Beta Bionics Announces FDA Clearance of Mint Patch Pump

Irvine, California, USA - Beta Bionics, Inc. (Nasdaq: BBNX), a pioneering leader in advanced diabetes management solutions, announced the U.S. Food and Drug Administration (FDA) clearance of Mint, its new patch pump featuring a transformative reusable and disposable architecture. Additionally, the company unveiled 3D Intelligence, its next-generation insulin dosing algorithm, which has been submitted to the FDA via a 510(k) application.

The Mint patch pump does not require recharging, integrates with industry-leading continuous glucose monitors, and enables smartphone control for both iOS and Android users. The full commercial launch in the United States is anticipated to begin in the first quarter of 2027, with expected manufacturing capacity to produce at least 1.5 million disposable units during 2027.

The newly unveiled 3D Intelligence algorithm is designed to offer clinicians three selectable experiences: Original, Optimized, and Conservative. Subject to regulatory clearance, the algorithm is expected to power both iLet 3D and Mint 3D platforms, maximizing user choice in hardware and treatment approach.

Key Highlights

• FDA clearance received for the Mint patch pump architecture.
• Full U.S. commercialization expected in Q1 2027.
• 3D Intelligence algorithm submitted to the FDA through a 510(k) application.
• Updated full year 2026 revenue guidance estimated at approximately $121 million to $126 million.