Beta Bionics, Inc. (Nasdaq: BBNX) announced FDA clearance of its Mint patch pump on Sept. 14, 2026, with a full U.S. commercial launch expected in the first quarter of 2027, ahead of the company's previous target.

Mint uses a two-piece reusable and disposable architecture that does not require recharging. The device carries an IPX8 waterproof rating, holds a 200-unit insulin reservoir, and supports three days of wear with a 12-hour grace period. It is compatible with Dexcom G7, Dexcom G7 15 Day, and Abbott's FreeStyle Libre 3 Plus continuous glucose monitors, and can be controlled via iOS and Android smartphones.

The company expects manufacturing capacity to produce at least 1.5 million disposable Mint units during 2027. Mint is planned to launch exclusively through the pharmacy channel, with approximately 40% of insured U.S. lives expected to have pharmacy benefit access at launch, rising to at least 50% within the first year.

Beta Bionics also announced it has submitted a 510(k) application to the FDA for 3D Intelligence, its next-generation insulin dosing algorithm. The algorithm offers three clinician-selectable experiences: Original, Optimized, and Conservative. Subject to FDA clearance, the company expects to commercialize 3D Intelligence as iLet 3D by the end of 2026 and as Mint 3D at the time of Mint's full launch in early 2027.

The company revised its full-year 2026 revenue guidance to approximately $121 million to $126 million, down from a prior range of $131 million to $136 million. The company attributed the reduction to a potential revenue deferral of up to $10 million in the fourth quarter of 2026, as prospective iLet users may choose to wait for Mint's launch. Full-year 2026 gross margin guidance of 58.5% to 59.5% was reiterated. The company expects Mint to recapture any revenue deferred in the fourth quarter of 2026 during 2027, while noting that Mint is expected to be modestly dilutive to full-year 2027 gross margin.