 guidance, estimating total revenue of approximately $121 million to $126 million. This reflects a potential revenue deferral impact of up to $10 million in the fourth quarter of 2026, as new prospective iLet users may choose to await the launch of Mint.
In other news, Beta Bionics disclosed that a securities class action lawsuit has been filed against the company and certain executive officers in the U.S. District Court for the Central District of California. The complaint alleges violations of federal securities laws regarding statements concerning the safety, efficacy, and commercial success of the iLet device.
