Beta Bionics wins FDA clearance for Mint pump
Beta Bionics said the FDA cleared its Mint pump, which does not require recharging and integrates with continuous glucose monitors. The company also lowered full-year 2026 sales guidance to $121 million-$126 million from $131 million-$136 million.
Mint allows smartphone control for iOS and Android users, according to the company, and is expected to broaden Beta Bionics’ addressable insulin delivery market, especially among people with diabetes looking for a patch pump form factor. The company also said it is unveiling 3D Intelligence, its next-generation insulin dosing algorithm, which has been submitted to the FDA under a 510(k) application. 3D Intelligence is designed with three algorithm experiences to support a more customizable treatment approach tailored to each user’s insulin requirements.
Subject to FDA clearance, Mint 3D and iLet 3D would be Beta Bionics’ next-generation automated insulin delivery (AID) platforms, built to maximize user choice through hardware and algorithm optionality. Beta Bionics President & CEO Sean Saint said the next-generation AID platform, comprising Mint 3D and iLet 3D, would represent a transformational advancement for people living with diabetes, subject to regulatory clearance by the FDA.
Beta Bionics said Mint 3D and iLet 3D are intended to give users a choice between a patch pump and a tubed pump, together with an algorithm experience tailored to each individual, with a focus on improving affordability by expanding access for both products in the pharmacy channel. 5 million total disposable units in the full year 2027. 5 million unit target by accelerating staffing, improving efficiency through additional automation and enhancing manufacturing yield. S.
lives expected to be able to purchase it using their pharmacy benefit. S. lives within the period stated in the source. Beta Bionics said Mint 3D is expected to feature a two-piece reusable and disposable design, with a smaller profile than the industry-leading patch pump and a disposable patch change process that does not require phone re-pairing.
The system is described as supporting firmware-over-the-air updates, limiting environmental waste, and offering three days of wear time with an additional 12-hour grace period. It is expected to include a 200-unit insulin reservoir, never require recharging and carry an IPX8 waterproof rating for up to 5 feet deep for 60 minutes. Beta Bionics also said Mint 3D is expected to offer software and digital integration powered by its 3D Intelligence algorithm, with compatibility for Dexcom G7, Dexcom G7 15 Day and Abbott’s FreeStyle Libre 3 Plus, as well as iOS and Android smartphone control.
The company said commercialization of Mint 3D remains subject to regulatory clearance and that the device is currently investigational and not available for sale. It also said actual product specifications and features may vary. Beta Bionics said 3D Intelligence is the next generation of its fully adaptive system. Beta Bionics said its 3D Intelligence automated insulin delivery technology builds on experience with iLet and its real-world use across more than 40,000 users.
The company said 3D Intelligence is designed to give people with diabetes more choice in how the insulin delivery algorithm responds to individual needs. It said clinicians will be able to choose from three algorithm experiences: Original, which is the algorithm currently available with iLet and has proven real-world experience across more than 40,000 users; Optimized, an enhanced version that builds on the current algorithm and incorporates learnings from the company’s real-world experience with iLet; and Conservative, an alternative designed to provide a more measured response when correcting high glucose levels.
Beta Bionics said the three experiences are intended to provide greater personalization while preserving the core simplicity and automation of the current iLet experience. The company said the 3D Intelligence insulin system remains subject to regulatory clearance by the FDA. Beta Bionics said the dosing algorithm is expected to power both iLet 3D and Mint 3D. Commercialization of iLet 3D in the United States is expected by the end of 2026, while commercialization of Mint 3D in the United States is expected alongside the full Mint Iaunch in the first quarter of 2027, subject in each case to regulatory clearance by the FDA.
The company said commercialization of iLet 3D and Mint 3D remains subject to FDA clearance and that the devices are currently investigational and not available for sale. It added that actual product features may vary and that minor differences in adaptation versus the previous algorithm are not anticipated to have a significant impact on outcomes. For full-year 2026, Beta Bionics now expects total revenue of about $121 million to $126 million, down from its prior view of $131 million to $136 million, after flagging a potential revenue deferral effect of up to $10 million in the fourth quarter of 2026 as new prospective iLet users could choose to wait for the Mint launch.
The company said Mint is expected to recapture any revenue lost in the fourth quarter of 2026 during the full year 2027. The company said it expects 37% to 39% of new patient starts to be reimbursed through the pharmacy channel. For full-year 2027, the company said pharmacy coverage for iLet is expected to rise year over year, while the share of iLet new patient starts reimbursed through the pharmacy channel is expected to decline as more pharmacy-covered individuals adopt Mint. With Mint’s contribution, pharmacy channel revenue as a percentage of total revenue is expected to increase in 2027 versus the prior year.
5%. The company said Mint is expected to be modestly dilutive to full-year 2027 gross margin and highly accretive to the company’s long-term gross margin profile at scale.